中成药治疗眩晕随机对照试验的证据总结与评价

Summary and evaluation of randomized controlled trial on Chinese patent medicine in treatment of vertigo

关键词:  中成药  眩晕  随机对照试验  循证医学  临床评价

Key words:  Chinese patent medicine  vertigo  randomized controlled trial  evidence-based medicine  clinical evaluation

摘要:

[目的] 通过收集、整理各数据库建库以来中成药治疗眩晕的临床随机对照试验（RCT），系统评价、分析，为后续研究开展提供参考，帮助提高临床证据质量，并为制定相关指南提供依据。[方法] 基于中医药循证研究证据库系统（EVDS）旗下中成药临床证据数据库（AICED-CPM）收录的文献，结合检索中国知网（CNKI）、万方数据知识服务平台（Wanfang Database）等中英文数据库中中成药治疗眩晕的RCT，进行统计分析，采用RoB和CONSORT对纳入文献进行评价。[结果] 检索得到符合纳排标准的RCTs 242篇，其中纳入患者样本量300例及以上的RCTs 7篇，包含8种中成药；所有文献涉及中成药共有97种（口服中成药65种，中药注射剂32种），发文量最多的中成药为天麻素注射液（75篇，30.99%）；干预/对照设计27种，其中“中成药+西药vs.西药”为最常用设计（66篇，27.27%）；疗程以7~28 d为主（164篇，67.77%）；评价指标中，共出现9种计数指标（331次），46种计量指标（599次）；方法学质量方面，分配隐藏及其他偏倚均为中高风险，报告质量方面，方法、随机方法、讨论中部分小条目报告情况较差。[结论] 中成药治疗眩晕RCT的方法学质量和报告质量较低，偏倚风险过高，试验设计不够严谨。后续研究开展应遵循CONSORT声明规范研究方案设计，在研究过程中加强质量控制，重视试验注册，为指南制定提供更高级别证据支持，为未来研究的开展提供有价值的参考。

Abstract:

[Objective] This study collected and sorted out the clinical randomized controlled trials（RCTs） of Chinese patent medicine in the treatment of vertigo since the establishment of each database，systematically evaluated and analyzed，provided reference for the follow-up study，helped to improve the quality of clinical evidence，and provided the basis for the formulation of relevant guidelines. [Methods] Based on the literature included in the Chinese patent medicine clinical evidence database（AICED-CPM） under the evidence-based Chinese medicine research evidence database system（EVDS），combined with the retrieval of Chinese patent medicine treatment of vertigo RCT in Chinese and English databases such as CNKI and Wanfang data knowledge service platform（Wanfang Database），statistical analysis was conducted. RoB and CONSORT were applied to evaluate the included literature. [Results] A total of 242 RCTs that met the exclusion criteria were retrieved. Among them，7 RCTs with a sample size of 300 patients or more were included，including 8 kinds of Chinese patent medicines. It involved 97 kinds of Chinese patent medicines（65 kinds of oral Chinese patent medicines and 32 kinds of traditional Chinese medicine injections），and gastrodine injection（75 articles，30.99%） was the most published Chinese patent medicines. There were 27 intervention/control designs，of which “Chinese patent medicines+Western medicine vs. Western medicine” was the most commonly used design（66 articles，27.27%）. The main duration of treatment was 7 to 28 days（164 articles，67.77%）. Among the evaluation indexes，there were 9 counting indexes（331 times） and 46 measuring indexes（599 times）. In terms of methodological quality，allocation concealment and other biases are at medium and high risk. In terms of reporting quality，methods，random methods，and some small items in the discussion are poorly reported. [Conclusions] The methodological quality and reporting quality of RCT for treatment of vertigo with Chinese patent medicines are low，the risk of bias is too high，and the trial design is not rigorous. Follow-up research should follow the CONSORT declaration to standardize the design of research protocols，strengthen quality control during the research process，attach importance to experiment registration，provide a higher-level evidence support for the formulation of guidelines，and provide a valuable reference for future research.