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目的:系统评价雷公藤(TWP)用药者消化系统不良事件发生率。方法:以“tripterygiumwilfordiihook.f”、“toxicity”、“side effect”、“adverse”、“safety”和“tolerability”为关键词在CMCC、CBMDisc、CNKI、VIP、万方、MEDLINE、EMBASE和The Cochrane Library等8个数据库检索雷公藤发生消化系统不良事件的临床研究,采用Meta-Analyst软件分析。结果:共纳入84篇文献,结果显示总的用药者消化系统不良事件为每百人29.8次;36个有对照的研究结果显示,TWP组发生消化系统不良事件风险是对照组的2.4倍(95%CI:1.5~3.9)。针对转氨酶升高、恶心、腹泻和肝功能异常,合并发生率分别为10.4%(95%CI:7.4%~14.3%)、11.0%(95%CI:8.3%~14.5%)、5.8%(95%CI:3.8%~8.9%)和7.4%(95%CI:5.0%~11.0%);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:TWP用药者消化系统不良事件的发生率较高,应重视对消化系统不良事件的防治。
Objective: To systematically evaluate the incidence of digestive system adverse events in TWP patients. Methods: The keywords “CMCC”, “CBMDisc”, “TBMDisc”, “toxicity”, “side effect”, “adverse”, “safety” and “tolerability” VIP, Wanfang, MEDLINE, EMBASE and The Cochrane Library were used to search clinical data of adverse reactions of digestive system of Tripterygium wilfordii, and analyzed by Meta-Analyst software. RESULTS: A total of 84 articles were included and the overall adverse event of digestive system was 29.8 times per 100 inhabitants for the total medication use. Results from 36 controlled trials showed that the risk of digestive system adverse events in the TWP group was 2.4-fold (95% CI: 1.5 to 3.9). The incidences of elevated aminotransferases, nausea, diarrhea and liver dysfunction were 10.4% (95% CI: 7.4% to 14.3%), 11.0% (95% CI: 8.3% to 14.5%) and 5.8% % CI: 3.8% ~ 8.9%) and 7.4% (95% CI: 5.0% ~ 11.0%). Sensitivity analysis showed that the high quality studies combined with the total combined values were close. Conclusion: The prevalence of adverse events in the digestive system of TWP drug users is high. Prevention and treatment of adverse events in the digestive system should be emphasized.