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联合噻托溴铵或安慰剂治疗哮喘控制不佳的比较:一项荟萃分析

2013/12/30

   摘要
   目的:荟萃分析被用于评估标准疗法联合噻托溴铵治疗哮喘控制不佳的疗效和安全性。
   方法:系统性检索Pubmed,EMBASE,Medline,CENTRAL数据库和Clinicaltrials.gov,并查找相关主要的呼吸道期刊。观察随机、双盲临床试验中关于比较哮喘控制不佳者额外联合噻托溴铵4周或4周以上或安慰剂治疗的数据。所有研究被汇总分析了风险比(OR)、加权平均数(WMD)以及95%的可信区间(CI)。
   结果:6项试验被纳入评估。与安慰剂相比,联合噻托溴铵显著改善所有肺测定指标,包括晨间和晚间PEF (分别为WMD 20.59 L/min,95% CI 15.36 -25.81 L/min, P<.001和WMD24.95 L/min,95% CI 19.22 - 30.69 L/min, P<.001),峰谷FEV1 (分别为WMD 0.13 L,95% CI 0.09- 0.18 L,P<.001 和 WMD 0.10 L, 95% CI 0.06 -0.14 L,P<.001),FEV1AUC0-3小时 (WMD 0.13 L, 95% CI 0.08 - 0.18 L,P<.001),峰谷FVC (分别为WMD 0.1 L, 95% CI 0.05 -0.15 L,P<.001 和WMD 0.08 L,95% CI 0.04 - 0.13 L, P<.001),FVCAUC0-3小时(WMD 0.11 L,95%CI 0.06 -0.15 L,P<.001)。ACQ-7的平均变化值 (WMD -0.12,95% CI -0.21--0.03,P=.01)在联合噻托溴铵组中显著更低,但无临床意义。AQLQ 评分(WMD 0.09,95%CI -0.01 - 0.20, P=.09), 夜间觉醒 (WMD 0.00,95% CI -0.05 - 0.05,P=.99) 或抢救药物的使用(WMD -0.18,95% CI -0.36- 0.00,P=.06)没有显著差异。联合噻托溴铵组不良事件没有显著增加(OR 0.80,95% CI 0.62 - 1.03,P=.08)。
   结论:标准疗法联合噻托溴铵治疗哮喘控制不佳显著改善肺功能,且无不良事件的的增加。长期试验被用于评估联合噻托溴铵治疗哮喘急性加重和治疗无效的疗效。

 

(苏楠 审校)
Respir Care. 2013 Oct 29. [Epub ahead of print]



 

 

Tiotropium versus placebo for inadequately controlled asthma: a meta-analysis.
 

Tian JW, Chen JW, Chen R, Chen X.
 

Abstract
OBJECTIVE:
This meta-analysis was performed to evaluate the efficacy and safety of addition of tiotropium to standard treatment regimens for inadequately controlled asthma.
METHODS: A systematic search was made of Pubmed, EMBASE, Medline, CENTRAL databases and Clinicaltrials.gov, and a hand search of leading respiratory journals. Randomized, double-blinding clinical trials on treatment of inadequately controlled asthma for 4 or more weeks with the addition of tiotropium, compared with placebo, were reviewed. Studies were pooled to odds ratio (OR) and weighted mean differences (WMD), with 95% confidence interval (CI).
RESULTS: Six trials met the inclusion criteria. Addition of tiotropium, compared with placebo, significantly improved all spirometric indices, including morning and evening PEF (WMD 20.59 L/min, 95% CI 15.36 to 25.81 L/min, P<.001 and WMD 24.95 L/min, 95% CI 19.22 to 30.69 L/min, P<.001, respectively), trough and peak FEV1 (WMD 0.13 L, 95% CI 0.09 to 0.18 L, P<.001 and WMD 0.10 L, 95% CI 0.06 to 0.14 L, P<.001 respectively), FEV1AUC0-3h (WMD 0.13 L, 95% CI 0.08 to 0.18 L, P<.001), trough and peak FVC (WMD 0.1 L, 95% CI 0.05 to 0.15 L, P<.001 and WMD 0.08 L, 95% CI 0.04 to 0.13 L, P<.001 respectively), FVCAUC0-3h(WMD 0.11 L, 95% CI 0.06 to 0.15 L, P<.001). The mean change in ACQ-7 (WMD -0.12, 95% CI -0.21 to -0.03, P=.01) was markedly lower in tiotropium group, but not clinically significant. There were no significant differences in AQLQ score (WMD 0.09, 95% CI -0.01 to 0.20, P=.09), night awakenings (WMD 0.00, 95% CI -0.05 to 0.05, P=.99) or rescue medication use (WMD -0.18, 95% CI -0.36 to 0.00, P=.06). No significant increase was noticed in adverse events in tiotropium group (OR 0.80, 95% CI 0.62 to 1.03, p=.08).
CONCLUSION: Addition of tiotropium to standard treatment regimens has significantly improved lung function without increasing adverse events in patients with inadequately controlled asthma. Long-term trials are required to assess the effects of addition of tiotropium on asthma exacerbations and mortality.

 

Respir Care. 2013 Oct 29. [Epub ahead of print]


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