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进行开放性自身对照临床试验,验证添加拉莫三嗪治疗顽固性癫痫63例的疗效和安全性。以治疗前3个月的发作频度为基础,治疗后观察3~15个月。未服丙戊酸钠的成人平均维持量为289mg/d;已服者为142mg/d。癫痫全部发作类型的平均发作频度在治疗12周时比治疗前降低31%,发作频度减少≥50%者占41%,发作消失者占14%。全身强直-阵挛型和全面性发作者疗效最佳,发作频度减少≥50%者,在12周时分别达61%和60%,平均发作频度分别减少59%和36%。治疗4~15个月者51例,疗效和近期相仿。Lennox-Gastaut综合征的5例患者治疗12周后,3例发作减少≥96%。脑电图高度和中度不正常患者的比例,由治疗前的50%,下降为17%。拉莫三嗪副作用小,皮疹为主要表现,停药后消失。
To carry out open self-controlled clinical trials to validate the efficacy and safety of adding lamotrigine in 63 patients with intractable epilepsy. Based on the frequency of seizures in the first 3 months of treatment, the patients were observed for 3 to 15 months after treatment. Adult underage sodium valproate was maintained at an average of 289 mg / day and 142 mg / day. The average seizure frequency of all episodes of epilepsy decreased by 31% at 12 weeks of treatment, by 41% by 50% or more, and by 14% by episodes of episodes. Patients with generalized tonic-clonic and full-blown episodes had the best response with a 50% reduction in seizure frequency, 61% and 60% at 12 weeks, and a mean reduction of 59% and 36%, respectively. Treatment of 4 to 15 months in 51 cases, the effect and the recent similar. Five patients with Lennox-Gastaut syndrome had a reduction of ≥96% in 3 episodes after 12 weeks of treatment. The proportion of patients with high and moderate EEG abnormalities decreased from 50% before treatment to 17%. Little side effects of lamotrigine, rash as the main performance, disappeared after stopping.