国际麻醉学与复苏杂志   2023, Issue (11): 10-10
    
瑞马唑仑在门诊短小手术镇静中有效性和安全性的Meta分析
徐路路, 张扬, 杨丽娟, 丁银银, 涂育铭, 高巨1()
1.徐州医科大学
Safety and efficacy of remimazolam in procedural sedation for outpatient minor surgery:a meta-analysis
 全文:
摘要:

目的:采用Meta分析比较瑞马唑仑与丙泊酚在门诊短小手术镇静中的有效性和安全性。方法:计算机检索Pubmed、Web of Science、Cochrane Library、中国知网、万方、维普数据库,检索时间从建库到2022年7月,纳入比较瑞马唑仑与丙泊酚用于门诊短小手术镇静中有效性和安全性的临床随机对照试验(RCT),瑞马唑仑组采用瑞马唑仑作为麻醉用药,复合或不复合其他镇痛药,丙泊酚组采用相同配伍的镇静方案。由两位研究员按照纳入与排除标准选择试验、提取资料,并根据Cochrane系统手册提供的质量评价标准评价纳入研究质量,采用RevMan5.3软件进行Meta分析。结果 共纳入19项RCT,2633例患者,其中瑞马唑仑组1322例,丙泊酚组1311例。Meta分析结果显示:瑞马唑仑的镇静效果与丙泊酚相当(OR=0.68,95%CI 0.09~4.96,P=0.70)。与丙泊酚相比,瑞马唑仑能明显增加血流动力学稳定性MAP(MD=6.41mmHg,95%CI2.44~10.38mmHg,P=0.002)、HR(MD=3.38次/分,95%CI 1.43~5.32次/分,P<0.001),降低低血压发生率(OR=0.23,95%CI0.18~0.29,P<0.001)、低氧血症发生率(OR=0.19,95%CI0.11~0.31,P<0.001)、注射痛发生率(OR=0.04,95%CI0.01~0.1,P<0.001)、呼吸抑制发生率(OR=0.04,95%CI0.01~0.1,P<0.001)、心动过缓发生率(OR=0.38,95%CI0.24~0.60,P<0.001),同时缩短术毕苏醒时间(MD=-0.92min,95%CI-1.59~-0.26min,P=0.006)及离室时间(MD=-2.46min,95%CI-3.89~-1.02min,P<0.001),但诱导后起效时间明显延长(MD=0.16min,95%CI0.02~0.31min,P=0.03)。两者头晕发生率(OR=0.60,95%CI0.34~1.06,P=0.08)及恶心呕吐发生率(OR=0.79,95%CI0.43~1.47,P=0.46)无明显差异。结论 瑞马唑仑是一种安全有效的门诊短小手术镇静药物,镇静效果不劣于丙泊酚;低血压、低氧血症、注射痛、呼吸抑制、心动过缓发生率更低,术后恶心呕吐及头晕发生率与丙泊酚相当;术后恢复更快,但诱导后起效时间明显延长。

关键词: 瑞马唑仑;丙泊酚;门诊短小手术;镇静;Meta分析
Abstract:

Objective To compare the safety and efficacy of remimazolam and propofol in outpatient sedation for minor surgery by meta-analysis.Methods Pubmed,Web of Science,Cochrane Library,CNKI,Wanfang,and VIP databases weresearched by computer,and the search time was from the establishment of thedatabase to July 2022.The comparison of remimazolam and propofol in proce-dural sedation was included.In a randomized controlled trial (RCT) of safety and efficacy,the remimazolam group used remimazolam as an anesthetic,with or without other analgesics,and the propofol group used propofol in the same combination.Two researchers selected trials according to the inclusion and exclusion criteria,extracted data,and evaluated the quality of the included studiesaccording to the quality evaluation criteria provided by the Cochrane System Manual.RevMan5.3 software was used for meta-analysis.Results A total of 19 RCTs involving 2633 patients were included,including 1322 in the remimazolam group and 1311 in the propofol group.Meta-analysis results showed that the sedation effect of remimazolam is comparable to that of propofol(OR=0.68,95%CI0.09~4.96,P=0.70).Compared with propofol group,remimazolam could sign-ificantly increase hemodynamic stability MAP(MD=6.41mmHg,95%CI2.44~10.38mmHg, P=0.002),HR(MD=3.38per minute,95%CI1.43~5.32per minute,P0.001),re-duce the incidence of hypotension(OR=0.23,95%CI0.18~0.29,P0.001),the incid-ence of hypoxemia(OR=0.19,95%CI0.11~0.31,P0.001),incidence of injection pa-in(OR=0.04,95%CI0.01~0.1,P0.001), incidence of respiratory depression(OR=0.04,95%CI0.01~0.1,P0.001),incidence of bradycardia(OR=0.38,95%CI0.24~0.60,P0.001),and shortened recovery time after surgery(MD=-0.92min,95%CI-1.59~-0.26min,P=0.006)and time of leaving the chamber(MD=-2.46min,95%CI-3.89~-1.02min,P0.001),but the time to fall asleep after induction was significantly prol-onged(MD=0.16min,95%CI0.02~0.31min,P=0.03).There was no significant differe-nce in the incidence of dizziness(OR=0.60,95%CI0.34~1.06,P=0.08)and nausea and vomiting(OR=0.79,95%CI0.43~1.47,P=0.46)between the two groups.Conclus-ion Remimazolam is a safe and effective sedative drug for outpatient minor surgery,its sedative effect is not inferior to propofol,and the incidence of adv-erse reactions such as hypotension,hypoxemia,injection pain,respiratory depress-ion,bradycardia is lower.The incidence of postoperative nausea,vomiting and di-zziness is similar to that of propofol,and the postoperative recovery is faster, but the onset time after induction is significantly prolonged.

Key words: Remimazolam;Propofol;outpatient minor surgery;sedation;meta-analysis