近7年中医药治疗特发性面神经麻痹随机对照试验结局指标的现状分析

Status of Outcome Indicators in Randomized Controlled Trials on Traditional Chinese Medicine Intervention for Idiopathic Facial Nerve Palsy in Recent Seven Years

目的:评价中医药治疗特发性面神经麻痹(IFP)随机对照试验(RCT)的结局指标应用现状。方法:全面检索7个数据库、2个临床试验注册中心,按预先制定的遴选标准筛选出相关的RCT,根据Cochrane风险偏倚评估工具对纳入文献进行偏倚风险评估,对结局指标、测量时间点、研究时间、结局指标等级情况进行统计描述。结果:初步检索出相关文献13489篇,最终纳入45篇RCT(中文文献44篇,英文文献1篇),报告95个结局指标,使用频次233次。研究发现中医药治疗IFP的RCT总体偏倚不明确,临床研究中结局指标存在参考标准、命名、测量时间点杂乱,选用类别不均,主次不明确的问题。结论:中医药治疗IFP的RCT结局指标集研究尚处于起步阶段,参考国际经验,结合中医药特点制定实用的研究流程,仍需要精确的临床及统计工作来构建规范、统一、公认的核心指标集。

Objective:To evaluate the status of outcome measures in a randomized controlled trial(RCT)of traditional Chinese medicine for the treatment of idiopathic facial nerve palsy(IFP).Methods:A total of seven databases and two clinical trial registries were searched,and relevant RCTs were screened according to pre-defined selection criteria.The bias risk assessment of the included studies was performed according to the Cochrane risk bias assessment tool,and the outcome indicators,measurement time,study time,and outcome indicator levels were statistically described.Results:A total of 13489 relevant literature was preliminary searched,and finally 45 RCTs(44 Chinese literature and one English literature)were included.95 outcome indicators were reported,with a frequency of 233 times.The study found that the overall bias of RCTs in the treatment of IFP with traditional Chinese medicine was not clear,and the outcome indicators in clinical studies involved problems such as irregular reference standards,definitions,and measurement time points,uneven selection categories,and unclear primary and secondary levels.Conclusion:The research on the RCT outcome indicator set in the treatment of IFP with traditional Chinese medicine is still in its infancy.According to international experience and practical research processes based on the characteristics of traditional Chinese medicine,it is still necessary to have accurate clinical and statistical work to construct a standardized,unified,and recognized core indicator set.