温阳化饮法治疗恶性胸腔积液的Meta分析

Efficacy and Safety of Warming Yang and Resolving Fluid Retention Therapeutic in Clinical Treatment of Malignant Pleural Effusion:A Meta-analysis of Randomized Randomized Controlled Trials

目的温阳化饮法是临床上治疗恶性胸腔积液(MPE)常用的治则之一,该研究通过采用Meta分析对既往公开发表的文献进行归纳整理,分析温阳化饮法治疗MPE的临床效果。方法检索中国知网、万方、维普、PubMed、The Cochrane数据库2007年—2019年3月关于温阳化饮法治疗恶性胸腔积液的随机对照试验,按照预先设定的纳入及排除标准,由两名质量人员独立筛选并提取相关数据,采用Rev Man 5.3软件进行Meta分析。结果最终纳入11篇温阳化饮法治疗MPE的临床研究,其中试验组有449例,对照组有423例,结果显示,与单纯西医治疗相比,联合温阳化饮法可以明显提高临床有效率(RR=1.46,95%CI[1.30,1.66],P<0.00001),差异具有统计学意义;对7项研究进行生活质量的Meta分析,结果示RR=1.72,95%CI[1.38,2.14],P<0.00001,差异具有统计学意义;在不良反应发生中,胃肠道反应(RR=0.45,95%CI[0.34,0.59],P<0.00001)骨髓抑制(RR=0.38,95%CI[0.21,0.71],P=0.002<0.05)、发热(RR=0.16,95%CI[0.03,0.85],P=0.03<0.05)发生率方面试验组较对照组相比具有统计学意义,但在头晕头痛(RR=0.64,95%CI[0.17,2.32,P=0.49>0.05)等不良反应方面,两组对比无统计学意义。结论联合温阳化饮法可以有效提高患者近期临床疗效,改善生活质量,并降低胃肠道反应、骨髓抑制、发热等不良反应发生率。纳入的文献普遍质量不高,且存在一定的发表偏倚风险,这对本研究分析结果的可靠性有一定的影响,故期待今后更高质量的RCT对此结果进行验证。

Objective Warming Yang and resolving fluid retention method is one of the commonly-used therapeutic principle in clinical treatment of malignant pleural effusion(MPE).The purpose of the clinical study was to analyze the clinical effects of warming Yang and resolving fluid retention method on MPE by summarizing previously published literature through Meta-analysis.Methods We retrieved randomized controlled trials of warming Yang for resolving fluid retention method on MPE in CNKI,Wanfang Data,VIP,PubMed and The Cochrane database from 2007 to March 2019.According to the pre-set inclusion and exclusion criteria,two quality personnel independently screened and extracted the relevant data,and Rev Man 5.3 software was used for Meta-analysis.Results Eleven clinical studies on the treatment of MPE with warming Yang and resolving fluid retention method were finally included,including 449 cases in the experimental group and 423 cases in the control group.The results showed that compared with the treatment of western medicine alone,the treatment combined with warming Yang and resolving fluid retention method could significantly improve the clinical efficiency(RR=1.46,95%CI[1.30,1.66],P<0.00001),and the difference was statistically significant.Meta-analysis on quality of life of 7 studies showed significance(RR=1.72,95%CI[1.38,2.14],P<0.00001),and the difference was statistically significant.In the occurrence of adverse reactions,gastrointestinal reactions(RR=0.45,95%CI[0.34,0.59],P<0.00001),bone marrow suppression(RR=0.38,95%CI[0.21,0.71],P=0.002<0.05)and fever(RR=0.16,95%CI[0.03,0.94],P=0.03<0.05)were statistically significant compared with those of the control group.However,there was no significant difference between the two groups in terms of adverse reactions such as dizziness and headache(RR=0.64,95%CI[0.17,2.32],P=0.49>0.05).Conclusion The treatment combined with warming Yang and resolving fluid retention method can effectively improve the short-term clinical efficacy and the quality of life,and reduce the incidence of gastrointestinal reactions,bone marrow suppression,fever and other adverse reactions.The included literature was generally of low quality,and there was a risk of publication bias,which had a certain impact on the reliability of the analysis results of this study.Therefore,it is expected that this result will be verified by higher-quality RCTs in the future.