托吡酯引起泌汗障碍的多中心研究及危险因素分析

A multicentre study on risk factors for topiramate-associated hypohidrosis

目的探讨托吡酯治疗中出现泌汗障碍的临床特点及相关危险因素。方法回顾全国托吡酯上市后疗效和安全性监测多中心观察的10106例癫痫患者的临床资料,分析泌汗障碍的发生率、临床特点及危险因素。结果378例(3.74%)发生泌汗障碍,儿童发生率(5.50%)显著高于成人(0.37%)(P<0.05)。性别、发作频率、是否加用其他抗癫痫药物及疗效并不影响泌汗障碍的发生,而低龄、剂量较高者在夏季较易出现此种不良反应。儿童患者各年龄组内,泌汗障碍患者与未发生泌汗障碍者的平均剂量均无明显差异。结论泌汗障碍在托吡酯治疗的儿童患者中较为常见,应积极预防并予以相应处理。夏季和低龄是发生泌汗障碍的危险因素,而剂量并不是发生泌汗障碍的主要影响因素。

Objective To investigate the risk factors for hypohidrosis in patients receiving topiramate therapy. Methods Clinical data from 10 106 patients with epilepsy participated in national topiramate post-marketing surveillance （PMS） were reviewed. Incidence rate, clinical characteristic and risk factors for hypohidrosis were analyzed. Restdts Three hundred seventy eight patients （ 3.74% ） developed hypohidrosis and incidence rate in children （ 5.50% ） was much higher than that in aduhs（0. 37% ）. Gender, seizure frequency, therapeutic effect or add-on drug therapy did not have a significant effect on the occurrence of hypohidrosis. During the summer, young patients or those receiving high dose of topiramate were susceptible to develop hypohidrosis. However, there was no significant difference in the average dosage between children with and without hypohidrosis. Conclusions Hypohidrosis is a frequent adverse effect in children with topiramate therapy. Precautionary measures and appropriate treatment should be emphasized. Young age and summer weather rather than drug dosage are independent risk factors for topiramate-associated hypohidrosis.