双相障碍临床药物疗效研究的循证医学评价
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Evaluation of clinical efficacy of bipolar disorder in the evaluation of evidence-based medicine
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    目的 了解我国双相障碍临床药物治疗性研究文献的方法学现状以及国内精神科医师对 CONSORT声明及Jadad 评分量表的了解与熟悉程度。方法 采用计算机检索中国知网、万方数据库、 Medline、Web of Science、PsycINFO 以及Embase 等中英文数据库中我国研究者已发表的双相障碍临床药 物治疗的随机对照研究(RCT)。按照中国双相障碍防治指南的出版和更新时间将文献分为A 组(2007 年 以前)、B 组(2007— 2015 年度)和C 组(2015— 2017 年度)运用CONSORT 声明和Jadad 评分量表评定文献 的方法学质量。结果 共纳入154 篇RCT 文献,中文149 篇(96.8%),英文5 篇(3.2%)。CONSORT 声明评 价结果:受试者来源、干预措施、结局指标的界定、统计学方法、纳入分析人数、不良反应以及试验结果 普遍意义的报告率均高于90%,但样本量的计算、随机序列的产生与分配方案的隐藏、盲法、受试者的 失访和依从性描述等项目的报告率均低于50%;Jadad 评分量表评定结果:国内高质量文献数为5 篇,占 3.4%,国外发表的文献高质量者为3 篇,占60%。结论 我国目前发表的双相障碍临床药物治疗性研究 文献,采用CONSORT声明和Jadad 评分量表评定方法学质量还有较大提升空间,精神科临床科研工作 者对CONSORT 声明和Jadad 评分量表了解甚少,有待进一步专题培训。

    Abstract:

    Objective To explore the current status of the literature on the clinical drug treatment research on bipolar disorder in China and the familiarity of CONSORT statement and Jadad scale issued by psychiatrists in Chinese psychiatrists. Methods Randomized controlled trials( RCT) on bipolar disorder clinical drug research in China were searched by Computer on CNKI, Wanfang database, Medline, Web of Science, PsycINFO, Embase and other Chinese and English databases. All the papers were divided into Group A( before 2007), B( 2007-2015) and C( 2015-2017) according to the publication and update time of the Chinese Bipolar Disorder Prevention Guidance. The methodology quality of the literatures was assessed using CONSORT statement and Jadad scale. Results A total of 154 RCT papers were searched, and the RCT researches included 149 Chinese( 96.8%), 5 English( 3.2%). The evaluation result of CONSORT statements indicated that the reporting rate of subject sources, interventions, outcome indicators, statistical methods, number of subjects included, the adverse reactions and the universal significance of the search results were all higher than 90%. However, the reporting rate of sample size, the creation of random sequence and the hiding of distribution scheme, blindness, loss and compliance of subjects are all below 50%. The result of Jadad scale showed that the number of high quality literature in China was 5, accounting for 3.4%. The number of high quality literature published abroad was 3, accounting for 60%. Conclusions There is still much room for improvement in the quality of methodological quality in the literature published in the current clinical treatment research literature of bipolar disorder in China, which is evaluated by CONSORT statement and Jadad scale. The psychiatric clinical researchers know little about the CONSORT statement and the Jadad scale, and need further special training.

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刘晓东 李晓菊 史战明 袁媛 刘蜀东 唐光路 桂竟涛 张庆辉.双相障碍临床药物疗效研究的循证医学评价[J].神经疾病与精神卫生,2018,18(3):
DOI :10.3969/j. issn.1009-6574.2018.03.003.

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  • 在线发布日期: 2018-08-21