Chmielewska B, Stelmasiak Z
Department of Clinic of Neurology, Medical University of Lublin.
Ann Univ Mariae Curie Sklodowska Med. 2001;56:35-42.
Second generation antiepileptics lamotrigine (LTG) and tiagabine (TGB) were primarily licensed for adjunctive treatment of simple and complex partial seizures with/without secondary generalisation as similarly effective drugs. Reduction of seizures frequency is the most important index of drug efficacy, but overall therapeutic benefit estimated as a quality of life is nowadays the target goal of management. In this study efficacy and tolerability of LTG or TGB as short-term add-on treatment in patients with refractory complex partial seizures were assessed by the use of both physician-rated measures (mean monthly seizure frequency, responders rate, adverse events, clinical biochemistry) and patients perceived change in their own quality of life estimation (descriptive scale and visual analogue scale-VAS). Comparable efficacy of LTG (n-22, 378 mg/day) and TGB (n-26, 43 mg/g) was assessed as 41 and 35% of responders and above half of patients with noticeable improvement. 25% of patients in both groups reported reduction of seizures severity in 4-points descriptive scale. Biochemistry values did not show clinically significant changes after treatment. 13% of patients on LTG reported adverse events (headache, asthenia, irritability, insomnia). This coefficient was greater for TGB-35% (asthenia, headache, sleepiness, vertigo). However, no case of discontinuation as a result of adverse events was reported for either of the tested drugs. Even if efficacy of LTG and TGB was comparable in objective measurements, only patients on LTG reported a significant quality of life improvement in VAS. This might be the consequence of more frequent adverse events and treatment schedule of TGB (triple dosing/day). This trial confirmed that VAS might be used as an easy additional test in evaluation of antiepileptic drug for individual patient in everyday clinical practice.
第二代抗癫痫药物拉莫三嗪（LTG）和替加宾（TGB）最初获批用于辅助治疗伴有或不伴有继发性全面发作的简单及复杂部分性发作，二者疗效相似。癫痫发作频率降低是药物疗效的最重要指标，但如今以生活质量来评估的整体治疗效益才是治疗的目标。在本研究中，通过医生评定指标（平均每月发作频率、有效率、不良事件、临床生化指标）以及患者自身对生活质量评估的感知变化（描述性量表和视觉模拟量表-VAS），对LTG或TGB作为难治性复杂部分性发作患者短期附加治疗的疗效和耐受性进行了评估。LTG（n = 22，378毫克/天）和TGB（n = 26，43毫克/天）的疗效相当，有效率分别为41%和35%，且超过半数患者有明显改善。两组中25%的患者在4分量表中报告癫痫发作严重程度有所降低。治疗后生化指标未显示出具有临床意义的变化。服用LTG的患者中有13%报告了不良事件（头痛、乏力、易怒、失眠）。TGB的这一系数更高，为35%（乏力、头痛、嗜睡、眩晕）。然而，两种受试药物均未报告因不良事件而停药的病例。即使LTG和TGB在客观测量中的疗效相当，但只有服用LTG的患者在VAS中报告生活质量有显著改善。这可能是由于TGB不良事件更频繁以及给药方案（每日三次给药）所致。该试验证实，在日常临床实践中，VAS可作为评估抗癫痫药物对个体患者疗效的一种简便的附加检测方法。
