促肾上腺皮质激素注射剂治疗婴儿痉挛症的临床研究

Clinical trial of adrenocorticotrophic hormone injection in the treatment of infantile spasms

目的比较不同剂量促肾上腺皮质激素(ACTH)注射剂治疗婴儿痉挛症(IS)的临床疗效及安全性。方法将80例IS患儿随机分为对照组和试验组,每组40例。对照组予以ACTH 4~5 U·kg^(-1)·d^(-1),qd,静脉滴注;试验组予以ACTH 1 U·kg^(-1)·d^(-1),qd,静脉滴注,ACTH疗程均为2周。随后2组患儿均予以序贯泼尼松1.5 mg·kg^(-1)·d^(-1),足量2周后逐渐减量,泼尼松总疗程2~3个月。比较2组患儿的临床疗效、脑电图(EEG)改变和药物不良反应的发生情况。结果 ACTH治疗后2周和3,6,12个月,试验组的总有效率分别为82.50%(33例/40例),75.00%(30例/40例),75.00%(30例/40例)和72.50%(29例/40例),对照组的总有效率分别为82.50%(33例/40例),80.00%(32例/40例),82.50%(33例/40例)和82.50%(33例/40例),差异均无统计学意义(均P>0.05)。ACTH治疗后,试验组和对照组的EEG恢复率分别为10.00%和15.00%,总改善率分别为60.00%和75.00%,差异均无统计学意义(均P>0.05)。2组患儿最常见的药物不良反应均为白细胞和血小板升高,其次多见感染、高血压、低血钾、肝功能损害、易激惹等。2组患儿的总药物不良反应发生率比较,差异无统计学意义(P>0.05),但试验组的低钾血症发生率显著低于对照组,差异有统计学意义(P<0.05)。结论 ACTH是治疗IS的有效药物,小剂量1 U·kg^(-1)·d^(-1)、短疗程2周的ACTH疗效显著,且不增加药物不良反应的发生率。

Objective To compare the clinical efficacy and safety of two different doses of adrenocorticotropic hormone（ ACTH） injection in treatment of infantile spasms（ IS）. Methods Eighty children with IS were randomly divided into control and treatment groups with 40 cases per group. Control group received 4-5 U·kg^（-1）·d^（-1） ACTH,qd,intravenous injection and treatment group received 1 U·kg^（-1）·d^（-1） ACTH,qd,intravenous injection for 2 weeks. Both groups received 1. 5 mg·kg^（-1）·d^（-1） prednisone sequentially for 2 weeks. The dose of prednisone was gradually reduced with total course of 2-3 months. The clinical efficacy,improvement of electroencephalogram（ EEG） and adverse drug reactions were compared between two groups. Results After 2 weeks,3 months,6 months and 12 months of ACTH treatment,the total effective rate was82. 50%（ 33 cases/40 cases）,75. 00%（ 30 cases/40 cases）,75. 00%（ 30 cases/40 cases） and 72. 50%（ 29 cases/40 cases） in treatmentgroup,without difference by comparison with those in control group which were 82. 50%（ 33 cases/40 cases）,80. 00%（ 32 cases/40 cases）,82. 50%（ 33 cases/40 cases） and 82. 50%（ 33 cases/40 cases）（ all P 0. 05）. After the treatment of ACTH,the recovery rate of EEG was 10. 00% and total improved rate was 60. 00% in treatment group,in control group which were 15. 00% and 75. 00%（ all P 0. 05）. The most common adverse drug reactions were elevation of white blood cells and platelets in both groups,followed by infection,hypertension,hypokalemia,liver functional impairment and irritability,et al. The incidence of ACTH therapy related-adverse drug reactions in two groups had no significant difference（ P 0. 05）,but the incidence of hypokalemia in treatment group was significantly lower than that in control group（ P 0. 05）. Conclusion ACTH is an effective therapy drug for IS. Low dose of 1 U·kg^（-1）·d^（-1） and short course of 2 weeks of ACTH treatment might be effective and safe for IS without increasing the incidence of adverse drug reactions.