不同剂量促肾上腺皮质激素治疗婴儿痉挛的对照研究

A comparative study of the different dose adrenocorticotrophic hormone therapy for Infantile spasms

目的:比较不同剂量促肾上腺皮质激素(ACTH)治疗婴儿痉挛(Infantile spasms,IS)疗效的差异,寻找ACTH的最小有效剂量。方法:采用前瞻性随机对照研究,将45例IS随机分为大剂量组(n=15)、中等剂量组(n=15)及小剂量组(n=15)。大剂量组ACTH 5 IU/(kg.d),×2周,随后2周减量至停药;中等剂量组ACTH 2IU/(kg.d),×2周,随后2周减量至停药;小剂量组每日1 IU/kg×2周,随后2周减量至停药。比较ACTH不同剂量治疗IS的疗效、不良反应及治疗后脑电图变化。结果:大剂量组治疗IS的有效率最高,中等剂量与大剂量治疗IS的近期疗效相似,有效率相比差异无显著性(P>0.05),治疗后脑电图变化、痉挛复发及复发时间两组间差异无显著性(P>0.05),小剂量组有效率最低,与大剂量组相比差异有显著性(P<0.05)。小剂量组不良反应发生率最低,中等剂量组不良反应发生率略高于小剂量组,两者相比差异无显著性(P>0.05),大剂量组不良反应发生率最高,与小剂量组相比差异有显著性(P<0.05)。结论:中等剂量ACTH治疗婴儿痉挛安全有效。

Objective：The efficacy and adverse effects of the different dose adrenocorticotrophic hormone（ACTH） therapy for Infantile spasms（IS） were compared in order to identify a low effective dose with few adverse effects.Methods：A prospective randomized controlled study was conducted.Forty-five children IS were enrolled.They were randomly assigned to receive large dose and middle dose or low dose ACTH therapy.For the large dose group,5 IU /kg per day was administered for 2 weeks and tapered to zero over the subsequent 2 weeks.For the middle dose group,2 IU /kg per day was administered for 2 weeks and tapered to zero over the subsequent 2 weeks.For the low dose group,1 IU /kg per day was injected for 2 weeks and tapered to zero over the subsequent 2 weeks.Both effectiveness and adverse effects were compared among the three groups.Results：There were no significant differences in the good initial responses between the large and the middle dose groups,which were 60% and 53%,respectively（P〉0.05）.EEG findings after ACTH therapy,the rate of relapse of spasms,and the interval to relapse were not different between the two groups（P〉0.05）.But there were significant differences in the good initial responses between the large dose and the low dose groups,which were 60% and 20%,respectively（P〈0.05）.The incidence of ACTH therapy related adverse effects in the large dose group（93%） was significantly higher than in the low dose group（20%）（P〈0.01）.But the incidence of ACTH therapy related adverse effects in the middle dose group（26.7%） was not significantly higher than in the low dose group（20%）（P〉0.05）.Conclusions：These findings suggest that the middle dose ACTH is effective,safe and well tolerated in patients with Infantile spasms.