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噻托溴铵治疗中重度哮喘患者的疗效:基于14项随机对照试验的荟萃分析和系统评价

Efficacy of tiotropium in treating patients with moderate-to-severe asthma: A meta-analysis and systematic review based on 14 randomized controlled trials.

作者信息

Meng Jian-Feng, Li Hua, Luo Ming-Jie, Li Hai-Bin

机构信息

Department of Respiratory Medicine, Nanxishan Hospital of Guangxi Zhuang Autonomous Region, Guilin, Guangxi, China.

出版信息

Medicine (Baltimore). 2019 Aug;98(33):e16637. doi: 10.1097/MD.0000000000016637.

Abstract

BACKGROUND

The goal of the current meta-analysis and systematic review was to explore the efficacy of tiotropium in treating patients with moderate-to-severe asthma on the basis of qualified randomized controlled trials (RCTs).

METHODS

The following online electronic databases, such as Cochrane, PubMed, and Embase database were screened to identify qualified studies updated to January 2019 through the use of index words. Several literatures that were relevant to the present analysis were also included. To further analyze the main outcomes, we utilized the odds rations (OR), and mean difference (MD) along with its 95% confidence interval (95% CI).

RESULTS

A total of 14 RCTs with 4998 patients in the tiotropium group and 5074 patients in the control group were included in the present study. On the basis of the pooled results, tiotropium was significantly associated with improved morning PEF (SMD: 3.29, 95%CI: 2.03-4.55), evening PEF (SMD: 3.36, 95%CI: 2.24-4.48), peak FEV (SMD: 2.67, 95%CI: 1.47-3.88), and trough FEV (SMD: 1.90, 95%CI: 0.87-2.92) vs the control group. Nevertheless, no significant difference was observed in peak FVC (SMD: 0.77, 95%CI: -0.21-1.76), trough FVC (SMD: 0.67, 95%CI: -0.18-1.53), AE (RR: 0.98, 95%CI: 0.94-1.02) and serious AE (RR: 1.08, 95%CI: 0.77-1.52) between the 2 groups.

CONCLUSIONS

In this review, we summarized the significant effect of tiotropium for the treatment of moderate-to-severe asthma, mainly in increasing morning PEF, evening PEF, peak FEV and trough FEV based on high-quality RCTs. Nevertheless, no significant difference in peak FVC, trough FVC, AE and serious AE was found between the 2 groups. A close comparison of the 2 groups revealed that more high-quality larger-sample RCTs are needed to gather more strong evidence on the therapeutic efficacy and safety of tiotropium for clinical practice.

摘要

背景

本次荟萃分析和系统评价的目的是基于合格的随机对照试验(RCT)探讨噻托溴铵治疗中重度哮喘患者的疗效。

方法

通过使用索引词筛选以下在线电子数据库,如Cochrane、PubMed和Embase数据库,以识别截至2019年1月更新的合格研究。还纳入了几篇与本分析相关的文献。为了进一步分析主要结局,我们使用了比值比(OR)、均值差(MD)及其95%置信区间(95%CI)。

结果

本研究共纳入14项RCT,噻托溴铵组4998例患者,对照组5074例患者。基于汇总结果,与对照组相比,噻托溴铵与改善晨间呼气峰流速(SMD:3.29,95%CI:2.03 - 4.55)、夜间呼气峰流速(SMD:3.36,95%CI:2.24 - 4.48)、第一秒用力呼气容积峰值(SMD:2.67,95%CI:1.47 - 3.88)和第一秒用力呼气容积谷值(SMD:1.90,95%CI:0.87 - 2.92)显著相关。然而,两组间在用力肺活量峰值(SMD:0.77,95%CI: - 0.21 - 1.76)、用力肺活量谷值(SMD:0.67,95%CI: - 0.18 - 1.53)、不良事件(RR:0.98,95%CI:0.94 - 1.02)和严重不良事件(RR:1.08,95%CI:0.77 - 1.52)方面未观察到显著差异。

结论

在本综述中,我们总结了噻托溴铵治疗中重度哮喘的显著效果,主要是基于高质量RCT提高晨间呼气峰流速、夜间呼气峰流速、第一秒用力呼气容积峰值和第一秒用力呼气容积谷值。然而,两组间在用力肺活量峰值、用力肺活量谷值、不良事件和严重不良事件方面未发现显著差异。两组的密切比较显示,需要更多高质量、大样本的RCT来收集更多关于噻托溴铵治疗效果和安全性的有力证据,以用于临床实践。

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