三种二十五味珊瑚丸配伍方案治疗症状性癫痫的临床疗效评价

Clinical assessment of three therapy schemes for addind Ershiwuwei Shanhu Pill in symptomatic epilepsy treatment

目的:观察三种二十五味珊瑚丸配伍方案治疗症状性癫痫的临床疗效和安全性,并评价何种配伍方案疗效最佳。方法:回顾性的临床对照研究,176例符合病例入选标准的癫痫患者,按不同的药物组分为4组,3组观察组均给予二十五味珊瑚丸(1g/d),按癫痫类型分别加单种常规剂量抗癫痫药(卡马西平或丙戊酸钠或复方苯硝那敏片),对照组给予顺气安神丸(16粒/d)加常规剂量丙戊酸类,治疗1年,以癫痫发作次数下降率及动态脑电图的变化作为主要疗效判断标准;以癫痫发作持续时间下降率作为次要疗效指标;以发作频率减少50%～75%和75%以上作为治疗有效和显效的评定标准;以不良事件发生率来评价药物的安全性。结果:3组观察组中加卡马西平组(P=0.022)、加丙戊酸钠组(P=0.016)和加复方苯硝那敏片组(P=0.001)的患者在癫痫发作次数下降率、动态脑电图改善(均P<0.01)、发作频率疗效等级(P=0.019)上与顺气安神丸加丙戊酸类组比较均有显著性差异,但3组观察组之间比较均无统计学意义(P>0.05);3组观察组中只有加复方苯硝那敏片组的发作时间下降率与对照组比较有统计学意义(P=0.024)。结论:3种二十五味珊瑚丸配伍方案治疗症状性癫痫皆能明显减少癫痫的发作次数、改善动态脑电图的结果、改善发作后头痛及认知功能,其中加丙戊酸钠组及加复方苯硝那敏片组还能明显减轻癫痫的发作类型程度,加复方苯硝那敏片组能显著缩短发作持续时间,综合得出观察组中加复方苯硝那敏片组疗效最佳。

Objective： To evaluate the efficacy and safety of AEDs combined Ershiwuwei Shanhu Pill in symptomatic epilepsy treatment.Methods： The efficacy and toxicity of three kinds of Ershiwuwei Shanhu Pill combination schemes were assessed by the percentage of patients with seizure-free in one year after treatment,the improvement of 24-hours ambulatory EEG（AEEG） and the incidence of side effects also obtained.Results： During the reduction of seizure frequency and the improvement of AEEG,the overall outcome with three observer drugs was good.There were significant difference between control group with three observer groups respectively.However,there was no difference among three observer groups.Conclusion： These three observer groups are effective for the treatment of symptomatic epilepsy.The seizure frequency and The AEEG are recommended after treatment.The group of Ershiwuwei Shanhu pill adding Valproate sodium and the group of adinng compound phenobarbital nitrazepam and chlorphenamine maleate tablets also alleviate the degree of epilepsy seizure types;In addition,three observer groups could reduce the number of headache days and ease cognitive impairment,comprehensive draw the group of adding Fufang Benxiaonamin Pian curative effect of the best.