BMJ medicine最新文献

Long covid as a long term condition.

BMJ medicine

Pub Date : 2025-01-31 eCollection Date: 2025-01-01 DOI: 10.1136/bmjmed-2025-001366

Manoj Sivan, Darren Charles C Greenwood, Tracey Smith

引用次数: 0

Blood level of neurofilament light chain as a biomarker for neurological disorders.

BMJ medicine

Pub Date : 2025-01-11 eCollection Date: 2025-01-01 DOI: 10.1136/bmjmed-2024-000958

Martin R Turner, Alexander G Thompson, Charlotte E Teunissen

引用次数: 0

Vaccine effectiveness against mild and severe covid-19 in pregnant individuals and their infants in England: test negative case-control study.

BMJ medicine

Pub Date : 2024-12-05 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000696

Freja C M Kirsebom, Nick Andrews, Anna A Mensah, Julia Stowe, Shamez Ladhani, Mary Ramsay, Jamie Lopez Bernal, Helen Julia Campbell

Objective: To estimate real world vaccine effectiveness against symptomatic disease and hospital admission with the delta and omicron variants of the SARS-CoV-2 virus in pregnant individuals, and to estimate the protection conferred by previous infection and maternal vaccination in their infants.Design: Test negative case-control study.Setting: Community and hospital testing for covid-19, in England, 26 April 2021 to 9 January 2022 (delta variant period) and 29 November 2021 to 31 March 2022 (omicron variant period). Testing data were linked to Hospital Episode Statistics and Maternal Services Data Set (for data on pregnant individuals and infants), National Immunisation Management System (for covid-19 vaccinations), and Secondary Uses Service (for hospital admissions).Participants: 35 206 negative and 16 693 positive eligible test results in the delta variant period from pregnant individuals with symptoms of infection, aged 16-55 years, whose pregnancy ended in 2021, and 5974 negative and 4715 positive eligible test results in the omicron variant period. For infants born in 2021, 23 053 negative and 2924 positive eligible test results in the delta variant period and 13 908 negative and 5669 positive test results from infants in the omicron period.Main outcome measures: Vaccine effectiveness against symptomatic disease and hospital admission with the delta and omicron variants of the SARS-CoV-2 virus in pregnant women. Also, effectiveness of maternal vaccination and the protection conferred by previous infection in mothers in preventing symptomatic disease and hospital admission in their infants in the first six months of life. Symptomatic SARS-CoV-2 infection was confirmed by a positive polymerase chain reaction test result.Results: Vaccine effectiveness against symptomatic disease (delta and omicron infection) and against hospital admission (delta infection only) in pregnant individuals was high, as seen in the general population. A booster dose of vaccine gave sustained protection, with no evidence of waning up to 15 weeks after vaccination. Vaccine effectiveness against symptomatic disease peaked at 98.4% (95% confidence interval (CI) 88.4% to 99.8%) and 80.1% (73.8% to 84.9%) against the delta and omicron variants, respectively, after the booster dose of vaccine. Vaccine effectiveness after a two dose primary schedule against hospital admission with delta infection peaked at 92.7% (95% CI 79.9% to 97.4%) in pregnant individuals. Maternal vaccination during and after pregnancy also provided sustained protection from symptomatic disease and hospital admission after delta and omicron infection in infants aged up to six months, with the highest protection seen when maternal vaccination occurred during later pregnancy. The effectiveness of two maternal doses when the last dose was given in the third trimester

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引用次数: 0

Caesarean section and risk of infection in offspring: systematic review and meta-analysis of observational studies. 剖宫产与后代感染风险：观察性研究的系统回顾和荟萃分析。

BMJ medicine

Pub Date : 2024-11-27 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-000995

Isobel Masson Francis Todd, Maria Christine Magnus, Lars Henning Pedersen, David Burgner, Jessica Eden Miller

Objective: To compare the risk of hospital admissions with infections and infections not in hospital in children born by caesarean section with children born by vaginal birth.Data sources: Medline, Embase, and PubMed were searched with no restriction on start date up to 12 February 2024.Study selection: Observational studies were included that reported the association between caesarean section and vaginal birth in relation to the risk of infections (both those that lead to hospital admission and those that do not) up to 18 years of age. Studies were excluded if they were not representative of a general population or if they focused on congenital, neonatal, or vertically acquired infections. No restrictions were made for language, publication date, or setting.Review methods: Findings for hospital admissions with infection were synthesised by meta-analyses of specific infection outcomes and type of caesarean birth (emergency v elective) and findings for other infections (ie, infection episodes reported by parents and primary care visits) by direction of effect. Risk of bias was assessed using the ROBINS-E tool and the overall certainty of evidence through the GRADE framework.Results: 31 eligible studies of over 10 million children were included. Findings were from population-based birth cohorts and registry data linkage studies in high income countries. Cohort sizes ranged from 288 to 7.2 million and follow up age was from one to 18 years. Outcomes included overall and specific clinical categories of infection. From studies of overall admission to hospital with infection, the proportion of children admitted ranged between 9-29% across exposure groups. In random-effects meta-analyses combining hazard ratios, children delivered by caesarean section had an increased rate of hospital admission with infections overall and in three common clinical infection categories: (1) overall admissions to hospital with infection (emergency caesarean section: n=6 study populations, hazard ratio 1.10 (95% confidence interval 1.06 to 1.14), <math><mi>τ</mi></math> 2=0.0009, I2=96%; elective caesarean section: n=7, 1.12 (1.09 to 1.15), <math><mi>τ</mi></math> 2=0.0006, I2=88%); (2) admission to hospital for upper respiratory infections (emergency caesarean section: n=7, 1.11 (1.09 to 1.13), <math><mi>τ</mi></math> 2=0.0003, I2=73%; elective caesarean section: n=7, 1.16 (1.12 to 1.20), <math><mi>τ</mi></math> 2=0.0012, I2=89%); (3) admission to hospital for lower respiratory infections (emergency caesarean section: n=8, 1.09 (1.06 to 1.12), <math><mi>τ</mi></math> 2=0.0010, I2=88%; elective caesarean section: n=8, 1.13 (1.10 to 1.16), <math><mi>τ</mi></math> 2=0.0009, I2=84%); (4) admission to hospital for gastrointesti

目的：比较剖宫产与顺产患儿住院感染与非院内感染的风险。数据来源：检索Medline， Embase和PubMed，没有开始日期限制，截止日期为2024年2月12日。研究选择：纳入了观察性研究，这些研究报告了剖宫产和阴道分娩与18岁以下感染风险（包括导致住院和不导致住院的感染风险）之间的关联。如果研究不能代表一般人群，或者关注先天性、新生儿或垂直获得性感染，则排除研究。没有对语言、出版日期或设置进行限制。回顾方法：通过对特定感染结局和剖宫产类型（急诊或选择性）的荟萃分析，以及对其他感染（即父母报告的感染事件和初级保健就诊）的研究结果，综合了感染住院的研究结果。使用ROBINS-E工具评估偏倚风险，并通过GRADE框架评估证据的总体确定性。结果：纳入了31项符合条件的研究，涉及1000多万儿童。研究结果来自高收入国家基于人口的出生队列和登记数据链接研究。队列规模从288万到720万不等，随访年龄从1岁到18岁不等。结果包括总体和特定临床感染类别。从感染住院总人数的研究来看，暴露组中住院儿童的比例在9-29%之间。在结合风险比的随机效应荟萃分析中，剖腹产分娩的儿童总体感染住院率和三种常见临床感染类别的住院率增加：(1)总体感染住院率(紧急剖腹产：n=6个研究人群，风险比1.10(95%置信区间1.06至1.14),τ 2=0.0009, I2=96%；择期剖宫产：n=7, 1.12 (1.09 ~ 1.15), τ 2=0.0006, I2=88%)；(2)因上呼吸道感染住院(紧急剖宫产：n=7, 1.11 (1.09 ~ 1.13), τ 2=0.0003, I2=73%；择期剖宫产：n=7, 1.16 (1.12 ~ 1.20), τ 2=0.0012, I2=89%)；(3)因下呼吸道感染住院(急诊剖宫产：n=8, 1.09 (1.06 ~ 1.12), τ 2=0.0010, I2=88%；择期剖宫产：n=8, 1.13 (1.10 ~ 1.16), τ 2=0.0009, I2=84%)；(4)因胃肠道感染住院(紧急剖宫产：n=7, 1.19 (1.13 ~ 1.26), τ 2=0.0025, I2=86%；择期剖宫产：n=7, 1.20 (1.15 ~ 1.25), τ 2=0.0009, I2=67%)。11项关于其他感染的研究中有8项表明，剖腹产出生的人原发性感染的风险增加。偏倚风险主要与混淆有关。结论：来自高收入国家的调查结果显示，在各种情况下，剖腹产分娩与儿童感染风险增加之间存在一致的关联。现有研究的局限性包括可能存在无法测量的混淆，特别是指征混淆，以及来自低收入和中等收入国家的研究稀缺。评审注册：PROSPERO （CRD42022369252）。

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引用次数: 0

Comparative effectiveness of monovalent XBB.1.5 containing covid-19 mRNA vaccines in Denmark, Finland, and Sweden: target trial emulation based on registry data.

BMJ medicine

Pub Date : 2024-11-17 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-001074

Niklas Worm Andersson, Emilia Myrup Thiesson, Nicklas Pihlström, Jori Perälä, Kristýna Faksová, Mie Agermose Gram, Eero Poukka, Tuija Leino, Rickard Ljung, Anders Hviid

Abstract:

Objective: To estimate the effectiveness of vaccination with a monovalent covid-19 mRNA vaccine containing the omicron XBB.1.5 subvariant against severe covid-19 disease in Denmark, Finland, and Sweden.

Design: Target trial emulation based on registry data.

Setting: Denmark, Finland, and Sweden, 1 October 2023 to 21 April 2024.

Participants: Source population of 3 898 264 individuals eligible for vaccination with the XBB.1.5 containing covid-19 mRNA vaccine at the start of the study on 1 October 2023. Study cohort comprised 1 876 282 recipients of an XBB.1.5 containing vaccine during the study period matched with 1 876 282 non-recipients. Individuals were aged ≥65 years (mean age 75.4 years, standard deviation 7.4 years) and had received at least four doses of a previous covid-19 vaccine.

Main outcome measures: Cumulative incidences of hospital admissions and deaths related to covid-19 in a follow-up period of 24 weeks after immunisation (defined as one week after vaccination) in recipients of an XBB.1.5 containing covid-19 mRNA vaccine and matched non-recipients. Cumulative incidences were used to calculate comparative vaccine effectiveness (1-risk ratio) and risk differences.

Results: The associated comparative vaccine effectiveness was 57.9% (95% confidence interval (CI) 49.9% to 65.8%) against hospital admission for covid-19 (1085 v 2635 events) and 75.2% (70.6% to 79.9%) against deaths related to covid-19 disease (348 v 1458 events) after 24 weeks of follow-up. This result corresponded to 154.7 (95% CI 78.3 to 231.0) hospital admissions for covid-19 and 120.3 (110.5 to 130.2) deaths prevented per 100 000 individuals who were vaccinated with an XBB.1.5 containing vaccine. The associated comparative vaccine effectiveness was similar irrespective of sex, age group (65-74 v ≥75 years), number of doses of previous covid-19 vaccines, subgroup of co-administered seasonal influenza vaccines, and period of when either the omicron XBB or BA.2.86 sublineage was predominant. Although the observed reduction in risk was highest during the first weeks after vaccination, comparative vaccine effectiveness was well maintained after 24 weeks of follow-up.

Conclusions: In this study, in adults aged ≥65 years, vaccination with a monovalent XBB.1.5 containing covid-19 mRNA vaccine was associated with reduced rates of hospital admissions for covid-19 and deaths related to covid-19, during the autumn and winter of 2023-24 in Denmark, Finland, and Sweden.

{"title":"Comparative effectiveness of monovalent XBB.1.5 containing covid-19 mRNA vaccines in Denmark, Finland, and Sweden: target trial emulation based on registry data.","authors":"Niklas Worm Andersson, Emilia Myrup Thiesson, Nicklas Pihlström, Jori Perälä, Kristýna Faksová, Mie Agermose Gram, Eero Poukka, Tuija Leino, Rickard Ljung, Anders Hviid","doi":"10.1136/bmjmed-2024-001074","DOIUrl":"10.1136/bmjmed-2024-001074","url":null,"abstract":"Abstract: Objective: To estimate the effectiveness of vaccination with a monovalent covid-19 mRNA vaccine containing the omicron XBB.1.5 subvariant against severe covid-19 disease in Denmark, Finland, and Sweden.Design: Target trial emulation based on registry data.Setting: Denmark, Finland, and Sweden, 1 October 2023 to 21 April 2024.Participants: Source population of 3 898 264 individuals eligible for vaccination with the XBB.1.5 containing covid-19 mRNA vaccine at the start of the study on 1 October 2023. Study cohort comprised 1 876 282 recipients of an XBB.1.5 containing vaccine during the study period matched with 1 876 282 non-recipients. Individuals were aged ≥65 years (mean age 75.4 years, standard deviation 7.4 years) and had received at least four doses of a previous covid-19 vaccine.Main outcome measures: Cumulative incidences of hospital admissions and deaths related to covid-19 in a follow-up period of 24 weeks after immunisation (defined as one week after vaccination) in recipients of an XBB.1.5 containing covid-19 mRNA vaccine and matched non-recipients. Cumulative incidences were used to calculate comparative vaccine effectiveness (1-risk ratio) and risk differences.Results: The associated comparative vaccine effectiveness was 57.9% (95% confidence interval (CI) 49.9% to 65.8%) against hospital admission for covid-19 (1085 v 2635 events) and 75.2% (70.6% to 79.9%) against deaths related to covid-19 disease (348 v 1458 events) after 24 weeks of follow-up. This result corresponded to 154.7 (95% CI 78.3 to 231.0) hospital admissions for covid-19 and 120.3 (110.5 to 130.2) deaths prevented per 100 000 individuals who were vaccinated with an XBB.1.5 containing vaccine. The associated comparative vaccine effectiveness was similar irrespective of sex, age group (65-74 v ≥75 years), number of doses of previous covid-19 vaccines, subgroup of co-administered seasonal influenza vaccines, and period of when either the omicron XBB or BA.2.86 sublineage was predominant. Although the observed reduction in risk was highest during the first weeks after vaccination, comparative vaccine effectiveness was well maintained after 24 weeks of follow-up.Conclusions: In this study, in adults aged ≥65 years, vaccination with a monovalent XBB.1.5 containing covid-19 mRNA vaccine was associated with reduced rates of hospital admissions for covid-19 and deaths related to covid-19, during the autumn and winter of 2023-24 in Denmark, Finland, and Sweden.","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e001074"},"PeriodicalIF":0.0,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11789462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Impact of multiple long term conditions on hospital admission and mortality during winter: importance of linked, population scale healthcare data. 多种长期病症对冬季入院和死亡率的影响：关联的人口规模医疗数据的重要性。

BMJ medicine

Pub Date : 2024-11-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-001114

Jonathan Adam Batty, Lesley Smith, Marlous Hall

引用次数: 0

Combinations of multiple long term conditions and risk of hospital admission or death during winter 2021-22 in England: population based cohort study. 英格兰 2021-22 年冬季多种长期病症组合与入院或死亡风险：基于人群的队列研究。

BMJ medicine

Pub Date : 2024-11-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-001016

Nazrul Islam, Sharmin Shabnam, Nusrat Khan, Clare Gillies, Francesco Zaccardi, Amitava Banerjee, Vahé Nafilyan, Kamlesh Khunti, Hajira Dambha-Miller

Objective: To describe which combinations of long term conditions were associated with a higher risk of hospital admission or death during winter 2021-22 (the third wave of the covid-19 pandemic) in adults in England.Design: Population based cohort study.Setting: Linked primary and secondary care data from the General Practice Extraction Service Data for Pandemic Planning and Research (GDPPR) database, Hospital Episode Statistics, and Office for National Statistics death registry, comprising pseudoanonymised routinely collected electronic medical records from the whole population of England registered at a general practice, 1 December 2021 to 31 March 2022.Participants: 48 253 125 individuals, registered in GDPPR in England, aged ≥18 years, and alive on 1 December 2021.Main outcomes measures: All cause hospital admissions and deaths associated with combinations of multiple long term conditions compared with those with no long term conditions, during the winter season (1 December 2021 to 31 March 2022). Overdispersed Poisson regression models were used to estimate the incidence rate ratios after adjusting for age, sex, ethnic group, and index of multiple deprivation.Results: Complete data were available for 48 253 125 adults, of whom 15 million (31.2%) had multiple long term conditions. Rates of hospital admissions and deaths among individuals with no long term conditions were 96.3 and 0.8 per 1000 person years, respectively. Compared with those with no long term conditions, the adjusted incidence rate ratio of hospital admissions were 11.0 (95% confidence interval (CI) 9.4 to 12.7) for those with a combination of cancer, chronic kidney disease, cardiovascular disease, and type 2 diabetes mellitus; 9.8 (8.3 to 11.4) for those with cancer, chronic kidney disease, cardiovascular disease, and osteoarthritis; and 9.6 (8.6 to 10.7) for those with cancer, chronic kidney disease, and cardiovascular disease. Compared with those with no long term conditions, the adjusted rate ratio of death was 21.4 (17.5 to 26.0) for those with chronic kidney disease, cardiovascular disease, and dementia; 23.2 (17.5 to 30.3) for those with cancer, chronic kidney disease, cardiovascular disease, and dementia; and 24.3 (19.1 to 30.4) for those with chronic kidney disease, cardiovascular disease, dementia, and osteoarthritis. Cardiovascular disease with dementia appeared in all of the top five combinations of multiple long term conditions for mortality, and this two disease combination was associated with a substantially higher rate of death than many three, four, and five disease combinations.Conclusions: In this study, rates of hospital admission and death varied by combinations of multiple long term conditions and were substantially higher in those with than in those without any long term conditions. High risk

目的描述在2021-22年冬季（covid-19大流行的第三波），哪些长期病症组合与英格兰成年人较高的入院或死亡风险相关：设计：基于人群的队列研究：从全科医生提取服务数据用于大流行病规划和研究（GDPPR）数据库、医院病例统计和国家统计局死亡登记中获取的初级和二级医疗数据，包括2021年12月1日至2022年3月31日期间在全科医生处登记的全英格兰人口的假匿名常规收集电子病历：48 253 125人，在英格兰GDPPR登记，年龄≥18岁，2021年12月1日时健在：主要结果测量指标：冬季（2021 年 12 月 1 日至 2022 年 3 月 31 日）与无长期病症者相比，与多种长期病症组合相关的全因入院和死亡人数。在对年龄、性别、种族群体和多重贫困指数进行调整后，使用过度分散泊松回归模型估算发病率比：有 48 253 125 名成年人的完整数据，其中 1 500 万人（31.2%）患有多种长期疾病。无长期病症者的入院率和死亡率分别为每千人年 96.3 例和 0.8 例。与无长期病症者相比，合并患有癌症、慢性肾病、心血管疾病和 2 型糖尿病者的调整后入院发病率比为 11.0（95% 置信区间（CI）为 9.4 至 12.7）；癌症、慢性肾病、心血管疾病和骨关节炎患者的调整后入院发病率比为 9.8（8.3 至 11.4）；癌症、慢性肾病和心血管疾病患者的调整后入院发病率比为 9.6（8.6 至 10.7）。与无长期病症者相比，患有慢性肾脏疾病、心血管疾病和痴呆症者的调整后死亡比率为 21.4（17.5 至 26.0）；患有癌症、慢性肾脏疾病、心血管疾病和痴呆症者的调整后死亡比率为 23.2（17.5 至 30.3）；患有慢性肾脏疾病、心血管疾病、痴呆症和骨关节炎者的调整后死亡比率为 24.3（19.1 至 30.4）。心血管疾病合并痴呆症出现在死亡率最高的五种多种长期疾病组合中，这种两种疾病组合的死亡率远远高于许多三种、四种和五种疾病组合：结论：在这项研究中，入院率和死亡率因多种长期病症组合而异，患有多种长期病症者的入院率和死亡率远高于未患有任何长期病症者。研究强调了政策制定者需要优先考虑和采取预防措施的高风险组合，以帮助应对国家医疗服务体系冬季压力所带来的挑战。

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引用次数: 0

Risk of dementia associated with anticholinergic drugs for overactive bladder in adults aged ≥55 years: nested case-control study. 与抗胆碱能药物治疗膀胱过度活动症相关的痴呆症风险：巢式病例对照研究。

BMJ medicine

Pub Date : 2024-11-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000799

Barbara Iyen, Carol Coupland, Brian Gregory Bell, Darren M Ashcroft, Martin William Orrell, Delia Bishara, Tom Dening, Anthony J Avery

Abstract: Objective: To investigate whether different anticholinergic drug treatments for overactive bladder have differential risks for incident dementia, in a large representative population of older adults in England.Design: Nested case-control study.Setting: General practices in England providing data to the Clinical Practice Research Datalink (CPRD) GOLD database, with linked patient admission records from secondary care (Hospital Episode Statistics), 1 January 2006 and 16 February 2022.Participants: 170 742 patients aged ≥55 years, with a first reported diagnosis of dementia during the study period, matched by age, sex, and general practice with 804 385 individuals without dementia (controls).Interventions: Cumulative drug use (defined using total standardised daily dose) of different anticholinergic drugs used for the treatment of an overactive bladder, and a non-anticholinergic drug, mirabegron, in the period 3-16 years before a diagnosis of dementia (or equivalent date in matched controls).Main outcome measures: Odds ratios for onset of dementia associated with the different anticholinergic drugs used for the treatment of an overactive bladder, adjusted for sociodemographic characteristics, clinical comorbidities, and use of other anticholinergic drug treatments.Results: The study population comprised 62.6% women, and median age was 83 (interquartile range 77-87) years. 15 418 (9.0%) patients with dementia and 63 369 (7.9%) controls without dementia had used anticholinergic drugs for the treatment of an overactive bladder in the 3-16 years before diagnosis (or equivalent date for controls). The adjusted odds ratio for dementia associated with the use of any anticholinergic drug used to treat an overactive bladder was 1.18 (95% confidence interval (CI) 1.16 to 1.20), and was higher in men (1.22, 1.18 to 1.26) than women (1.16, 1.13 to 1.19). The risk of dementia was substantially increased with the use of oxybutynin hydrochloride (adjusted odds ratio 1.31, 95% CI 1.21 to 1.42 and 1.28, 1.15 to 1.43 for use of 366-1095 and >1095 total standardised daily doses, respectively), solifenacin succinate (1.18, 1.09 to 1.27 and 1.29, 1.19 to 1.39), and tolterodine tartrate (1.27, 1.19 to 1.37 and 1.25, 1.17 to 1.34). No significant increases in the risk of dementia associated with darifenacin, fesoterodine fumarate, flavoxate hydrochloride, propiverine hydrochloride, and trospium chloride were found. The association between mirabegron, a non-anticholinergic drug, and dementia was variable across the dose categories and might be caused by previous use of anticholinergic drugs for the treatment of an overactive bladder in these individuals.Conclusions: Of the different anticholinergic drugs used to treat an overactive bladder, oxybutynin hyd

摘要：目的：在英格兰具有代表性的老年人群中，研究治疗膀胱过度活动症的不同抗胆碱能药物是否会导致不同的痴呆症发病风险：在英格兰一个具有代表性的大型老年人群中，调查不同的抗胆碱能药物治疗膀胱过度活动症是否会导致不同的痴呆症发病风险：设计：嵌套病例对照研究：英国全科医生向临床实践研究数据链接（CPRD）GOLD数据库提供数据，并与二级医疗机构（医院病历统计）2006年1月1日至2022年2月16日的患者入院记录相链接：170 742 名年龄≥55 岁、在研究期间首次报告诊断为痴呆症的患者，与 804 385 名无痴呆症的患者（对照组）进行年龄、性别和全科匹配：干预措施：在痴呆症确诊前 3-16 年内（或匹配对照组的同等日期），累计使用用于治疗膀胱过度活动症的不同抗胆碱能药物和非抗胆碱能药物米拉贝琼（mirabegron）（以标准化每日总剂量定义）：与治疗膀胱过度活动症的不同抗胆碱能药物相关的痴呆症发病率，并根据社会人口学特征、临床合并症和使用其他抗胆碱能药物治疗进行调整：研究对象中 62.6% 为女性，中位年龄为 83 岁（四分位数间距为 77-87 岁）。15 418 名（9.0%）痴呆症患者和 63 369 名（7.9%）非痴呆症对照组患者在确诊前 3-16 年内（或对照组的同等日期）曾使用抗胆碱能药物治疗膀胱过度活动症。与使用任何抗胆碱能药物治疗膀胱过度活动症相关的痴呆调整后几率为 1.18（95% 置信区间 (CI) 1.16 至 1.20），男性（1.22，1.18 至 1.26）高于女性（1.16，1.13 至 1.19）。使用盐酸奥昔布宁会大大增加痴呆症的风险（调整后的几率比为 1.31，95% CI 为 1.21 至 1.42 和 1.28，1.15 至 1.43）。43）、琥珀酸索利那新（1.18，1.09 至 1.27 和 1.29，1.19 至 1.39）和酒石酸托特罗定（1.27，1.19 至 1.37 和 1.25，1.17 至 1.34）。没有发现达非那新、富马酸非索特罗定、盐酸黄连素、盐酸丙哌维林和氯化曲司铵会明显增加痴呆症风险。米拉贝琼（一种非抗胆碱能药物）与痴呆症之间的关联在不同剂量类别之间存在差异，这可能是由于这些患者以前曾使用抗胆碱能药物治疗膀胱过度活动症所致：结论：在用于治疗膀胱过度活动症的各种抗胆碱能药物中，盐酸奥昔布宁、琥珀酸索利那新和酒石酸托特罗定与老年人痴呆症风险的关系最为密切。这一发现强调临床医生有必要考虑到现有治疗老年人膀胱过度活动症的方案可能带来的长期风险和后果，并考虑开具可能与较低痴呆症风险相关的替代治疗处方。

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引用次数: 0

Characteristics of non-randomised studies of drug treatments: cross sectional study. 药物治疗非随机研究的特点：横断面研究。

BMJ medicine

Pub Date : 2024-10-30 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-000932

Sally Yaacoub, Raphael Porcher, Anna Pellat, Hillary Bonnet, Viet-Thi Tran, Philippe Ravaud, Isabelle Boutron

Abstract:

Objective: To examine the characteristics of comparative non-randomised studies that assess the effectiveness or safety, or both, of drug treatments.

Design: Cross sectional study.

Data sources: Medline (Ovid), for reports published from 1 June 2022 to 31 August 2022.

Eligibility criteria for selecting studies: Reports of comparative non-randomised studies that assessed the effectiveness or safety, or both, of drug treatments were included. A randomly ordered sample was screened until 200 eligible reports were found. Data on general characteristics, reporting characteristics, and time point alignment were extracted, and possible related biases, with a piloted form inspired by reporting guidelines and the target trial emulation framework.

Results: Of 462 reports of non-randomised studies identified, 262 studies were excluded (32% had no comparator and 25% did not account for confounding factors). To assess time point alignment and possible related biases, three study time points were considered: eligibility, treatment assignment, and start of follow-up. Of the 200 included reports, 70% had one possible bias, related to: inclusion of prevalent users in 24%, post-treatment eligibility criteria in 32%, immortal time periods in 42%, and classification of treatment in 23%. Reporting was incomplete, and only 2% reported all six of the key elements considered: eligibility criteria (87%), description of treatment (46%), deviations in treatment (27%), causal contrast (11%), primary outcomes (90%), and confounding factors (88%). Most studies used routinely collected data (67%), but only 7% reported using validation studies of the codes or algorithms applied to select the population. Only 7% of reports mentioned registration on a trial registry and 3% had an available protocol.

Conclusions: The findings of the study suggest that although access to real world evidence could be valuable, the robustness and transparency of non-randomised studies need to be improved.

摘要：目的：研究评估药物治疗有效性或安全性或两者兼而有之的非随机比较研究的特点：研究评估药物治疗有效性或安全性或两者兼而有之的非随机对比研究的特点：数据来源数据来源：Medline（Ovid），2022年6月1日至2022年8月31日期间发表的报告：纳入评估药物治疗有效性或安全性或两者兼具的非随机对比研究报告。对样本进行随机排序筛选，直至找到 200 份符合条件的报告。在报告指南和目标试验仿真框架的启发下，采用试行表格提取了关于一般特征、报告特征和时间点一致性的数据，以及可能存在的相关偏差：在确定的 462 项非随机研究报告中，有 262 项研究被排除在外（32% 没有参照物，25% 没有考虑混杂因素）。为了评估时间点的一致性和可能存在的相关偏差，我们考虑了三个研究时间点：资格审查、治疗分配和随访开始。在纳入的 200 份报告中，70% 的报告存在一种可能的偏差，涉及：24% 的报告纳入了流行用户、32% 的报告纳入了治疗后资格标准、42% 的报告纳入了不确定的时间段、23% 的报告纳入了治疗分类。报告不完整，只有 2% 的研究报告了全部六项关键要素：资格标准（87%）、治疗描述（46%）、治疗偏差（27%）、因果对比（11%）、主要结果（90%）和混杂因素（88%）。大多数研究使用了常规收集的数据（67%），但只有 7% 的研究报告对用于选择人群的代码或算法进行了验证研究。只有 7% 的报告提到在试验登记处登记，3% 的报告有可用的方案：研究结果表明，尽管获取真实世界的证据很有价值，但非随机研究的稳健性和透明度仍有待提高。

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引用次数: 0

Therapeutic drug monitoring for immune mediated inflammatory diseases. 免疫介导的炎症性疾病的治疗药物监测。

BMJ medicine

Pub Date : 2024-10-28 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2024-001130

Neil Chanchlani, Zenas Z N Yiu, Lisa K Stamp, Andrew S Day

引用次数: 0