细辛脑注射液不良反应的Meta分析

Meta-analysis on the Adverse Events of Asarone Injection

目的:采用Meta分析法评价细辛脑注射液临床应用的安全性。方法:检索中国生物医学文献光盘数据库(CBM)、中国学术期刊全文数据库(CNKI)和万方数据库2000-2013年期间发表的有关细辛脑注射液的临床随机对照研究,对纳入的文献进行评价。采用Rev Man5.2软件,对符合标准的文献中细辛脑注射液的不良反应发生率进行Meta分析,对不同适应证、不同对照措施、不同年龄发生的不良反应发生率进行亚组分析。结果:符合标准的31篇文献纳入研究。Meta分析结果显示:毛细支气管炎亚组实验组[RR=0.35,95%CI(0.22,0.58),P<0.05]、氨茶碱亚组[RR=0.11,95%CI(0.06,0.19),P<0.05]、其他药物亚组[RR=0.35,95%CI(0.21,0.58),P<0.05]、小儿亚组[RR=0.62,95%CI(0.48,0.80),P<0.05]、中老年亚组[RR=0.29,95%CI(0.16,0.53),P<0.05]不良反应发生率低于对照组,常规治疗亚组[RR=3.06,95%CI(1.91,4.90),P<0.05]实验组不良反应发生率高于对照组,支气管肺炎亚组[RR=2.73,95%CI(0.74,10.03),P>0.05]、喘息性支气管炎亚组[RR=0.97,95%CI(0.39,2.40),P>0.05]、喘息性支气管肺炎亚组[RR=5.67,95%CI(1.01,31.90),P=0.05]治疗组和对照组比较不良反应发生率,差异无统计学意义。结论:常规治疗亚组细辛脑注射液的不良反应发生率高于对照组;支气管肺炎亚组、喘息性支气管炎组和喘息性支气管肺炎亚组尚不足以证明实验因素对不良反应的发生有影响;其他亚组细辛脑注射液的不良反应发生率低于对照组。受纳入研究数量和质量限制,上述结论尚待开展更多高质量研究加以验证。

Objective： To evaluate the safety of asarone injection in clinical application with meta-analysis. Methods： The databases of Pubmed, FMJS, CNKI, Wanfang and CBM were retrieved with computer for collecting randomized controlled trials（RCTs） about the safety of asarone injection in clinical application. The included RCTs were given strict reviews and the data was extracted, then the ones met the criterion were given Meta analysis by using Rev Man 5.2 software. Subgroup analyses in different indications, different control measures and different ages were also carried out. Results： 31 RCTs or quasi-RCTs were included in the study. The result of Meta-analysis showed that the adverse drug reaction rates of subgroups, such as bronchiolitis[RR=0.35, 95%CI（0.22, 0.58）, P0.05], aminophylline[RR=0.11, 95%CI（0.06, 0.19）, P0.05], other drugs[RR=0.35,95%CI（0.21,0.58）, P0.05], pediatric [RR=0.62, 95%CI（0.48, 0.80）, P0.05] and the elderly subgroups [RR=0.29, 95%CI（0.16, 0.53）, P0.05],were lower than that of the control group. The adverse drug reaction rates of asarone injection in conventional treatment group[RR=3.06,95%CI（1.91, 4.90）, P0.05]was higher than the control group. There was no significance between the three subgroups in adverse drug reaction rates： bronchiolitis[RR=2.73,95%CI（0.74, 10.03）, P0.05], asthmatic bronchitis[RR=0.97,95%CI（0.39, 2.40）, P0.05] and Asthmatic bronchial pneumonia [RR =5.67, 95% CI（1.01, 31.90）, P=0.05].Conclusion： The adverse drug reaction rates of asarone injection in conventional treatment group was higher than the control group; there was no evidence in three subgroups of bronchiolitis, Asthmatic bronchitis and Asthmatic bronchial pneumonia to prove that experimental factors has effects on adverse drug reaction rates; The adverse drug reaction rates of asarone injection in other groups lower than the control group.More high-quality randomized controlled clinical trials were needed to confirm the safety of asarone injection.