桉柠蒎肠溶软胶囊辅助治疗慢性阻塞性肺疾病有效性和安全性的Meta分析

Meta-analysis on Effectiveness and Safety of Eucalyptol Limonene and Pinene Enteric Soft Capsule in the Treatment of Chronic Obstructive Pulmonary Disease

目的:系统评价桉柠蒎肠溶软胶囊辅助治疗慢性阻塞性肺疾病(COPD)的有效性与安全性。方法:使用计算机系统检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库、Cochrane Library、Embase、Pubmed,筛选出桉柠蒎肠溶软胶囊治疗COPD的随机对照试验(RCT),由2名独立评价员分别进行试验筛选和质量评价;提取有效数据,采用RevMan 5.3. 3版本软件进行荟萃(Meta)分析。结果:共纳入15项RCTs,病例共计1582例。Meta分析结果显示,桉柠蒎肠溶软胶囊联合常规治疗COPD在总有效率、用力肺活量(FVC)、第1 s用力呼气容积(FEV_(1))、第1 s用力呼气容积占预计值百分比(FEV_(1)%)、FEV_(1)/FVC相较于单纯常规治疗均具有统计学差异(P <0.05);不良反应发生率方面,桉柠蒎肠溶软胶囊联合常规药物治疗相较于单纯常规治疗无统计学差异(P> 0.05)。结论:桉柠蒎肠溶软胶囊用于治疗COPD患者的总有效率、FVC、FEV_(1)、FEV_(1)%、FEV_(1)/FVC等方面效果更好、安全性更高,但在临床还需更多设计严谨的高质量、大样本、多中心的随机双盲对照试验,以提供数据依据。

Objective:To systemically review the effectiveness and safety of eucalyptol limonene and pinene enteric soft capsule in the treatment of chronic obstructive pulmonary disease(COPD).Methods:CNKI,Wan Fang database,VIP database,CBM,Cochrane Library,Embase,PubMed were retrieved for collecting randomized controlled trial(RCT)about the treatment of COPD with eucalyptol limonene and pinene enteric soft capsule.Case selection and quality evaluation was conducted by two independent investigators.Meta-analyses were performed by RevMan 5.3.3.Results:Fifteen RCTs and 1582 cases were included.From the results of Meta-analysis,the effectiveness of eucalyptol limonene and pinene enteric soft capsule group was superior to groups with conventional treatment alone in the overall efficiency、FVC、FEV 1、FEV 1%、FEV 1/FVC,with statistical significance(P<0.05).The incidence of adverse reactions of eucalyptol limonene and pinene enteric soft capsule combined with conventional treatment showed no statistical significant difference while compared with groups of conventional treatment alone(P>0.05).Conclusion:In the treatment of COPD,eucalyptol limonene and pinene enteric soft capsule showed better results in overall efficacy、FVC、FEV 1、FEV 1%、FEV 1/FVC,with high safety.However,clinical trial with vigorous design of high quality,large sample and multi centered as well as double blind setting are needed to provide more data support.