Pub Date : 2024-08-01Epub Date: 2024-06-11DOI: 10.1007/s12325-024-02902-0
Mark Gudesblatt, Barbara Bumstead, Marijean Buhse, Myassar Zarif, Sarah A Morrow, Jacqueline A Nicholas, Laura M Hancock, Jeffrey Wilken, Joanna Weller, Nicole Scott, Anne Gocke, James B Lewin, Olivia Kaczmarek, Jason P Mendoza, Daniel Golan
Introduction: Switching disease-modifying therapy (DMT) may be considered for relapsing-remitting multiple sclerosis (RRMS) if a patient's current therapy is no longer optimal. This was particularly important during the recent COVID-19 pandemic because of considerations around immune deficiency and impaired vaccine response associated with B cell-depleting DMTs. This real-world, single-center study aimed to evaluate change or decline in functional ability and overall disease stability in people with RRMS who were switched from B cell-depleting ocrelizumab (OCRE) to diroximel fumarate (DRF) because of safety concern related to the COVID-19 pandemic.
Methods: Adults with RRMS were included if they had been clinically stable for ≥ 1 year on OCRE. Data collected at baseline and 1 year post switch included relapse rate, magnetic resonance imaging (MRI), blood work for assessment of peripheral immune parameters, the Cognitive Assessment Battery (CAB), optical coherence tomography (OCT), and patient-reported outcomes (PROs).
Results: Participants (N = 25) had a mean (SD) age of 52 (9) years, and a mean (SD) duration of 26 (8) months' treatment with OCRE before the switch to DRF. Median washout duration since the last OCRE infusion was 7 months (range 4-18 months). No participants relapsed on DRF during follow-up, and all remained persistent on DRF after 1 year. There were no significant changes in peripheral immune parameters, other than an increase in the percentage of CD19+ cells 1 year after switching (p < 0.05). Similarly, there were no significant changes in CAB, OCT, and PROs.
Conclusion: These preliminary findings suggest that transition to DRF from OCRE may be an effective treatment option for people with RRMS who are clinically stable but may need to switch for reasons unrelated to effectiveness. Longer follow-up times on larger samples are needed to confirm these observations.
{"title":"De-escalation of Disease-Modifying Therapy for People with Multiple Sclerosis Due to Safety Considerations: Characterizing 1-Year Outcomes in 25 People Who Switched from Ocrelizumab to Diroximel Fumarate.","authors":"Mark Gudesblatt, Barbara Bumstead, Marijean Buhse, Myassar Zarif, Sarah A Morrow, Jacqueline A Nicholas, Laura M Hancock, Jeffrey Wilken, Joanna Weller, Nicole Scott, Anne Gocke, James B Lewin, Olivia Kaczmarek, Jason P Mendoza, Daniel Golan","doi":"10.1007/s12325-024-02902-0","DOIUrl":"10.1007/s12325-024-02902-0","url":null,"abstract":"<p><strong>Introduction: </strong>Switching disease-modifying therapy (DMT) may be considered for relapsing-remitting multiple sclerosis (RRMS) if a patient's current therapy is no longer optimal. This was particularly important during the recent COVID-19 pandemic because of considerations around immune deficiency and impaired vaccine response associated with B cell-depleting DMTs. This real-world, single-center study aimed to evaluate change or decline in functional ability and overall disease stability in people with RRMS who were switched from B cell-depleting ocrelizumab (OCRE) to diroximel fumarate (DRF) because of safety concern related to the COVID-19 pandemic.</p><p><strong>Methods: </strong>Adults with RRMS were included if they had been clinically stable for ≥ 1 year on OCRE. Data collected at baseline and 1 year post switch included relapse rate, magnetic resonance imaging (MRI), blood work for assessment of peripheral immune parameters, the Cognitive Assessment Battery (CAB), optical coherence tomography (OCT), and patient-reported outcomes (PROs).</p><p><strong>Results: </strong>Participants (N = 25) had a mean (SD) age of 52 (9) years, and a mean (SD) duration of 26 (8) months' treatment with OCRE before the switch to DRF. Median washout duration since the last OCRE infusion was 7 months (range 4-18 months). No participants relapsed on DRF during follow-up, and all remained persistent on DRF after 1 year. There were no significant changes in peripheral immune parameters, other than an increase in the percentage of CD19<sup>+</sup> cells 1 year after switching (p < 0.05). Similarly, there were no significant changes in CAB, OCT, and PROs.</p><p><strong>Conclusion: </strong>These preliminary findings suggest that transition to DRF from OCRE may be an effective treatment option for people with RRMS who are clinically stable but may need to switch for reasons unrelated to effectiveness. Longer follow-up times on larger samples are needed to confirm these observations.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263251/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141299702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-14DOI: 10.1007/s12325-024-02900-2
Bhumika Aggarwal, Mohamed Al-Moamary, Riyad Allehebi, Ashraf Alzaabi, Mona Al-Ahmad, Muhammad Amin, Triya Damayanti, Nguyen Van Tho, Pham Thi Le Quyen, Thitiwat Sriprasart, Orapan Poachanukoon, Andrea Ban Yu-Lin, Ahmad Izuanuddin Ismail, Maria Encarnita B Limpin, Steven Koenig, Gur Levy, Abhay Phansalkar, Farouz Rafih, Mark Silvey, Laura Miriams, Gary Milligan
Introduction: Asthma management is strongly dependent on physician and patient beliefs and perceptions about the disease and its long-term treatment. The APPaRENT 3 study was conducted to explore factors influencing treatment choice and to understand patients' and physicians' attitudes and perspectives on the use of controller inhalers in regular versus flexible dosing for asthma management.
Methods: This cross-sectional survey of patients with asthma and treating physicians was conducted in seven countries: Indonesia, Malaysia, Philippines, Thailand, Vietnam (patient survey only), Saudi Arabia, and the United Arab Emirates. Assessment was carried out through an online/face-to-face questionnaire, where patients' viewpoints were focused on their attitudes and beliefs about asthma and treatment adherence, whereas physicians' viewpoints were gathered on their attitudes and beliefs about asthma management, knowledge of and adherence to asthma treatment guidelines, and asthma treatment regimens.
Results: Overall, 1400 patients (mean age, 34 years) and 599 physicians (mean age, 43 years) were included in the survey. Physicians similarly prioritised symptom control (39%) and exacerbation reduction (40%) in moderate asthma, whereas patients prioritised symptom control (41%) over exacerbation reduction (22%). Although both groups (physicians, 86%; patients, 84%) perceived asthma as well-controlled, poor management was evident based on Asthma Control Test (ACT) scores (mean, 15.7; standard deviation, 4.14; 82% had an ACT score < 20) and high symptom burden (39% reported nighttime awakenings or early mornings ≥ 2 nights/week). Most patients (76%) with moderate asthma were prescribed regular dosing, with the most common treatment being inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) with as-needed inhaled short-acting β2-agonist (SABA; 20%). Among patients on maintenance and reliever therapy, 93% of patients received a separate inhaled reliever.
Conclusions: Despite high symptom burden, patients overestimated their level of asthma control. Physicians prioritised controlling symptoms and reducing exacerbations as treatment goals for moderate asthma, often prescribing regular dosing with ICS/LABA with as-needed inhaled SABA.
{"title":"APPaRENT 3: Asthma Patients' and Physicians' Perspectives on the Burden and Management of Asthma in Seven Countries.","authors":"Bhumika Aggarwal, Mohamed Al-Moamary, Riyad Allehebi, Ashraf Alzaabi, Mona Al-Ahmad, Muhammad Amin, Triya Damayanti, Nguyen Van Tho, Pham Thi Le Quyen, Thitiwat Sriprasart, Orapan Poachanukoon, Andrea Ban Yu-Lin, Ahmad Izuanuddin Ismail, Maria Encarnita B Limpin, Steven Koenig, Gur Levy, Abhay Phansalkar, Farouz Rafih, Mark Silvey, Laura Miriams, Gary Milligan","doi":"10.1007/s12325-024-02900-2","DOIUrl":"10.1007/s12325-024-02900-2","url":null,"abstract":"<p><strong>Introduction: </strong>Asthma management is strongly dependent on physician and patient beliefs and perceptions about the disease and its long-term treatment. The APPaRENT 3 study was conducted to explore factors influencing treatment choice and to understand patients' and physicians' attitudes and perspectives on the use of controller inhalers in regular versus flexible dosing for asthma management.</p><p><strong>Methods: </strong>This cross-sectional survey of patients with asthma and treating physicians was conducted in seven countries: Indonesia, Malaysia, Philippines, Thailand, Vietnam (patient survey only), Saudi Arabia, and the United Arab Emirates. Assessment was carried out through an online/face-to-face questionnaire, where patients' viewpoints were focused on their attitudes and beliefs about asthma and treatment adherence, whereas physicians' viewpoints were gathered on their attitudes and beliefs about asthma management, knowledge of and adherence to asthma treatment guidelines, and asthma treatment regimens.</p><p><strong>Results: </strong>Overall, 1400 patients (mean age, 34 years) and 599 physicians (mean age, 43 years) were included in the survey. Physicians similarly prioritised symptom control (39%) and exacerbation reduction (40%) in moderate asthma, whereas patients prioritised symptom control (41%) over exacerbation reduction (22%). Although both groups (physicians, 86%; patients, 84%) perceived asthma as well-controlled, poor management was evident based on Asthma Control Test (ACT) scores (mean, 15.7; standard deviation, 4.14; 82% had an ACT score < 20) and high symptom burden (39% reported nighttime awakenings or early mornings ≥ 2 nights/week). Most patients (76%) with moderate asthma were prescribed regular dosing, with the most common treatment being inhaled corticosteroid (ICS)/long-acting β<sub>2</sub>-agonist (LABA) with as-needed inhaled short-acting β<sub>2</sub>-agonist (SABA; 20%). Among patients on maintenance and reliever therapy, 93% of patients received a separate inhaled reliever.</p><p><strong>Conclusions: </strong>Despite high symptom burden, patients overestimated their level of asthma control. Physicians prioritised controlling symptoms and reducing exacerbations as treatment goals for moderate asthma, often prescribing regular dosing with ICS/LABA with as-needed inhaled SABA.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141316503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-25DOI: 10.1007/s12325-024-02914-w
Gabriel Garcia, Sven C van Dijkman, Ian Pavord, Dave Singh, Sean Oosterholt, Sourabh Fulmali, Anurita Majumdar, Oscar Della Pasqua
Introduction: The relationship between immediate symptom control, reliever medication use and exacerbation risk on treatment response and factors that modify it have not been assessed in an integrated manner. Here we apply simulation scenarios to evaluate the effect of individual baseline characteristics on treatment response in patients with moderate-severe asthma on regular maintenance dosing monotherapy with fluticasone propionate (FP) or combination therapy with fluticasone propionate/salmeterol (FP/SAL) or budesonide/formoterol (BUD/FOR).
Methods: Reduction in reliever medication use (puffs/24 h), change in symptom control scores (ACQ-5), and annualised exacerbation rate over 12 months were simulated in a cohort of patients with different baseline characteristics (e.g. time since diagnosis, asthma control questionnaire (ACQ-5) symptom score, smoking status, body mass index (BMI) and sex) using drug-disease models derived from large phase III/IV clinical studies.
Results: Simulation scenarios show that being a smoker, having higher baseline ACQ-5 and BMI, and long asthma history is associated with increased reliever medication use (p < 0.01). This increase correlates with a higher exacerbation risk and higher ACQ-5 scores over the course of treatment, irrespective of the underlying maintenance therapy. Switching non-responders to ICS monotherapy to combination therapy after 3 months resulted in immediate reduction in reliever medication use (i.e. 1.3 vs. 1.0 puffs/24 h for FP/SAL and BUD/FOR, respectively). In addition, switching patients with ACQ-5 > 1.5 at baseline to FP/SAL resulted in 34% less exacerbations than those receiving regular dosing BUD/FOR (p < 0.01).
Conclusions: We have identified baseline characteristics of patients with moderate to severe asthma that are associated with greater reliever medication use, poor symptom control and higher exacerbation risk. Moreover, the effects of different inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) combinations vary significantly when considering long-term treatment performance. These factors should be considered in clinical practice as a basis for personalised management of patients with moderate-severe asthma symptoms.
{"title":"A Simulation Study of the Effect of Clinical Characteristics and Treatment Choice on Reliever Medication Use, Symptom Control and Exacerbation Risk in Moderate-Severe Asthma.","authors":"Gabriel Garcia, Sven C van Dijkman, Ian Pavord, Dave Singh, Sean Oosterholt, Sourabh Fulmali, Anurita Majumdar, Oscar Della Pasqua","doi":"10.1007/s12325-024-02914-w","DOIUrl":"10.1007/s12325-024-02914-w","url":null,"abstract":"<p><strong>Introduction: </strong>The relationship between immediate symptom control, reliever medication use and exacerbation risk on treatment response and factors that modify it have not been assessed in an integrated manner. Here we apply simulation scenarios to evaluate the effect of individual baseline characteristics on treatment response in patients with moderate-severe asthma on regular maintenance dosing monotherapy with fluticasone propionate (FP) or combination therapy with fluticasone propionate/salmeterol (FP/SAL) or budesonide/formoterol (BUD/FOR).</p><p><strong>Methods: </strong>Reduction in reliever medication use (puffs/24 h), change in symptom control scores (ACQ-5), and annualised exacerbation rate over 12 months were simulated in a cohort of patients with different baseline characteristics (e.g. time since diagnosis, asthma control questionnaire (ACQ-5) symptom score, smoking status, body mass index (BMI) and sex) using drug-disease models derived from large phase III/IV clinical studies.</p><p><strong>Results: </strong>Simulation scenarios show that being a smoker, having higher baseline ACQ-5 and BMI, and long asthma history is associated with increased reliever medication use (p < 0.01). This increase correlates with a higher exacerbation risk and higher ACQ-5 scores over the course of treatment, irrespective of the underlying maintenance therapy. Switching non-responders to ICS monotherapy to combination therapy after 3 months resulted in immediate reduction in reliever medication use (i.e. 1.3 vs. 1.0 puffs/24 h for FP/SAL and BUD/FOR, respectively). In addition, switching patients with ACQ-5 > 1.5 at baseline to FP/SAL resulted in 34% less exacerbations than those receiving regular dosing BUD/FOR (p < 0.01).</p><p><strong>Conclusions: </strong>We have identified baseline characteristics of patients with moderate to severe asthma that are associated with greater reliever medication use, poor symptom control and higher exacerbation risk. Moreover, the effects of different inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) combinations vary significantly when considering long-term treatment performance. These factors should be considered in clinical practice as a basis for personalised management of patients with moderate-severe asthma symptoms.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-18DOI: 10.1007/s12325-024-02908-8
Lidan Yi, Xiaohui Zeng, Zhen Zhou, Qiao Liu
Introduction: This study sought to investigate the affordable price of sotorasib among patients with previously treated advanced KRASG12C-mutant non-small cell lung cancer (NSCLC) through a cost-effectiveness analysis from the perspectives of both the Chinese healthcare system and the patients.
Methods: We developed a Markov model spanning a 20-year time horizon with a cycle length of 21 days. Our data were derived from the CodeBreaK 200 clinical trial, supplemented with published literature, publicly available national databases, and local hospitals. The primary outcomes were the affordable prices of sotorasib which would result in the incremental cost-effectiveness ratios (ICERs) of sotorasib relative to docetaxel below the preset willing-to-pay (WTP) threshold. Sensitivity analyses were performed to evaluate the model's robustness.
Results: At the national level, from the perspective of the Chinese healthcare system and patients, the price of sotorasib should be lower than US$0.04673 and $0.03231, respectively, to make it affordable, which is equivalent to $1346 and $931 per box (120 mg × 240 pieces). At the provincial level, the price ceiling of sotorasib/mg fluctuated between $0.04084 to $0.08061 from the Chinese healthcare system's perspective and between $0.02642 to $0.06620 from the patients' perspective. Probabilistic sensitivity analyses revealed that, as the price of sotorasib decreased, its likelihood of being cost-effective increased.
Conclusion: Sotorasib might be a cost-effective therapy in China. The pharmaco-economic evidence generated from this study has significant implications not only for guiding the drug pricing of the upcoming sotorasib but also for determining the reimbursement ratio for its potential inclusion in the National Reimbursement Drugs List in the future.
{"title":"Comparison Between Sotorasib with Docetaxel for the Treatment of Chinese Patients with Previously Treated NSCLC with KRASG12C Mutation: A Cost-Effectiveness Analysis to Inform Drug Pricing.","authors":"Lidan Yi, Xiaohui Zeng, Zhen Zhou, Qiao Liu","doi":"10.1007/s12325-024-02908-8","DOIUrl":"10.1007/s12325-024-02908-8","url":null,"abstract":"<p><strong>Introduction: </strong>This study sought to investigate the affordable price of sotorasib among patients with previously treated advanced KRASG12C-mutant non-small cell lung cancer (NSCLC) through a cost-effectiveness analysis from the perspectives of both the Chinese healthcare system and the patients.</p><p><strong>Methods: </strong>We developed a Markov model spanning a 20-year time horizon with a cycle length of 21 days. Our data were derived from the CodeBreaK 200 clinical trial, supplemented with published literature, publicly available national databases, and local hospitals. The primary outcomes were the affordable prices of sotorasib which would result in the incremental cost-effectiveness ratios (ICERs) of sotorasib relative to docetaxel below the preset willing-to-pay (WTP) threshold. Sensitivity analyses were performed to evaluate the model's robustness.</p><p><strong>Results: </strong>At the national level, from the perspective of the Chinese healthcare system and patients, the price of sotorasib should be lower than US$0.04673 and $0.03231, respectively, to make it affordable, which is equivalent to $1346 and $931 per box (120 mg × 240 pieces). At the provincial level, the price ceiling of sotorasib/mg fluctuated between $0.04084 to $0.08061 from the Chinese healthcare system's perspective and between $0.02642 to $0.06620 from the patients' perspective. Probabilistic sensitivity analyses revealed that, as the price of sotorasib decreased, its likelihood of being cost-effective increased.</p><p><strong>Conclusion: </strong>Sotorasib might be a cost-effective therapy in China. The pharmaco-economic evidence generated from this study has significant implications not only for guiding the drug pricing of the upcoming sotorasib but also for determining the reimbursement ratio for its potential inclusion in the National Reimbursement Drugs List in the future.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141417280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-11DOI: 10.1007/s12325-024-02888-9
Ashley Ross, Kelsie Brewer, Stacie Hudgens, Bruce Brown, Mark Fallick, Simon de Paauw-Holt, Bhakti Arondekar, Jennifer Clegg, Elke Hunsche
Introduction: This qualitative research study was conducted to develop a novel, comprehensive, patient-reported outcome measure (PRO), the "Symptoms and Impacts of Androgen Deprivation Therapy (ADT) for Prostate Cancer" (SIADT-PC), assessing hormonal therapy-related symptoms and their impacts on men with advanced prostate cancer.
Methods: Concept elicitation (CE) interviews were conducted among adult men with prostate cancer to evaluate their experiences with ADT. Based on key symptom and impact concepts mentioned, an initial PRO measure was developed. The draft measure was further assessed in cognitive debriefing (CD) interviews with men with prostate cancer, in which participants reviewed items, response options, and recall periods. Initial item-based psychometric analyses were conducted using interview data. The draft questionnaire was revised on the basis of participant feedback, quantitative psychometric results, and consultation with clinical experts.
Results: A total of 21 participants were interviewed (CE concept elicitation, n = 12; CD cognitive debriefing, n = 17; n = 8 completed both). Mean participant age (SD) was 59.7 (8.7) years and 76.2% were white. The de novo SIADT-PC measure consists of 27 items: 11 symptoms (e.g., fatigue, hot flashes, and erectile dysfunction), 2 long-term symptoms (e.g., weight gain), 10 impacts (e.g., impacts on physical activities and relationships), and 4 related to mode of administration (i.e., injection-site reactions). Items were assessed with a 5-point verbal rating scale, with answer choices that capture frequency or severity.
Conclusions: Once fully validated, this de novo measure may be used in clinical studies and clinical practice to assess hormone therapy-related symptoms and impacts, enabling physicians to identify timely and appropriate interventions.
{"title":"Development of a Novel Patient-Reported Outcome Measure to Assess Symptoms and Impacts of Androgen Deprivation Therapy for Advanced Prostate Cancer.","authors":"Ashley Ross, Kelsie Brewer, Stacie Hudgens, Bruce Brown, Mark Fallick, Simon de Paauw-Holt, Bhakti Arondekar, Jennifer Clegg, Elke Hunsche","doi":"10.1007/s12325-024-02888-9","DOIUrl":"10.1007/s12325-024-02888-9","url":null,"abstract":"<p><strong>Introduction: </strong>This qualitative research study was conducted to develop a novel, comprehensive, patient-reported outcome measure (PRO), the \"Symptoms and Impacts of Androgen Deprivation Therapy (ADT) for Prostate Cancer\" (SIADT-PC), assessing hormonal therapy-related symptoms and their impacts on men with advanced prostate cancer.</p><p><strong>Methods: </strong>Concept elicitation (CE) interviews were conducted among adult men with prostate cancer to evaluate their experiences with ADT. Based on key symptom and impact concepts mentioned, an initial PRO measure was developed. The draft measure was further assessed in cognitive debriefing (CD) interviews with men with prostate cancer, in which participants reviewed items, response options, and recall periods. Initial item-based psychometric analyses were conducted using interview data. The draft questionnaire was revised on the basis of participant feedback, quantitative psychometric results, and consultation with clinical experts.</p><p><strong>Results: </strong>A total of 21 participants were interviewed (CE concept elicitation, n = 12; CD cognitive debriefing, n = 17; n = 8 completed both). Mean participant age (SD) was 59.7 (8.7) years and 76.2% were white. The de novo SIADT-PC measure consists of 27 items: 11 symptoms (e.g., fatigue, hot flashes, and erectile dysfunction), 2 long-term symptoms (e.g., weight gain), 10 impacts (e.g., impacts on physical activities and relationships), and 4 related to mode of administration (i.e., injection-site reactions). Items were assessed with a 5-point verbal rating scale, with answer choices that capture frequency or severity.</p><p><strong>Conclusions: </strong>Once fully validated, this de novo measure may be used in clinical studies and clinical practice to assess hormone therapy-related symptoms and impacts, enabling physicians to identify timely and appropriate interventions.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263404/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141299703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Severe exacerbations of chronic obstructive pulmonary disease (COPD) are known to increase the risk of cardiovascular events. However, this association has not been investigated specifically in patients with COPD in Japan, whose characteristics may differ from those of Western patients (i.e., western Europe, the US, and Canada).
Methods: This longitudinal retrospective cohort study analyzed secondary claims data and included patients aged ≥ 40 years with COPD (International Classification of Diseases-10 codes J41-J44). All exacerbations occurring during follow-up were measured. Time-dependent Cox models were used to estimate hazard ratios (HRs) for the association between time periods following an exacerbation of COPD (vs. time prior to a first exacerbation) and occurrence of a first hospitalization for a severe fatal or non-fatal cardiovascular event.
Results: The analysis included 152,712 patients with COPD with a mean age of 73.8 years and 37.6% of whom were female. During a median follow-up of 37 months, 63,182 (41.4%) patients experienced ≥ 1 exacerbation and 13,314 (8.7%) patients experienced ≥ 1 severe cardiovascular event. Following an exacerbation of COPD, the risk of a severe cardiovascular event was increased in the first 30 days [adjusted HR (aHR) 1.44, 95% confidence interval (CI) 1.33-1.55] and remained elevated for 365 days post-exacerbation (aHR 1.13, 95% CI 1.04-1.23). Specifically, the risks of acute coronary syndrome or arrhythmias remained significantly increased for up to 180 days, and the risk of decompensated heart failure for 1 year.
Conclusion: Among Japanese patients with COPD, the risk of experiencing a severe cardiovascular event increased following a COPD exacerbation and remained elevated for 365 days, emphasizing the need to prevent exacerbations.
{"title":"Increased Risk of Severe Cardiovascular Events Following Exacerbations of Chronic Obstructive Pulmonary Disease: Results of the EXACOS-CV Study in Japan.","authors":"Kazuto Matsunaga, Yuri Yoshida, Naoyuki Makita, Kenichiro Nishida, Kirsty Rhodes, Clementine Nordon","doi":"10.1007/s12325-024-02920-y","DOIUrl":"10.1007/s12325-024-02920-y","url":null,"abstract":"<p><strong>Introduction: </strong>Severe exacerbations of chronic obstructive pulmonary disease (COPD) are known to increase the risk of cardiovascular events. However, this association has not been investigated specifically in patients with COPD in Japan, whose characteristics may differ from those of Western patients (i.e., western Europe, the US, and Canada).</p><p><strong>Methods: </strong>This longitudinal retrospective cohort study analyzed secondary claims data and included patients aged ≥ 40 years with COPD (International Classification of Diseases-10 codes J41-J44). All exacerbations occurring during follow-up were measured. Time-dependent Cox models were used to estimate hazard ratios (HRs) for the association between time periods following an exacerbation of COPD (vs. time prior to a first exacerbation) and occurrence of a first hospitalization for a severe fatal or non-fatal cardiovascular event.</p><p><strong>Results: </strong>The analysis included 152,712 patients with COPD with a mean age of 73.8 years and 37.6% of whom were female. During a median follow-up of 37 months, 63,182 (41.4%) patients experienced ≥ 1 exacerbation and 13,314 (8.7%) patients experienced ≥ 1 severe cardiovascular event. Following an exacerbation of COPD, the risk of a severe cardiovascular event was increased in the first 30 days [adjusted HR (aHR) 1.44, 95% confidence interval (CI) 1.33-1.55] and remained elevated for 365 days post-exacerbation (aHR 1.13, 95% CI 1.04-1.23). Specifically, the risks of acute coronary syndrome or arrhythmias remained significantly increased for up to 180 days, and the risk of decompensated heart failure for 1 year.</p><p><strong>Conclusion: </strong>Among Japanese patients with COPD, the risk of experiencing a severe cardiovascular event increased following a COPD exacerbation and remained elevated for 365 days, emphasizing the need to prevent exacerbations.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263248/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141553984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-21DOI: 10.1007/s12325-024-02910-0
Vera A Kachko, Lee P Shulman, Irina V Kuznetsova, Yulia B Uspenskaya, Denis I Burchakov
Introduction: Perimenopause is a time of transition in a woman's life that links her reproductive years to the cessation of ovulation, or menopause. For many women, this time is characterized by a variety of physiological and lifestyle changes, including increasing irregularity in menstrual bleeding, frequency and severity of vasomotor symptoms, etc. Therapies evaluated specifically for the perimenopausal women are very limited. This study aimed to evaluate the effectiveness and safety of Amberen® (a succinate-based non-hormonal supplement) combined with a Smart B® (vitamin B) complex in women with typical (without complications) mild to moderate climacteric syndrome during perimenopause.
Methods: Women up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.
Results: A total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.
Conclusion: The use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life.
{"title":"Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen<sup>®</sup> and Smart B<sup>®</sup> in Women with Climacteric Syndrome in Perimenopause.","authors":"Vera A Kachko, Lee P Shulman, Irina V Kuznetsova, Yulia B Uspenskaya, Denis I Burchakov","doi":"10.1007/s12325-024-02910-0","DOIUrl":"10.1007/s12325-024-02910-0","url":null,"abstract":"<p><strong>Introduction: </strong>Perimenopause is a time of transition in a woman's life that links her reproductive years to the cessation of ovulation, or menopause. For many women, this time is characterized by a variety of physiological and lifestyle changes, including increasing irregularity in menstrual bleeding, frequency and severity of vasomotor symptoms, etc. Therapies evaluated specifically for the perimenopausal women are very limited. This study aimed to evaluate the effectiveness and safety of Amberen<sup>®</sup> (a succinate-based non-hormonal supplement) combined with a Smart B<sup>®</sup> (vitamin B) complex in women with typical (without complications) mild to moderate climacteric syndrome during perimenopause.</p><p><strong>Methods: </strong>Women up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.</p><p><strong>Results: </strong>A total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.</p><p><strong>Conclusion: </strong>The use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT03897738.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141431147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-08DOI: 10.1007/s12325-024-02882-1
Patrick Connor Johnson, Abigail Bailey, Qiufei Ma, Neil Milloy, Emilia Biondi, Ruben G W Quek, Sarah Weatherby, Sophie Barlow
Introduction: Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin's lymphoma (NHL), characterized by a long natural course of remissions/relapses. We aimed to evaluate real-world quality of life (QoL) in patients with FL, by line of therapy (LOT), and across countries.
Methods: Data were drawn from the Adelphi FL Disease Specific Programme™, a cross-sectional survey of physicians and their patients in Europe [France, Germany, Italy, Spain, the United Kingdom (UK)], and the United States (US) from June 2021 to January 2022. Patients provided demographics and patient-reported outcomes via the European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Bivariate analysis assessed QoL versus NHL, across LOT [first line (1L), second line (2L), third line or later (3L+)] and country.
Results: Patients (n = 401) had a mean [standard deviation (SD)] age of 66.0 (9.24) years, 58.1% were male, and 41.9%/22.9% were Ann Arbor stage III/IV. Patients with FL mean EORTC global health status (GHS)/QoL, nausea/vomiting, pain, dyspnea, appetite loss, and diarrhea scores were statistically significantly worse (p < 0.05) versus the NHL reference values. Mean (SD) GHS/QoL worsened from 1L [56.5 (22.21)] to 3L+ [50.4 (20.11)]. Physical and role functioning, fatigue, pain, dyspnea, and diarrhea scores also significantly worsened across later LOTs (p < 0.05). Across all functional domains, mean scores were significantly lower (p < 0.05) and almost all symptom scores (excluding diarrhea) were significantly higher (p < 0.05) for European versus US patients.
Conclusions: Patients with FL at later LOTs had significantly worse scores in most QoL aspects than earlier LOTs. European patients had significantly lower functioning and higher symptom burden than in the US. These real-world findings highlight the need for novel FL therapies that alleviate patient burden, positively impacting QoL.
简介滤泡性淋巴瘤(FL)是非霍奇金淋巴瘤(NHL)的一种隐匿性亚型,其特点是缓解/复发的自然病程较长。我们的目的是评估FL患者在现实世界中的生活质量(QoL),按治疗方案(LOT)和国家进行评估:数据来自阿德尔菲 FL 特定疾病计划(Adelphi FL Disease Specific Programme™),这是一项于 2021 年 6 月至 2022 年 1 月对欧洲(法国、德国、意大利、西班牙、英国)和美国的医生及其患者进行的横断面调查。患者通过欧洲癌症研究和治疗组织 QoL 问卷(EORTC QLQ-C30)提供人口统计数据和患者报告结果。双变量分析评估了QoL与NHL、LOT[一线(1L)、二线(2L)、三线或三线以上(3L+)]和国家的关系:患者(n = 401)的平均[标准差(SD)]年龄为 66.0 (9.24)岁,58.1%为男性,41.9%/22.9%为Ann Arbor III/IV期。FL患者的平均EORTC总体健康状况(GHS)/生活质量(QoL)、恶心/呕吐、疼痛、呼吸困难、食欲不振和腹泻评分在统计学上明显降低(P晚期 LOT 的 FL 患者在大多数 QoL 方面的得分明显低于早期 LOT 患者。与美国相比,欧洲患者的功能明显较低,症状负担较重。这些真实世界的研究结果凸显了对新型 FL 疗法的需求,这种疗法可减轻患者的负担,并对 QoL 产生积极影响。
{"title":"Quality of Life Evaluation in Patients with Follicular Cell Lymphoma: A Real-World Study in Europe and the United States.","authors":"Patrick Connor Johnson, Abigail Bailey, Qiufei Ma, Neil Milloy, Emilia Biondi, Ruben G W Quek, Sarah Weatherby, Sophie Barlow","doi":"10.1007/s12325-024-02882-1","DOIUrl":"10.1007/s12325-024-02882-1","url":null,"abstract":"<p><strong>Introduction: </strong>Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin's lymphoma (NHL), characterized by a long natural course of remissions/relapses. We aimed to evaluate real-world quality of life (QoL) in patients with FL, by line of therapy (LOT), and across countries.</p><p><strong>Methods: </strong>Data were drawn from the Adelphi FL Disease Specific Programme™, a cross-sectional survey of physicians and their patients in Europe [France, Germany, Italy, Spain, the United Kingdom (UK)], and the United States (US) from June 2021 to January 2022. Patients provided demographics and patient-reported outcomes via the European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Bivariate analysis assessed QoL versus NHL, across LOT [first line (1L), second line (2L), third line or later (3L+)] and country.</p><p><strong>Results: </strong>Patients (n = 401) had a mean [standard deviation (SD)] age of 66.0 (9.24) years, 58.1% were male, and 41.9%/22.9% were Ann Arbor stage III/IV. Patients with FL mean EORTC global health status (GHS)/QoL, nausea/vomiting, pain, dyspnea, appetite loss, and diarrhea scores were statistically significantly worse (p < 0.05) versus the NHL reference values. Mean (SD) GHS/QoL worsened from 1L [56.5 (22.21)] to 3L+ [50.4 (20.11)]. Physical and role functioning, fatigue, pain, dyspnea, and diarrhea scores also significantly worsened across later LOTs (p < 0.05). Across all functional domains, mean scores were significantly lower (p < 0.05) and almost all symptom scores (excluding diarrhea) were significantly higher (p < 0.05) for European versus US patients.</p><p><strong>Conclusions: </strong>Patients with FL at later LOTs had significantly worse scores in most QoL aspects than earlier LOTs. European patients had significantly lower functioning and higher symptom burden than in the US. These real-world findings highlight the need for novel FL therapies that alleviate patient burden, positively impacting QoL.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141553942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-08DOI: 10.1007/s12325-024-02937-3
Yujin Lee, Dominik Zalewski, Piotr Oleksy, Edward Wylęgała, Michał Orski, Jiwon Lee, Sunji Kim
Introduction: SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO).
Methods: This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.
Results: A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.
Conclusions: This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.
Trial registration: ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.
{"title":"Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases.","authors":"Yujin Lee, Dominik Zalewski, Piotr Oleksy, Edward Wylęgała, Michał Orski, Jiwon Lee, Sunji Kim","doi":"10.1007/s12325-024-02937-3","DOIUrl":"10.1007/s12325-024-02937-3","url":null,"abstract":"<p><strong>Introduction: </strong>SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis<sup>®</sup>; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO).</p><p><strong>Methods: </strong>This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.</p><p><strong>Results: </strong>A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.</p><p><strong>Conclusions: </strong>This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141553944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-11DOI: 10.1007/s12325-024-02903-z
Hongxia Wu, Kaiquan Zhuo, Li Guo, Faming Jiang, Bo Zhang, Ye Wang, Deyun Cheng
Introduction: Pulmonary artery (PA) masses are rare. Distinguishing PA tumours from embolism is sometimes difficult, and surgical biopsy is expensive and risky. We aimed to evaluate the efficacy of imaging-guided percutaneous endovascular biopsy (PEB) for obtaining tissues for histological diagnosis.
Methods: We searched Cochrane, Medline, Embase, and Web of Science for PEB trials involving patients with PA masses, published from the inception of the database until August 2023.
Results: We retrospectively reviewed 33 studies including 87 patients (median age 55 ± 69.3 years, 44 men) with PA masses who underwent a total of 110 PEBs. Of these patients, 34.5% (n = 38) underwent PEB-catheter aspiration (PEB-CA), 50.9% (n = 56) underwent PEB-forceps biopsy (PEB-FB) and 2.7% (n = 3) underwent PEB-directional atherectomy (PEB-DA). The most common histological aetiology of PA masses was mesenchymal tumours (n = 67, 75.9%). Tumour embolism (n = 6, 6.9%) and pulmonary embolism (n = 3, 3.4%) were the second and third most common types of PA masses, respectively. The technical success rates of PEB-CA, PEB-FB and PEB-DA were 92.1%, 94.6% and 100% (p = 0.796), respectively. Histopathological analysis provided clinical diagnostic success rates of 44.7%, 85.7% and 100% for PEB-CA, PEB-FB and PEB-DA (p < 0.001), respectively. In pairwise comparison, PEB-FB had a higher success rate in pathological diagnosis than PEB-CA (p = 0.000). Apart from one patient suffering from haemorrhagic cardiac tamponade, no other complications occurred.
Conclusion: Imaging-guided PEB is a safe and effective technique for the early pathological diagnosis of PA masses.
简介:肺动脉(PA)肿块非常罕见:肺动脉(PA)肿块非常罕见。有时很难将肺动脉肿瘤与栓塞区分开来,而手术活检既昂贵又有风险。我们旨在评估影像引导下经皮血管内活检(PEB)获取组织进行组织学诊断的有效性:我们检索了Cochrane、Medline、Embase和Web of Science数据库中从数据库建立之初到2023年8月发表的涉及PA肿块患者的PEB试验:我们回顾性研究了33项研究,包括87名PA肿块患者(中位年龄55±69.3岁,44名男性),他们共接受了110例PEB治疗。在这些患者中,34.5%(n = 38)接受了PEB-导管抽吸术(PEB-CA),50.9%(n = 56)接受了PEB-钳活检术(PEB-FB),2.7%(n = 3)接受了PEB-定向动脉瘤切除术(PEB-DA)。PA肿块最常见的组织学病因是间质瘤(67例,75.9%)。肿瘤栓塞(6例,6.9%)和肺栓塞(3例,3.4%)分别是第二和第三常见的PA肿块类型。PEB-CA、PEB-FB和PEB-DA的技术成功率分别为92.1%、94.6%和100%(P = 0.796)。组织病理学分析显示,PEB-CA、PEB-FB和PEB-DA的临床诊断成功率分别为44.7%、85.7%和100%(P 结论:PEB-CA、PEB-FB和PEB-DA的临床诊断成功率分别为92.1%、94.6%和100%:影像引导下 PEB 是一种安全有效的 PA 肿块早期病理诊断技术。
{"title":"Imaging-Guided Percutaneous Endovascular Biopsy Applied in Patients with Pulmonary Artery Masses: A Review.","authors":"Hongxia Wu, Kaiquan Zhuo, Li Guo, Faming Jiang, Bo Zhang, Ye Wang, Deyun Cheng","doi":"10.1007/s12325-024-02903-z","DOIUrl":"10.1007/s12325-024-02903-z","url":null,"abstract":"<p><strong>Introduction: </strong>Pulmonary artery (PA) masses are rare. Distinguishing PA tumours from embolism is sometimes difficult, and surgical biopsy is expensive and risky. We aimed to evaluate the efficacy of imaging-guided percutaneous endovascular biopsy (PEB) for obtaining tissues for histological diagnosis.</p><p><strong>Methods: </strong>We searched Cochrane, Medline, Embase, and Web of Science for PEB trials involving patients with PA masses, published from the inception of the database until August 2023.</p><p><strong>Results: </strong>We retrospectively reviewed 33 studies including 87 patients (median age 55 ± 69.3 years, 44 men) with PA masses who underwent a total of 110 PEBs. Of these patients, 34.5% (n = 38) underwent PEB-catheter aspiration (PEB-CA), 50.9% (n = 56) underwent PEB-forceps biopsy (PEB-FB) and 2.7% (n = 3) underwent PEB-directional atherectomy (PEB-DA). The most common histological aetiology of PA masses was mesenchymal tumours (n = 67, 75.9%). Tumour embolism (n = 6, 6.9%) and pulmonary embolism (n = 3, 3.4%) were the second and third most common types of PA masses, respectively. The technical success rates of PEB-CA, PEB-FB and PEB-DA were 92.1%, 94.6% and 100% (p = 0.796), respectively. Histopathological analysis provided clinical diagnostic success rates of 44.7%, 85.7% and 100% for PEB-CA, PEB-FB and PEB-DA (p < 0.001), respectively. In pairwise comparison, PEB-FB had a higher success rate in pathological diagnosis than PEB-CA (p = 0.000). Apart from one patient suffering from haemorrhagic cardiac tamponade, no other complications occurred.</p><p><strong>Conclusion: </strong>Imaging-guided PEB is a safe and effective technique for the early pathological diagnosis of PA masses.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141299704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}