托吡酯治疗儿童青少年躁狂症的疗效和安全性

Effect and Safety of Topiramate on Mania in Children and Adolescents

目的观察托吡酯对儿童青少年躁狂发作的临床疗效及安全性。方法躁狂发作的儿童青少年患者97例,随机分成两组,治疗组49例,给予托吡酯100～400 mg·d^(-1),一天2次,口服,治疗12周,平均剂量(211.25±67.21) mg·d^(-1);对照组48例,给予丙戊酸钠缓释片1000～2000 mg·d^(-1),一天2次,口服,治疗12周,平均剂量(1171. 05±240.39) mg·d^(-1)。分别于治疗前和治疗后第2,4,8,12周末,比较两组的临床疗效、Young躁狂评定量表(YMRS)、临床总体印象量表(CGI)和不良反应量表(TESS)的评分及相关实验室指标的变化情况。结果治疗组和对照组有效率分别为80.00%和78.95%(P>0.05)。两组治疗后YMRS评分均较治疗前明显下降(P<0.05),但两组间差异无统计学意义(P>0.05)。治疗12周末,治疗组不良反应特别是嗜睡、转氨酶升高发生率低于对照组(P<0.05);体质量及体质量指数均明显低于对照组(P<0.05)。结论托吡酯治疗儿童青少年躁狂发作的疗效与丙戊酸钠缓释片相当,不良反应发生率低,安全性好。

Objective To observe the clinical effect and safety of topiramate on mania in children and adolescents. Methods A total of 97 children and adolescent patients diagnosed with mania were recruited and randomly divided into two groups: treatment group (49 cases) and control group (48 cases). The treatment group was treated with oral topiramate 100-400 mg·d ^-1 twice a day for 12 weeks, with an average dose of (211.25±67.21) mg·d ^-1 . And control group was treated with oral sodium valproate 1000-2000 mg·d ^-1 twice a day for 12 weeks, with an average dose of (1171.05±240.39) mg·d ^-1 . The clinical effects was evaluated by scores of Young Manic Rating Scale (YMRS ), Clinical Global Impression (CGI) and Treatment Emergent Symptom Scale (TESS), and the variations of related laboratory results were compared between these two groups before and after 2, 4, 8 and 12 weeks of treatment. Results The treatment response rates of treatment group and control group were 80.00% and 78.95%, respectively ( P >0.05). The YMRS scores in both groups were significantly decreased after treatment ( P <0.05) when compared to pre-treatment, but there was no crucial difference between the two groups ( P > 0.05 ). After treatment for 12 weeks, the side effects, especially in lethargy and elevated transaminase, were more noticeable in control group than that in treatment group ( P <0.05). However, body mass and body mass index in treatment group were remarkably lower than control group with a statistically significant difference ( P <0.05). Conclusion Topiramate has a curative effect similar to valproate in treatment of in children and adolescents with mania. Moreover, the incidence of adverse reactions happened less frequently and thus the medicine is safe to use.