瑞马唑仑在内镜检查中镇静的有效性和安全性的meta分析

Meta-analysis of the Effectiveness and Safety of the Sedative Effect of Remimazolam in Endoscopy

关键词:  瑞马唑仑  丙泊酚  咪达唑仑  内镜检查  meta分析

Key words:  remimazolam  propofol  midazolam  endoscopy  meta-analysis

摘要:

目的 系统性评价瑞马唑仑在内镜检查中镇静的有效性和安全性，并与丙泊酚和咪达唑仑进行比较。方法 在PubMed、Embase、Cochrane图书馆、万方数据库、中国知网等数据库进行检索，收集内镜检查中瑞马唑仑用于镇静的随机对照试验文献。检索时间从2018年瑞马唑仑获批准于临床试验开始到2022年4月。搜索策略包括以下变量关键词：瑞马唑仑、胃镜检查、支气管镜检查和结肠镜检查。通过RevMan 5.4软件对纳入文献质量进行评估并进行meta分析。结果 共有10项瑞马唑仑与丙泊酚和咪达唑仑的随机对照研究，共有2 076例患者纳入分析。结果表明，瑞马唑仑镇静效应优于咪达唑仑[OR=0.03，95% CI(0.02， 0.05)，I²=0%， P<0.000 01]；逊于丙泊酚[OR=11.32， 95%CI(2.12，60.56)，I²=0%，P=0.005]。瑞马唑仑起效时间较丙泊酚慢，较咪达唑仑快；但苏醒时间快于丙泊酚和咪达唑仑。与咪达唑仑相比，其不良反应发生风险无明显差异。与丙泊酚相比，瑞马唑仑的低血压、心率减慢、低氧血症和注射痛发生风险更低，但恶心发生风险升高，二者呕吐发生风险无差异。结论 瑞马唑仑用于内镜检查时，其镇静效应和起效时间优于咪达唑仑，但不及丙泊酚。苏醒时间快于丙泊酚和咪达唑仑。瑞马唑仑对呼吸、循环抑制发生率低于丙泊酚，不良反应与咪达唑仑相比无统计学差异。

Abstract:

OBJECTIVE To systematically evaluate the efficacy and safety of the sedative effect of remimazolam in endoscopy and to compare it with propofol and midazolam. METHODS Search PubMed, Embase, Cochrane Library, Wanfang database, CNKI and other databases to collect the literature of randomized controlled trials of remimazolam for sedation in endoscopy. The search period was from 2018 onwards when remimazolam was approved for clinical trials until April 2022. The search strategy included the following variable keywords: remimazolam, gastroscopy, bronchoscopy, and colonoscopy. The quality of the included literature was assessed and the collected data were subjected to meta-analysis by RevMan 5.4 software. RESULTS Ten relevant RCTs involving midazolam and propofol, involving a total of 2 076 patients were included in the analysis. The results showed that the sedative effect of remimazolam was significantly higher than that of midazolam [OR=0.03, 95%CI(0.02, 0.05), I²=0%, P<0.000 01]; but lower than that of propofol [OR=11.32, 95%CI(2.12, 60.56), I²=0%, P=0.005]. The onset time of remimazolam was longer than that of propofol, but shorter than that of midazolam; the recovery time was faster than that of propofol and midazolam. Compared with midazolam, there was no significant difference in the incidence of adverse reactions. Compared with propofol, remimazolam was associated with lower rates of hypotension, slowed heart rate, hypoxemia, and injection pain, but higher risk ratio of nausea, with no difference invomiting. CONCLUSION The sedative effect and onset of action of remimazolam are better than midazolam but less than propofol when used for endoscopy. Wake-up time is faster than that of propofol and midazolam. The incidence of respiratory and circulatory depression is lower with remimazolam than with propofol, and there are no significant differences in adverse effects compared with midazolam.