柴贝止痫汤联合抗痫药物治疗痰气郁滞证耐药性癫痫伴意识障碍的局灶发作患者34例随机对照试验  

Chaibei Zhixian Decoction(柴贝止痫汤)Combined with Anti-epileptic Drugs in Treating 34 Patients with Drug-resistant Focal Epilepsy and Disturbance of Consciousness of Phlegm-qi Constraint and Stagnation Pattern:A Randomized Controlled Trial

作　　者：孙江燕[1,2] 王潇慧 刘冲冲 袁斯远 吴婧 刘金民 SUN Jiangyan;WANG Xiaohui;LIU Chongchong;YUAN Siyuan;WU Jing;LIU Jinmin(Henan University of Chinese Medicine,Zhengzhou,450046;The First Affiliated Hospital of Henan University of Chinese Medicine;Qingdao Traditional Chinese Medicine Hospital;Ddngfang Hospital,Beijing University of Chinese Medicine)

机构地区：[1]河南中医药大学,郑州450046 [2]河南中医药大学第一附属医院 [3]青岛市中医医院 [4]北京中医药大学东方医院

出　　处：《中医杂志》2021年第9期796-801,共6页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81774277);北京市科委首都特色项目(Z161100000516105);河南中医药大学优秀博士科研启动金项目(RSBSJJ2019-25)。

摘　　要：目的评价柴贝止痫汤联合抗痫药物(AEDs)治疗耐药性癫痫伴意识障碍的局灶发作痰气郁滞证患者的疗效及安全性。方法采用区组随机、安慰剂平行对照的临床试验设计,纳入耐药性癫痫伴意识障碍的局灶发作痰气郁滞证患者,随机分为治疗组36例和对照组35例。治疗组和对照组在原有AEDs上分别联合柴贝止痫汤或安慰剂,每日1剂,疗程3个月。比较两组不同时间癫痫发作频次、50%应答率(RR)、完全缓解率、利物浦痫性发作严重程度量表(LSSS)评分,并进行安全性评价。结果治疗3个月后治疗组发作频次、LSSS评分低于对照组、完全缓解率高于对照组(P<0.05),治疗组LSSS评分下降幅度大于对照组(P<0.01)。治疗2、3个月后治疗组50%RR高于对照组(P<0.05或P<0.01)。未发现与柴贝止痫汤添加治疗相关的不良事件。结论柴贝止痫汤联合AEDs可减少痰气郁滞证耐药性癫痫伴意识障碍的局灶发作患者的发作频次,降低发作严重程度,安全性好。Objective To evaluate the effectiveness and safety of Chaibei Zhixian Decoction(柴贝止痫汤) combined with anti-epileptic drugs(AEDs) for the treatment of patients with drug-resistant focal epilepsy(DRFE) and consciousness disturbance of phlegm-qi constraint and stagnation(PQCS) pattern. Methods A block randomized, placebo-controlled parallel trial was designed. PQCS patients with consciousness disturbance of PQCS pattern were randomly divided into treatment group(36 cases) and control group(35 cases). Based on the conventional AEDs, Chaibei Zhixian Decoction was administered in treatment group while placebo was given in control group, one dose per day for 3 months. The frequency of seizures, the 50% response rate(RR), the complete remission rate, and the Liverpool seizure severity scale(LSSS) scores were compared between groups at different time points, and the safety of the interventions was evaluated. Results After 3-month treatment, the frequency of seizures and the LSSS score of the treatment group were significantly lower than those of the control group, while the complete remission rate of the treatment group was higher than that of the control group(P<0.05);the LSSS score of the treatment group decreased more than that of the control group(P<0.01). The 50% RR of the treatment group was significantly higher than that of the control group when assessed after 2-month treatment and after 3-month treatment(P<0.05 or P<0.01). No adverse events in relation to the add-on therapy of Chaibei Zhixian Decoction were found. Conclusion Chaibei Zhixian Decoction combined with AEDs can decrease the frequency of seizures and reduce the severity of seizures in DRFE patients with consciousness disturbance of PQCS pattern, and is safe.

关 键 词：柴贝止痫汤 耐药性癫痫 难治性癫痫 随机对照试验 

分 类 号：R742.1[医药卫生—神经病学与精神病学] R749.1[医药卫生—临床医学]