瑞马唑仑复合瑞芬太尼用于无痛胃镜检查的半数有效剂量

Median effective dose of remimazolam combined with remifentanil used in painless gastroscope and Clinical validation

目的测定瑞马唑仑复合瑞芬太尼用于无痛胃镜检查时的半数有效剂量(ED_(50))及95%有效剂量(ED_(95))。方法本研究共纳入患者73例,分为三组:第一组纳入患者性别不限(n=22),第二组仅纳入男性患者(n=29),第三组仅纳入女性患者(n=22)。根据Dixon改良序贯法,所有患者缓慢静注瑞芬太尼0.5μg/kg,随后注射瑞马唑仑0.2 mg/kg,待睫毛反射消失后行胃镜检查。若在进镜时及检查过程中出现呛咳、吞咽、皱眉、体动影响检查操作等反应为阳性反应,下一例患者增加0.05 mg/kg,否则降低0.05 mg/kg,以阳性反应转为阴性反应为交叉点,当出现七个交叉点时终止研究。采用概率单位Probit回归分析法计算第一组瑞马唑仑的ED_(50)和ED_(95)及其95%CI,并分别测定第二组、第三组瑞马唑仑的ED_(50)及其95%CI。结果第一组瑞马唑仑ED_(50)为0.19 mg/kg(95%CI 0.155~0.229 mg/kg),ED_(95)为0.31 mg/kg(95%CI 0.248~0.492 mg/kg)。第二组瑞马唑仑ED_(50)为0.161 mg/kg(95%CI 0.135~0.192 mg/kg),第三组瑞马唑仑ED_(50)为0.194 mg/kg(95%CI 0.159~0.235 mg/kg)。结论瑞马唑仑复合瑞芬太尼用于无痛胃镜检查的ED_(50)、ED_(95)分别为0.19 mg/kg和0.31 mg/kg,且男性患者瑞马唑仑ED_(50)低于女性患者。

Objective To determine the 50%effective dose(ED_(50))and 95%effective dose(ED_(95))of remazolam combined with remifentanil in painless gastroscopy.Methods Seventy-three patients were selected to receive painless gastroscopy and were divided into 3 groups:the first group had no limit to the gender(n=22),the second group only included males(n=29),and the third group only included females(n=22).According to up-and-down method,they were slowly injected remifentanil 0.5μg/kg in advance,then remimazolam 0.2 mg/kg,and gastroscopy was performed after the eyelash reflex disappeared.The standard for a positive response in patients undergoing gastroscopy:coughing,swallowing,frowning,and physical movement affecting the operation during the examination.The next patient would be increased remimazolam 0.05 mg/kg if there is a positive standrd,otherwise it would be decreased 0.05 mg/kg.And the study was terminated when seven crossing points occurred.Probit regression analysis method was used to calculate the ED_(50),ED_(95)and corresponding 95%CI of remimazolam in the first group.The same method was used to calculate the ED_(50)and 95%CI of remimazolam in the second group and the third group.Results The ED_(50)of remimazolam was 0.19 mg/kg and 95%CI was 0.155-0.229 mg/kg,the ED_(95)was 0.31 mg/kg and 95%CI was 0.248-0.492 mg/kg in the first group.The ED_(50)of remimazolam in the second group was 0.161 mg/kg and 95%CI was 0.135-0.192 mg/kg.The ED_(50)of remimazolam in the third group was 0.194 mg/kg and 95%CI was 0.159-0.235 mg/kg.Conclusion The ED_(50)and ED_(95)of remimazolam combined with remifentanil for painless gastroscopy respectively are 0.19 mg/kg and 0.31 mg/kg.The ED_(50)value of male patients is lower than that of female patients.