痰热清注射液治疗急性气管-支气管炎随机对照试验的系统综述及文献质量评价

目的：系统综述痰热清注射液治疗急性气管-支气管炎的临床疗效及安全性,分析随机对照试验报告的质量。方法：采用系统综述的方法,利用Jadad计分表及CONSORT for TCM评价纳入文献的质量;纳入的文献按不同治疗策略进行分层,评价其临床结果。结果：符合纳入标准的文献共10篇。其中2篇有纳入标准,4篇有排除标准,无1篇文献对样本量估算以及随机化相关细节进行说明,无1篇文献应用盲法设计。仅报道2例与痰热清注射液可能有关的不良事件。结论：①纳入的随机对照试验文献存在未充分说明随机方法、纳入标准、排除标准,未进行样本量估算及盲法设计等不足,尚不能对痰热清注射液治疗急性气管-支气管炎的临床疗效提供确切的循证依据。②痰热清注射液有可能引发变态反应的风险,需加以防范,过敏体质者应慎用。

Systematic Review and Quality Assessment on Literatures of "Tanreqing Injection" in Treatment of Acute Tracheobronchitis

Objective： To review systematically the efficacy and safety of ＂Tanreqing Injection＂ for acute tracheobronchitis, and assess the quality of literatures of randomized controlled trials （RCTs）. Methods： The RCTs of ＂Tanreqing Injection＂ for acute tracheobronchitis were reviewed and the methodological quality of the trials was assessed by the Jadad scale and consolidated standards for reporting trials of traditional Chinese medicine （ CONSORT for TCM）. The RCTs were delaminated according to different treatment strategies and the clinical effects were evaluated. Results： A total of ten RCTs were included. Two RCTs reported the inclusion criteria, and four RCTs reported the exclusion criteria. There was no RCT to explain the sample size estimation and the details of randomization, and there was no RCT applying blind method. Only two cases of adverse events possibly related to ＂Tanreqing Injection＂ were reported. Conclusion： （1）The following deficiencies exist in the included RCTs： not illustrating the randomized method, and inclusion and exclusion criteria , and not applying the sample size estimation and blind method design. So the RCTs can not provide the definitive evidence for the efficacy of ＂Tanreqing Injection＂ in treatment of acute traeheobronchitis. （2）The ＂ Tanreqing Injection＂ has the risk of causing allergy, and the severe allergy should be prevented, especially for the patients with allergic constitution.