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Outcomes reporting in clinical trials of Chinese herbal medicine on ulcerative colitis: A systematic review 中草药治疗溃疡性结肠炎临床试验的结果报告:系统综述。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-28 DOI: 10.1111/jebm.12649
Xuan Zhang, Lin Zhang, Juan Wang, Lihan Hu, Xuanqi Zhang, Nana Wang, Hanzhi Tan, Chung Wah Cheng, Ji Li, Fei Han, Ping Wang, Aiping Lyu, Zhaoxiang Bian
<p>Ulcerative colitis (UC) is a prevalent type of inflammatory bowel disease (IBD) characterized by inflammation and ulceration in the rectum and colon.<span><sup>1</sup></span> The optimal therapeutic effect of current treatment strategies for UC may be unattainable; even surgery may be followed by ongoing morbidity. Pharmacological therapies, mainly including aminosalicylates, steroids, immunosuppressants, etc., are used to control the acute onset of UC, heal the mucosa, and prevent complications.<span><sup>2</sup></span> In clinical practice, some patients, however, may experience a gradual loss of response to the therapy while others may show intolerance to the adverse effects of drugs.<span><sup>3</sup></span> Consequently, an increasing number of UC patients (21%–60%) prefer to seek additional help from Chinese herbal medicine (CHM). While numerous clinical studies have demonstrated the efficacy of CHM therapies in relieving symptoms, enhancing the therapeutic effects of chemical drugs, and reducing side effects and recurrence rates in UC patients, recommending CHM interventions for UC treatment remains cautious due to significant issues related to the choice and reporting of outcome measures.<span><sup>4-7</sup></span> The lack of agreed-upon and standardized evaluation criteria, such as tongue and pulses in Chinese medicine (CM), contributes to considerable variation in outcome measurement and reporting among studies, making comparisons challenging.<span><sup>8</sup></span> Therefore, we aim to summarize existing endpoint definitions and measurement tools, and inspect the efficacy and safety outcomes reported in randomized controlled trials (RCTs) of CHM in adults with UC. Given that some UC patients in China receive integrative Chinese and Western Medicine (ICWM) therapy over CHM or Western Medicine (WM) alone, the development of a core outcome set (COS) for CHM studies of UC is crucial. Such a COS would help reduce outcome heterogeneity, enhance study quality, and contribute to generating robust evidence for innovative UC therapies, ultimately fostering international recognition in the field.</p><p>This study included RCTs that investigated CHM, including single herbs, formulas, or both as interventions to treat UC. Accordingly, RCTs published in English or Chinese from January 1, 2011 to December 31, 2022 were limited to adults with UC diagnosis based on clear diagnostic criteria or references, but without limitations in control groups or outcomes. A systematic search was conducted in six databases: All EBM Reviews (Ovid), Allied and Complementary Medicine (Ovid), Embase and Ovid MEDLINE(R) (Ovid), CNKI, VIP, and Wanfang. Detailed inclusion and exclusion criteria and search strategy are presented in Supplementary File 1. Two reviewers were independently involved in reviewing the titles and abstracts, full text of the selected studies based on the criteria. Any disagreements between the reviewers were resolved through discussion or cons
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引用次数: 0
Technical specification for developing a clinical practice guideline for the integration of traditional Chinese medicine and Western medicine 制定中西医结合临床实践指南的技术规范。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-17 DOI: 10.1111/jebm.12654
Jianxin Wang, Rui Sun, Fengwen Yang, Jianping Liu, Jiajie Yu, Yuanyuan Sun, Xuemin Gao, Boli Zhang, Junhua Zhang, Jinzhou Tian

Developing a clinical practice guideline (CPG) for integrating traditional Chinese medicine (TCM) and Western medicine (WM) requires the accurate identification, collation, and integration of all available evidence on TCM and WM in a comprehensive, meaningful, and resource-efficient manner. This entails framing appropriate clinical questions, retrieving and synthesizing evidence from multiple resources, and providing concise and complete recommendations for specific diseases. However, some existing CPGs for integrating TCM and WM lack deep and organic integration. As the effective preparation of a CPG for integrating TCM and WM typically involves a complex set of principles, methodology, and steps, we believe that a cohesive, step-by-step guide on how to prepare a CPG for integrating TCM and WM is essential. To facilitate the design and development of a robust CPG, we present a clear and concise methodology, outlining relevant principles and procedures, supported by references for guidance. This technical specification aims to simplify the methodology for preparing a CPG for integrating TCM and WM; provide healthcare professionals and researchers with methodologically sound tools; and enhance the quality of CPGs for integrating TCM and WM. This technical specification may help elucidate this complex process, facilitate evaluation of the quality of published CPGs for integrating TCM and WM, and improve the understanding and application of recommendations for the combined and integrated use of TCM and WM in a new system.

制定中西医结合临床实践指南(CPG)需要以全面、有意义和节约资源的方式准确识别、整理和整合所有可用的中西医结合证据。这就需要提出适当的临床问题,从多种资源中检索和综合证据,并针对特定疾病提供简明、完整的建议。然而,现有的一些中西医结合临床指导原则缺乏深度和有机的结合。由于有效编制中西医结合CPG通常涉及一系列复杂的原则、方法和步骤,因此我们认为有必要就如何编制中西医结合CPG制定一份具有凝聚力的、循序渐进的指南。为便于设计和开发稳健的 CPG,我们提出了一套简洁明了的方法论,概述了相关原则和步骤,并辅以参考文献作为指导。本技术规范旨在简化编制中西医结合CPG的方法,为医护人员和研究人员提供方法上合理的工具,并提高中西医结合CPG的质量。本技术规范有助于阐明这一复杂过程,促进对已发布的中西医结合CPG质量的评估,并提高对新系统中中西医结合建议的理解和应用。
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引用次数: 0
Efficacy and safety of vancomycin compared with those of alternative treatments for methicillin-resistant Staphylococcus aureus infections: An umbrella review 万古霉素与耐甲氧西林金黄色葡萄球菌感染替代疗法的疗效和安全性比较:综述。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-30 DOI: 10.1111/jebm.12644
Sujata Purja, Minji Kim, Yomna Elghanam, Hae Jung Shim, Eunyoung Kim

Objective

To summarize the evidence on the efficacy and safety of vancomycin compared with those of alternative treatments in adult patients with methicillin-resistant Staphylococcus aureus (MRSA) infection.

Methods

PubMed, Embase, and Web of Science were searched up to December 15, 2023, for systematic reviews and meta-analyses comparing vancomycin with alternative MRSA treatments. Primary outcomes included clinical cure and microbiological eradication rates. Organ-specific safety outcomes were assessed. Summary estimates were recalculated using a random-effects model. Evidence was graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. This study was registered in PROSPERO (CRD42022340359).

Results

This umbrella review included 19 studies and 71 meta-analyses (46 efficacy and 25 safety) comparing vancomycin with 10 alternative treatments across different MRSA infection types and populations. GRADE assessment showed that 29.58% of the meta-analyses were of high quality. Linezolid and daptomycin showed higher efficacy in MRSA-induced skin and soft tissue infections and pneumonia (moderate evidence quality) and bacteremia (very low evidence quality), respectively, compared with that of vancomycin. Cephalosporins had a higher risk of nausea, whereas linezolid had a higher risk of nausea, diarrhea, and thrombocytopenia than that of vancomycin. Vancomycin posed a higher risk of rash, pruritus, red man syndrome, and nephrotoxicity than that of alternatives.

Conclusions

The quality of evidence supporting the higher efficacy of alternative treatment over vancomycin for MRSA infection was not high. Given varying safety profiles and advancements in therapeutic monitoring, careful consideration of patient-specific factors and pharmacokinetics is crucial when selecting treatment alternatives to vancomycin.

目的总结在耐甲氧西林金黄色葡萄球菌(MRSA)感染的成年患者中,万古霉素与其他治疗方法的疗效和安全性比较的证据:截至 2023 年 12 月 15 日,在 PubMed、Embase 和 Web of Science 上检索了比较万古霉素与其他 MRSA 治疗方法的系统综述和荟萃分析。主要结果包括临床治愈率和微生物根除率。对器官特异性安全性结果进行了评估。采用随机效应模型重新计算了汇总估计值。采用建议、评估、发展和评价分级(GRADE)工具对证据进行分级。本研究已在 PROSPERO 注册(CRD42022340359):本综述包括 19 项研究和 71 项荟萃分析(46 项疗效分析和 25 项安全性分析),比较了万古霉素与 10 种替代治疗方法在不同 MRSA 感染类型和人群中的疗效。GRADE 评估显示,29.58% 的荟萃分析具有较高的质量。与万古霉素相比,利奈唑胺和达托霉素对MRSA引起的皮肤和软组织感染、肺炎(中等证据质量)和菌血症(极低证据质量)的疗效更高。头孢菌素类出现恶心的风险较高,而利奈唑胺出现恶心、腹泻和血小板减少的风险高于万古霉素。万古霉素出现皮疹、瘙痒、红人综合征和肾毒性的风险高于替代品:支持替代疗法在 MRSA 感染中疗效高于万古霉素的证据质量不高。考虑到不同的安全性和治疗监测方面的进步,在选择万古霉素的替代治疗方法时,仔细考虑患者的特异性因素和药代动力学至关重要。
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引用次数: 0
Clinical practice guidelines addressing Chinese patent medicine interventions: A systematic survey of 113 guidelines and 993 recommendations 针对中成药干预的临床实践指南:对 113 份指南和 993 项建议的系统调查。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-29 DOI: 10.1111/jebm.12640
Jianxin Wang, Rui Sun, Xuemin Gao, Rui Gao
<p>Chinese patent medicines (CPM) are widely used in China and are increasingly used in Western countries.<span><sup>1</sup></span> CPMs have gained social acceptance for fixed prescription, precise dosage, ease of use, and storage. Numerous CPM clinical trials have been conducted, with approximately 14,000 systematic reviews published in journals. Over 600 guidelines were published in the past two decades.<span><sup>2</sup></span> However, the clinical and methodological status, usefulness, and recommendations of CPMs remain understudied. This systematic review aimed to summarizes the clinical and methodological characteristics of CPM-related guidelines, critically assessing their methodological quality and usefulness.</p><p>China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, MEDLINE, EMBASE, and Guidelines International Network, the scientific, transparent, and applicable ranking (STAR) tools for clinical practice guidelines<span><sup>3</sup></span> and Practice Guideline Registration for Transparency (PREPARE) were searched. All of CPM-related guidelines published from January 2021 to December 2023 were included, no matter the type of guideline, which include CPM-specific guidelines (all recommendations solely focused on CPM interventions), TCM guidelines (encompassing recommendations on traditional Chinese herbal medicines, CPMs, acupuncture, and other TCM interventions), and integrated TCM and WM guidelines (offering recommendations on both conventional medicine and TCM interventions together).</p><p>A structured data extraction table was used to collect the data. Reviewers extracted three types of information from each guideline: (1) general information, including types of guidelines, target users, subjects, journal of the publication, sponsoring institutions, and diseases or conditions investigated; (2) CPM recommendation information, including the types of CPM recommended in the guidelines, strength and direction of the recommendation, and details of CPM interventions; and (3) usefulness information of CPM recommendations, for example, clinical questions, comparators, outcomes, and presentation of the recommendation. χ<sup>2</sup> was used to compare the variables across different types of guidelines when necessary and the significance level was set at 5% (<i>p</i> < 0.05).</p><p>A total of 113 guidelines with 933 recommendations for the use of CPMs were included. Only 4 (3.5%) guidelines were published in English and almost all guidelines (94.7%) focused on treatment. For the target users of the guidelines, more than half of the guidelines (56.6%) were formulated for TCM physicians and 46.5% for WM physicians. Only one guideline was enacted by primary physicians. 13.3% of the guidelines were investigator-initiated and the rest were sponsored by the China Association of TCM (31%), China Association of Traditional Medicine, China Association of Integrative Medicine and World Federation of Chinese Medicine Societi
中成药(CPM)在中国被广泛使用,在西方国家的使用也越来越多。1 中成药以处方固定、剂量精确、使用方便、易于储存等特点获得了社会的认可。目前已开展了大量 CPM 临床试验,在期刊上发表了约 14,000 篇系统综述。2 然而,对 CPM 的临床和方法学现状、实用性和建议的研究仍然不足。本系统综述旨在总结CPM相关指南的临床和方法学特征,严格评估其方法学质量和实用性。检索了中国国家知识基础设施(CNKI)、万方数据、VIP、SinoMed、MEDLINE、EMBASE和指南国际网络、临床实践指南科学、透明和适用排名(STAR)工具3以及实践指南透明度注册(PREPARE)。所有从 2021 年 1 月至 2023 年 12 月发表的中医药相关指南均被纳入其中,无论其类型如何,其中包括中医药特定指南(所有建议均仅针对中医药干预措施)、中医药指南(包括传统中药、中医药、针灸和其他中医药干预措施的建议)以及中医药和 WM 综合指南(同时提供传统医学和中医药干预措施的建议)。审稿人从每份指南中提取了三类信息:(1)一般信息,包括指南类型、目标用户、研究对象、发表期刊、赞助机构、研究的疾病或病症;(2)CPM推荐信息,包括指南中推荐的CPM类型、推荐的强度和方向、CPM干预措施的细节;(3)CPM推荐的有用性信息,例如临床问题、比较对象、结果、推荐的表述方式等。必要时使用χ2对不同类型指南的变量进行比较,显著性水平定为5%(p &lt;0.05)。只有 4 份(3.5%)指南以英语出版,几乎所有指南(94.7%)都侧重于治疗。就指南的目标用户而言,半数以上(56.6%)的指南是为中医师制定的,46.5%是为妇科医生制定的。只有一份指南是由基层医生制定的。13.3%的指南由研究者发起,其余由中国中医药学会(31%)、中国传统医药学会、中国中西医结合学会和世界中医药学会联合会(38.9%)发起。中国医师协会和中国老年学学会等非中医药组织赞助的指南占 12.4%。与中医相关的指南分为三类,分别是中医指南(40.7%)、中医与中西医结合指南(28.3%)和中医专用指南(31%)。几乎所有针对 CPM 的指南(94.7%)都侧重于治疗。就目标用户而言,半数以上(56.6%)是为中医制定的,46.5%是为妇科医生制定的。CPM特定指南的疾病或病症主要集中在慢性病(38.1%,包括心脑血管疾病、慢性气道炎症性疾病、糖尿病和癌症)、生殖医学(19.5%,包括男性的勃起功能障碍、早泄、精索静脉曲张、少精子症和无精子症,以及女性的原发性卵巢功能障碍和多囊卵巢综合征)、儿科(8.79项研究(69.9%)采用了 "建议评估、发展和评价分级法"(GRADE)来评估证据的确定性。此外,11 项研究(9.7%)使用了中国研究人员于 2007 年提出的循证分级工具--传统医学证据库,以评估中医临床研究的特点和现状。有 5 份指南使用了牛津循证医学中心(OCEBM)系统。值得注意的是,有 13 份指南(11.5%)没有使用任何证据分级工具,且推荐中没有确定的证据。在所有 933 项 CPM 建议中,强推荐占 122 项(22.4%),弱推荐占 590 项(63.2%),221 项(23.7%)建议未提供任何方向或强度。44.7%的强烈建议有低度或极低度确定性的证据支持。30.
{"title":"Clinical practice guidelines addressing Chinese patent medicine interventions: A systematic survey of 113 guidelines and 993 recommendations","authors":"Jianxin Wang,&nbsp;Rui Sun,&nbsp;Xuemin Gao,&nbsp;Rui Gao","doi":"10.1111/jebm.12640","DOIUrl":"10.1111/jebm.12640","url":null,"abstract":"&lt;p&gt;Chinese patent medicines (CPM) are widely used in China and are increasingly used in Western countries.&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt; CPMs have gained social acceptance for fixed prescription, precise dosage, ease of use, and storage. Numerous CPM clinical trials have been conducted, with approximately 14,000 systematic reviews published in journals. Over 600 guidelines were published in the past two decades.&lt;span&gt;&lt;sup&gt;2&lt;/sup&gt;&lt;/span&gt; However, the clinical and methodological status, usefulness, and recommendations of CPMs remain understudied. This systematic review aimed to summarizes the clinical and methodological characteristics of CPM-related guidelines, critically assessing their methodological quality and usefulness.&lt;/p&gt;&lt;p&gt;China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, MEDLINE, EMBASE, and Guidelines International Network, the scientific, transparent, and applicable ranking (STAR) tools for clinical practice guidelines&lt;span&gt;&lt;sup&gt;3&lt;/sup&gt;&lt;/span&gt; and Practice Guideline Registration for Transparency (PREPARE) were searched. All of CPM-related guidelines published from January 2021 to December 2023 were included, no matter the type of guideline, which include CPM-specific guidelines (all recommendations solely focused on CPM interventions), TCM guidelines (encompassing recommendations on traditional Chinese herbal medicines, CPMs, acupuncture, and other TCM interventions), and integrated TCM and WM guidelines (offering recommendations on both conventional medicine and TCM interventions together).&lt;/p&gt;&lt;p&gt;A structured data extraction table was used to collect the data. Reviewers extracted three types of information from each guideline: (1) general information, including types of guidelines, target users, subjects, journal of the publication, sponsoring institutions, and diseases or conditions investigated; (2) CPM recommendation information, including the types of CPM recommended in the guidelines, strength and direction of the recommendation, and details of CPM interventions; and (3) usefulness information of CPM recommendations, for example, clinical questions, comparators, outcomes, and presentation of the recommendation. χ&lt;sup&gt;2&lt;/sup&gt; was used to compare the variables across different types of guidelines when necessary and the significance level was set at 5% (&lt;i&gt;p&lt;/i&gt; &lt; 0.05).&lt;/p&gt;&lt;p&gt;A total of 113 guidelines with 933 recommendations for the use of CPMs were included. Only 4 (3.5%) guidelines were published in English and almost all guidelines (94.7%) focused on treatment. For the target users of the guidelines, more than half of the guidelines (56.6%) were formulated for TCM physicians and 46.5% for WM physicians. Only one guideline was enacted by primary physicians. 13.3% of the guidelines were investigator-initiated and the rest were sponsored by the China Association of TCM (31%), China Association of Traditional Medicine, China Association of Integrative Medicine and World Federation of Chinese Medicine Societi","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"474-476"},"PeriodicalIF":3.6,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12640","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348229","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}
引用次数: 0
International Traditional Medicine Clinical Trial Registry: A meaningful initiative and its future development 国际传统医学临床试验登记处:一项有意义的倡议及其未来发展。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-26 DOI: 10.1111/jebm.12651
Ning Liang, Yujing Zhang, Xuefei Zhang, Lijiao Yan, Chen Zhao, Sihong Yang, Ziteng Hu, Zehui Ye, Qianzi Che, Bin Liu, Haili Zhang, Huizhen Li, Zhao Chen, Qi Zhang, Taixiang Wu, Yanping Wang, Nannan Shi, Luqi Huang
<p>Traditional medicine (TM) has become an indispensable resource worldwide and it makes great contributions to global health. Searching for “traditional medicine” and related items by setting filters for clinical trials and randomized controlled trials, returns almost 17,000 items in the PubMed database till 2024 April. Moreover, more than 22,000 TM clinical studies have been found in the WHO International Clinical Trial Registry Platform (ICTRP) when conducting a systematic search. Despite the growing interest and number of clinical studies in TM, issues concerning the quality of the evidence have emerged.<span><sup>1, 2</sup></span> Empirical studies have found that studies with positive results are more likely to be published, and outcomes with significant effect estimates are very likely to be fully reported.<span><sup>3</sup></span> Similar to conventional medicine, selective outcome reporting is widespread in TM, accounting for almost one-third of relative clinical studies when comparing between the registered outcomes and the reported ones in the publications.<span><sup>2</sup></span> Conclusions based on biased evidence due to selective reporting can be misleading. An alternative approach to solve this issue is the registration of the protocol before the conduct of the clinical study.</p><p>To register the key administrative and scientific information of clinical studies on an open-access platform before enrolling participants has been imperative from ethical, scientific, and even legal perspectives.<span><sup>4, 5</sup></span> Since 2005, the initiative by the WHO to develop ICTRP marks an important milestone in which region- or country-based registration platforms have been developed following unified standards, and ensuring that all registered trials receive a unique identification number for global searching.<span><sup>6</sup></span> Many efforts have been made to promote the transparency of the design and reporting the results of clinical studies; however, it seems that there is still a long way to go.<span><sup>7</sup></span> In a recent analysis of the registration of TM clinical studies, Zhang et al. have analyzed a total of 3339 Traditional Chinese Medicine studies registered in WHO ICTRP and found that 39% of the studies were retrospectively registered, and only 12.8% of studies shared resultant publications.<span><sup>8</sup></span> Compared to the 20 items required by WHO, none of the registered studies had a 100% reporting rate, and 11 items had a reporting rate lower than 65%. The fact that the registration quality of clinical studies in TM is not satisfactory is thought-provoking.</p><p>First, a unified portal for registering clinical studies in TM is necessary. Before 2023, people conducting TM clinical studies mainly registered the protocols by selecting one of the registries of WHO ICTRP or other publicly accessible registries such as ClinicalTrials.gov available in their regions or countries. Therefore, registered TM c
传统医学(TM)已成为全球不可或缺的资源,为全球健康做出了巨大贡献。通过设置临床试验和随机对照试验过滤器搜索 "传统医学 "及相关项目,截至 2024 年 4 月,PubMed 数据库中检索到近 17,000 个项目。此外,在世界卫生组织国际临床试验登记平台(ICTRP)上进行系统搜索时,也发现了 22,000 多项传统医学临床研究。尽管人们对中医临床研究的兴趣与日俱增,但有关证据质量的问题也随之出现。1, 2 经验性研究发现,具有积极结果的研究更有可能被发表,而具有显著效果估计值的结果也很有可能被充分报告。3 与传统医学类似,选择性结果报告在中医中也很普遍,在比较注册结果和出版物中报告的结果时,选择性结果报告几乎占到相关临床研究的三分之一。4, 5 自 2005 年以来,世界卫生组织(WHO)开发 ICTRP 的举措标志着一个重要的里程碑,在此过程中,以地区或国家为基础的注册平台已经按照统一的标准建立起来,并确保所有注册的试验都能获得一个唯一的识别码,以便在全球范围内进行检索。7 在最近一项关于中医临床研究注册的分析中,Zhang 等人分析了在世界卫生组织 ICTRP 中注册的 3339 项中医药研究,发现 39% 的研究是回顾性注册的,只有 12.8% 的研究共享了结果出版物。8 与世界卫生组织要求的 20 个项目相比,没有一项注册研究的报告率达到 100%,有 11 个项目的报告率低于 65%。TM 临床研究注册质量不尽如人意的事实发人深省。首先,有必要建立统一的 TM 临床研究注册门户网站。2023 年以前,开展 TM 临床研究的人员主要通过选择世界卫生组织 ICTRP 的注册中心之一或本地区或本国家可公开访问的其他注册中心(如 ClinicalTrials.gov)来注册方案。因此,已登记的 TM 临床研究分散在不同的登记处。此外,除了世卫组织 ICTRP 制定的注册标准外,各注册机构还可以提出自己的要求。一些登记处之间的不一致限制了整合和比较 TM 等同一领域临床研究的可能性,而且研究人员在不同登记处之间搜索某类临床研究需要花费更长的时间。其次,根据世界卫生组织要求的最低数据集,可能需要扩展登记项目,以提高 TM 临床研究报告的透明度,因为 TM 采用的健康和治疗方法与现代医学不同,临床数据在诊断模式、疾病体征和症状方面具有独特的信息内容、10 此外,由于 TM 干预的复杂性,例如针灸和推拿等 TM 技术的医患互动性,对 TM 干预的评估会产生特定的方法学问题。11 在这种情况下,中国中医药循证医学研究中心(CCEBTCM)于 2019 年启动了以 TM 临床研究为重点的统一注册项目。经过3年多的筹备,国际传统医学临床试验注册中心(ITMCTR,http://itmctr.ccebtcm.org.cn/;Email:[email protected])于2023年2月被正式认定为世界卫生组织ICTRP的一级注册中心。建立 ITMCTR 是一项伟大的创举,旨在提高传统医学研究的透明度,并通过在招募第一名参与者之前在一个可公开访问的门户网站上注册方案,帮助避免选择性地报告研究结果。除了世卫组织现有的国家和全球登记处之外,ITMCTR 是一个独特的平台,专注于跨国家和地区的单一主题(即 TM),旨在使用统一的登记标准开发一个完整的 TM 临床研究数据库,并显示所有正在进行和已完成的 TM 临床研究的设计趋势和结果。
{"title":"International Traditional Medicine Clinical Trial Registry: A meaningful initiative and its future development","authors":"Ning Liang,&nbsp;Yujing Zhang,&nbsp;Xuefei Zhang,&nbsp;Lijiao Yan,&nbsp;Chen Zhao,&nbsp;Sihong Yang,&nbsp;Ziteng Hu,&nbsp;Zehui Ye,&nbsp;Qianzi Che,&nbsp;Bin Liu,&nbsp;Haili Zhang,&nbsp;Huizhen Li,&nbsp;Zhao Chen,&nbsp;Qi Zhang,&nbsp;Taixiang Wu,&nbsp;Yanping Wang,&nbsp;Nannan Shi,&nbsp;Luqi Huang","doi":"10.1111/jebm.12651","DOIUrl":"10.1111/jebm.12651","url":null,"abstract":"&lt;p&gt;Traditional medicine (TM) has become an indispensable resource worldwide and it makes great contributions to global health. Searching for “traditional medicine” and related items by setting filters for clinical trials and randomized controlled trials, returns almost 17,000 items in the PubMed database till 2024 April. Moreover, more than 22,000 TM clinical studies have been found in the WHO International Clinical Trial Registry Platform (ICTRP) when conducting a systematic search. Despite the growing interest and number of clinical studies in TM, issues concerning the quality of the evidence have emerged.&lt;span&gt;&lt;sup&gt;1, 2&lt;/sup&gt;&lt;/span&gt; Empirical studies have found that studies with positive results are more likely to be published, and outcomes with significant effect estimates are very likely to be fully reported.&lt;span&gt;&lt;sup&gt;3&lt;/sup&gt;&lt;/span&gt; Similar to conventional medicine, selective outcome reporting is widespread in TM, accounting for almost one-third of relative clinical studies when comparing between the registered outcomes and the reported ones in the publications.&lt;span&gt;&lt;sup&gt;2&lt;/sup&gt;&lt;/span&gt; Conclusions based on biased evidence due to selective reporting can be misleading. An alternative approach to solve this issue is the registration of the protocol before the conduct of the clinical study.&lt;/p&gt;&lt;p&gt;To register the key administrative and scientific information of clinical studies on an open-access platform before enrolling participants has been imperative from ethical, scientific, and even legal perspectives.&lt;span&gt;&lt;sup&gt;4, 5&lt;/sup&gt;&lt;/span&gt; Since 2005, the initiative by the WHO to develop ICTRP marks an important milestone in which region- or country-based registration platforms have been developed following unified standards, and ensuring that all registered trials receive a unique identification number for global searching.&lt;span&gt;&lt;sup&gt;6&lt;/sup&gt;&lt;/span&gt; Many efforts have been made to promote the transparency of the design and reporting the results of clinical studies; however, it seems that there is still a long way to go.&lt;span&gt;&lt;sup&gt;7&lt;/sup&gt;&lt;/span&gt; In a recent analysis of the registration of TM clinical studies, Zhang et al. have analyzed a total of 3339 Traditional Chinese Medicine studies registered in WHO ICTRP and found that 39% of the studies were retrospectively registered, and only 12.8% of studies shared resultant publications.&lt;span&gt;&lt;sup&gt;8&lt;/sup&gt;&lt;/span&gt; Compared to the 20 items required by WHO, none of the registered studies had a 100% reporting rate, and 11 items had a reporting rate lower than 65%. The fact that the registration quality of clinical studies in TM is not satisfactory is thought-provoking.&lt;/p&gt;&lt;p&gt;First, a unified portal for registering clinical studies in TM is necessary. Before 2023, people conducting TM clinical studies mainly registered the protocols by selecting one of the registries of WHO ICTRP or other publicly accessible registries such as ClinicalTrials.gov available in their regions or countries. Therefore, registered TM c","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"486-489"},"PeriodicalIF":3.6,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12651","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348232","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}
引用次数: 0
Systematic review/meta-analysis on the role of CB1R regulation in sleep-wake cycle in rats 关于 CB1R 在大鼠睡眠-觉醒周期中调控作用的系统综述/元分析。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-26 DOI: 10.1111/jebm.12643
Jianjun Xue, Ziqing Xu, Jie Zhang, Huaijing Hou, Long Ge, Kehu Yang
<div> <section> <h3> Objective</h3> <p>A systematic review/meta-analysis was conducted to investigate the effect of cannabinoid type-1 receptor (CB1R) regulation on the sleep-wake cycle of rats and to provide new ideas and evidence-based basis for clinical research on the treatment of sleep disorders.</p> </section> <section> <h3> Methods</h3> <p>We searched Cochrane Library, PubMed, Web of Science, Embase, Chinese Biomedicine Literature Database (CBM), China National Knowledge Infrastructure, WanFang, and VIP databases for relevant papers, about the effects of CB1R agonists/antagonists on sleep-wake cycle in rats, from inception to November 2023. Two reviewers performed study screening, data extraction, and risk of bias assessment using the SYRCLE's risk of bias tool. Meta-analysis was performed using RevMan 5.3 software. Heterogeneity test was performed on the included studies (Test standard α = 0.1). <i>I</i><sup>2</sup> value was used to evaluate the heterogeneity. Forest plot was drawn, and <i>p</i> ≤ 0.05 indicates statistically significant difference.</p> </section> <section> <h3> Results</h3> <p>A total of 16 trials involving 484 experimental rats were included. The methodological quality evaluation results showed that the overall quality of the included studies was low. The results of the meta-analysis showed that single administration of CB1R agonists could shorten the wakefulness (W) time in the first 6 h (h) (standardized mean difference (SMD) = –2.52, 95% confidence interval (CI) (–3.83, –1.22), <i>p</i> = 0.0002) and 24 h (SMD = –0.84, 95% CI (–1.31, –0.36), <i>p</i> = 0.0005) after administration, prolong nonrapid eye movement sleep (NREM) time (SMD = 1.75, 95% CI (0.54, 2.95), <i>p</i> = 0.005) and rapid eye movement sleep (REM) time (SMD = 1.76, 95% CI (0.26, 3.26), <i>p</i> = 0.02), and increase REM frequency after administration (SMD = 1.67, 95% CI (0.98, 2.35), <i>p</i> < 0.00001), these results were all statistically different. There were no significant differences in sleep latency and average duration of REM. Single administration of CB1R antagonists prolonged the first 6 h W time after administration (SMD = 1.36, 95%CI (0.29, 2.43), <i>p</i> = 0.01), shortened the first 6 h NREM time (SMD = –1.73, 95% CI (–2.88, –0.57), <i>p</i> = 0.003) and REM time (SMD = –2.07, 95% CI (–3.17, –0.96), <i>p</i> = 0.0003) after administration, and increased the frequency of W after administration (SMD = 3.57, 95% CI (1.42, 5.72), <i>p</i> = 0.001). There was no statistical difference in the average duration of W. REM time and REM frequency increased after continuous CB1R agonist withdrawal.</p> </section>
目的通过系统综述/荟萃分析,研究大麻素 1 型受体(CB1R)调节对大鼠睡眠-觉醒周期的影响,为临床研究治疗睡眠障碍提供新思路和循证依据:方法:我们检索了Cochrane Library、PubMed、Web of Science、Embase、中国生物医学文献数据库(CBM)、中国国家知识基础设施、万方数据库和VIP数据库中有关CB1R激动剂/拮抗剂对大鼠睡眠-觉醒周期影响的相关论文。两位审稿人使用 SYRCLE 的偏倚风险工具进行了研究筛选、数据提取和偏倚风险评估。使用RevMan 5.3软件进行元分析。对纳入的研究进行了异质性检验(检验标准 α = 0.1)。I2 值用于评估异质性。绘制森林图,P≤0.05表示差异有统计学意义:结果:共纳入 16 项试验,涉及 484 只实验鼠。方法学质量评价结果显示,纳入研究的总体质量较低。荟萃分析结果显示,单次给药 CB1R 激动剂可缩短给药后前 6 h(h)的觉醒(W)时间(标准化平均差(SMD)= -2.52,95% 置信区间(CI)(-3.83,-1.22),p = 0.0002)和 24 h(SMD = -0.84,95% CI(-1.31,-0.36),p = 0.0005),延长非快速眼动睡眠(NREM)时间(SMD = 1.75,95% CI (0.54,2.95),p = 0.005)和快速眼动睡眠(REM)时间(SMD = 1.76,95% CI (0.26,3.26),p = 0.02),并增加给药后的 REM 频率(SMD = 1.67,95% CI (0.98,2.35),p 结论:根据现有证据,CB1R 在调节大鼠睡眠-觉醒周期中起着关键作用。CB1R 激动剂倾向于减少 W 时间、增加 NREM 和 REM 睡眠时间、提高 REM 频率并促进睡眠。相反,CB1R 拮抗剂可增加 W 的持续时间和频率,缩短 NREM 和 REM 睡眠时间,促进 W。
{"title":"Systematic review/meta-analysis on the role of CB1R regulation in sleep-wake cycle in rats","authors":"Jianjun Xue,&nbsp;Ziqing Xu,&nbsp;Jie Zhang,&nbsp;Huaijing Hou,&nbsp;Long Ge,&nbsp;Kehu Yang","doi":"10.1111/jebm.12643","DOIUrl":"10.1111/jebm.12643","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Objective&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;A systematic review/meta-analysis was conducted to investigate the effect of cannabinoid type-1 receptor (CB1R) regulation on the sleep-wake cycle of rats and to provide new ideas and evidence-based basis for clinical research on the treatment of sleep disorders.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We searched Cochrane Library, PubMed, Web of Science, Embase, Chinese Biomedicine Literature Database (CBM), China National Knowledge Infrastructure, WanFang, and VIP databases for relevant papers, about the effects of CB1R agonists/antagonists on sleep-wake cycle in rats, from inception to November 2023. Two reviewers performed study screening, data extraction, and risk of bias assessment using the SYRCLE's risk of bias tool. Meta-analysis was performed using RevMan 5.3 software. Heterogeneity test was performed on the included studies (Test standard α = 0.1). &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt; value was used to evaluate the heterogeneity. Forest plot was drawn, and &lt;i&gt;p&lt;/i&gt; ≤ 0.05 indicates statistically significant difference.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;A total of 16 trials involving 484 experimental rats were included. The methodological quality evaluation results showed that the overall quality of the included studies was low. The results of the meta-analysis showed that single administration of CB1R agonists could shorten the wakefulness (W) time in the first 6 h (h) (standardized mean difference (SMD) = –2.52, 95% confidence interval (CI) (–3.83, –1.22), &lt;i&gt;p&lt;/i&gt; = 0.0002) and 24 h (SMD = –0.84, 95% CI (–1.31, –0.36), &lt;i&gt;p&lt;/i&gt; = 0.0005) after administration, prolong nonrapid eye movement sleep (NREM) time (SMD = 1.75, 95% CI (0.54, 2.95), &lt;i&gt;p&lt;/i&gt; = 0.005) and rapid eye movement sleep (REM) time (SMD = 1.76, 95% CI (0.26, 3.26), &lt;i&gt;p&lt;/i&gt; = 0.02), and increase REM frequency after administration (SMD = 1.67, 95% CI (0.98, 2.35), &lt;i&gt;p&lt;/i&gt; &lt; 0.00001), these results were all statistically different. There were no significant differences in sleep latency and average duration of REM. Single administration of CB1R antagonists prolonged the first 6 h W time after administration (SMD = 1.36, 95%CI (0.29, 2.43), &lt;i&gt;p&lt;/i&gt; = 0.01), shortened the first 6 h NREM time (SMD = –1.73, 95% CI (–2.88, –0.57), &lt;i&gt;p&lt;/i&gt; = 0.003) and REM time (SMD = –2.07, 95% CI (–3.17, –0.96), &lt;i&gt;p&lt;/i&gt; = 0.0003) after administration, and increased the frequency of W after administration (SMD = 3.57, 95% CI (1.42, 5.72), &lt;i&gt;p&lt;/i&gt; = 0.001). There was no statistical difference in the average duration of W. REM time and REM frequency increased after continuous CB1R agonist withdrawal.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 ","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"714-728"},"PeriodicalIF":3.6,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348228","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}
引用次数: 0
Efficacy and safety of RS plus bevacizumab versus RS plus fruquintinib as the third-line therapy in patients with refractory metastatic colorectal cancer: A real-world propensity score matching study RS联合贝伐单抗与RS联合福罗替尼作为难治性转移性结直肠癌患者三线疗法的疗效与安全性:一项真实世界倾向评分匹配研究。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-26 DOI: 10.1111/jebm.12652
Yuwen Zhou, Qian Xu, Jialing Wang, Wei-Bing Leng, Peng Cao, Ye Chen, De-Yun Luo, Meng Qiu, Jiyan Liu

Background

This study aims to compare the effectiveness and safety of the combination of raltitrexed, S-1 (RS), and fruquintinib with the combination of RS and bevacizumab in patients with refractory metastatic colorectal cancer (mCRC).

Methods

This retrospective cohort included mCRC patients who received the RS plus fruquintinib or regorafenib as the third-line therapy from May 2019 to April 2023. A propensity score matching (PSM) analysis was used to balance the baseline characteristics of all patients. Overall survival (OS), progression-free survival (PFS), tumor response, and safety of the two regimens were evaluated.

Results

Of the 153 patients enrolled, 123 patients received the RS plus bevacizumab and 30 patients received the RS plus fruquintinib. After PSM, 30 pairs were analyzed. Patients treated with RS plus fruquintinib had a longer PFS than those treated with RS plus bevacizumab before PSM (5.0 months vs. 4.3 months, = 0.008) and after PSM (5.0 months vs. 4.4 months, = 0.012). A longer OS was also observed in RS plus fruquintinib group before PSM and after PSM, but there was no statistic difference between two groups after PSM. Both objective response rate and disease control rate were higher in the RS plus fruquintinib cohort than those in the RS plus bevacizumab cohort before PSM, and the difference in values between the two groups reduced after PSM. The adverse effects (AEs) of both groups were well tolerated.

Conclusion

In patients with refractory mCRC, RS plus fruquintinib demonstrated a superior OS, PFS than RS plus bevacizumab and had manageable AEs.

研究背景本研究旨在比较雷替曲塞、S-1(RS)和fruquintinib联合疗法与RS和贝伐珠单抗联合疗法在难治性转移性结直肠癌(mCRC)患者中的有效性和安全性:这项回顾性队列研究纳入了2019年5月至2023年4月期间接受RS加fruquintinib或瑞戈非尼作为三线疗法的mCRC患者。采用倾向评分匹配(PSM)分析平衡所有患者的基线特征。对两种方案的总生存期(OS)、无进展生存期(PFS)、肿瘤反应和安全性进行了评估:在153名入组患者中,123名患者接受了RS加贝伐珠单抗治疗,30名患者接受了RS加福昆替尼治疗。PSM 后,对 30 对患者进行了分析。在 PSM 前(5.0 个月 vs. 4.3 个月,p = 0.008)和 PSM 后(5.0 个月 vs. 4.4 个月,p = 0.012),接受 RS 加夫鲁喹替尼治疗的患者的 PFS 比接受 RS 加贝伐单抗治疗的患者更长。在 PSM 前和 PSM 后,RS 加夫鲁喹替尼组的 OS 也更长,但 PSM 后两组间无统计学差异。在PSM前,RS加弗仑替尼组的客观反应率和疾病控制率均高于RS加贝伐单抗组,而在PSM后,两组之间的数值差异缩小。两组患者的不良反应(AEs)耐受性良好:结论:在难治性mCRC患者中,RS联合fruquintinib的OS和PFS均优于RS联合贝伐珠单抗,且不良反应(AEs)可控。
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引用次数: 0
Efficacy and safety of Supine Daoyin in the treatment of acute exacerbation of chronic obstructive pulmonary disease: A randomized controlled trial 仰卧位导引术治疗慢性阻塞性肺疾病急性加重期的有效性和安全性:随机对照试验。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-25 DOI: 10.1111/jebm.12650
Jiansheng Li, Hailong Zhang, Jun Wang, Xuechao Lu, Mingyan Zuo, Li Jiao, Xiaofan Lu, Yang Wang

Aim

This study aimed to develop and evaluate the efficacy and safety of Supine Daoyin, a TCM PR technique, in hospitalized patients with AECOPD.

Methods

This is a multicenter, prospective, randomized, controlled trial involving AECOPD inpatients recruited from April 2021 to December 2023 in five tertiary hospitals in China. Participants were randomly assigned to 14 days of Supine Daoyin group or control group and evaluated at days 3, 7, and 14 (posttreatment). The primary outcomes were LOS and CCQ and secondary outcomes were 6MWD, 30-STS, BI, Borg CR10, time on mechanical ventilation, SGRQ, mCOPD-PRO, and mESQ-COPD.

Results

Out of 369 participants screened, 228 were randomly assigned (Supine Daoyin group: n = 114; control group: n = 114). For primary outcomes, there was no significant between-group difference in LOS (p > 0.05), but for CCQ the Supine Daoyin was superior to control at days 7 (p < 0.01) and 14 (p < 0.01). For secondary outcomes, Supine Daoyin groups showed robust and superior improvements in 6MWD, 30-STS, BI, Borg CR10, SGRQ, mCOPD-PRO, and mESQ-COPD (all p < 0.05), but for time on mechanical ventilation there was no significant difference in two groups (p > 0.05).

Conclusion

Supine Daoyin, a novel TCM PR technique, demonstrates safety and efficacy for AECOPD inpatients, yielding clinically meaningful improvements in health status, exercise capacity, and quality of life. This study offers a viable PR option for AECOPD patients with severe symptoms and limited mobility.

目的:本研究旨在开发和评估中医公关技术--仰卧位导引术在AECOPD住院患者中的疗效和安全性:本研究是一项多中心、前瞻性、随机对照试验,涉及 2021 年 4 月至 2023 年 12 月期间在中国 5 家三级医院招募的 AECOPD 住院患者。参与者被随机分配到为期 14 天的仰卧位道意组或对照组,并在第 3、7 和 14 天(治疗后)进行评估。主要结果为LOS和CCQ,次要结果为6MWD、30-STS、BI、Borg CR10、机械通气时间、SGRQ、mCOPD-PRO和mESQ-COPD:在筛选出的 369 名参与者中,228 人被随机分配(仰卧位叩齿组:n = 114;对照组:n = 114)。在主要结果方面,LOS 组间无显著差异(P > 0.05),但在第 7 天的 CCQ 方面,Supine Daoyin 组优于对照组(P 0.05):结论: Supine Daoyin 是一种新颖的中医 PR 技术,对 AECOPD 住院患者具有安全性和有效性,在健康状况、运动能力和生活质量方面都取得了有临床意义的改善。这项研究为症状严重、行动不便的 AECOPD 患者提供了一种可行的 PR 方案。
{"title":"Efficacy and safety of Supine Daoyin in the treatment of acute exacerbation of chronic obstructive pulmonary disease: A randomized controlled trial","authors":"Jiansheng Li,&nbsp;Hailong Zhang,&nbsp;Jun Wang,&nbsp;Xuechao Lu,&nbsp;Mingyan Zuo,&nbsp;Li Jiao,&nbsp;Xiaofan Lu,&nbsp;Yang Wang","doi":"10.1111/jebm.12650","DOIUrl":"10.1111/jebm.12650","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>This study aimed to develop and evaluate the efficacy and safety of Supine Daoyin, a TCM PR technique, in hospitalized patients with AECOPD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This is a multicenter, prospective, randomized, controlled trial involving AECOPD inpatients recruited from April 2021 to December 2023 in five tertiary hospitals in China. Participants were randomly assigned to 14 days of Supine Daoyin group or control group and evaluated at days 3, 7, and 14 (posttreatment). The primary outcomes were LOS and CCQ and secondary outcomes were 6MWD, 30-STS, BI, Borg CR10, time on mechanical ventilation, SGRQ, mCOPD-PRO, and mESQ-COPD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Out of 369 participants screened, 228 were randomly assigned (Supine Daoyin group: <i>n</i> = 114; control group: <i>n</i> = 114). For primary outcomes, there was no significant between-group difference in LOS (<i>p</i> &gt; 0.05), but for CCQ the Supine Daoyin was superior to control at days 7 (<i>p</i> &lt; 0.01) and 14 (<i>p</i> &lt; 0.01). For secondary outcomes, Supine Daoyin groups showed robust and superior improvements in 6MWD, 30-STS, BI, Borg CR10, SGRQ, mCOPD-PRO, and mESQ-COPD (all <i>p</i> &lt; 0.05), but for time on mechanical ventilation there was no significant difference in two groups (<i>p</i> &gt; 0.05).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Supine Daoyin, a novel TCM PR technique, demonstrates safety and efficacy for AECOPD inpatients, yielding clinically meaningful improvements in health status, exercise capacity, and quality of life. This study offers a viable PR option for AECOPD patients with severe symptoms and limited mobility.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"654-666"},"PeriodicalIF":3.6,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12650","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348231","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}
引用次数: 0
Validation of the Generic Version of China Health Related Outcomes Measures (CHROME-G) among individuals with type 2 diabetes in China 在中国 2 型糖尿病患者中验证通用版中国健康相关结果测量(CHROME-G)。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-24 DOI: 10.1111/jebm.12642
Meixuan Li, Shitong Xie, Minyan Yang, Yanan Wu, Zijun Li, Rui Li, Xiuxia Li, Xue Li, Yijun Liu, Jing Wu, Kun Zhao, Feng Xie, Kehu Yang

Objective

The Generic Version of China Health Related Outcomes Measures (CHROME-G) was a new preference-based health-related quality of life (HRQoL) instrument designed specifically for the Chinese population. This study aimed to validate and compare measurement properties of CHROME-G with EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), Short Form-6 Dimensions version 2 (SF-6Dv2), and Diabetes-Specific Quality of Life (DSQL) scales among the elderly Chinese population with type 2 diabetes.

Methods

A representative sample population was recruited across the country. Internal consistency was assessed using Cronbach's alpha. Hypotheses testing including convergent validity and known-groups validity were evaluated using Spearman's rank correlation and effect sizes, respectively. Sensitivity was examined using relative efficiency and receiver operating characteristic curve.

Results

A total of 131 individuals with type 2 diabetes (54.20% male; mean age 69.03 years) were enrolled. Cronbach's alpha was 0.94 for DSQL, 0.93 for CHROME-G, 0.87 for EQ-5D-5L, and 0.88 for SF-6Dv2. For the convergent validity of CHROME-G, 24/29 (82.76%) correlations met the predefined hypotheses, with Spearman's rank correlation coefficients ranging from 0.51 to 0.96. Among the different health subgroups, the effect sizes for CHROME-G, DSQL, EQ-5D-5L, and SF-6Dv2 were 0.19–1.26, 0.36–1.62, 0.22–1.06, and 0.49–0.87, respectively. CHROME-G, DSQL, and SF-6Dv2 had higher efficiency compared with EQ-5D-5L in detecting differences in self-reported health status, with relative efficiency of 3.18 and 1.76, 4.38 and 6.52, and 1.56 and 2.09, respectively.

Conclusions

CHROME-G demonstrates relatively good measurement properties compared with EQ-5D-5L and SF-6Dv2 for measuring the HRQoL among the elderly Chinese population with type 2 diabetes. The sensitivity of DSQL appears to be better than that of the three generic instruments.

目的:中国健康相关结果测量通用版(CHROME-G)是专为中国人群设计的基于偏好的健康相关生活质量(HRQoL)新工具。本研究旨在中国老年 2 型糖尿病患者中验证 CHROME-G 与欧洲量表 5 维度 5 级(EQ-5D-5L)、简表 6 维度 2 版(SF-6Dv2)和糖尿病特异性生活质量(DSQL)量表的测量特性并进行比较:方法:在全国范围内招募具有代表性的样本人群。采用 Cronbach's alpha 评估内部一致性。假设检验包括收敛效度和已知组效度,分别使用斯皮尔曼等级相关性和效应大小进行评估。灵敏度采用相对效率和接收者操作特征曲线进行检验:共有 131 名 2 型糖尿病患者(54.20% 为男性,平均年龄 69.03 岁)参加了研究。DSQL 的 Cronbach's alpha 为 0.94,CHROME-G 为 0.93,EQ-5D-5L 为 0.87,SF-6Dv2 为 0.88。就 CHROME-G 的收敛效度而言,24/29(82.76%)个相关系数符合预定义假设,斯皮尔曼等级相关系数在 0.51 至 0.96 之间。在不同的健康亚组中,CHROME-G、DSQL、EQ-5D-5L 和 SF-6Dv2 的效应大小分别为 0.19-1.26、0.36-1.62、0.22-1.06 和 0.49-0.87。与 EQ-5D-5L 相比,CHROME-G、DSQL 和 SF-6Dv2 在检测自我报告健康状况差异方面的效率更高,相对效率分别为 3.18 和 1.76、4.38 和 6.52 以及 1.56 和 2.09:与 EQ-5D-5L 和 SF-6Dv2 相比,CHROME-G 在测量中国老年 2 型糖尿病患者的 HRQoL 方面具有相对较好的测量特性。DSQL的灵敏度似乎优于这三种通用工具。
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引用次数: 0
Efficacy and safety of various corticosteroids in the treatment of children with allergic rhinitis: A systematic review and network meta-analysis 各种皮质类固醇治疗儿童过敏性鼻炎的有效性和安全性:系统综述和网络荟萃分析。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-23 DOI: 10.1111/jebm.12645
Yuxin Li, Jun Xiong, Zheng Zhang, Kai Liao, Xiaohong Zho, Jun Li, Jie Xiang, Lingling Xu

Background

Intranasal corticosteroids were recommended as first-line drugs for the treatment of allergic rhinitis (AR) children. A variety of corticosteroids were available for clinical choice; however, which could relieve the clinical symptoms of patients to the greatest extent was currently unknown. Thus, we performed a network meta-analysis (NMA) to systematically evaluate the effectiveness and safety of different corticosteroids in treating children with AR, which might provide a basis for more rational clinical treatment decisions.

Methods

Seven electronic databases were searched, and the retrieval time range was the time from their inception to November 2023. The literature screening, data extraction, and assessment of the risk of bias of included studies were completed independently by two reviewers. A frequentist NMA was performed with Stata17.0 software.

Results

A total of 43 RCTs covering 10,897 participants were included. In the improvement of reflective total nasal symptom score (rTNSS) and instantaneous total nasal symptom score (iTNSS), fluticasone furoate nasal spray (FFNS) and beclomethasone dipropionate (BDP) nasal aerosol presented the best efficacy. Regarding the incidence of adverse reactions, mometasone furoate aqueous nasal spray (MFANS) and BDP showed a good safety profile. In terms of the influence of cortisol (urinary free cortisol, plasma cortisol) and growth, no significant difference was observed between the different groups.

Conclusion

The results showed that BDP nasal aerosol and FFNS had best efficacy; MFANS and BDP had the best safety profile. However, this conclusion was less convincing because of the limited numbers of patients/controls and study quality.

背景:鼻内皮质类固醇被推荐为治疗儿童过敏性鼻炎(AR)的一线药物。临床上有多种皮质类固醇可供选择,但目前尚不清楚哪种药物能最大程度地缓解患者的临床症状。因此,我们进行了一项网络荟萃分析(NMA),以系统评估不同皮质类固醇治疗儿童过敏性鼻炎的有效性和安全性,从而为更合理的临床治疗决策提供依据:方法:检索了七个电子数据库,检索时间范围为这些数据库的起始时间至 2023 年 11 月。文献筛选、数据提取和纳入研究的偏倚风险评估由两名审稿人独立完成。使用Stata17.0软件进行了频数主义NMA分析:结果:共纳入 43 项 RCT 研究,覆盖 10,897 名参与者。在改善反射性鼻部症状总分(rTNSS)和瞬时鼻部症状总分(iTNSS)方面,糠酸氟替卡松鼻喷雾剂(FFNS)和二丙酸倍氯米松(BDP)鼻气雾剂的疗效最佳。在不良反应发生率方面,糠酸莫米松水鼻喷雾剂(MFANS)和二丙酸倍氯米松(BDP)显示出良好的安全性。在皮质醇(尿游离皮质醇、血浆皮质醇)和生长的影响方面,不同组之间没有观察到显著差异:结果表明,BDP 鼻用气雾剂和 FFNS 的疗效最好;MFANS 和 BDP 的安全性最好。然而,由于患者/对照组数量有限以及研究质量问题,这一结论的说服力较弱。
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引用次数: 0
期刊
Journal of Evidence‐Based Medicine
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