一项关于肺动脉高压随机对照试验的荟萃分析。

A meta-analysis of randomized controlled trials in pulmonary arterial hypertension.

作者信息

Galiè Nazzareno, Manes Alessandra, Negro Luca, Palazzini Massimiliano, Bacchi-Reggiani Maria Letizia, Branzi Angelo

机构信息

Institute of Cardiology, University of Bologna, Bologna, Italy.

出版信息

Eur Heart J. 2009 Feb;30(4):394-403. doi: 10.1093/eurheartj/ehp022. Epub 2009 Jan 20.

Abstract

AIMS

There is no cure for pulmonary arterial hypertension, but current approved treatment options include prostanoids, endothelin-receptor antagonists, and phosphodiesterase type-5 inhibitors. The effect on survival of these compounds has not been appropriately assessed in individual trials because of small sample size and short duration. We performed a meta-analysis of all randomized controlled trials with drugs published in this condition.

METHODS AND RESULTS

Trials were searched in the Medline database from January 1990 to October 2008. The primary analysis included only studies with a placebo comparator arm, the sensitivity analysis also included studies comparing two active treatment arms. The main outcome measure was all-cause mortality. Twenty-one trials were included in the primary analysis (3140 patients) and two additional studies (59 patients) were included in the sensitivity analysis. Average duration of the trials was 14.3 weeks. All-cause mortality rate in the control group was 3.8%. Active treatments were associated with a reduction in mortality of 43% (RR 0.57; 95% CI 0.35-0.92; P = 0.023); the sensitivity analysis confirmed a reduction in mortality of 38% (RR 0.62; 95% CI 0.39-1.00; P = 0.048).

CONCLUSION

The results of this meta-analysis suggest an improvement of survival in the patients treated with the targeted therapies approved for pulmonary arterial hypertension.

摘要

目的

肺动脉高压无法治愈,但目前已获批的治疗方案包括前列环素类药物、内皮素受体拮抗剂和5型磷酸二酯酶抑制剂。由于样本量小和研究持续时间短,这些化合物对生存率的影响在单个试验中未得到适当评估。我们对所有已发表的关于此疾病药物治疗的随机对照试验进行了荟萃分析。

方法与结果

在1990年1月至2008年10月期间检索了Medline数据库中的试验。主要分析仅纳入了有安慰剂对照臂的研究,敏感性分析还纳入了比较两个活性治疗臂的研究。主要结局指标是全因死亡率。主要分析纳入了21项试验(3140例患者),敏感性分析还纳入了另外两项研究(59例患者)。试验的平均持续时间为14.3周。对照组的全因死亡率为3.8%。活性治疗与死亡率降低43%相关(风险比0.57;95%置信区间0.35 - 0.92;P = 0.023);敏感性分析证实死亡率降低38%(风险比0.62;95%置信区间0.39 - 1.00;P = 0.048)。

结论

这项荟萃分析的结果表明,接受肺动脉高压获批靶向治疗的患者生存率有所提高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09fb/2642921/e93dcfa28024/ehp02201.jpg

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