目的 系统评价射干麻黄汤治疗支气管哮喘急性发作的疗效及安全性，为临床射干麻黄汤治疗支气管哮喘提供循证医学支持。方法 计算机检索中国知网、PubMed等数据库，提取符合纳入标准的临床随机对照试验（RCT），使用Cochrane 5.1.0手册中的偏倚风险评估工具评价纳入文献质量，使用Stata 14.0软件进行Meta分析，结局指标包括：有效率、肺功能[FEV1/FVC和（或）FEV1%]、中医症候总积分及不良反应发生情况，最后进行试验序贯分析，通过TSA 0.9软件计算出Meta分析所需样本量。结果 共纳入文献20篇，试验组患者有效率[RR＝1.18，95％CI（1.14，1.23），P＝0.00]优于对照组，亚组分析①疗程≤7 d的研究合并分析后显示试验组疗效[RR＝1.17，95％CI（1.11，1.24），P＝0.00]优于对照组，②疗程7～15 d研究合并分析后同样试验组疗效[RR＝1.17，95％CI（1.10，1.24），P＝0.00]优于对照组，经漏斗图和Begg’s检验提示不存在发表偏倚，试验序贯分析后表明试验组疗效证据可靠；试验组患者肺功能相关指标，FEV1/FVC[SMD＝1.17，95％CI（0.44，1.90），P＝0.00]显著优于对照组、FEV1%[SMD＝1.38，95％CI（0.24，2.52），P＝0.018]显著优于对照组；试验组中医症候总积分[WMD＝-2.79，95％CI（-3.39，-2.18），P＝0.00]显著低于对照组；肺功能相关指标及中医症候总积分经敏感性分析后结果均未发生逆转，结果较为稳健；所有研究均未报道严重不良反应的发生。结论 射干麻黄汤联合常规西医治疗，相较于单纯常规西医治疗，在治疗支气管哮喘急性发作方面更具优势，但由于纳入研究在方法学设计上的不足，未来尚需更高质量RCT进一步评价其疗效和安全性。
Objective To evaluate the efficacy and safety of Shegan Mahuang Decoction in the treatment of acute attack of bronchial asthma, and provide the support of evidence-based medicine for clinical treatment of bronchial asthma. Methods The databases such as CNKI and PubMed were searched by computer, and RCT meeting the inclusion criteria was extracted. Cochrane 5.1.0 bias risk assessment tool was used to evaluate the quality of included literatures, and Stata14.0 was used for Meta analysis. The outcome indicators included effective rate, pulmonary function (FEV1 / FVC and / or FEV1%), TCM symptoms score and adverse reactions. Finally, TSA 0.9 was used for trial sequential analysis. Results A total of 20 articles were included in the study. The effective rate [RR = 1.18, 95% CI (1.14, 1.23), P = 0.00] in the trial group was significantly better than that in the control group. Subgroup analysis showed that the effective rate in the trial group with a course of treatment≤7 d[RR = 1.17, 95% CI (1.11, 1.24), P = 0.00] and 7—15 d[RR = 1.17, 95% CI (1.10, 1.24), P = 0.00] was significantly better than that in the control group. According to funnel chart and Begg's test, there was no published bias. The trial sequential analysis showed that the evidence of the effect was reliable. FEV1/FVC, the indexes of pulmonary function test, in the trial group were [SMD＝1.17, 95%CI (0.44，1.90), P = 0.00] was significantly better than the control group, and FEV1% [SMD = 1.38, 95% CI (0.24, 2.52), P = 0.018] was also significantly better than the control group. The TCM syndrome score [WMD = -2.79, 95% CI (-3.39, -2.18), P = 0.00] in the trial group was significantly lower than the control group. The indicators of pulmonary function and TCM syndrome score were not reversed after sensitivity analysis, and the results were relatively stable. Serious adverse reactions were not reported in all studies. Conclusion Shegan Mahuang Decoction combined with conventional western medicine has more advantages in the treatment of acute attack of bronchial asthma than conventional western medicine alone. However, due to the limitations of this study, depth evaluation of its efficacy and safety needs more high quality RCTs in the future.