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一项关于紫杉醇洗脱支架和西罗莫司洗脱支架用于阻塞性冠状动脉疾病患者的临床试验的荟萃分析。

A meta-analysis of clinical trials of paclitaxel- and sirolimus-eluting stents in patients with obstructive coronary artery disease.

作者信息

Shafiq N, Malhotra S, Pandhi P, Grover A, Uboweja A

机构信息

Department of Pharmacology 2, Postgraduate Institute of Medical Education & Research, Chandigarh-160 012, India.

出版信息

Br J Clin Pharmacol. 2005 Jan;59(1):94-101. doi: 10.1111/j.1365-2125.2005.02258.x.

Abstract

AIM

This meta-analysis was conducted to compare the effects of drug (paclitaxel and sirolimus)-eluting stents with bare metal stents on major adverse cardiac events, restenosis rates and late loss of arterial lumen diameter in patients with obstructive coronary artery disease.

METHODS

Randomized, controlled clinical trials comparing sirolimus- and paclitaxel-eluting stents with bare metal stents were identified through electronic and manual search. Fixed effects method of Mantel-Haenszel and random effects method of DerSimonian and Laird were used for computing the pooled odds ratio (OR) and 95% confidence intervals (CI) for major adverse cardiac events and restenosis rates. Standardized mean difference with 95% CI was calculated for late-loss of arterial lumen diameter.

RESULTS

A total of 13 studies were included in the meta-analysis. As compared with bare metal stents, the use of sirolimus- and paclitaxel-eluting stents significantly reduced the major adverse cardiac events (pooled OR 0.35; 95% CI 0.24-0.50), restenosis rates (pooled OR 0.27; 95% CI 0.15-0.47), and late loss of arterial lumen diameter (mean difference 0.57 mm, 95% CI 0.49-0.68).

CONCLUSION

Paclitaxel- and sirolimus-eluting stents significantly reduced the incidence of major adverse cardiac events, restenosis rates, and late loss of arterial lumen diameter as compared with bare metal stents.

摘要

目的

本荟萃分析旨在比较药物洗脱支架(紫杉醇和西罗莫司)与裸金属支架对阻塞性冠状动脉疾病患者主要不良心脏事件、再狭窄率及动脉管腔直径晚期丢失的影响。

方法

通过电子检索和手动检索确定比较西罗莫司洗脱支架和紫杉醇洗脱支架与裸金属支架的随机对照临床试验。采用Mantel-Haenszel固定效应法和DerSimonian和Laird随机效应法计算主要不良心脏事件和再狭窄率的合并比值比(OR)及95%置信区间(CI)。计算动脉管腔直径晚期丢失的标准化均数差值及95%CI。

结果

本荟萃分析共纳入13项研究。与裸金属支架相比,使用西罗莫司洗脱支架和紫杉醇洗脱支架可显著降低主要不良心脏事件(合并OR 0.35;95%CI 0.24-0.50)、再狭窄率(合并OR 0.27;95%CI 0.15-0.47)以及动脉管腔直径晚期丢失(均数差值0.57mm,95%CI 0.49-0.68)。

结论

与裸金属支架相比,紫杉醇洗脱支架和西罗莫司洗脱支架可显著降低主要不良心脏事件的发生率、再狭窄率以及动脉管腔直径晚期丢失。

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