复合丙泊酚时瑞马唑仑用于不同年龄段患儿胃镜检查术的药效学  

Pharmacodynamics of remimazolam for gastroscopy when combined with propofol in pediatric patients of different ages

作　　者：吴清杏 李艳 蒙伟 尹顺花 李晓莹 Wu Qingxing;Li Yan;Meng Wei;Yin Shunhua;Li Xiaoying(Department of Anesthesiology,The First Affiliated Hospital,Hainan Medical University,Haikou 570102,China;Department of Anesthesiology,Hainan Women and Children's Medical Center,Haikou 570206,China)

机构地区：[1]海南医学院第一附属医院麻醉科,海口570102 [2]海南省妇女儿童医学中心麻醉科,海口570206

出　　处：《中华麻醉学杂志》2024年第10期1211-1216,共6页Chinese Journal of Anesthesiology

基　　金：海南省卫生健康科技创新联合项目(WSJK2024MS210)。

摘　　要：目的确定复合丙泊酚时瑞马唑仑用于不同年龄段患儿胃镜检查术的半数有效剂量(ED_(50))和95%有效剂量(ED_(95))。方法本研究为前瞻性研究。选择2024年1月至2月在海南省妇女儿童医学中心行胃镜检查术患儿,年龄3~12岁,ASA分级Ⅰ或Ⅱ级,将患儿分为学龄前组(3~6岁)和学龄组(7~12岁)。静脉注射戊乙奎醚0.01 mg/kg、阿芬太尼8μg/kg、相应剂量瑞马唑仑及丙泊酚1 mg/kg,待改良警觉/镇静评分≤1分后行胃镜检查术。采用改良序贯法进行试验,胃镜通过咽部时出现呛咳反射、恶心、呕吐、体动、皱眉为进镜反应阳性,反之为阴性。瑞马唑仑起始剂量为0.2 mg/kg,剂量梯度为0.02 mg/kg。采用probit回归法计算复合丙泊酚时瑞马唑仑抑制胃镜置入反应的ED_(50)、ED_(95)及其95%置信区间(CI)。记录麻醉相关不良事件发生情况。结果学龄前组共27例完成试验,学龄组共26例完成试验。学龄前组ED_(50)为0.266 mg/kg(95%CI 0.249~0.285 mg/kg),ED_(95)为0.302 mg/kg(95%CI 0.283~0.409 mg/kg);学龄组ED_(50)为0.160 mg/kg(95%CI 0.147~0.170 mg/kg),ED_(95)为0.183 mg/kg(95%CI 0.172~0.234 mg/kg)。与学龄前组比较,学龄组ED_(50)和ED_(95)降低(P<0.05)。麻醉期间学龄前组发生低血压3例(11%),学龄组发生低血压3例(12%)、呼吸抑制2例(8%)、呃逆2例(8%)、注射痛1例(4%)、肌肉僵直1例(4%)。2组不良反应发生率比较差异无统计学意义(P>0.05)。结论复合丙泊酚时,瑞马唑仑用于学龄前及学龄患儿胃镜检查术的ED_(50)分别为0.266、0.160 mg/kg,ED_(95)分别为0.302、0.183 mg/kg,用于学龄患儿的麻醉效力更强;两者复合应用时不良反应发生概率较低。Objective:To determine the median effective dose(ED_(50))and 95%effective dose(ED_(95))of remimazolam for gastroscopy when combined with propofol in pediatric patients of different ages.Methods:This was a prospective study.American Society of Anesthesiologists Physical Status classificationⅠorⅡpediatric patients,aged 3-12 yr,who underwent painless gastroscopy in Hainan Women and Children′s Medical Center from January to February 2024,were divided into the following groups:preschool group(3-6 yr)and school-age group(7-12 yr).Penehyclidine 0.01 mg/kg,afentanil 8μg/kg and corresponding doses of remimazolam and propofol 1 mg/kg were intravenously injected,and gastroscopy was performed when the Modified Observer′s Assessment of Alertness/Sedation Scale score)≤1.Up-and-down sequential allocation was used.A positive response was defined as bucking,nausea,vomiting,body movement,and frowning occurred when the gastroscope entered the pharynx.The initial dose of remimazolam was 0.2 mg/kg,and the dose of remimazolam was increased/decreased by 0.02 mg/kg each time in the next patient.Probit regression method was applied to calculate the ED_(50),ED_(95) and 95%confidence interval(CI)of remimazolam inhibiting responses to gastroscope placement when combined with propofol.The anesthesia-related adverse events were recorded.Results:A total of 27 pediatric patients completed the trial in preschool group and 26 cases in school-age group.The ED_(50) of remimazolam was 0.266 mg/kg(95%CI 0.249-0.285 mg/kg)and the ED_(95) was 0.302 mg/kg(95%CI 0.283-0.409 mg/kg)in preschool group.The ED_(50) of remimazolam was 0.16 mg/kg(95%CI 0.147-0.170 mg/kg)and ED_(95) was 0.183 mg/kg(95%CI 0.172-0.234 mg/kg)in school-age group.The ED_(50) and ED_(95) were significantly decreased in school-age group as compared with preschool group(P<0.05).During anesthesia,3 patients suffered hypotension(11%)in preschool group,and 3 patients suffered hypotension(12%),2 patients suffered respiratory depression(8%),2 patients suffered hiccup(8%),1 patient

关 键 词：苯二氮类 二异丙酚 儿童 胃镜检查 剂量效应关系 药物 

分 类 号：R726.1[医药卫生—儿科]