福多司坦治疗慢性阻塞性肺疾病急性加重期的系统评价

Systematic Review of Fudosteine in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

目的:基于Meta分析方法,系统评价福多司坦治疗慢性阻塞性肺疾病急性加重期(AECOPD)患者的疗效和安全性。方法:检索中国知网、中国生物医学文献服务系统、万方数据库、维普数据库、PubMed、the Cochrane Library、Web of Science和Embase等数据库,纳入福多司坦用于AECOPD患者的临床随机对照试验(观察组干预措施为常规治疗联合福多司坦,对照组干预措施为常规治疗),检索时间为建库至2022年12月10日。使用Cochrane偏倚风险评估工具对纳入文献进行质量评价,运用RevMan 5.4软件行Meta分析。结果:共纳入15项随机对照试验,包括1145例AECOPD患者。Meta分析结果显示,观察组患者的临床总有效率显著高于对照组,第1秒用力呼气容积占用力肺活量百分比(FEV_(1)/FVC)、第1秒用力呼气容积占预计值百分比(FEV_(1)%Pred)显著高于对照组,差异均有统计学意义(P<0.05);两组患者不良事件发生率的差异无统计学意义(P=0.05)。结论:在常规治疗基础上联合应用福多司坦治疗AECOPD患者,可提高临床总有效率,提高FEV_(1)/FVC、FEV_(1)%Pred水平,且目前尚未出现严重不良反应,具有较好的疗效和安全性。

OBJECTIVE:To systematically review the efficacy and safety of fudosteine in the treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD)based on Meta-analysis method.METHODS:CNKI,SinoMed,Wanfang Data,VIP,PubMed,the Cochrane Library,Web of Science and Embase were retrieved for relevant randomized controlled clinical trial of AECOPD(intervention of observation group was conventional therapy combined with fudosteine,intervention of control group was conventional therapy).The retrieval time was from the establishment of the database to Dec.10th,2022.The Cochrane risk of bias assessment was used to assess the quality of the included literature,and Meta-analysis was performed by using RevMan 5.4 software.RESULTS:A total of 15 randomized controlled trials were enrolled,including 1145 patients with AECOPD.Meta-analysis showed that the total effective rate of observation group was significantly higher than that of control group,and the percentage of forced expiratory volume at one second to forced expiratory capacity(FEV_(1)/FVC)and the percentage of forced expiratory volume at one second to predicted(FEV_(1)%Pred)were significantly higher than those of control group,the differences were statistically significant(P<0.05).There was no significant difference in the incidence of adverse events between two groups(P=0.05).CONCLUSIONS:Conventional therapy combined with fudosteine in the treatment of AECOPD can improve the total clinical effective rate,increase the level of FEV_(1)/FVC and FEV_(1)%Pred,and no severe adverse drug reactions have been observed,with significant efficacy and safety.