Pub Date : 2025-01-28DOI: 10.1002/14651858.CD015984
Miao Yu, Micki Washburn, John L Bayhi, Wen Xu, Lynley Carr, McClain Sampson
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits of home visiting models for postpartum depression amongst mothers of young children, where either the mothers or the children are enrolled in early childhood home visiting programs or interventions. To identify core components essential for a home visiting program to effectively address postpartum depression in mothers of young children. The hypothesized core components of such a program include the priority level given to PPD intervention, the type of home visitors, the intensity of the program, the percentage of BIPOC participants, and the service recipients' baseline level of and risk for depression.
{"title":"Home visiting for postpartum depression.","authors":"Miao Yu, Micki Washburn, John L Bayhi, Wen Xu, Lynley Carr, McClain Sampson","doi":"10.1002/14651858.CD015984","DOIUrl":"10.1002/14651858.CD015984","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits of home visiting models for postpartum depression amongst mothers of young children, where either the mothers or the children are enrolled in early childhood home visiting programs or interventions. To identify core components essential for a home visiting program to effectively address postpartum depression in mothers of young children. The hypothesized core components of such a program include the priority level given to PPD intervention, the type of home visitors, the intensity of the program, the percentage of BIPOC participants, and the service recipients' baseline level of and risk for depression.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD015984"},"PeriodicalIF":8.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-28DOI: 10.1002/14651858.CD013816.pub2
Brett Chen, Mi Phan, Vinay Pasupuleti, Yuani M Roman, Adrian V Hernandez
<p><strong>Background: </strong>Guideline-recommended strategies to interrupt chronic anticoagulation with warfarin or direct oral anticoagulants (DOAC) during the perioperative period of cardiac implantable electronic device (CIED) surgery differ worldwide. There is uncertainty concerning the benefits and harms of interrupted and uninterrupted anticoagulation in patients undergoing CIED surgery.</p><p><strong>Objectives: </strong>To assess the benefits and harms of interrupted anticoagulation (IAC) with either warfarin or DOAC in the perioperative period of CIED surgery versus uninterrupted anticoagulation (UAC), with or without heparin bridging, during an equivalent time frame, for CIED surgery.</p><p><strong>Search methods: </strong>CENTRAL, MEDLINE, Embase, Web of Science, and two trials registers were searched on 26 November 2021 together with reference checking, citation searching and contact with study authors to identify additional studies. We plan to update this review imminently.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) evaluating IAC vs. UAC in adults with a diagnosed cardiac rhythm disorder, who underwent elective CIED surgery and received at least one month of warfarin or DOAC anticoagulation. Comparisons of interest were: (1) continued warfarin vs. interrupted warfarin anticoagulation, with or without heparin bridging; and (2) continued DOAC (apixaban, betrixaban, dabigatran, edoxaban, or rivaroxaban) vs. interrupted DOAC, with or without heparin bridging.</p><p><strong>Data collection and analysis: </strong>Primary outcomes were composite thromboembolic events (transient ischemic attack, ischemic stroke, deep vein thrombosis, pulmonary embolism, peripheral embolism, or valve thrombosis) and device-pocket hematoma. Secondary outcomes included individual components of composite thromboembolic events, composite bleeding events, all-cause mortality, adverse events, quality of life and days of hospitalization. Two authors independently selected studies, extracted data, and assessed the risk of bias. We assessed the certainty of evidence using GRADE. The inverse variance random-effects model was used for meta-analyses, and the DerSimonian and Laird method was used for calculating the between-study variance Tau<sup>2</sup>. Dichotomous outcomes were calculated as risk ratios (RRs) and we used mean differences (MDs) for continuous outcomes, with respective 95% confidence intervals (95% CIs).</p><p><strong>Main results: </strong>We identified 10 eligible studies (2221 participants), of which one is ongoing. Of these 10 studies, six compared IAC vs. UAC with warfarin (1267 participants) and four compared IAC vs. UAC with DOAC (954 participants). Follow-up duration ranged between 0.5 to three months. The mean age of participants ranged from 68 to 76 years. Definitions of thromboembolic events, device-pocket hematoma, and bleeding events varied across studies. IAC vs. UAC with warfarin IAC with
{"title":"Interrupted versus uninterrupted anticoagulation for cardiac rhythm management device insertion.","authors":"Brett Chen, Mi Phan, Vinay Pasupuleti, Yuani M Roman, Adrian V Hernandez","doi":"10.1002/14651858.CD013816.pub2","DOIUrl":"10.1002/14651858.CD013816.pub2","url":null,"abstract":"<p><strong>Background: </strong>Guideline-recommended strategies to interrupt chronic anticoagulation with warfarin or direct oral anticoagulants (DOAC) during the perioperative period of cardiac implantable electronic device (CIED) surgery differ worldwide. There is uncertainty concerning the benefits and harms of interrupted and uninterrupted anticoagulation in patients undergoing CIED surgery.</p><p><strong>Objectives: </strong>To assess the benefits and harms of interrupted anticoagulation (IAC) with either warfarin or DOAC in the perioperative period of CIED surgery versus uninterrupted anticoagulation (UAC), with or without heparin bridging, during an equivalent time frame, for CIED surgery.</p><p><strong>Search methods: </strong>CENTRAL, MEDLINE, Embase, Web of Science, and two trials registers were searched on 26 November 2021 together with reference checking, citation searching and contact with study authors to identify additional studies. We plan to update this review imminently.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) evaluating IAC vs. UAC in adults with a diagnosed cardiac rhythm disorder, who underwent elective CIED surgery and received at least one month of warfarin or DOAC anticoagulation. Comparisons of interest were: (1) continued warfarin vs. interrupted warfarin anticoagulation, with or without heparin bridging; and (2) continued DOAC (apixaban, betrixaban, dabigatran, edoxaban, or rivaroxaban) vs. interrupted DOAC, with or without heparin bridging.</p><p><strong>Data collection and analysis: </strong>Primary outcomes were composite thromboembolic events (transient ischemic attack, ischemic stroke, deep vein thrombosis, pulmonary embolism, peripheral embolism, or valve thrombosis) and device-pocket hematoma. Secondary outcomes included individual components of composite thromboembolic events, composite bleeding events, all-cause mortality, adverse events, quality of life and days of hospitalization. Two authors independently selected studies, extracted data, and assessed the risk of bias. We assessed the certainty of evidence using GRADE. The inverse variance random-effects model was used for meta-analyses, and the DerSimonian and Laird method was used for calculating the between-study variance Tau<sup>2</sup>. Dichotomous outcomes were calculated as risk ratios (RRs) and we used mean differences (MDs) for continuous outcomes, with respective 95% confidence intervals (95% CIs).</p><p><strong>Main results: </strong>We identified 10 eligible studies (2221 participants), of which one is ongoing. Of these 10 studies, six compared IAC vs. UAC with warfarin (1267 participants) and four compared IAC vs. UAC with DOAC (954 participants). Follow-up duration ranged between 0.5 to three months. The mean age of participants ranged from 68 to 76 years. Definitions of thromboembolic events, device-pocket hematoma, and bleeding events varied across studies. IAC vs. UAC with warfarin IAC with","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD013816"},"PeriodicalIF":8.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-27DOI: 10.1002/14651858.CD015509
Lisandra Almeida de Oliveira, Anita R Gross, Jill A Hayden, Lisa Carlesso, Steven Hanna, Nora Bakaa, Diego Silva, Luciana G Macedo
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of graded activity compared to placebo, sham, or no treatment, on pain and function in adults with acute and subacute non-specific low back pain.
{"title":"Graded activity for acute and subacute low back pain.","authors":"Lisandra Almeida de Oliveira, Anita R Gross, Jill A Hayden, Lisa Carlesso, Steven Hanna, Nora Bakaa, Diego Silva, Luciana G Macedo","doi":"10.1002/14651858.CD015509","DOIUrl":"10.1002/14651858.CD015509","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of graded activity compared to placebo, sham, or no treatment, on pain and function in adults with acute and subacute non-specific low back pain.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD015509"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-27DOI: 10.1002/14651858.CD016119
Teesta Dey, Maia G Cole, Daisy Brown, Ruaraidh A Hill, Marty Chaplin, Hanna E Huffstetler, Ffion Curtis
<p><strong>Rationale: </strong>Postpartum haemorrhage, defined as a blood loss of 500 mL or more within 24 hours of birth, is the leading global cause of maternal morbidity and mortality. Uterine fibroids are non-cancerous growths that develop in or around the uterus, and affect an increasing number of women. Caesarean myomectomy is the surgical removal of fibroids during a caesarean section. Traditionally, obstetricians have avoided this procedure given the risk of uncontrollable haemorrhage. There is also the risk of longer operating time and more days in the hospital. However, there could be potential benefits in removing uterine fibroids for improved fertility, and caesarean section may provide an effective and efficient opportunity to perform this procedure. Given the link between removal of uterine fibroids and postpartum haemorrhage, it is prudent to evaluate current literature and assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids.</p><p><strong>Objectives: </strong>To assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids undergoing caesarean section.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Global Index Medicus, ICTRP portal, and ClinicalTrials.gov; performed supplementary searches of references and citations; and contacted study authors on 2 February 2024.</p><p><strong>Eligibility criteria: </strong>We included published randomised and quasi-randomised controlled trials, and observational controlled studies that assessed the impact of myomectomy on maternal health outcomes in pregnant women with fibroids undergoing caesarean birth. We excluded qualitative studies, case reports or series, conference abstracts, opinion papers, letters, and book chapters. There were no restrictions on ethnicity, race, socioeconomic status, education level, or place of residence.</p><p><strong>Outcomes: </strong>Critical outcomes were requirement for blood transfusion, risk of haemorrhage, change in haemoglobin, length of hospitalisation, length of operation, major surgery at time of procedure, fertility outcome, and postpartum fever.</p><p><strong>Risk of bias: </strong>We assessed risk of bias for non-randomised controlled studies using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool.</p><p><strong>Synthesis methods: </strong>We conducted a meta-analysis for each outcome when more than one study provided data. If it was not possible to analyse data via meta-analysis, we synthesised results narratively using Synthesis Without Meta-analysis (SWiM) guidance. We used GRADE to assess certainty of evidence for each critical and important outcome.</p><p><strong>Included studies: </strong>We included 23 non-randomised studies with 7504 women. Most studies were conducted in high-income or upper-middle-income countries. Five studies enrolled women with singleton pregnancies and one study was restricted to women with a t
{"title":"Caesarean myomectomy in pregnant women with uterine fibroids.","authors":"Teesta Dey, Maia G Cole, Daisy Brown, Ruaraidh A Hill, Marty Chaplin, Hanna E Huffstetler, Ffion Curtis","doi":"10.1002/14651858.CD016119","DOIUrl":"10.1002/14651858.CD016119","url":null,"abstract":"<p><strong>Rationale: </strong>Postpartum haemorrhage, defined as a blood loss of 500 mL or more within 24 hours of birth, is the leading global cause of maternal morbidity and mortality. Uterine fibroids are non-cancerous growths that develop in or around the uterus, and affect an increasing number of women. Caesarean myomectomy is the surgical removal of fibroids during a caesarean section. Traditionally, obstetricians have avoided this procedure given the risk of uncontrollable haemorrhage. There is also the risk of longer operating time and more days in the hospital. However, there could be potential benefits in removing uterine fibroids for improved fertility, and caesarean section may provide an effective and efficient opportunity to perform this procedure. Given the link between removal of uterine fibroids and postpartum haemorrhage, it is prudent to evaluate current literature and assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids.</p><p><strong>Objectives: </strong>To assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids undergoing caesarean section.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Global Index Medicus, ICTRP portal, and ClinicalTrials.gov; performed supplementary searches of references and citations; and contacted study authors on 2 February 2024.</p><p><strong>Eligibility criteria: </strong>We included published randomised and quasi-randomised controlled trials, and observational controlled studies that assessed the impact of myomectomy on maternal health outcomes in pregnant women with fibroids undergoing caesarean birth. We excluded qualitative studies, case reports or series, conference abstracts, opinion papers, letters, and book chapters. There were no restrictions on ethnicity, race, socioeconomic status, education level, or place of residence.</p><p><strong>Outcomes: </strong>Critical outcomes were requirement for blood transfusion, risk of haemorrhage, change in haemoglobin, length of hospitalisation, length of operation, major surgery at time of procedure, fertility outcome, and postpartum fever.</p><p><strong>Risk of bias: </strong>We assessed risk of bias for non-randomised controlled studies using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool.</p><p><strong>Synthesis methods: </strong>We conducted a meta-analysis for each outcome when more than one study provided data. If it was not possible to analyse data via meta-analysis, we synthesised results narratively using Synthesis Without Meta-analysis (SWiM) guidance. We used GRADE to assess certainty of evidence for each critical and important outcome.</p><p><strong>Included studies: </strong>We included 23 non-randomised studies with 7504 women. Most studies were conducted in high-income or upper-middle-income countries. Five studies enrolled women with singleton pregnancies and one study was restricted to women with a t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD016119"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-27DOI: 10.1002/14651858.CD016026
Emma Olsson, Marcus G Prescott, Kristine B Titlestad, Michelle Fiander, Roger F Soll, Matteo Bruschettini
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of individualized developmental care interventions for promoting development and preventing morbidity in preterm infants.
{"title":"Individualized developmental care interventions for promoting development and preventing morbidity in preterm infants.","authors":"Emma Olsson, Marcus G Prescott, Kristine B Titlestad, Michelle Fiander, Roger F Soll, Matteo Bruschettini","doi":"10.1002/14651858.CD016026","DOIUrl":"10.1002/14651858.CD016026","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of individualized developmental care interventions for promoting development and preventing morbidity in preterm infants.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD016026"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-27DOI: 10.1002/14651858.CD011762.pub2
Carlos A Salazar, Juan E Basilio Flores, German Malaga, Giuliana N Malasquez, Roberto Bernardo
<p><strong>Background: </strong>People undergoing major orthopaedic surgery are at increased risk of postoperative thromboembolic events. Low molecular weight heparins (LMWHs) are recommended for thromboprophylaxis in this population. New oral anticoagulants, including direct factor Xa inhibitors, are recommended as alternatives. They may have more advantages than disadvantages compared to LMWHs and vitamin K antagonists (VKAs, another type of anticoagulant).</p><p><strong>Objectives: </strong>To assess the benefits and harms of prophylactic anticoagulation with direct factor Xa inhibitors compared with low molecular weight heparins and vitamin K antagonists in people undergoing major orthopaedic surgery for elective total hip or knee replacement or hip fracture surgery.</p><p><strong>Search methods: </strong>We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registers to 11 November 2023. We conducted reference checks to identify additional studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing the effects of direct factor Xa inhibitors to LMWHs or VKAs in people undergoing major orthopaedic surgery.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were all-cause mortality, major venous thromboembolism (VTE), symptomatic VTE, major bleeding, and serious hepatic and non-hepatic adverse events. We evaluated the risk of bias in the included studies using Cochrane's risk of bias 1 tool. We calculated estimates of treatment effects using risk ratios (RR) with 95% confidence intervals (CIs), and used GRADE criteria to assess the certainty of the evidence.</p><p><strong>Main results: </strong>We included 53 RCTs (44,371 participants). Participants' average age was 64 years (range: 18 to 93 years). Only one RCT compared a VKA with direct factor Xa inhibitors. All 53 RCTs compared direct factor Xa inhibitors with LMWHs. Twenty-three studies included participants undergoing total hip replacement; 21 studies, total knee replacement; and three studies included people having hip fracture surgery. The studies' average duration was approximately 42 days (range: two to 720 days). Compared to LMWHs, direct factor Xa inhibitors may have little to no effect on all-cause mortality, but the evidence is very uncertain (RR 0.83, 95% CI 0.52 to 1.31; I<sup>2</sup> = 0%; 28 studies, 29,698 participants; very low-certainty evidence). Direct factor Xa inhibitors may make little to no difference to major venous thromboembolic events compared to LMWHs, but the evidence is very uncertain (RR 0.51, 95% CI 0.37 to 0.71; absolute risk difference: 12 fewer major VTE events per 1000 participants, 95% CI 16 fewer to 7 fewer; I<sup>2</sup> = 48%; 28 studies, 24,574 participants; very low-certainty evidence). Compared to LMWHs, direct factor Xa inhibitors may reduce symptomatic VTE (RR 0.64, 95% CI 0.50 t
{"title":"Direct factor Xa inhibitors versus low molecular weight heparins or vitamin K antagonists for prevention of venous thromboembolism in elective primary hip or knee replacement or hip fracture repair.","authors":"Carlos A Salazar, Juan E Basilio Flores, German Malaga, Giuliana N Malasquez, Roberto Bernardo","doi":"10.1002/14651858.CD011762.pub2","DOIUrl":"10.1002/14651858.CD011762.pub2","url":null,"abstract":"<p><strong>Background: </strong>People undergoing major orthopaedic surgery are at increased risk of postoperative thromboembolic events. Low molecular weight heparins (LMWHs) are recommended for thromboprophylaxis in this population. New oral anticoagulants, including direct factor Xa inhibitors, are recommended as alternatives. They may have more advantages than disadvantages compared to LMWHs and vitamin K antagonists (VKAs, another type of anticoagulant).</p><p><strong>Objectives: </strong>To assess the benefits and harms of prophylactic anticoagulation with direct factor Xa inhibitors compared with low molecular weight heparins and vitamin K antagonists in people undergoing major orthopaedic surgery for elective total hip or knee replacement or hip fracture surgery.</p><p><strong>Search methods: </strong>We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registers to 11 November 2023. We conducted reference checks to identify additional studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing the effects of direct factor Xa inhibitors to LMWHs or VKAs in people undergoing major orthopaedic surgery.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were all-cause mortality, major venous thromboembolism (VTE), symptomatic VTE, major bleeding, and serious hepatic and non-hepatic adverse events. We evaluated the risk of bias in the included studies using Cochrane's risk of bias 1 tool. We calculated estimates of treatment effects using risk ratios (RR) with 95% confidence intervals (CIs), and used GRADE criteria to assess the certainty of the evidence.</p><p><strong>Main results: </strong>We included 53 RCTs (44,371 participants). Participants' average age was 64 years (range: 18 to 93 years). Only one RCT compared a VKA with direct factor Xa inhibitors. All 53 RCTs compared direct factor Xa inhibitors with LMWHs. Twenty-three studies included participants undergoing total hip replacement; 21 studies, total knee replacement; and three studies included people having hip fracture surgery. The studies' average duration was approximately 42 days (range: two to 720 days). Compared to LMWHs, direct factor Xa inhibitors may have little to no effect on all-cause mortality, but the evidence is very uncertain (RR 0.83, 95% CI 0.52 to 1.31; I<sup>2</sup> = 0%; 28 studies, 29,698 participants; very low-certainty evidence). Direct factor Xa inhibitors may make little to no difference to major venous thromboembolic events compared to LMWHs, but the evidence is very uncertain (RR 0.51, 95% CI 0.37 to 0.71; absolute risk difference: 12 fewer major VTE events per 1000 participants, 95% CI 16 fewer to 7 fewer; I<sup>2</sup> = 48%; 28 studies, 24,574 participants; very low-certainty evidence). Compared to LMWHs, direct factor Xa inhibitors may reduce symptomatic VTE (RR 0.64, 95% CI 0.50 t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD011762"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-27DOI: 10.1002/14651858.CD015120.pub2
Annika Theodoulou, Thomas R Fanshawe, Eleanor Leavens, Effie Theodoulou, Angela Difeng Wu, Laura Heath, Cristina Stewart, Nicole Nollen, Jasjit S Ahluwalia, Ailsa R Butler, Anisa Hajizadeh, James Thomas, Nicola Lindson, Jamie Hartmann-Boyce
<p><strong>Background: </strong>People from lower socioeconomic groups are more likely to smoke and less likely to succeed in achieving abstinence, making tobacco smoking a leading driver of health inequalities. Contextual factors affecting subpopulations may moderate the efficacy of individual-level smoking cessation interventions. It is not known whether any intervention performs differently across socioeconomically-diverse populations and contexts.</p><p><strong>Objectives: </strong>To assess whether the effects of individual-level smoking cessation interventions on combustible tobacco cigarette use differ by socioeconomic groups, and their potential impact on health equalities.</p><p><strong>Search methods: </strong>We searched the Cochrane Database of Systematic Reviews from inception to 1 May 2023 for Cochrane reviews investigating individual-level smoking cessation interventions. We selected studies included in these reviews that met our criteria. We contacted study authors to identify further eligible studies.</p><p><strong>Selection criteria: </strong>We included parallel, cluster or factorial randomised controlled trials (RCTs) investigating any individual-level smoking cessation intervention which encouraged complete cessation of combustible tobacco cigarette use compared to no intervention, placebo, or another intervention in adults. Studies must have assessed or reported smoking quit rates, split by any measure of socioeconomic status (SES) at longest follow-up (≥ six months), and been published in 2000 or later.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methods for screening, data extraction, and risk of bias assessment. We assessed the availability of smoking abstinence data by SES in lieu of selective reporting. The primary outcome was smoking cessation quit rates, split by lower and higher SES, at the longest follow-up (≥ six months). Where possible, we calculated ratios of odds ratios (ROR) with 95% confidence intervals (CIs) for each study, comparing lower to higher SES. We pooled RORs by intervention type in random-effects meta-analyses, using the generic inverse-variance method. We subgrouped by type of SES indicator and economic classification of the study country. We summarised all evidence in effect direction plots and categorised the intervention impact on health equality as: positive (evidence that the relative effect of the intervention on quit rates was greater in lower rather than higher SES groups), possibly positive, neutral, possibly neutral, possibly negative, negative, no reported statistically significant difference, or unclear. We evaluated certainty using GRADE.</p><p><strong>Main results: </strong>We included 77 studies (73 from high-income countries), representing 127,791 participants. We deemed 12 studies at low overall risk of bias, 13 at unclear risk, and the remaining 52 at high risk. Included studies investigated a range of pharmacological interventions, behaviou
{"title":"Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status.","authors":"Annika Theodoulou, Thomas R Fanshawe, Eleanor Leavens, Effie Theodoulou, Angela Difeng Wu, Laura Heath, Cristina Stewart, Nicole Nollen, Jasjit S Ahluwalia, Ailsa R Butler, Anisa Hajizadeh, James Thomas, Nicola Lindson, Jamie Hartmann-Boyce","doi":"10.1002/14651858.CD015120.pub2","DOIUrl":"10.1002/14651858.CD015120.pub2","url":null,"abstract":"<p><strong>Background: </strong>People from lower socioeconomic groups are more likely to smoke and less likely to succeed in achieving abstinence, making tobacco smoking a leading driver of health inequalities. Contextual factors affecting subpopulations may moderate the efficacy of individual-level smoking cessation interventions. It is not known whether any intervention performs differently across socioeconomically-diverse populations and contexts.</p><p><strong>Objectives: </strong>To assess whether the effects of individual-level smoking cessation interventions on combustible tobacco cigarette use differ by socioeconomic groups, and their potential impact on health equalities.</p><p><strong>Search methods: </strong>We searched the Cochrane Database of Systematic Reviews from inception to 1 May 2023 for Cochrane reviews investigating individual-level smoking cessation interventions. We selected studies included in these reviews that met our criteria. We contacted study authors to identify further eligible studies.</p><p><strong>Selection criteria: </strong>We included parallel, cluster or factorial randomised controlled trials (RCTs) investigating any individual-level smoking cessation intervention which encouraged complete cessation of combustible tobacco cigarette use compared to no intervention, placebo, or another intervention in adults. Studies must have assessed or reported smoking quit rates, split by any measure of socioeconomic status (SES) at longest follow-up (≥ six months), and been published in 2000 or later.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methods for screening, data extraction, and risk of bias assessment. We assessed the availability of smoking abstinence data by SES in lieu of selective reporting. The primary outcome was smoking cessation quit rates, split by lower and higher SES, at the longest follow-up (≥ six months). Where possible, we calculated ratios of odds ratios (ROR) with 95% confidence intervals (CIs) for each study, comparing lower to higher SES. We pooled RORs by intervention type in random-effects meta-analyses, using the generic inverse-variance method. We subgrouped by type of SES indicator and economic classification of the study country. We summarised all evidence in effect direction plots and categorised the intervention impact on health equality as: positive (evidence that the relative effect of the intervention on quit rates was greater in lower rather than higher SES groups), possibly positive, neutral, possibly neutral, possibly negative, negative, no reported statistically significant difference, or unclear. We evaluated certainty using GRADE.</p><p><strong>Main results: </strong>We included 77 studies (73 from high-income countries), representing 127,791 participants. We deemed 12 studies at low overall risk of bias, 13 at unclear risk, and the remaining 52 at high risk. Included studies investigated a range of pharmacological interventions, behaviou","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD015120"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-27DOI: 10.1002/14651858.CD001155.pub3
George A Wells, Shu-Ching Hsieh, Joan Peterson, Carine Zheng, Shannon E Kelly, Beverley Shea, Peter Tugwell
<p><strong>Rationale: </strong>Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Alendronate belongs to the bisphosphonate class of drugs, which inhibit bone resorption by interfering with the activity of osteoclasts (bone cells that break down bone tissue). This is an update of a Cochrane review first published in 2008.</p><p><strong>Objectives: </strong>To assess the benefits and harms of alendronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women at lower and higher risk of fracture, respectively.</p><p><strong>Search methods: </strong>We searched Evidence-Based Medicine Reviews (which includes CENTRAL), MEDLINE, Embase, two trial registers, drug approval agency websites, and the bibliographies of relevant systematic reviews to identify the studies included in this review. The latest search date was 01 February 2023. We imposed no restrictions on language, date, form of publication, or reported outcomes.</p><p><strong>Eligibility criteria: </strong>We included only randomized controlled trials that assessed the effects of alendronate on postmenopausal women. Targeted participants must have received at least one year of alendronate. We classified a study as secondary prevention if its population met one or more of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, a low bone mineral density T-score (-2.5 or lower), and 75 years old or older. If a study population met none of those criteria, we classified it as a primary prevention study.</p><p><strong>Outcomes: </strong>Our major outcomes were clinical vertebral, non-vertebral, hip, and wrist fractures, withdrawals due to adverse events, and serious adverse events.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias 1 tool.</p><p><strong>Synthesis methods: </strong>We used standard methodological procedures expected by Cochrane. Based on the previous review experience, in which the clinical and methodological characteristics in the primary and secondary prevention studies were homogeneous, we used a fixed-effect model for meta-analysis and estimated effects using the risk ratio (RR) for dichotomous outcomes. Our base case analyses included all eligible placebo-controlled studies with usable data. We selected the data available for the longest treatment period. We consider a relative change exceeding 15% as clinically important.</p><p><strong>Included studies: </strong>We included 119 studies, of which 102 studies provided data for quantitative synthesis. Of these, we classified 34 studies (15,188 participants) as primary prevention and 68 studies (29,577 participants) as secondary prevention. We had concerns about risks of bias in most studies. Selection bias was the most frequently overlooked domain, with only 20 studies (19%) describing appropriate methods for both sequence generation and allocation concealment. Eight studie
{"title":"Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women.","authors":"George A Wells, Shu-Ching Hsieh, Joan Peterson, Carine Zheng, Shannon E Kelly, Beverley Shea, Peter Tugwell","doi":"10.1002/14651858.CD001155.pub3","DOIUrl":"10.1002/14651858.CD001155.pub3","url":null,"abstract":"<p><strong>Rationale: </strong>Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Alendronate belongs to the bisphosphonate class of drugs, which inhibit bone resorption by interfering with the activity of osteoclasts (bone cells that break down bone tissue). This is an update of a Cochrane review first published in 2008.</p><p><strong>Objectives: </strong>To assess the benefits and harms of alendronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women at lower and higher risk of fracture, respectively.</p><p><strong>Search methods: </strong>We searched Evidence-Based Medicine Reviews (which includes CENTRAL), MEDLINE, Embase, two trial registers, drug approval agency websites, and the bibliographies of relevant systematic reviews to identify the studies included in this review. The latest search date was 01 February 2023. We imposed no restrictions on language, date, form of publication, or reported outcomes.</p><p><strong>Eligibility criteria: </strong>We included only randomized controlled trials that assessed the effects of alendronate on postmenopausal women. Targeted participants must have received at least one year of alendronate. We classified a study as secondary prevention if its population met one or more of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, a low bone mineral density T-score (-2.5 or lower), and 75 years old or older. If a study population met none of those criteria, we classified it as a primary prevention study.</p><p><strong>Outcomes: </strong>Our major outcomes were clinical vertebral, non-vertebral, hip, and wrist fractures, withdrawals due to adverse events, and serious adverse events.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias 1 tool.</p><p><strong>Synthesis methods: </strong>We used standard methodological procedures expected by Cochrane. Based on the previous review experience, in which the clinical and methodological characteristics in the primary and secondary prevention studies were homogeneous, we used a fixed-effect model for meta-analysis and estimated effects using the risk ratio (RR) for dichotomous outcomes. Our base case analyses included all eligible placebo-controlled studies with usable data. We selected the data available for the longest treatment period. We consider a relative change exceeding 15% as clinically important.</p><p><strong>Included studies: </strong>We included 119 studies, of which 102 studies provided data for quantitative synthesis. Of these, we classified 34 studies (15,188 participants) as primary prevention and 68 studies (29,577 participants) as secondary prevention. We had concerns about risks of bias in most studies. Selection bias was the most frequently overlooked domain, with only 20 studies (19%) describing appropriate methods for both sequence generation and allocation concealment. Eight studie","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD001155"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-20DOI: 10.1002/14651858.CD009730.pub3
Matthew N Hurley, Sherie Smith, Patrick Flume, Nikki Jahnke, Andrew P Prayle
<p><strong>Background: </strong>Cystic fibrosis is a multisystem disease characterised by the production of thick secretions causing recurrent pulmonary infection, often with unusual bacteria. Intravenous (IV) antibiotics are commonly used in the treatment of acute deteriorations in symptoms (pulmonary exacerbations); however, recently the assumption that exacerbations are due to increases in bacterial burden has been questioned. This is an update of a previously published review.</p><p><strong>Objectives: </strong>To establish whether IV antibiotics for the treatment of pulmonary exacerbations in people with cystic fibrosis improve short-term and long-term clinical outcomes.</p><p><strong>Search methods: </strong>We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews and ongoing trials registers. Date of last search of Cochrane Trials Register: 19 June 2024.</p><p><strong>Selection criteria: </strong>Randomised controlled trials and the first treatment cycle of cross-over studies comparing IV antibiotics (given alone or in an antibiotic combination) with placebo, or inhaled or oral antibiotics for people with cystic fibrosis experiencing a pulmonary exacerbation. Studies comparing different IV antibiotic regimens were also eligible.</p><p><strong>Data collection and analysis: </strong>We assessed studies for eligibility and risk of bias, and extracted data. Using GRADE, we assessed the certainty of the evidence for the outcomes lung function % predicted (forced expiratory volume in one second (FEV<sub>1</sub>) and forced vital capacity (FVC)), time to next exacerbation and quality of life.</p><p><strong>Main results: </strong>We included 45 studies involving 2810 participants. The included studies were mostly small, and inadequately reported, many of which were quite old. The certainty of the evidence was mostly low. Combined intravenous antibiotics versus placebo Data reported for absolute change in % predicted FEV<sub>1</sub> and FVC suggested a possible improvement in favour of IV antibiotics, but the evidence is very uncertain (1 study, 12 participants; very low-certainty evidence). The study did not measure time to next exacerbation or quality of life. Intravenous versus nebulised antibiotics Five studies (122 participants) reported FEV<sub>1</sub>, with analysable data only from one study (16 participants). We found no difference between groups (moderate-certainty evidence). Three studies (91 participants) reported on FVC, with analysable data from only one study (54 participants). We are very uncertain on the effect of nebulised antibiotics (very low-certainty evidence). In one study, the 16 participants on nebulised plus IV antibiotics had a lower mean number of days to next exacerbation than those on combined IV antibiotics (low-certainty evidence), but we found
{"title":"Intravenous antibiotics for pulmonary exacerbations in people with cystic fibrosis.","authors":"Matthew N Hurley, Sherie Smith, Patrick Flume, Nikki Jahnke, Andrew P Prayle","doi":"10.1002/14651858.CD009730.pub3","DOIUrl":"10.1002/14651858.CD009730.pub3","url":null,"abstract":"<p><strong>Background: </strong>Cystic fibrosis is a multisystem disease characterised by the production of thick secretions causing recurrent pulmonary infection, often with unusual bacteria. Intravenous (IV) antibiotics are commonly used in the treatment of acute deteriorations in symptoms (pulmonary exacerbations); however, recently the assumption that exacerbations are due to increases in bacterial burden has been questioned. This is an update of a previously published review.</p><p><strong>Objectives: </strong>To establish whether IV antibiotics for the treatment of pulmonary exacerbations in people with cystic fibrosis improve short-term and long-term clinical outcomes.</p><p><strong>Search methods: </strong>We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews and ongoing trials registers. Date of last search of Cochrane Trials Register: 19 June 2024.</p><p><strong>Selection criteria: </strong>Randomised controlled trials and the first treatment cycle of cross-over studies comparing IV antibiotics (given alone or in an antibiotic combination) with placebo, or inhaled or oral antibiotics for people with cystic fibrosis experiencing a pulmonary exacerbation. Studies comparing different IV antibiotic regimens were also eligible.</p><p><strong>Data collection and analysis: </strong>We assessed studies for eligibility and risk of bias, and extracted data. Using GRADE, we assessed the certainty of the evidence for the outcomes lung function % predicted (forced expiratory volume in one second (FEV<sub>1</sub>) and forced vital capacity (FVC)), time to next exacerbation and quality of life.</p><p><strong>Main results: </strong>We included 45 studies involving 2810 participants. The included studies were mostly small, and inadequately reported, many of which were quite old. The certainty of the evidence was mostly low. Combined intravenous antibiotics versus placebo Data reported for absolute change in % predicted FEV<sub>1</sub> and FVC suggested a possible improvement in favour of IV antibiotics, but the evidence is very uncertain (1 study, 12 participants; very low-certainty evidence). The study did not measure time to next exacerbation or quality of life. Intravenous versus nebulised antibiotics Five studies (122 participants) reported FEV<sub>1</sub>, with analysable data only from one study (16 participants). We found no difference between groups (moderate-certainty evidence). Three studies (91 participants) reported on FVC, with analysable data from only one study (54 participants). We are very uncertain on the effect of nebulised antibiotics (very low-certainty evidence). In one study, the 16 participants on nebulised plus IV antibiotics had a lower mean number of days to next exacerbation than those on combined IV antibiotics (low-certainty evidence), but we found ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD009730"},"PeriodicalIF":8.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-20DOI: 10.1002/14651858.CD012429.pub2
Dawid Storman, Magdalena Koperny, Krzysztof Styczeñ, Wojciech Datka, Rafal R Jaeschke
<p><strong>Background: </strong>Antipsychotic drugs are the mainstay of treatment for schizophrenia. Even though several novel second-generation antipsychotics (i.e. lurasidone, iloperidone and cariprazine) have been approved in recent years, typical antipsychotics (e.g. chlorpromazine, haloperidol, and fluphenazine) remain a crucial therapeutic option for the condition around the world. Little is known about the relative risk-to-benefit ratio of the 'latest' second-generation antipsychotics compared to the typical agents of 'established stature'.</p><p><strong>Objectives: </strong>To systematically review the efficacy and safety of lurasidone versus typical antipsychotics for adults with schizophrenia or schizophrenia-related disorders.</p><p><strong>Search methods: </strong>We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials on 5 June 2019. We also ran an update search in CENTRAL, MEDLINE, Embase, and three additional databases as well as two trial registers and the US Food and Drug Administration database on 1 April 2024.</p><p><strong>Selection criteria: </strong>We searched for randomized controlled trials (RCTs) comparing lurasidonewith typical antipsychotic drugs (such as chlorpromazine, fluphenazine, haloperidol, loxapine, mesoridazine, molindone, perphenazine, thioridazine, thiothixene, zuclopenthixol) for adults with schizophrenia. No additional search restrictions were applied.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methodological procedures. We extracted information on participant characteristics, interventions, study outcomes, study design, trial methods, and funding sources. Two review authors independently extracted data and assessed the risk of bias. We assessed the certainty of evidence with GRADE for these key outcomes: change in mental state, death by suicide or natural cause, quality of life, total serious adverse events and severe adverse events (as defined by study authors).</p><p><strong>Main results: </strong>We included two studies with a total of 308 individuals diagnosed with schizophrenia (220 men and 85 women). A total of 223 participants received lurasidone (20, 40, or 80 mg/day), and 82 received haloperidol (up to 10 mg/day) or perphenazine (up to 32 mg/day); three people did not receive any study medication. Both studies were performed in the US. The duration of the follow-up was four to six weeks. Death by suicide/natural causes and quality of life were not reported by the two included studies. The evidence is very uncertain about the effects of lurasidone on change in mental state: the Brief Psychiatric Rating Scale (BPRS) (MD 3.74, 95% CI 0.57 to 6.90; 1 RCT, 281 participants; very low-certainty evidence); and the Positive and Negative Syndrome Scale (PANSS) (MD 6.68, 95% CI 2.45 to 10.91; 1 RCT, 281 participants; very low-certainty evidence). The evidence is also very uncertain about the effects of lurasidone on total serious adverse events (
背景:抗精神病药物是治疗精神分裂症的主要药物。尽管近年来已经批准了几种新的第二代抗精神病药物(如鲁拉西酮、依哌啶酮和卡吡嗪),但典型的抗精神病药物(如氯丙嗪、氟哌啶醇和氟非那嗪)仍然是世界各地治疗该病的关键选择。关于“最新”的第二代抗精神病药物与“成熟”的典型药物的相对风险-收益比,我们知之甚少。目的:系统回顾鲁拉西酮与典型抗精神病药物对成人精神分裂症或精神分裂症相关疾病的疗效和安全性。检索方法:我们于2019年6月5日检索了Cochrane精神分裂症组的基于研究的试验登记册。我们还于2024年4月1日在CENTRAL、MEDLINE、Embase和另外三个数据库以及两个试验注册库和美国食品和药物管理局数据库中进行了更新检索。选择标准:我们检索了鲁拉西酮与典型抗精神病药物(如氯丙嗪、氟非那嗪、氟哌啶醇、洛沙平、美索里嗪、莫林酮、奋那嗪、硫硝嗪、硫噻吩、zuclopenthxol)治疗成人精神分裂症的随机对照试验(rct)。没有施加额外的搜索限制。数据收集和分析:我们遵循标准的Cochrane方法程序。我们提取了参与者特征、干预措施、研究结果、研究设计、试验方法和资金来源的信息。两位综述作者独立提取数据并评估偏倚风险。我们用GRADE评估这些关键结局的证据确定性:精神状态改变、自杀或自然原因死亡、生活质量、总严重不良事件和严重不良事件(由研究作者定义)。主要结果:我们纳入了两项研究,共308名被诊断为精神分裂症的个体(220名男性和85名女性)。共有223名参与者接受鲁拉西酮(20,40或80mg /天),82名接受氟哌啶醇(高达10mg /天)或奋那嗪(高达32mg /天);其中三人没有接受任何研究药物。两项研究都是在美国进行的。随访时间为4至6周。这两项纳入的研究未报告自杀/自然原因死亡和生活质量。关于鲁拉西酮对精神状态改变的影响的证据非常不确定:简短精神病学评定量表(BPRS) (MD 3.74, 95% CI 0.57至6.90;1项随机对照试验,281名受试者;极低确定性证据);阳性和阴性综合征量表(PANSS) (MD 6.68, 95% CI 2.45 ~ 10.91;1项随机对照试验,281名受试者;非常低确定性证据)。关于鲁拉西酮对总严重不良事件的影响,证据也非常不确定(RR 0.98, 95% CI 0.37 ~ 2.60;2项随机对照试验,303名受试者;证据确定性极低)和严重不良事件(RR 1.70, 95% CI 0.46 ~ 6.32;1项随机对照试验,281名受试者;证据的确定性非常低)。作者的结论:我们非常不确定鲁拉西酮是否对精神分裂症患者的精神状态有益,总的严重不良事件,或者与典型的抗精神病药物相比,严重的不良事件。本综述中纳入的证据的确定性非常低,来自两个小型试验。研究的局限性(偏倚风险)和不精确的结果影响了我们对证据的信心。此外,关于死亡率(由于自杀或自然原因)或生活质量的数据也没有。需要进一步的大规模随机研究来更清楚地了解鲁拉西酮与典型抗精神病药物治疗精神分裂症的利弊。
{"title":"Lurasidone versus typical antipsychotics for schizophrenia.","authors":"Dawid Storman, Magdalena Koperny, Krzysztof Styczeñ, Wojciech Datka, Rafal R Jaeschke","doi":"10.1002/14651858.CD012429.pub2","DOIUrl":"10.1002/14651858.CD012429.pub2","url":null,"abstract":"<p><strong>Background: </strong>Antipsychotic drugs are the mainstay of treatment for schizophrenia. Even though several novel second-generation antipsychotics (i.e. lurasidone, iloperidone and cariprazine) have been approved in recent years, typical antipsychotics (e.g. chlorpromazine, haloperidol, and fluphenazine) remain a crucial therapeutic option for the condition around the world. Little is known about the relative risk-to-benefit ratio of the 'latest' second-generation antipsychotics compared to the typical agents of 'established stature'.</p><p><strong>Objectives: </strong>To systematically review the efficacy and safety of lurasidone versus typical antipsychotics for adults with schizophrenia or schizophrenia-related disorders.</p><p><strong>Search methods: </strong>We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials on 5 June 2019. We also ran an update search in CENTRAL, MEDLINE, Embase, and three additional databases as well as two trial registers and the US Food and Drug Administration database on 1 April 2024.</p><p><strong>Selection criteria: </strong>We searched for randomized controlled trials (RCTs) comparing lurasidonewith typical antipsychotic drugs (such as chlorpromazine, fluphenazine, haloperidol, loxapine, mesoridazine, molindone, perphenazine, thioridazine, thiothixene, zuclopenthixol) for adults with schizophrenia. No additional search restrictions were applied.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methodological procedures. We extracted information on participant characteristics, interventions, study outcomes, study design, trial methods, and funding sources. Two review authors independently extracted data and assessed the risk of bias. We assessed the certainty of evidence with GRADE for these key outcomes: change in mental state, death by suicide or natural cause, quality of life, total serious adverse events and severe adverse events (as defined by study authors).</p><p><strong>Main results: </strong>We included two studies with a total of 308 individuals diagnosed with schizophrenia (220 men and 85 women). A total of 223 participants received lurasidone (20, 40, or 80 mg/day), and 82 received haloperidol (up to 10 mg/day) or perphenazine (up to 32 mg/day); three people did not receive any study medication. Both studies were performed in the US. The duration of the follow-up was four to six weeks. Death by suicide/natural causes and quality of life were not reported by the two included studies. The evidence is very uncertain about the effects of lurasidone on change in mental state: the Brief Psychiatric Rating Scale (BPRS) (MD 3.74, 95% CI 0.57 to 6.90; 1 RCT, 281 participants; very low-certainty evidence); and the Positive and Negative Syndrome Scale (PANSS) (MD 6.68, 95% CI 2.45 to 10.91; 1 RCT, 281 participants; very low-certainty evidence). The evidence is also very uncertain about the effects of lurasidone on total serious adverse events (","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD012429"},"PeriodicalIF":8.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}