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乌美溴铵维兰特罗治疗慢性阻塞性肺疾病的系统评价/Meta分析

再评价 Δ

兰 瑛 ，徐 敏，陆一菱，马 晴，何 琴（成都市第三人民医院药学部，成都 610031）
＊

中图分类号 R563.3；R974 文献标志码 A 文章编号 1001-0408（2022）01-0096-08
DOI 10.6039/j.issn.1001-0408.2022.01.17

摘 要 目的 对乌美溴铵维兰特罗（UMEC/VIL）治疗慢性阻塞性肺疾病（COPD）的系统评价/Meta分析进行再评价，以期为临床
治疗COPD提供循证依据。方法 计算机检索PubMed（Medline）、Cochrane Library、Embase、中国期刊全文数据库、中国生物医学
文献数据库、中文科技期刊数据库与万方数据库等，搜集 UMEC/VIL 治疗 COPD 的系统评价，检索时限均为建库起至 2021 年 4
月。由2名评价者独立进行文献筛选、资料提取，并运用AMSTAR 2量表、PRISMA声明以及GRADE评价系统对纳入研究的方法
学质量、报告质量以及结局指标证据质量进行评价，并对UMEC/VIL治疗COPD的有效性和安全性进行报道。结果 最终纳入6篇
系统评价。AMSTAR 2量表评价结果显示，1 篇为方法学高质量，2篇为方法学中等质量，3篇为方法学低质量；PRISMA声明的评
分介于21.5～27分之间，纳入研究的报告质量相对较完善；GRADE评价结果显示，纳入研究的134个结局指标中60％以上为中高
证据质量。有效性和安全性比较结果显示，在改善1秒用力呼气量谷值或峰值、用力肺活量等肺功能指标方面，UMEC/VIL优于
安慰剂、单方支气管扩张剂及氟替卡松/沙美特罗；在改善短暂呼吸困难指数、圣乔治呼吸问卷评分、呼吸急促与日常活动问卷评
分等方面，UMEC/VIL优于安慰剂、单方支气管扩张剂；在各种不良反应发生率、急性加重发生率、全因死亡率、总体退出试验率、
肺炎发生率等负性指标上，UMEC/VIL不劣于安慰剂、单方支气管扩张剂及氟替卡松/沙美特罗。结论 相较于安慰剂、单方支气管
扩张剂，UMEC/VIL能明显改善患者肺功能、症状及生活质量，并且在负性指标上具有非劣效；与β2受体激动剂联合糖皮质激素比
较，UMEC/VIL能更好地改善COPD患者的肺功能，但在其他方面二者相似。
关键词 乌美溴铵维兰特罗；慢性阻塞性肺疾病；系统评价；Meta 分析；系统评价再评价

Umeclidinium bromide and vilanterol trifenatate in the treatment of COPD：an overview of systematic
review and meta-analysis
LAN Ying，XU Min，LU Yiling，MA Qing，HE Qin（Dept. of Pharmacy，the Third People’s Hospital of
Chengdu，Chengdu 610031，China）

ABSTRACT OBJECTIVE To re-evaluate the systematic review and meta-analysis of umeclidinium bromide and vilanterol
trifenatate（UMEC/VIL）in the treatment of chronic obstructive pulmonary disease（COPD），so as to provide evidence-based basis
for the treatment of COPD. METHODS Retrieved from PubMed（Medline），the Cochrane library，Embase，CNKI，CBM，VIP
and Wanfang database，etc.，the systematic review and meta-analysis of UMEC/VIL in the treatment of COPD were collected from
the inception to Apr. 2021. Two reviewers independently screened the literatures and extracted the data. AMSTAR 2 scale，PRISMA
statement，and GRADE evaluation system were used to evaluate the methodological quality of the included studies，the quality of
reports and the grade of outcome indexes. The efficacy and safety of UMEC/VIL in the treatment of COPD were reported.
RESULTS Six systematic reviews were finally included. The results of AMSTAR 2 scale showed that 1 study was of high quality，
2 were of medium quality and 3 were of low quality. The score of PRISMA statement was between 21.5 and 27，and the quality of
the report was relatively perfect. The results of GRADE evaluation showed that more than 60％ of the 134 outcome indicators were
of medium to high quality of evidence. Comparison of effectiveness and safety showed that UMEC/VIL was superior to placebo，
unilateral bronchodilator and salmeterol fluticasone in improving forced expiratory volume in one second （FEV1 ） trough，FEV1
peak and forced vital capacity（FVC）. In the improvement of transition dyspnea index（TDI），SGRQ and SOBDA scores，UMEC/
VIL was better than placebo，unilateral bronchodilator and fluticasone propionate/salmeterol. The adverse reaction rate，acute
exacerbation rate，mortality rate，withdrawal rate，pneumonia rate and other negative indicators of UMEC/VIL were not inferior to
placebo，unilateral bronchodilator and fluticasone propionate/salmeterol. CONCLUSIONS Compared with placebo and unilateral
bronchodilator，UMEC/VIL can significantly improve lung function，symptoms and quality of life，and has non-inferior effect for
negative indicators. Compared with β 2 adrenoceptor agonists combined with glucocorticoid，UMEC/VIL can improve lung function
of COPD patients，but they are similar in other aspects.
Δ 基 金 项 目 ：四 川 省 卫 生 和 计 划 生 育 委 员 会 科 研 课 题
（No.18PJ539） KEYWORDS umeclidinium bromide and vilanterol
＊主管药师，硕士。研究方向：循证药学与药物经济学。电话： trifenatate；chronic obstructive pulmonary disease；systematic
028-61318605。E-mail：lanying0212@126.com review；meta-analysis；overview of systematic reviews

·96 · China Pharmacy 2022 Vol. 33 No. 1 中国药房 2022年第33卷第1期