瑞马唑仑用于不同年龄患儿术前镇静的半数有效剂量  

Median effective dose of remimazolam for preoperative sedation in pediatric patients of different ages

作　　者：陈月月 张文华[2] 马君屹 刘文兴 宋兴荣 陈茜 Chen Yueyue;Zhang Wenhua;Ma Junyi;Liu Wenxing;Song Xingrong;Chen Xi(Department of Anesthesiology,Guangzhou Women and Children's Medical Center Guangzhou Medical University,Guangdong Provincial Clinical Research Center for Child Health,Guangzhou 510623,China;Department of Anesthesioloy,The Third Afiliated Hospital of Guangzhou Medical University,Guangzhou 510150,China)

机构地区：[1]广州医科大学附属妇女儿童医疗中心麻醉科、广东省儿童健康与疾病临床医学研究中心,广州510623 [2]广州医科大学附属第三医院麻醉科,广州510150

出　　处：《中华麻醉学杂志》2024年第10期1207-1210,共4页Chinese Journal of Anesthesiology

基　　金：广州市卫生健康科技一般引导项目(20181A010021)。

摘　　要：目的确定瑞马唑仑用于不同年龄患儿术前镇静的半数有效剂量(ED50)。方法本研究为前瞻性研究。选取本院2023年7月至12月拟行择期手术患儿,年龄1~6岁,ASA分级I或Ⅱ级,使用非药物干预后术前焦虑仍不缓解[亲子分离焦虑评分(PSAS)≥3分]。根据年龄将患儿分为1~<2岁组、2~<3岁组、3~<4岁组、4~<5岁组和5~6岁组。与家长分离时患儿PSAS 1分为镇静效果满意,PSAS评分≥2分为镇静效果不满意。首例患儿瑞马唑仑剂量为0.3 mg/kg,剂量比1.15。若患儿镇静效果满意,下一例患儿瑞马唑仑剂量下降1个梯度;若患儿镇静效果不满意,下一例患儿瑞马唑仑剂量上升1个梯度。当出现7个交替波形时结束试验。采用Dixon-Massey方法计算ED50及其95%置信区间(CI)。结果1~<2岁组、2~<3岁组、3~<4岁组、4~<5岁组和5~6岁组分别纳入26、23、21、27、23例患儿,瑞马唑仑术前镇静的ED50(95%CI)分别为0.152(0.126~0.178)、0.159(0.135~0.183)、0.171(0.147~0.196)、0.150(0.126~0.174)、0.146(0.121~0.170)mg/kg,组间比较差异无统计学意义(P>0.05)。结论1~6岁患儿中每隔1岁,瑞马唑仑术前镇静ED50分别为0.152、0.159、0.171、0.150、0.146 mg/kg,且年龄因素并不影响该年龄段患儿瑞马唑仑术前镇静效应。Objective:To determine the median effective dose(ED 50)of remimazolam for preoperative sedation in pediatric patients of different ages.Methods:This was a prospective study.American Society of Anesthesiologists Physical Status classification I orⅡpediatric patients,aged 1-6 yr,scheduled for elective surgery in our hospital from July to December 2023,in whom the preoperative anxiety was still not relieved after non-drug intervention(preoperative separation anxiety score[PSAS]≥3),were selected.According to the age,the children were divided into 1-<2 yr group,2-<3 yr group,3-<4 yr group,4-<5 yr group and 5-6 yr group.A child's PSAS score=1 at the time of separation from parents was classified as satisfactory sedation,and a PSAS score≥2 was classified as unsatisfactory sedation.The initial dose of remimazolam in each group was 0.3 mg/kg,dose ratio 1.15.If the child was satisfactorily sedated,the next patient received a lower dose of remimazolam,or conversely if the child was not satisfactorily sedated,a higher dose was given in the next patient.The test was ended when 7 alternating waveforms appeared.The Dixon-Massey method was used to calculate the ED 50 and 95%confidence interval.Results:In 1-<2 yr group,2-<3 yr group,3-<4 yr group,4-<5 yr group and 5-6 yr group,a total of 120 children were included in this study,with 26,23,21,27 and 23 cases,respectively,and the ED 50(95%confidence interval)of remimazolam for preoperative sedation was 0.152(0.126-0.178),0.159(0.135-0.183),0.171(0.147-0.196),0.150(0.126-0.174),and 0.146(0.121-0.170)mg/kg,respectively.There was no significant difference between the groups(P>0.05).Conclusions:The ED 50 of remimazolam for preoperative sedation is 0.152,0.159,0.171,0.150 and 0.146 mg/kg for every 1 yr in children aged 1-6 yr,and the age factor does not affect the preoperative sedative effect of remimazolam in children of this age group.

关 键 词：瑞马唑仑 儿童 清醒镇静 剂量效应关系 药物 

分 类 号：R726.1[医药卫生—儿科]