CAJ | 학술논문

目的：观察评价刘金民教授治疗难治性癫痫经验用方柴贝止痫汤联合抗癫痫药物（ anti－epileptic drugs ， AEDs）治疗难治性癫痫复杂部分性发作的临床疗效和安全性。方法选择符合诊断和纳入标准的病例60例，随机分为治疗组和对照组，分别给予AEDs添加柴贝止痫汤及单纯的AEDs治疗。定期随诊并记录治疗后患者的痫性发作频率、中医症状积分及不良反应等。以痫性发作频率、中医症状积分及脑电图异常程度的改善程度作为疗效判定标准。结果在改善患者的痫性发作频率方面，经Wilcoxon秩和检验，治疗12周后，治疗组疗效优于对照组（ P＜0．05）；经χ2检验，治疗8周、12周后，治疗组疗效优于对照组（ P＜0．05）。在改善患者的中医症状积分方面，经Repested Measures检验（ Greenhouse－Geisser法校正），治疗4周、8周、12周的不同观测时点、观测时点与组别的交互作用及组别之间的差异均具有统计学意义（ P＜0．05）；经χ2检验，治疗8周、12周后，治疗组疗效优于对照组（P＜0．05）；经秩和检验，治疗4周后，在失眠症状积分上，治疗组疗效优于对照组（P＜0．05），治疗8周、12周后，在胸闷、痰多、疲乏、失眠四个症状积分上，治疗组疗效优于对照组（ P＜0．05）。结论柴贝止痫汤添加用药治疗难治性癫痫复杂部分性发作，在改善患者的痫性发作频率及中医症状积分上均有明显的优势，且随着疗程的延长，疗效逐渐显著，未发现任何不良反应。柴贝止痫汤添加治疗难治性癫痫复杂部分性发作安全、有效。
목적：관찰평개류금민교수치료난치성전간경험용방시패지간탕연합항전간약물（ anti－epileptic drugs ， AEDs）치료난치성전간복잡부분성발작적림상료효화안전성。방법선택부합진단화납입표준적병례60례，수궤분위치료조화대조조，분별급여AEDs첨가시패지간탕급단순적AEDs치료。정기수진병기록치료후환자적간성발작빈솔、중의증상적분급불량반응등。이간성발작빈솔、중의증상적분급뇌전도이상정도적개선정도작위료효판정표준。결과재개선환자적간성발작빈솔방면，경Wilcoxon질화검험，치료12주후，치료조료효우우대조조（ P＜0．05）；경χ2검험，치료8주、12주후，치료조료효우우대조조（ P＜0．05）。재개선환자적중의증상적분방면，경Repested Measures검험（ Greenhouse－Geisser법교정），치료4주、8주、12주적불동관측시점、관측시점여조별적교호작용급조별지간적차이균구유통계학의의（ P＜0．05）；경χ2검험，치료8주、12주후，치료조료효우우대조조（P＜0．05）；경질화검험，치료4주후，재실면증상적분상，치료조료효우우대조조（P＜0．05），치료8주、12주후，재흉민、담다、피핍、실면사개증상적분상，치료조료효우우대조조（ P＜0．05）。결론시패지간탕첨가용약치료난치성전간복잡부분성발작，재개선환자적간성발작빈솔급중의증상적분상균유명현적우세，차수착료정적연장，료효축점현저，미발현임하불량반응。시패지간탕첨가치료난치성전간복잡부분성발작안전、유효。
Objective To observe and assess the clinical efficacy and safety of Prof .LIU Jin-min’s Chaibei Zhixian Decoction in combination with AEDs in the treatment of intractable epilepsy complex partial seizures .Methods A total of 60 eligible patients who met the diagnostic criteria and enrollment re-quirements were randomly divided into treatment group which was assigned to receive AEDs in combination with Chaibei Zhixian Decoction and control group which was assigned to receive AEDs alone .After treat-ment, all patients were regularly followed up , and their seizure frequency , traditional Chinese medicine (TCM) symptom scores and adverse reactions were recorded .The coprimary efficacy end points were sei-zure frequency , TCM symptom scores and the improvement of abnormality of EEG .Results In seizure fre-quency , after 12-week treatment , Wilcoxon rank sum test revealed a better therapeutic benefit in the treat-ment group than in the control group ( P<0.05) ;Chi-square test showed a better therapeutic efficacy in the treatment group than in the control group after 8 and 12 weeks’treatment (P<0.05).In TCM symptom scores, repetitive measure analysis of variance ( ANOVA) showed statistically significant differences at time point, groups and the interaction of time point by groups after 4, 8 and 12 weeks’treatment ( P<0.05);Chi-square test showed a better therapeutic efficacy in the treatment group than in the control group after 8 and 12 weeks’treatment (P<0.05).As for insomnia score, rank test revealed a better therapeutic efficacy with the treatment group as compared with the control group after 4-week treatment ( P<0.05 ) .After 8 and 12 weeks’treatment, therapeutic efficacies in chest tightness , phlegm, fatigue, insomnia scores were better in the treatment group than in the control group (P<0.05).Conclusion In the treatment of intrac-table epilepsy complex partial seizures , the combination of Chaibei Zhixian Decoction with AEDs has re-markable benefits in improving seizure frequency and TCM symptom scores .Moreover, the efficacy is more prominent as the treatment course is prolonged , without any obvious adverse reactions .The combination of Chaibei Zhixian Decoction with AEDs is safe and effective for intractable epilepsy complex partial seizures .