腹型过敏性紫癜临床研究结局指标现状分析

Current status of outcome indicators in clinical studies of abdominal Henoch-Schonlein purpura

目的调查分析我国腹型过敏性紫癜临床研究结局指标现状,为该领域核心结局指标集的建立提供参考依据。方法计算机检索CBM、CNKI、VIP和万方数据库、PubMed、EMbase、The Cochrane Library、Web of Science,收集公开发表的腹型过敏性紫癜研究,检索时限均为2010年1月1日至2019年10月31日。由两名评价员按照纳入与排除标准独立筛选文献和提取资料,并对结局指标数据进行处理分析。结果①共纳入腹型过敏性紫癜研究89篇,其中86篇为随机对照研究,3篇为队列研究。②腹型过敏性紫癜研究结局指标以临床体征指标为主(45.79%),其次为总体疗效指标(22.37%)。③报告率前5的结局指标分别为临床疗效(70.79%)、不良反应(35.96%)、腹痛缓解时间(32.58%)、皮疹消退时间(26.97%)和血便消失时间(21.35%)。④所有研究未明确区分主要和次要结局指标。结论2010~2019年国内腹型过敏型紫癜研究结局指标种类甚多,异质性大。研究关注疗效指标而忽视不良结局指标。有必要建立腹型过敏性紫癜临床干预性研究结局指标核心指标集,为同类研究的结局选择提供参考依据。

Objective To investigate and analysis the current situation of clinical outcome indicators of abdominal Henoch-Schonlein purpura(AHSP)in China,and to provide reference for the establishment of core outcome indicators in this field.Methods The databases of CBM,CNKI,VIP Database,WanFang Data,PubMed,EMbase,The Cochrane Library and Web of Science were retieved with computer for collecting published studies on AHSP from Jan.1,2010 to Oct.31,2019.The literature was screened and materials were extracted according to inclusion and exclusion criteria by 2 reviewers independently,and data of outcome indicators was processed and analyzed.Results①There were totally 89 studies on AHSP included,including 86 randomized controlled studies and 3 cohort studies.②The main outcome indicators of AHSP was clinical signs(45.79%),followed by the indicators of overall curative effect(22.37%).③The top five outcome indicators were clinical efficacy(70.79%),adverse reactions(35.96%),abdominal pain relief time(32.58%),rash regression time(26.97%)and bloody stool disappearance time(21.35%).④There was no clear distinction between primary and secondary outcome indicators in all studies.Conclusion There are many kinds of outcome indicators of AHSP in China from 2010 to 2019,and the heterogeneity is large.The studies focus on efficacy indicators and ignore adverse outcome indicators.It is necessary to establish a core set of outcome indicators for clinical intervention studies of AHSP,so as to provide reference for the outcome selection in similar studies.