氟桂利嗪剂量递增法治疗难治性癫痫部分性发作的疗效观察

Flunarizine used as an open add-on therapy in an increasing dosage for the treatment of intractable partial epilepsy seizure

目的 研究氟桂利嗪作为添加剂 ,采用剂量递增法治疗难治性癫痫部分性发作的疗效和安全性。方法 对 1997年 1月至 2 0 0 0年 1月收治的 43例难治性部分性发作患者 (男 2 5例 ,女 18例 ,年龄 8～ 5 6岁 ) ,进行氟桂利嗪添加治疗的开放性自身对照研究 ,原服用的抗癫痫药种类和剂量不变。氟桂利嗪剂量递增给药方法为 :8～ 12岁儿童 ,第 1周口服 5mg/d ,以后每周增加 5mg/d ;成人第1周口服 10mg/d ,以后每周增加 10mg/d ;至第 4周时 ,儿童以 2 0mg/d、成人以 40mg/d维持量给药 ,分 2次口服 ,连续观察半年。结果 2例失访 ,3例因不能耐受的副反应 ,在剂量递增期间退出观察。38例完成氟桂利嗪剂量递增添加治疗。总有效率为 6 3% ,其中单纯部分性发作 (SPS)有效率为 75 % ,复杂部分性发作 (CPS)为 6 2 % ,继发性全身性发作 (SGS)为 5 6 %。同添加治疗前比较 ,总的发作频率减少 6 9% ,其中SPS为 73% ,CPS为 6 6 % ,SGS为 5 7%。脑电图呈中度或重度异常的患者比例 ,由 76 %下降到 47%。治疗前后的心电图及肝、肾、血、尿等化验检查均无明显变化。 16例患者出现轻度副反应 ,但未影响治疗。结论 氟桂利嗪作为添加剂 ,用剂量递增法治疗难治性癫痫部分性发作 ,疗效确切 。

Objective To study the efficacy and safety of flunarizine (FNR) used as an open add on therapy with increasing dosage for treatment of intractable partial seizures (IPS) Methods Fourty three patients with IPS received FNR add on therapy more than 6 months in addition to the medication of existing antiepileptic drug The administration of FNR in increasing dosage was executed as follows: for children aged 8 12 years,the initial dosage was 5 mg/d in the first week,then with a subsquent increase of 5 mg/d every week; for adult,10 mg/d for the first week,and then increased 10 mg/d each week And at the fourth week,the dosage of FNR for children was added up to 20 mg/d,and for the adult, 40 mg/d served as a maintenance dosage continuously for 6 months Results Two patients dropped out for personal reasons Three cases discontinued FNR add on therapy because of untolerable adverse effects of increasing dosage Thiry eight patients accomplished the whole course of 6 month treatment Total effective rate was 63%,in which there was 75% for simple partial seizures (SPS), 62% for complex partial seizures(CPS) and 56% for the secondary general seizures(SGS) There was a seizure reduction of 69% as compared with pre FNR treatment period ( P <0 01),showing 73% for SPS ,66% for CPS and 57% for SGS respectively The patients with severe and mediate abnormal EEG reduced a rate from 76% to 47% The changes in ECG and clinical tests of liver,kidney, blood and urine were insignificant as compered with its before and after FNR administration Sixteen cases had manifestations of mildly adverse effects,but no influence to the treatment Conclusion FNR as an add on therapy with increasing dosage has a definite efficacy and a higher safety for the treatment of IPS