手术纠治对先天性心脏病婴儿右美托咪定滴鼻镇静半数有效剂量的影响

Effect of surgical correction on the median effective dose of dexmedetomidine nasal sedation in infants with congenital heart disease

目的测定低龄先天性心脏病患儿心脏超声检查镇静时右美托咪定滴鼻的半数有效剂量(ED_(50)),探讨手术纠治对其药效学的影响。方法选择在右美托咪定滴鼻下完成心脏超声检查的先天性心脏病患儿66例,男32例,女34例,年龄1~6个月,体重3.9~8.0 kg。根据是否行先天性心脏病手术将患儿分为两组:手术纠治前组(B组,n=32)和手术纠治后组(P组,n=34)。两组右美托咪定滴鼻的初始剂量均为2μg/kg,根据上一例患儿检查中镇静效果,下一例患儿增加或减少0.2μg/kg,采用改良序贯法测定两组的ED_(50),采用概率回归法外推两组ED 95,计算ED_(50)和ED 95的95%可信区间(CI)。记录患儿镇静检查过程中的SpO_(2)、HR、镇静起效时间、苏醒时间及不良反应情况。结果B组和P组右美托咪定滴鼻的ED_(50)分别为1.3μg/kg(95%CI 1.17~1.43μg/kg)和1.4μg/kg(95%CI 1.13~1.59μg/kg),ED 95分别为1.7μg/kg(95%CI 1.51~2.28μg/kg)和1.8μg/kg(95%CI 1.54~2.34μg/kg),两组ED_(50)和ED 95差异无统计学意义。两组患儿在镇静检查过程中均未发生不良反应。结论低龄先天性心脏病婴儿手术纠治前后右美托咪定滴鼻镇静检查剂量无需调整。

Objective To determine the median effective dose of single-dose intranasal dexmedetomidine to induce sedation in infants younger than 6 months with congenital heart disease both before and after operation and to explore the effects of surgical medication on pharmacodynamics.Methods Sixty-six infants with congential heart disease,32 males and 34 females,aged 1-6 months were enrolled in this study.Infants were stratified into two groups according to whether they received surgery:before surgery group(group B)and postoperative group(group P).Intranasal dexmedetomidine started at a dose of 2μg/kg on the first infant at both groups.The dose of dexmedetomidine for each subsequent patient was determined by the previous patient s response using Dixon s up-and-down method with an interval of 0.2μg/kg.The meadian effective dose and 95%effective dose and their 95%confidence interval of dexmedetomidire nasal sedation were recorded.Heart rate,pulse oxygen saturation,sedation onset time,recovery time and adverse reactions were collected.Results The median effective dose was 1.3μg/kg(95%CI 1.17-1.43μg/kg)in the group B and 1.4μg/kg(95%CI 1.13-1.59μg/kg)in the group P,the 95%effective dose was 1.7μg/kg(95%CI 1.51-2.28μg/kg)in group B and 1.8μg/kg(95%CI 1.54-2.23μg/kg)in group P,with no significant differences.No significant adverse events occurred in both groups.Conclusion There is no need to adjust the dose of dexmedetomidine for intranasal sedation in children younger than 6 months after congenital heart surgery.