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目的评估托吡酯(TPM)治疗儿童偏头痛的疗效、安全性及合适剂量。方法采用单中心、随机、对照研究,偏头痛儿童20l例随机分为四组:TPMa组(n=52,TPM 25 mg·d~(-1))、TPMb组(n=50,TPM 50 mg·d~(-1))、TPMc组(n=50,TPM 75 mg·d~(-1))和银杏叶片(GBE)组(n=49,GBE 80 mg·d~(-1)),疗程均为7个月。观察记录各组患儿头痛发作频率、发作持续时间、发作严重程度、经颅多普勒超声(TCD)异常率、儿童生活质量量表4.0(PedsQL~(TM)4.0)评分、不良反应、肝功能、肾功能、药物保留率等。结果各组治疗后各项指标均有一定程度改善。治疗4、7个月末,TPM各剂量组头痛发作频率和持续时间、TCD异常率均低于GBE组(P<0.05),TPMb组低于TPMa、TPMc组(P<0.05);TPM各剂量组药物保留率高于GBE组(P<0.05),TPMb组高于TPMa、TPMc组(P<0.05)。治疗7个月末,TPMb组(85.9分)PedsQL~(TM)4.0评分高于GBE组(72.8分)、TPMa组(79.0分)和TPMc组(80.0分),差异显著(P<0.05)。各组均无严重不良反应发生,TPMa、TPMb、TPMc及GBE组不良反应发生率分别为14%、16%、20%和22%,TPMa组最低,GBE组最高,但各组间无显著差异(P>0.05)。各组肝、肾功无明显异常。结论 TPM治疗儿童偏头痛疗效优于GBE,其中TPM 50 mg·d~(-1)药物保留率高、安全,患儿耐受性好。
Objective To evaluate the efficacy, safety and appropriate dosage of topiramate (TPM) in children with migraine. Methods A single-center, randomized, controlled study was conducted in 20 children with migraine who were randomly divided into four groups: TPMa group (n = 52, TPM 25 mg · d -1), TPMb group · D -1, TPMc group (n = 50, TPM 75 mg · d -1) and GBE group (n = 49, GBE 80 mg · d -1) , Treatment are 7 months. The frequency of headache attack, duration of attack, severity of seizure, abnormal TCD rate, children’s quality of life scale 4.0 (PedsQL TM 4.0) score, adverse reactions, liver Function, renal function, drug retention rate and so on. Results After treatment, each index improved to some extent. At the end of 4 and 7 months of treatment, the frequency and duration of headache attacks and the TCD abnormalities in each dose group were lower than those in GBE group (P <0.05), TPMb group (P <0.05) The drug retention rate was higher than that of GBE group (P <0.05), TPMb group was higher than that of TPMa and TPMc group (P <0.05). At the end of 7 months of treatment, the PedsQL TM 4.0 score in the TPMb group (85.9) was significantly higher than that in the GBE group (72.8), the TPMa group (79.0) and the TPMc group (80.0) (P <0.05). There was no serious adverse reactions in each group, the incidence of adverse reactions in TPMa, TPMb, TPMc and GBE groups were 14%, 16%, 20% and 22% respectively, the lowest in TPMa group and the highest in GBE group, but no significant difference among the groups (P> 0.05). Each group of liver, kidney function no obvious abnormalities. Conclusion TPM is superior to GBE in the treatment of migraine in children. The TPM 50 mg · d ~ (-1) drug has high retention rate, safety and good tolerance in children.