文章摘要

中国中药治疗抽动障碍的随机对照试验发表趋势与质量评价

作者: 1王平平, 1吴雪
1 中国人民解放军联勤保障部队第924医院药剂科,广西 桂林 541002
通讯: 吴雪 Email: xue181924@163.com
DOI: 10.3978/j.issn.2095-6959.2022.02.026

摘要

目的:评价中国中药治疗抽动障碍(tic disorders,TDs)的随机对照治疗试验(randomized controlled trials,RCTs)的现状及未来趋势。方法:通过计算机检索国内外6个数据库,纳入国内外发表的中国中药治疗TDs的RCTs,根据Cochrane偏倚风险评价工具对所有纳入的RCTs进行质量评价。结果:共纳入67篇文献,5 760例患者,其中男4 561例。1996至2021年发表的RCTs数量不多。纳入的所有研究未进行样本量计算,7.5%(5/67)为多中心研究,研究中心2~7个。41.8%(28/67)在教学医院完成。干预措施中,71.6%(48/67)为中药治疗、28.4%(19/67)为中西药结合治疗。对照措施中,所有研究采用阳性药物对照。14.9%(10/67)报道了正确的随机分配方法,所有报道未采用完善的分配方案隐藏,仅3.0%(2/67)采用正确盲法。结论:近25年中国发表中药治疗抽动障碍的RCT数量较少,缺乏安慰对照或分配隐藏的多中心随机对照试验,且样本量过少,大部分研究质量较差,应高度重视提高抽动障碍治疗试验的设计与实施质量的水平。
关键词: 抽动障碍;中药治疗;随机对照试验;质量评价

Trend and quality evaluation of randomized controlled trials of tic disorder by traditional Chinese medicine treatment

Authors: 1WANG Pingping, 1WU Xue
1 Pharmaceutical Preparation Section, the 924st Hospital of People’s Liberation Army, Guilin Guangxi 541002, China

CorrespondingAuthor: WU Xue Email: xue181924@163.com

DOI: 10.3978/j.issn.2095-6959.2022.02.026

Abstract

Objective: To evaluate the current status and publication tendency of randomized controlled trials (RCTs) of tic disorders (TDs) by traditional Chinese medicine treatment, and to provide references for the design and guideline formulation of domestic clinical research in the future. Methods: Through searching 6 databases, the RCTs of TDs by traditional Chinese medicine treatment published home and abroad were included, and the quality evaluation of all the RCTs was carried out according to the Cochrane bias risk assessment. Results: Sixty-seven articles were included, with a total of 5 760 patients. All studies included in this article did not carry out the sample size calculation, 7.5% (5/67) of which are multi-center (2–7 centers) studies. 41.8% (28/67) of studies were completed in the teaching hospital. 71.6% (48/67) of studies adopted Chinese medicine treatment, and 28.4% (19/67) of studies adopted Chinese and Western medicine. All the studies applied positive drug control. Only 14.9% (10/67) of studies reported the right random allocation methods. All reports did not use complete allocation concealment methods. Only 3% (2/67) of studies used the correct method of blinding. Conclusion: There are few randomized controlled trials of traditional Chinese medicine in the treatment of TDs. The studies lacked placebo-controlled or group-hidden multicenter randomized trials. The study sample size is small, and the report quality is poor overall. Therefore, we should pay attention to the quality of the design or implementation of TDs treatment trials.
Keywords: tic disorder; traditional Chinese medicine treatment; randomized controlled trial; quality evaluation

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