摘要：
目的 与传统镇静药物比较,评估1岁以内(1个月～1岁)先天性心脏病(congenital heart disease,CHD)患儿放射学检查时,右美托咪定(dexmedetomidine,Dex)作为首剂口服水合氯醛镇静失败后补救用药的疗效及安全性. 方法 根据意向性治疗原则,前瞻性、随机、单盲临床随机对照试验分析2016年3月29日～6月2日于我院行心血管放射学检查且需镇静的患儿225例,采用随机均衡分组法分为3组(每组75例):A组(5 mg/kg苯巴比妥肌内注射)、B组(25 mg/kg水合氯醛口服)、C组(1 μg/kg Dex滴鼻).比较首剂口服水合氯醛失败后3组补救镇静的成功率及副作用发生情况,同时分析家属满意度,比较起效时间、苏醒时间及总镇静时间,评估给药前(T0)、给药后5 min(T1)、给药后10 min(T2)、给药后20 min(T3)、起效时(T4)、检查结束时(T5)、苏醒时(T6)患儿SpO2及HR的变化. 结果 A组、B组及C组放射学检查补救镇痛成功率分别为75.8％、83.3％、90.7％,C组与A组成功率比较,差异有统计学意义(P＜0.05).分层研究后发现,C组右向左分流型CHD患儿放射学检查成功率较A组高(P＜0.05).C组起效时间与B组比较,差异有统计学意义(P＜0.05).C组苏醒时间及总镇静时间与A组及B组比较,差异有统计学意义(P＜0.05).A组、B组及C组副作用发生率分别为3.2％、7.6％、4.0％,差异无统计学意义(P＞0.05).3组HR及SpO2变化差异无统计学意义(P＞0.05). 结论 1μg/kg Dex滴鼻可以有效用于CHD患儿放射学检查补救镇静,具有起效快,效果持久的特点,其对右向左分流的紫绀型CHD患儿镇静效果较苯巴比妥更好,且不增加CHD患儿副作用的发生率.%Objective The purpose of this study was to evaluate the efficacy and safety of intranasal dexmedetomidine(Dex) compared with traditional medications for rescue sedation during radiological scanning in infants under 12 months with congenital heart disease (CHD).Methods Based on an intention of treating protocol,this prospective single-blinded randomized clinical trial includes total 347 infants diagnosed with CHD who were not adequately sedated after initial oral dose of 50 mg/kg chloral hydrate.They were randomly divided into three groups.Group A received intramuscular phenobarbital of 5 mg/kg.Group B received second oral dose chloral hydrate 25 mg/kg.Group C received intranasal Dex 1 μg/kg.Sedation onset and duration,parents satisfaction were recorded.The readings of heart rate,and oxygen saturation were recorded at baseline(T0),at 5 min(T1),10 min(T2),20 min(T3),sedation (T4),check end (T5) and time of wake-up (T6).Results The success rate of rescue sedation among three groups was 75.8％,83.3％ and 90.7％ respectively.There was significantly difference in success rate between group C and group A (P＜0.05).The proportion of infants with right to left shunt subgroup successfully sedated in group C was higher than proportion of group A (P＜0.05).The sedation induced time was significantly shorter in group C than in group B (P＜0.05).The wake-up time and the total sedation time of group C were significantly different with other two groups(P＜0.05).The incidence of side-effects were 3.2％,7.6％ and 4.0％ separately with no significantly differences (P＞0.05).There were no significant differences in hemodynamic changes among three groups (P＞0.05).Conclusions A dosage of intranasal Dex 1 μg/kg was found to be effective in infants under 12 months with congenital heart disease during radiological scanning as a rescue sedative with quicker sedation onset time,longer sedated time.Intranasal Dex is also more effective in infants with right to left shunt lesions than effect of phenobarbital.It did not increase the incidence of side effects and hemodynamic changes.
