摘要： 目的 采用循证医学方法评价孕激素治疗月经期癫痫的疗效和药物不良反应，为月经期癫痫提供有循证依据的最佳治疗方案。方法 以月经期癫痫（catamenial epilepsy）、药物治疗（drug therapy）、孕激素（progesterone）、四氢孕酮（allopregnanolone）、系统评价（systematic review）、随机对照试验（randomized controlled trials）等中英文词汇为检索词，分别检索万方数据库、维普期刊资源整合服务平台、中国知网中国知识基础设施工程、英国Cochrane 图书馆、美国国立医学图书馆、Google 学术搜索等国内外数据库，获得系统评价、随机对照试验、开放性试验、前瞻性或回顾性病例分析研究、病例观察研
究和综述等文献，采用Jadad 量表质量标准评价文献质量。结果 经筛选共纳入孕激素治疗月经期癫痫相关英文文献18 篇，包括系统评价1 篇、随机对照试验3 篇、开放性试验1 篇、前瞻性病例研究2 篇、病例随访研究1 篇、综述10 篇。其中10 篇为高质量文献（评分≥ 4 分），8 篇为低质量文献（评分< 4 分）。对各项临床试验治疗原则以及疗效和安全性评价显示：（1）孕激素作为抗癫痫药物的添加方案治疗月经期癫痫，可显著减少月经期癫痫发作频率，且安全性和耐受性良好。（2）天然孕激素和人工合成孕激素均可用于月经期癫痫的治疗。（3）孕激素治疗月经期癫痫的方式包括周期性孕激素治疗和抑制治疗，以前者更常用。结论 借助循证医学评价方法可为孕激素治疗月经期癫痫提供最佳临床证据。

关键词: 癫痫, 月经, 孕激素类, 药物疗法, 循证医学

Abstract: Objective  To formulate the best treatment plan for catamenial epilepsy patients by evaluating the efficacy and side effect of progesterone therapy via evidence-based medicine.  Methods  Catamenial epilepsy, drug therapy, progesterone, allopregnanolone, systematic review and randomized controlled trial (RCT) both in Chinese and English were used as retrieval words. Databases including Wanfang Data, VIP, China National Knowledge Infrastructure (CNKI), Cochrane Library, PubMed and Google Scholar were used with applying of manual searching. Systematic reviews, RCTs, open-label trials, prospective and retrospective case analysis, case-observation studies and reviews were collected and evaluated by Jadad Scale.  Results  After screening, 18 relevant resources were selected, including one systematic review, 3 RCTs, one open-label trial, 2 prospective case-controlled studies, one follow-up study and 10 reviews. Ten of the articles were evaluated to be high quality (Jadad Scale score ≥ 4), and the other 8 were of low quality (Jadad Scale score < 4). After the efficacy and safety of those clinical studies were evaluated, the results were summarized as follows: 1) progesterone combined with antiepileptic drugs (AEDs) was well tolerated and resulted in a significant reduction of seizure frequency in a majority of patients with catamenial epilepsy. 2) Both natural progesterone and synthetic progesterone could be used in the treatment for catamenial epilepsy. 3) There were two ways of progestogen therapy for catamenial epilepsy: cyclical progesterone hormone therapy and suppressive therapy. The former was more commonly used.  Conclusions  Using evidence-based medicine evaluation can provide best clinical evidence for the progesterone treatment on catamenial epilepsy.

Key words: Epilepsy, Menstruation, Progestins, Drug therapy, Evidence-based medicine