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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 observe the clinical efficacy and safety of three kinds of Twenty-five Coral Pills compatibility programs in the treatment of symptomatic epilepsy and to evaluate which kind of compatibility programs have the best curative effect. Methods: A retrospective, controlled clinical study of 176 patients with epilepsy who were eligible for inclusion in the study was divided into 4 groups according to the different drug components. The 3 observation groups were treated with 25 g coral pills (1 g / d) Respectively, plus a single dose of conventional antiepileptic drugs (carbamazepine or sodium valproate or compound benzene nitenate tablets), the control group was given Shun Qi Anshen pills (16 / d) plus conventional doses of valproic acid treatment 1 Year, with seizure frequency reduction and dynamic EEG as the main criteria to determine the efficacy of seizure duration decreased rate as a secondary efficacy index; seizure frequency reduction of 50% to 75% and more than 75% as a treatment effective And effective evaluation criteria; the incidence of adverse events to evaluate the safety of drugs. Results: The number of epileptic seizures decreased in patients in the three observation groups plus gacarbazepine (P = 0.022), plus valproate (P = 0.016), and benzodiazepin (P = 0.001) (P <0.01). There was a significant difference between Shunyi Anshen pill plus valproic acid group and seizure frequency efficacy grade (P = 0.019), but there were significant differences among the three observation groups (P> 0.05). The decreasing rate of attack time in the three groups was statistically significant only compared with the control group (P = 0.024). CONCLUSION: Three kinds of twenty-five coral pills compatibility treatment programs for the treatment of symptomatic epilepsy can significantly reduce the number of epileptic seizures, improve the dynamic EEG results and improve post-seizure headache and cognitive function, which plus sodium valproate group and Compound nitbenzene capsules group can significantly reduce the type of epilepsy seizures, plus compound nitidine triflate group can significantly reduce the duration of the attack, the combined observation that the observation group plus compound Benidanamin tablets group the best effect .