奥达特罗治疗慢性阻塞性肺疾病疗效和安全性的系统评价
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篇名: 奥达特罗治疗慢性阻塞性肺疾病疗效和安全性的系统评价
TITLE:
摘要: 目的:系统评价奥达特罗治疗慢性阻塞性肺疾病(COPD)的疗效和安全性,为临床提供循证参考。方法:计算机检索PubMed、Cochrane Library、中国知网、万方数据库、中国生物医学文献数据库、维普数据库等,收集奥达特罗单用或联用(试验组)对比噻托溴铵或安慰剂(对照组)治疗COPD的随机对照试验(RCT),提取资料并按照Cochrane系统评价员手册5.1.0提供的偏倚风险评估工具进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果:最终纳入17项RCT,共9 627例患者。Meta分析结果显示,治疗后试验组患者的第1秒用力呼气量(FEV1)[MD=0.08,95%CI(0.03,0.13),P=0.001]、用力肺活量(FVC)[MD=0.12,95%CI(0.03,0.22),P=0.01]、FEV1占预计值的百分比(FEV1%pred)[MD=0.77,95%CI(0.15,1.39),P=0.02]均显著优于对照组,差异均有统计学意义。在安全性方面,试验组患者的总不良反应[OR=1.02,95%CI(0.93,1.12),P=0.69]、严重不良反应[OR=1.04,95%CI(0.91,1.20),P=0.56]、COPD急性加重[OR=0.88,95%CI(0.77,1.01),P=0.07]、咳嗽[OR=1.07,95%CI(0.80,1.44),P=0.64]、头痛[OR=0.75,95%CI(0.53,1.05),P=0.10]、呼吸困难[OR=0.83,95%CI(0.61,1.15),P=0.27]、鼻咽炎[OR=1.11,95%CI(0.91,1.36),P=0.31]、上呼吸道感染[OR=1.13,95%CI(0.87,1.46),P=0.36]的发生率均与对照组相当,差异均无统计学意义。结论:奥达特罗用于治疗COPD能显著改善患者的肺功能,延缓疾病进展,且不增加患者的不良反应。
ABSTRACT: OBJECTIVE: To evaluate the therapeutic efficacy and safety of olodaterol for chronic obstructive pulmonary disease(COPD), and to provide evidence-based reference in clinic. METHODS: Retrieved from PubMed, Cochrane Library, CNKI, Wanfang database, CBM and VIP, RCTs about olodaterol use alone or combination (trial group) versus tiotropium bromide or placebo (control group) in the treatment of COPD were collected. Meta-analysis was conducted by using Rev Man 5.3 statistical software after data extraction and quality evaluation with bias risk evaluation tool of Cochrane system evaluator manual 5.1.0. RESULTS: A total of 17 RCTs were included, involving 9 627 patients. Results of Meta-analysis demonstrated that FEV1 [MD=0.08,95%CI(0.03,0.13),P=0.001],FVC [MD=0.12,95%CI(0.03,0.22),P=0.01] and FEV1%pred [MD=0.77,95%CI(0.15,1.39),P=0.02] of trial group were significantly better than those of control group after treatment, with statistical significance. In terms of safety, the incidence of total ADR [OR=1.02,95%CI(0.93,1.12),P=0.69], serious ADR [OR=1.04,95%CI(0.91,1.20),P=0.56], COPD exacerbation [OR=0.88,95%CI(0.77,1.01),P=0.07], cough [OR=1.07,95%CI(0.80,1.44),P=0.64], headache [OR=0.75,95%CI(0.53,1.05),P=0.10], dyspnea [OR=0.83,95%CI(0.61,1.15),P=0.27], nasopharyngitis [OR=1.11,95%CI(0.91,1.36),P=0.31] and upper respiratory tract infection [OR=1.13,95%CI(0.87,1.46),P=0.36] in trial group were similar to control group, without statistical significance. CONCLUSIONS: Olodaterol can significantly improve lung function in patients with COPD and delay disease progression without increasing ADR in patients.
期刊: 2018年第29卷第14期
作者: 万子琳,钟志容,叶云,黄毅岚,孙梦琦,张富勇,王述蓉
AUTHORS: WAN Zilin,ZHONG Zhirong,YE Yun,HUANG Yilan,SUN Mengqi,ZHANG Fuyong,WANG Shurong
关键字: 奥达特罗;慢性阻塞性肺疾病;疗效;安全性;系统评价
KEYWORDS: Olodaterol;COPD;Therapeutic efficacy; Safety;Systematic review
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