雷公藤用药者血液系统不良事件发生率的Meta分析  

Meta-analysis of blood system adverse events of Tripterygium wilfordii

作　　者：李志霞[1] 马冬梅[1] 杨兴华[2] 孙凤[1] 郁凯[3] 詹思延[1] 

机构地区：[1]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [2]首都医科大学公共卫生学院流行病与卫生统计学系,北京100069 [3]北京大学滨海医院骨科,天津300450

出　　处：《中国中药杂志》2015年第2期339-345,共7页China Journal of Chinese Materia Medica

基　　金：滨海新区卫生科技项目(2012BWKZ002;2011BHKY008)

摘　　要：文章系统评价了雷公藤（TWP）用药者血液系统不良事件的发生率情况。以“Tripterygium wilfordii Hook.f.”,“toxicity”,“side effect”,“adverse”,“safety”,“tolerability”为关键词在CMCC,CBMDisc,CNKI,VIP,万方,Medline,Embase,The Cochrane Library等8个数据库（均从最早至2013年5月25日）中,系统检索了雷公藤用药者发生血液系统不良事件的随访研究,包括随机对照试验、队列研究、病例系列研究。采用Meta Analyst软件进行了血液系统不良事件发生率的Meta分析,并按照年龄、用药方式、观察时间和就诊科室进行亚组分析和敏感性分析。根据入选及排除标准,共纳入49篇文献,拆分后形成54个研究纳入分析,因率的Meta分析各研究之间总是存在较大异质性,故采用随机效应模型。结果显示总的TWP用药者血液系统不良事件平均每1 000人发生61次。针对3个主要血液系统不良事件：白细胞减少、血红蛋白减少和血小板减少,加权合并的发生率分别为5.6%（95%CI,4.3%～7.3%）,1.7%（95%CI,0.5%～5.0%）,1.8%（95%CI,1.0%～3.1%）。54个研究中,45个为高质量研究,敏感性分析显示高质量研究合并后与总的合并值接近。由结果可知,TWP用药者血液系统不良事件的发生率较高,应重视对血液系统不良事件的防治。A systematic review was undertaken, including studies that evaluated the incidence of the blood system adverse events of Tripterygium wilfordii（TWP）. Medline, Embase and the Cochrane library were searched for relevant studies,including RCT, cohort studies and case series, of patients treated with TWP published in English and Chinese from inception up until May 25th, 2013 with the keywords including “Tripterygium wilfordii”, “toxicity”, “reproductive”, “side effect”, “adverse”, “safety” and “tolerability”. Relevant information was extracted and the incidence of the blood system adverse events was pooled with MetaAnalyst software. Besides, sub- group and sensitivity analyses were performed based on age, mode of medicine, observation time and disease system. According to inclu- sion and exclusion criteria, a total of 49 articles were included in the meta-analysis, they were split into 54 researches incorporated in the analysis. There is a large degree of heterogeneity among the studies, so data was analyzed using random-effects model and the sum- mary estimates of incidence of the blood system adverse events was 6. 1%. The weighted combined incidence of three major blood sys- tem adverse events were white-blood cells decreasing 5.6% （95 % CI, 4. 3 %-7.3 % ）, hemoglobin decreasing 1.7 % （95 % CI, 0. 5 %- 5.0% ） and platelet decreasing 1.8% （95% CI, 1.0% -3.1% ）, respectively. Sensitivity analyses based on 45 studies with high quality showed the combined value was close to the summary estimate of total 54 studies. The current evidence indicates that the incidence of the blood system adverse events induced by TWP was high; attentions should be paid on to the prevention and treatment of the blood system adverse events.

关 键 词：雷公藤 血液系统不良事件 发生率 META分析 

分 类 号：R285.6[医药卫生—中药学]