中药治疗儿童过敏性紫癜的随机对照试验中诊断标准和疗效评价指标的选用

Selection of diagnostic criteria and therapeutic effectiveness evaluation index about RCTs of Chinese herbal medicine for Henoch-Schonlein Purpura in children

目的:通过我们进行的一项中药治疗儿童过敏性紫癜(HSP)的随机对照试验(RCT)的系统综述工作,展示RCT中用到的诊断和疗效评价指标,与国际上通用的指标进行比较。方法:通过对国内外5个数据库的电子检索,经筛选后纳入所有以中药为主要干预措施的治疗儿童过敏性紫癜的RCT,对纳入文献的相关信息进行抽提,并与国际上通用的指标进行比较并分析之间的差异。结果:在国内进行的相关的RCT的诊断标准,多数是参考《诸福棠实用儿科学》(6版)中的过敏性紫癜的"临床表现"。现行的疗效评价标准分别是《中医病证诊断疗效标准》和《中药新药临床研究指导原则》所制订的标准,复合疗效指标是报告最多的疗效指标。结论:目前国内关于过敏性紫癜的诊断标准,没有紧跟国际制订的标准。疗效评价指标的科学性、操作中的可控性、稳定性需要质疑,期望能有统一的、科学严谨的指标发布,供业界人士参考。

Objective：The aim of this study is to illustrate the diagnostic criteria and therapeutic effectiveness evaluation index in the randomized controlled trials（RCTs） and compare to the international index,which based on a systematic review of RCTs of traditional Chinese medicine（TCM） for Henoch-Scholein Purpura（HSP） in children.Methods：By searching five popular databases of CNKI,VIP,Wanfang database,Cochrane Library and Pubmed,the full articles including the RCTs that use TCM as the main intervention for HSP in children were screened.The information of diagnostic criteria and therapeutic effectiveness evaluation index was extracted and compared to the international common index.The difference in the indexes between China and abroad was analyzed.Results：The diagnostic criteria of TCM for children HSP in China mainly used the ’HSP clinical syndrome’ in the Zhufutang’s Practical Pediatrics（6th version）.The effectiveness evaluation standard is usually referring to the TCM Syndromes Diagnostic Criteria and Guiding Principle of Clinical Research on New Drugs of Traditional Chinese Medicine.Compound therapeutic effect index is mostly reported.Conclusion：Currently,the diagnostic criteria for children HSP in China do not entirely follow the international criteria.The scientificity,controllability and stability in the practice of therapeutic effectiveness evaluation index of HSP in children should bequeried in China.We expect that there will be an index with united,scientific and rigorous for practitioners.