摘要
目的:通过随机对照试验观察柴贝止痫颗粒添加治疗难治性癫痫复杂部分性发作的有效性及安全性。方法:60例患者采用随机对照加载方法分为治疗组及对照组,治疗周期3个月。疗效指标为月发作频次、中医证候学评分和生活质量评价。安全性评价包括血常规及肝肾功能检查。观察过程中不良事件随时记录。结果:两组在年龄、病程、首次发病年龄、癫痫相关既往史、入组前1个月的发作频次方面差异无统计学意义。治疗后3个月两组的发作频次降低(P<0.05),且两组下降趋势在直线拟合模型上不平行(P<0.01)。中医证候学评分及生活质量评分总分治疗组较对照组升高,差异无统计学意义;在精力/疲劳、发作恐惧、药物副作用3项分值治疗组较对照组升高(P<0.05)。结论:添加柴贝止痫颗粒治疗难治性癫痫复杂部分性发作痰气郁滞证型有效、安全,在改善患者生活质量方面,对精力/疲劳、发作恐惧、社会支持、药物副作用4项具有一定的作用。
Objective:To observe the effectiveness and safety of Chaibei Zhixian Granules in treating drug-resistant epilepsy by a randomized controlled trial.Methods:A total of 60 patients with drug-resistant epilepsy were randomly assigned to control group or treatment group treated for 3 months.Frequency of seizure,efficacy evaluation of TCM symptom scores and quality of life were measured as curative effect index.The safety evaluation included blood routine examination and liver and kidney function examination.Adverse events were recorded during the trial.Results:There was no statistically difference in age,course of disease,age of the first attack,past history and frequency of attacks one month before admission.The frequency of episodes in the 3 rd month of treatment decreased significantly(P<0.05),and the declining trend of the two groups on the straight-line fitting model was not parallel(P<0.01).TCM symptom score and total score of quality of life was higher in the treatment group than that in the control group after 3 months of treatment,but the difference was not significant.And the scores of fatigue,seizure fear and drug side effects in the treatment group were higher than those in the control group(P<0.05).Conclusion:The addition use of Chaibei Zhixian Granules is effective and safe in the treatment of complex partial seizure of drug resistant epilepsy with phlegm-qi stagnation and binding.It has certain effects on energy/fatigue,seizure fear,social support and drug side effects in improving the patients’quality of life.
作者
王潇慧
丁成赟
孙江燕
袁斯远
刘金民
WANG Xiao-hui;DING Cheng-yun;SUN Jiang-yan;YUAN Si-yuan;LIU Jin-min(Qingdao Traditional Chinese Medicine Hospital,Qingdao Hiser Medical Group,Qingdao 266033,China;Fourth Medical Center of PLA General Hospital,Beijing 100048,China;Beijing University of Chinese Medicine,Beijing 100029,China;Dongfang Hospital Affiliated Beijing University of Chinese Medicine,Beijing 100078,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2019年第12期6012-6017,共6页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家自然科学基金项目(No.81373586,No.81774277)
北京市科委首都特色项目(No.Z161100000516105)
北京中医药大学自主选题资助项目(No.2017-jYB-XS-159).
关键词
柴贝止痫颗粒
痰气郁滞证
难治性癫痫
生活质量
随机对照试验
发作频次
Chaibei Zhixian Granules
Phlegm-qi stagnation and binding
Drug resistant epilepsy
Quality of life
Random control trial
Seizures frequency
