Zaccara Gaetano, Giovannelli Fabio, Cincotta Massimo, Loiacono Giulia, Verrotti Alberto
Unit of Neurology, Department of Medicine, Florence Health Authority, San Giovanni di Dio Hospital, Via Di Torregalli n 3, 50143, Florence, Italy,
J Neurol. 2015 Mar;262(3):501-15. doi: 10.1007/s00415-014-7391-y. Epub 2014 Jun 11.
Health-related quality of life of patients with epilepsy is heavily influenced by antiepileptic drug (AED) tolerability. However, an accepted method for precise assessment of AED-induced adverse events (AEs) has not yet been established. Assessment of tolerability and of the frequency of predefined AEs among drug-resistant epilepsy patients through an analysis of placebo-treated patients from randomized controlled studies (RCTs) performed in patients with partial onset epilepsies (POS) and evaluation of factors which may influence the occurrence of AEs in these patients are the objectives of this study. We searched all double-blind, placebo-controlled trials investigating any AED on adult patients with POS and extracted both for patients treated with placebo and for those treated with the active drug, number of patients, number of responders, number of patients withdrawing because of AEs, number of patients with AEs, and number of patients with 11 predefined AEs. We also explored the effect of multiple factors on AEs reporting. Seventy-nine RCTs were included in our study with 12,594 patients, 6,793 of whom randomized to placebo. In placebo-treated patients, overall responder rate was 15.2 %, proportion of placebo-treated patients withdrawing because of AEs was 3.9 %, and proportion of patients with AE was 60.3 %. The four most frequently reported AEs were headache (12.4 %) somnolence (8.6 %), dizziness (8.2 %), and fatigue (7.9 %). Several factors were found to influence these outcomes. Several factors influence AEs' appearance in RCTs. Among the most important, we found the expectations of patients and doctors and their attitudes on the positive or negative effect of a drug.
癫痫患者的健康相关生活质量受抗癫痫药物（AED）耐受性的严重影响。然而，尚未建立一种精确评估AED所致不良事件（AE）的公认方法。本研究的目的是通过分析部分性发作癫痫（POS）患者随机对照研究（RCT）中接受安慰剂治疗的患者，评估耐药性癫痫患者中AED耐受性及预定义AE的发生频率，并评估可能影响这些患者AE发生的因素。我们检索了所有针对成年POS患者研究任何AED的双盲、安慰剂对照试验，并提取了接受安慰剂治疗患者和接受活性药物治疗患者的患者数量、有效者数量、因AE退出的患者数量、发生AE的患者数量以及发生11种预定义AE的患者数量。我们还探讨了多种因素对AE报告的影响。我们的研究纳入了79项RCT，共12594例患者，其中6793例随机接受安慰剂治疗。在接受安慰剂治疗的患者中，总体有效率为15.2%，因AE退出的安慰剂治疗患者比例为3.9%，发生AE的患者比例为60.3%。报告最频繁的四种AE为头痛（12.4%）、嗜睡（8.6%）、头晕（8.2%）和疲劳（7.9%）。发现有几个因素会影响这些结果。在RCT中，有几个因素会影响AE的出现。其中最重要的是，我们发现患者和医生的期望以及他们对药物正负效应的态度。
