Zeng Kebin, Wang Xuefeng, Xi Zhiqing, Yan Yong
Department of Neurology, First Affiliated Hospital, Chongqing Medical University, Chongqing Key Laboratories of Neurology, 1 Youyi Road, Yuzhong County, Chongqing 400016, PR China.
Clin Neurol Neurosurg. 2010 May;112(4):291-5. doi: 10.1016/j.clineuro.2009.12.014. Epub 2010 Jan 13.
Antiepileptic drugs (AEDs) have been widely used in patients with epilepsy but the adverse effects in adult Chinese patients have not been investigated. This study evaluated the adverse effects of four commonly prescribed AED monotherapies with carbamazepine (CBZ), phenytoin (PHT), valproate (VPA), and lamotrigine (LTG) in adult Chinese patients with epilepsy.
The prospective open-label clinical trial was conducted at the Chongqing Epilepsy Center. The study enrolled 505 adults with newly diagnosed epilepsy, including generalized tonic-clonic (n=110), partial and partial secondarily generalized (n=395) seizures. Patients were evaluated by two clinicians at the Center and were prescribed one type of AED monotherapy with CBZ, PHT, VPA or LTG for a 24-month period. An adverse effect profile, as well as efficacy of monotherapy, was obtained through a face-to-face interview with the patient at each visit. A physical examination and routine laboratory tests were performed during a clinical screening.
A total of 62.6% (316/505) patients successfully completed the AED monotherapy study: 64.3% of those receiving CBZ, 55.9%--PHT, 61.5%--VPA, and 66.2%--LTG. However, 34.7% of the patients discontinued the AED monotherapy because of unsatisfactory seizure control. Overall, 18% of patients experienced adverse effects: for CBZ (25/168; 14.9%), PHT (18/59; 30.5%), VPA (32/192; 16.7%) and LTG (16/86; 18.6%). The most common drug-related adverse events included gastrointestinal disturbances, loss of appetite and nausea, weight gain and fatigue/tiredness. Tremor and nystagmus occurred in some patients receiving PHT and VPA. Two CBZ, one PHT and four LTG patients (n=7) discontinued the study due to rash.
Adult Chinese patients with epilepsy accepted and tolerated monotherapy with CBZ, PHT, VPA, and LTG. No fatal adverse events occurred. Unsatisfactory seizure control was a primary reason for withdrawal from the AED monotherapy study.
抗癫痫药物（AEDs）已广泛应用于癫痫患者，但尚未对成年中国患者的不良反应进行研究。本研究评估了卡马西平（CBZ）、苯妥英（PHT）、丙戊酸盐（VPA）和拉莫三嗪（LTG）这四种常用的AED单药疗法对成年中国癫痫患者的不良反应。
前瞻性开放标签临床试验在重庆癫痫中心进行。该研究纳入了505例新诊断的成年癫痫患者，包括全身强直阵挛发作（n = 110）、部分性发作和部分性继发全身性发作（n = 395）。患者由该中心的两名临床医生进行评估，并被处方一种AED单药疗法，使用CBZ、PHT、VPA或LTG，为期24个月。通过每次就诊时与患者进行面对面访谈，获取不良反应情况以及单药疗法的疗效。在临床筛查期间进行体格检查和常规实验室检查。
共有62.6%（316/505）的患者成功完成了AED单药疗法研究：接受CBZ治疗的患者中有64.3%，接受PHT治疗的患者中有55.9%，接受VPA治疗的患者中有61.5%，接受LTG治疗的患者中有66.2%。然而，34.7%的患者因癫痫控制不佳而停止了AED单药疗法。总体而言，18%的患者出现了不良反应：CBZ组（25/168；14.9%），PHT组（18/59；30.5%），VPA组（32/192；16.7%）和LTG组（16/86；18.6%）。最常见的药物相关不良事件包括胃肠道不适、食欲不振和恶心、体重增加以及疲劳/疲倦。一些接受PHT和VPA治疗的患者出现了震颤和眼球震颤。两名使用CBZ、一名使用PHT和四名使用LTG的患者（n = 7）因皮疹而停止了研究。
成年中国癫痫患者接受并耐受CBZ、PHT、VPA和LTG单药疗法。未发生致命不良事件。癫痫控制不佳是退出AED单药疗法研究的主要原因。
