Schapel G J, Wallace S J, Gordon G S
Department of Pharmacology and Therapeutics, University of Wales College of Medicine and University Hospital of Wales, Heath Park, Cardiff, UK.
Seizure. 1997 Dec;6(6):479-83. doi: 10.1016/s1059-1311(97)80024-6.
A retrospective survey was carried out of add-on treatment with lamotrigine (LTG) and vigabatrin (GVG) in 109 children with severe epilepsy, treated between 1987 and 1994, identified from a total population of 300 patients seen annually, in a tertiary referral outpatient clinic in Cardiff, Wales. Of 79 patient treatments with LTG and 86 with GVG, 42 patients were treated with add-on LTG, 52 with add-on GVG and 20 with both drugs simultaneously. A Kaplan-Meier curve, applied to each of the two index drugs, indicated that 71 and 62% of patients would be expected to continue taking LTG or GVG, respectively after 40 months. Improved seizure control (> or = 50%) at the time of audit was seen in 65% of LTG and 58% of GVG patient treatments for all epilepsy syndromes, but there was a higher proportion of patients with generalized epilepsy improved by LTG (28/41, 68%) than that improved by GVG (8/20, 40%), and only those with generalized epilepsy treated with LTG became seizure free (8/38, 21%). Similar proportions of patients discontinued LTG (16%) and GVG (15%) due to an adverse experience, but a higher proportion discontinued GVG (18%) compared with LTG (6%) because of lack of efficacy. This study supports the relative clinical effectiveness of LTG and GVG in the real world, where children with severe epilepsy are treated in clinical practice and serves to generate hypotheses to enable design of prospectively controlled trials, which should enable more rational use of these two drugs in the paediatric population with epilepsy.
对1987年至1994年间在威尔士加的夫一家三级转诊门诊就诊的109例重症癫痫患儿进行了一项回顾性调查,这些患儿是从每年就诊的300名患者中识别出来的,他们接受了拉莫三嗪(LTG)和氨己烯酸(GVG)的附加治疗。在79例接受LTG治疗的患者和86例接受GVG治疗的患者中,42例患者接受了LTG附加治疗,52例接受了GVG附加治疗,20例同时接受了两种药物治疗。应用于两种索引药物各自的Kaplan-Meier曲线表明,预计分别有71%和62%的患者在40个月后会继续服用LTG或GVG。在所有癫痫综合征中,审计时癫痫发作控制改善(≥50%)的情况在65%的LTG治疗患者和58%的GVG治疗患者中可见,但LTG改善的全身性癫痫患者比例(28/41,68%)高于GVG改善的患者比例(8/20,40%),并且只有接受LTG治疗的全身性癫痫患者实现了无癫痫发作(8/38,21%)。因不良事件停用LTG(16%)和GVG(15%)的患者比例相似,但因缺乏疗效而停用GVG(18%)的患者比例高于LTG(6%)。本研究支持了LTG和GVG在现实世界中的相对临床有效性,在现实世界中,重症癫痫患儿在临床实践中接受治疗,本研究有助于提出假设,以便设计前瞻性对照试验,这应该能够使这两种药物在癫痫患儿群体中得到更合理的使用。