托吡酯和丙戊酸钠预防小儿偏头痛的对比研究

Study of topiramate and sodium valproate preventing migraine in children

目的探索托吡酯预防小儿偏头痛发作的有效性、安全性和耐受性。方法采用前瞻性的方法，给予小儿偏头痛患者口服托吡酯25--50mg／d，分早晚两次口服，从第1周12．5mg／d开始，每周递增12．5mg，最大量至50mg／d；丙戊酸钠则从200mg／d，分早晚两次口服，必要时增至400mg／d。观察患者治疗前后头痛发作频率、天数和疼痛程度，同时将托吡酯和丙戊酸钠的上述指标进行对比。结果平均每月发作频率均较前减少，托吡酯组和丙戊酸钠组分别从12．38次减至3．52次和14．33次减至6．48次，2组差别无显著性；平均每月头痛天数均较前减少，分别从12．43d减至3．38d和14．58d减至7．19d，2组差别无显著性。头痛程度均较前减轻，分别从7．52分减轻至2．00分和7．24分减轻至3．19分，2组无显著差别。托吡酯的不良反应为记忆力下降、食欲减退、发热、上呼吸道感染、头痛加重。结论托吡酯和丙戊酸钠均能有效预防偏头痛发作，且二者疗效无显著性差异。

Objective To assess the efficacy, safety, and tolerability of topiramate as prophylactic therapy for migraine in children. Methods Total of 63 patients with migraine were randomly divided into two groups： TPM group（32 cases） and SV group（31 cases）. TPM group was titrated by12.5mg 1 week for 2--4 weeks. SV group was given 100mg twice daily during initial titration of therapy. The average duration of active therapy was 12 weeks in which patients＇ headache diaries were recorded and the severity of headaches was rated on a 0--10 rating scale. Results Mean frequency of headache occurrence decreased from 12.38times to 3. 52times and 14. 33times to 6. 48times per month in TPM and SV group, respectively. Mean days of headache occurrence decreased from 12.43d to 3.38d and 14.95d to 7.19d. Mean severity decreased from 7.52 to 2.00 in TPM group and from 7. 24 to 3.19 in SV group. There was no significant difference in mean frequency,days and severity of headache between two groups. The side effects of TPM were cognitive, anorexia, fever, upper respiratory tract infection, headache deterioration. Conclusion Both TPM and SV prophylaxis therapy can reduce migraine yielded significantly in migraine frequency and severity in children.