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用于股动脉穿刺部位止血的血管闭合装置安全性的随机试验网络荟萃分析

Network Meta-analysis of Randomized Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis.

作者信息

Jiang Jun, Zou Junjie, Ma Hao, Jiao Yuanyong, Yang Hongyu, Zhang Xiwei, Miao Yi

机构信息

Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing 210029, China.

出版信息

Sci Rep. 2015 Sep 8;5:13761. doi: 10.1038/srep13761.

Abstract

The safety of vascular closure devices (VCDs) is still debated. The emergence of more related randomized controlled trials (RCTs) and newer VCDs makes it necessary to further evaluate the safety of VCDs. Relevant RCTs were identified by searching PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials electronic databases updated in December 2014. Traditional and network meta-analyses were conducted to evaluate the rate of combined adverse vascular events (CAVEs) and haematomas by calculating the risk ratios and 95% confidence intervals. Forty RCTs including 16868 patients were included. Traditional meta-analysis demonstrated that there was no significant difference in the rate of CAVEs between all the VCDs and manual compression (MC). Subgroup analysis showed that FemoSeal and VCDs reported after the year 2005 reduced CAVEs. Moreover, the use of VCDs reduced the risk of haematomas compared with MC. Network meta-analysis showed that AngioSeal, which might be the best VCD among all the included VCDs, was associated with reduced rates of both CAVE and haematomas compared with MC. In conclusion, the use of VCDs is associated with a decreased risk of haematomas, and FemoSeal and AngioSeal appears to be better than MC for reducing the rate of CAVEs.

摘要

血管闭合装置(VCDs)的安全性仍存在争议。越来越多相关随机对照试验(RCTs)的出现以及新型VCDs的问世使得有必要进一步评估VCDs的安全性。通过检索2014年12月更新的PubMed、EMBASE、谷歌学术和Cochrane对照试验中央注册库电子数据库来识别相关RCTs。通过计算风险比和95%置信区间进行传统和网状荟萃分析,以评估合并不良血管事件(CAVEs)和血肿的发生率。纳入了40项RCTs,共16868例患者。传统荟萃分析表明,所有VCDs与手法压迫(MC)之间在CAVEs发生率上无显著差异。亚组分析显示,FemoSeal和2005年后报道的VCDs降低了CAVEs。此外,与MC相比,使用VCDs降低了血肿风险。网状荟萃分析表明,在所有纳入的VCDs中,AngioSeal可能是最佳的VCD,与MC相比,其CAVE和血肿发生率均降低。总之,使用VCDs与血肿风险降低相关,并且FemoSeal和AngioSeal在降低CAVEs发生率方面似乎优于MC。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbce/4562233/42b8a23d4aba/srep13761-f1.jpg

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