摘要
目的系统评价雷公藤用药者生殖毒性发生率。方法以＂Tripterygium wilfordii hook .f＂、＂toxicity＂、＂reproductive＂、、“side effect”、“adverse”、“safety”和“tolerability”为关键词在CMCC、CBMDisc、CNKI、VIP、万方、MEDLINE、EMBASE和Cochrane Library等8个数据库检索用药者生殖毒性的临床研究，采用MetaAnalyst进行合并，并做亚组分析。结果共56篇文献入选，总生殖毒性发生率为17．9％（95％CI：14．1％～22．5％），儿童和成人发生率分别为24．4％（95％CI：13．3％～40．3％）和15．7％（95％CI：11．9％～20．4％）；24个对照研究显示，用药组生殖毒性风险是对照组的5．1倍（OR95％CI：3．2～8．2），月经紊乱、闭经和精子活力下降合并发生率为17．6％（95％CI：13．4％～22．7％）、27．7％（95％CI：18．4％～39．3％）和20．3％（95％CI：11．3％～33．7％）；亚组分析显示提示用药时间越长，发生月经紊乱的风险越高。敏感性分析显示高质量研究合并后与总的合并值接近。结论雷公藤用药者生殖毒性的发生率较高，应重视对生殖毒性的防治。
Objective To systematically evaluate the incidence of reproductive toxicity of Tripterygium Wilfordii Hook .f （TWP）. Methods MEDLINE, EMBASE and the Cochrane Library were systematically searched from inception through May 25th, 2013 with the keywords including ＂Tripterygium wilfordii Hook .f＂, ＂toxicity＂, ＂reproductive＂, ＂side effect＂, ＂adverse＂, ＂safety＂ and ＂tolerability＂ for the follow-up studies of patients treated with TWP. Relevant information was extracted and data was analyzed using random-effects model. Meta-analysis was used to analyze the incidence of reproductive toxicity with MetaAnalyst software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. Results According to inclusion and exclusion criteria, a total of 56 articles were included, involving 60 researches in the analysis. There is a large degree of heterogeneity among the studies, so data was analyzed using random -effects model and the weighted combined incidence of reproductive toxicity was 17.9%（95%CI：14.1%-22.5%）,and the incidence of reproductive toxicity of children and adults were 24.4%（95%CI：13.3%-40.3%） and 15.7%（95%CI：11.9%-20.4%）,respectively. There were 24 researches with the control group, the result of random effects model showed that the odds ratio （OR） for TWP treatment group was 5.1 （OR95% CI： 3.2-8.2） comparing with control group. Three major events of reproductive toxicity： menstrual disorders, amenorrhea and decreased sperm motility, the weighted combined incidence were 17.6%（95% CI： 13.4% -22.7%）, 27.7%（95% CI： 18.4%-39.3% ） and 20.3%（95% CI： 11.3% -33.7%）, respectively. The subgroup analysis showed that the analysis results of follow-up ≥ 12 months and 〈 6 months group showed no cross-confidence interval, suggesting that the longer the treatment, the higher the risk of menstrual disorders, While the remaining subgroup results were cross-confidence interval, suggesting that the difference was not statistically significant. Sensitivity analysis based on 47 studies with high quality showed the combined value was close to the summary estimate of total 60 studies. Conclusion The incidence of reproductive toxicity induced by TWP was high. We should pay attention to the prevention and treatment of reproductive toxicity.
出处
《中国药物警戒》
2014年第2期94-99,103,共7页
Chinese Journal of Pharmacovigilance
关键词
雷公藤
生殖毒性
发生率
META分析
Tripterygium wilfordii Hook .f
reproductive toxicity
incidence
Meta-analysis
作者简介
孙凤，女，博士，副教授，药物流行病学。
通讯作者：詹思延，女，教授，博导，循证医学与药物流行病学。E-mail：siyan-zhan@bjmu．edu．cn
