妥泰治疗枕神经痛的随机对照临床试验

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目的 通过随机对照观察妥泰治疗枕神经痛的确切疗效及有效剂量。方法 将 16 7例枕神经痛患者 ,按单、双日就诊分为妥泰组和卡马西平组 ,并随访 3周。通过对两组各治疗段自评、医评分值及病情分度归转的比较 ,确定妥泰的疗效并计算每日平均有效剂量 ;通过不良事件分析确定妥泰的安全性。结果 完成观察 16 1例 ,其中妥泰组 87例 ,治疗有效率 93 1%;卡马西平组 74例 ,有效率 86 5 %,无显著性差异 (P >0 0 5 )。两组各阶段自评和医评分值间亦无显著性差异 (P >0 0 5 ) ;本试验妥泰的平均治疗量为 12 3 3± 5 6 4mg/d ,未发现妥泰有严重副作用。结论 妥泰治疗枕神经痛的疗效与卡马西平相近 ,用妥泰日平均治疗量治疗枕神经痛是安全有效的。 Objective To observe the exact efficacy and effective dose of topiramate in the treatment of occipital neuralgia by randomized controlled trials. Methods One hundred and seventy patients with occipital neuralgia were divided into topiramate group and carbamazepine group according to the single and double-day visits. The patients were followed up for 3 weeks. Through the comparison of self-assessment, medical score and disease index of two treatment groups, the curative effect of topiramate was determined and the daily average effective dose was calculated. The safety of topiramate was determined through the analysis of adverse events. RESULTS: One hundred and sixteen cases were completed, of which 87 cases were treated with Topiramate and the effective rate was 93.1%. There were 74 cases in the carbamazepine group with an effective rate of 86.5%. There was no significant difference (P> 0.05). There was no significant difference between the two groups in the self-assessment and the medical scores (P> 0.05). The average therapeutic dose of topiramate in this trial was 12 3 ± 5 6 4 mg / day, and no serious side effects were found . Conclusion Topoteil treatment of occipital neuralgia curative effect similar to carbamazepine, with topotec daily treatment of occipital neuralgia is safe and effective.
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