中国循证医学杂志

中国循证医学杂志

芜地溴铵/维兰特罗治疗慢性阻塞性肺疾病有效性和安全性的 Meta 分析

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目的 系统评价芜地溴铵/维兰特罗(UMEC/VI)治疗慢性阻塞性肺疾病(COPD)的有效性和安全性。 方法 计算机检索 PubMed、The Cochrane Library、WanFang Data、CNKI、VIP 等数据库,搜集 UMEC/VI 治疗 COPD 的随机对照试验(RCT),检索时限均为建库至 2017 年 3 月。由 2 位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行统计分析。 结果 共纳入 8 个 RCT,包括 8 992 例患者。Meta 分析结果显示:① UMEC/VI vs. 安慰剂:UMEC/VI 可显著改善 COPD 患者 1 秒用力呼气量谷值(Trough FEV1)[MD=0.20,95%CI(0.17,0.23),P<0.000 01];提高患者生存质量:TDI 评分[MD=0.99,95%CI(0.71,1.28),P<0.000 01]、SGRQ 评分[MD=–4.00,95%CI(–5.35,–2.66),P<0.000 01]、SOBDA 评分[MD=–0.16,95%CI(–0.23,–0.09),P<0.000 01];同时减少救援药物(沙丁胺醇的使用)且不增加不良反应。② UMEC/VIvs. 沙美特罗/氟替卡松:UMEC/VI 能改善患者 Trough FEV1[MD=0.09,95%CI(0.07,0.11),P<0.000 01],并可明显减少救援药物(沙丁胺醇)的使用,不良反应发生率也更低;但两者在改善患者生存质量方面差异无统计学意义。③ UMEC/VIvs. 单支气管扩张剂:UMEC/VI 可显著改善 Trough FEV1[MD=0.08,95%CI(0.07,0.10),P<0.000 01];且可提高生存质量:TDI 评分[MD=0.38,95%CI(0.17,0.59),P=0.000 3]、SGRQ 评分[MD=–1.18,95%CI(–2.06,–0.29),P=0.009];同时减少救援药物(沙丁胺醇)的使用而不增加不良反应。 结论 UMEC/VI 较安慰剂治疗 COPD 患者,可显著改善其肺功能、控制症状及提高生存质量,具有较好的安全性及耐受性;与沙美特罗/氟替卡相比,在不增加不良反应的基础上,对肺功能改善及控制症状方面的效果更显著,用法更简便,能很大程度上提高患者的依从性;与单用支气管扩张剂相比,可显著改善肺功能、控制症状及提高生活质量,且不增加不良反应发生率。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of umeclidinium/vilanterol in the treatment of chronic obstructive pulmonary disease. Methods PubMed, The Cochrane Library, WanFang Data, CNKI and VIP databases were electronically searched to collect randomized controlled trials (RCTs) about umeclidinium/vilanterol for chronic obstructive pulmonary disease from inception to March 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. Results Eight RCTs involving 8 992 patients were included. The results of meta-analysis showed that: ① Umeclidinium/vilanterol vs. placebo: umeclidinium/vilanterol significantly improved Trough FEV1 (MD=0.20, 95%CI 0.17 to 0.23, P<0.000 01), and the quality of life: TDI score (MD=0.99, 95%CI 0.71 to 1.28,P<0.000 01), SGRQ score (MD=–4.00, 95%CI –5.35 to –2.66,P<0.000 01), SOBDA score (MD=–0.16, 95%CI –0.23 to –0.09,P<0.000 01), and reduced the use of rescue drugs (salbutamol), but not increased the adverse events rate. ② umeclidinium/ vilanterolvs. fluticasone propionate/salmeterol: UMEC/VI improved lung function in patients with COPD: Trough FEV1 (MD=0.09, 95%CI 0.07 to 0.11, P<0.000 01), reduced the use of rescue drugs (salbutamol), and had a lower incidence of adverse reactions. But there were no significant differences in the quality of life. ③ umeclidinium/vilanterolvs. single bronchodilator: umeclidinium/vilanterol could significantly improve spirometric parameters: Trough FEV1 (MD=0.08, 95%CI 0.07 to 0.10, P<0.000 01), improved the quality of life: TDI score (MD=0.38, 95%CI 0.17 to 0.59,P=0.000 3), SGRQ score (MD=–1.18, 95%CI –2.06 to –0.29, P=0.009). Umeclidinium/vilanterol could significantly reduce the use of rescue drugs (salbutamol) without increasing the adverse events rate. Conclusion UMEC/VI is superior to placebo in the treatment of COPD patients, which can significantly improve the lung function, control symptoms and improve the quality of life, with good safety and tolerance. Compared with salmeterol/fluticacin, UMEC/VI has a significant effect on improving lung function and controlling symptoms without increasing adverse effects, and both of them have similar curative effect on improving quality of life, while UMEC/VI is easier to use, which can improve patient compliance in a large extent. UMEC/VI is superior to bronchodilator alone in improving lung function, controlling symptoms and improving quality of life without increasing the incidence of adverse reactions. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 芜地溴铵/维兰特罗; 慢性阻塞性肺疾病; 疗效; 安全性; 系统评价; Meta 分析; 随机对照试验

Key words: Umeclidinium/vilanterol; Chronic obstructive pulmonary disease; Efficacy; Safety; Systematic review; Meta-analysis; Randomized controlled trial

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