定喘汤治疗哮喘随机对照试验的系统评价

目的:系统地评价传统中药复方定喘汤治疗哮喘的疗效及不良反应。方法:系统、全面检索国内外相关数据库,鉴定并纳入定喘汤与安慰剂、西药等治疗哮喘的随机对照试验(RCT),采用国际公认的评价标准对纳入试验的质量包括随机化、分配隐藏、盲法、退出与失访进行评价,进而对疗效进行系统综合分析。结果:共计27篇RCT(2497名患者)文献符合纳入标准,但方法学质量较低,纳入的RCT文献中未发现定喘汤与安慰剂对照的研究。结果表明,定喘汤在改善哮喘症状方面明显优于单纯西医治疗;定喘汤联合西药在哮喘肺通气功能改善方面与单纯西医对症治疗相比,具有明显优势。所有纳入试验均未报告严重不良反应。结论:现有中等级别的证据表明,定喘汤在控制哮喘症状方面有一定疗效。然而,现有的RCT方法学和报告质量较低,疗效的证据需要进一步大样本严格设计的临床试验证实。

Systematic Review on Randomized Controlled Trials of Dingchuan Decoction for Asthma

Objective： To systematically evaluate effectiveness and adverse reaction that Dingchuan decoction treats asth- ma. Methods：Search domestic and external databases systematically and completely, then identify and include randomized controlled trials with Dingchuan decoction compared with placebo - treated , western medicines or other therapies. Evalu- ate quality of included RCT with international evaluation standards , and then analyze curative effect synthetically and systematically. Results ： 27 pieces of RCT （ 2497 patients ） fit inclusion criteria, howevermethodological quality was low and no studies about Dingchuan decoction compared with the placebo- treated which were found in these included pa- pers. Study results indicated ： Dingchuan decoction was better than pure western medical treatment in respect of improving asthma symtoms; Dingchuan decoction united with western medicine was better than pure western medical treatment in respect of ameliorating lung function;No serious adverse reaction was reported in all these studies. Conclusions：As far as results of this paper, mid - range evidences can prove curative effect of Dingchuan decoction in the way of controlling asthma symptoms. Nevertheless curative effect evidences need further strict - designed clinical trials in large numbers be- cause quality and mothodology of these reports are low.