气囊压迫止血器初次放气减压时间不同对桡动脉介入术后安全性的系统评价

A Systematic Review of the Safety of Balloon Compression Hemostat with Different Initial Decompression Time after Radial Artery Intervention

目的:系统评价桡动脉介入术后气囊压迫止血器不同初次放气减压时间对病人术后安全性的影响,并探究最佳初次放气时间。方法:系统检索PubMed、Web of Science、EMbase、中国期刊全文数据库(CNKI)、维普、万方数据库中2005年1月1日—2021年12月15日公开发表的包含桡动脉介入术后气囊压迫止血器不同初次放气时间对术后不良反应及并发症影响的随机对照试验(RCT)。采用RevMan 5.4软件进行Meta分析,运用R 4.2软件进行敏感性分析。结果:共纳入27项研究,涉及病人5843例。Meta分析结果显示,与术后>2 h初次放气减压相比,术后2 h初次放气减压急性桡动脉闭塞(RAO)发生率[RR=4.90,95%CI(1.69,14.24),P=0.003]、肢体麻木发生率[RR=3.16,95%CI(2.14,4.65),P<0.00001]、肢体发绀发生率[RR=4.35,95%CI(2.36,8.02),P<0.01]更低。与术后2 h初次放气减压相比,术后<2 h初次放气减压急性RAO发生率[RR=0.44,95%CI(0.20,0.97),P=0.04],肢体肿胀发生率[RR=0.41,95%CI(0.27,0.63),P<0.0001]、肢体麻木发生率[RR=0.49,95%CI(0.34,0.70),P<0.0001],肢体发绀发生率[RR=0.37,95%CI(0.18,0.75),P=0.006],病人穿刺部位疼痛发生率[RR=0.50,95%CI(0.34,0.73),P=0.0003]更低。采用逐一剔除文献方法进行敏感性分析,剔除前后结果未发生明显变化,提示Meta分析结果基本稳定。结论:现有证据表明,气囊压迫止血器初次放气减压时间距桡动脉介入术后<2 h比2 h或>2 h更能有效预防术后急性RAO及肢体肿胀、麻木、发绀、穿刺部位疼痛的发生。

Objective:To evaluate the safety of different initial deflation and decompression time of balloon compression hemostat on postoperative safety of patients after radial artery intervention,and to explore the best initial deflation time.Methods:Randomized controlled trials(RCTs)including the effects of different initial decompression time of balloon compression hemostat on postoperative adverse reactions and complications of PubMed,Web of Science,EMbase,China Journal Full-Text Database(CNKI),VIP and WanFang Databases from January 1,2005 to December 15,2021 were searched.Two researchers independently screened and evaluated the qualified literature,and the final literature was determined to be included after the evaluation of the third researcher.RevMan 5.4 software was used for Meta-analysis and R 4.2 software was used for sensitivity analysis.Results:A total of 27 literatures were included,including 5843 patients.Meta-analysis results showed that compared with postoperative>2 h initial deflation decompression,postoperative 2 h initial deflation decompression showed with lower arterial occlusion(RAO)(RR=4.90,95%CI 1.69-14.24,P=0.003),lower incidence of limb numbness(RR=3.16,95%CI 2.14-4.65,P<0.00001),and lower incidence of limb cyanosis(RR=4.35,95%CI 2.36-8.02,P<0.01).Compared with initial deflation and decompression after 2 hours postoperatively,initial deflation and decompression within 2 hours postoperatively showed with lower incidence of acute RAO(RR=0.44,95%CI 0.20-0.97,P=0.04),lower incidence of limb swelling(RR=0.41,95%CI 0.27-0.63,P<0.0001),lower incidence of limb numbness(RR=0.49,the 95%CI 0.34-0.70,P<0.0001),lower incidence of limb cyanosis(RR=0.37,95%CI 0.18-0.75,P=0.006),and lower incidence of pain at the patient′s puncture site(RR=0.50,95%CI 0.34-0.73,P=0.0003).The sensitivity analysis was performed using the literature-by-exclusion method,and the results did not change significantly before and after exclusion,suggesting that the results of Meta-analysis were stable and credible.Conclusion:The current evidence showed that based on the results of Meta-analysis,the time of initial deflation and decompression of the balloon compression hemostat<2 h after radial artery intervention was more effective than 2 h or>2 h in preventing the occurrence of postoperative acute RAO,swelling of the limbs,limb cyanosis,and pain at the puncture site.