Garcia Héctor H, Pretell E Javier, Gilman Robert H, Martinez S Manuel, Moulton Lawrence H, Del Brutto Oscar H, Herrera Genaro, Evans Carlton A W, Gonzalez Armando E
Department of Transmissible Diseases, Instituto Nacional de Ciencias Neurologicas, Barrios Altos, Lima, Peru.
N Engl J Med. 2004 Jan 15;350(3):249-58. doi: 10.1056/NEJMoa031294.
Neurocysticercosis is the main cause of adult-onset seizures in the developing world. Whether therapy with antiparasitic agents results in improved seizure control has been questioned because of the lack of adequate, controlled studies.
We conducted a double-blind, placebo-controlled trial in which 120 patients who had living cysticerci in the brain and seizures treated with antiepileptic drugs were randomly assigned to receive either 800 mg of albendazole per day and 6 mg of dexamethasone per day for 10 days (60 patients) or two placebos (60 patients). The patients were followed for 30 months or until they had been seizure-free for 6 months after the doses of the antiepileptic drugs had been tapered. The efficacy of treatment was measured as the decrease in the number of seizures after treatment.
In the albendazole group, there was a 46 percent reduction in the number of seizures (95 percent confidence interval, -74 to 83 percent) during months 2 to 30 after treatment. This reduction, which was not statistically significant, was composed of a nonsignificant reduction of 41 percent in the number of partial seizures (95 percent confidence interval, -124 to 84 percent) and a significant 67 percent reduction in the number of seizures with generalization (95 percent confidence interval, 20 to 86 percent). Most of the difference in the number of partial seizures was attributable to a few patients who had many seizures during follow-up. The proportions of patients who had partial seizures during follow-up were similar in the two groups (19 of 57 in the albendazole group and 16 of 59 in the placebo group), but the patients in the placebo group had a greater tendency to have seizures with generalization (22 of 59, vs. 13 of 57 in the albendazole group; risk ratio, 1.63; 95 percent confidence interval, 0.91 to 2.92). More of the intracranial cystic lesions resolved in the albendazole group than in the placebo group. With the sole exception of abdominal pain, side effects did not differ significantly between the two groups.
In patients with seizures due to viable parenchymal cysts, antiparasitic therapy decreases the burden of parasites and is safe and effective, at least in reducing the number of seizures with generalization.
在发展中世界,神经囊尾蚴病是成人癫痫发作的主要原因。由于缺乏充分的对照研究,抗寄生虫药物治疗是否能改善癫痫控制一直受到质疑。
我们进行了一项双盲、安慰剂对照试验,将120例脑内有活囊尾蚴且正在接受抗癫痫药物治疗的癫痫患者随机分为两组,一组60例患者每天接受800毫克阿苯达唑和6毫克地塞米松治疗,持续10天;另一组60例患者接受两种安慰剂治疗。对患者进行30个月的随访,或直至在抗癫痫药物剂量逐渐减少后无癫痫发作达6个月。治疗效果以治疗后癫痫发作次数的减少来衡量。
在阿苯达唑组,治疗后第2至30个月癫痫发作次数减少了46%(95%置信区间为-74%至83%)。这一减少无统计学意义,其中部分性发作次数减少41%(95%置信区间为-124%至84%)无统计学意义,全身性发作次数显著减少67%(95%置信区间为20%至86%)。部分性发作次数的差异主要归因于少数在随访期间癫痫发作频繁的患者。两组随访期间出现部分性发作的患者比例相似(阿苯达唑组57例中有19例,安慰剂组59例中有16例),但安慰剂组患者全身性发作的倾向更大(59例中有22例,阿苯达唑组57例中有13例;风险比为1.63;95%置信区间为0.91至2.92)。阿苯达唑组颅内囊性病变消失的比例高于安慰剂组。除腹痛外,两组的副作用无显著差异。
对于因存活的实质囊肿导致癫痫发作的患者,抗寄生虫治疗可减轻寄生虫负担,且至少在减少全身性发作次数方面是安全有效的。