镇脑宁胶囊治疗风邪上扰证慢性紧张型头痛的临床研究  

Clinical Study of Zhennaoning Capsules in the Treatment of Chronic Tension-Type Headache (Upward Disturbance of Pathogenic Wind)

作　　者：杜雅薇[1] 陈红 李香竹 吴圣贤[1] 

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]通化东宝药业股份有限公司,吉林通化134123

出　　处：《世界中西医结合杂志》2017年第8期1136-1139,共4页World Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价镇脑宁胶囊治疗风邪上扰证慢性紧张型头痛的有效性及临床应用的安全性。方法采用随机、双盲、双模拟、阳性药平行对照的多中心临床研究方法将入选病例分为试验组和对照组,试验组口服镇脑宁胶囊和正天丸模拟剂,对照组口服正天丸和镇脑宁胶囊模拟剂,两组疗程皆为8周。分别观察两组患者治疗后临床疗效及每月无头痛发作天数、疼痛持续时间、疼痛程度变化情况。结果两组患者治疗后,试验组总有效率为95.38%,对照组为83.94%,两组比较差异有统计学意义(P<0.05)。两组患者治疗后每月的无头痛发作天数均较治疗前增加,头痛发作持续时间均较治疗前下降,疼痛程度均较治疗前减轻,在服药第8周与本组治疗前比较差异有统计学意义(P<0.05);但在服药第4周试验组各指标改善情况明显优于对照组(P<0.05),表明镇脑宁的起效时间早于正天丸。两组患者服药第8周后除疼痛程度评分外的其他指标情况比较,试验组与对照组结果相当,差异无统计学意义(P>0.05)。结论镇脑宁胶囊治疗风邪上扰证慢性紧张型头痛的疗效确切,临床应用安全,具有临床推广价值。Objective To evaluate the effectiveness and the safety in clinical practice of zhennaoning capsules for chronic tension-type headache（ upward disturbance of pathogenic wind）. Methods The randomized,double-blind,double-dummy,positive-drug parallel controlled and multi-central trial was adopted. The enrolled cases were divided into a trial group and a control group. In the trial group,zhennaoning capsules and mimic zhengtian pills were used for oral administration. In the control group,zhengtian pills and mimic zhennaoning capsules were used for oral administration. The duration of treatment was 8 weeks in the two groups. The clinical therapeutic effects,the days of absent headache attack,the duration of pain and the degree of pain were observed after treatment in the patients of the two groups separately. Results After treatment,the total effective rate was 95. 38% in the trial group and 83. 94% in the control group,indicating the significant difference in comparison（ P 〈0. 05）. After treatment,the days of absent headache attack each month were increased as compared with those before treatment in the patients of the two groups,the duration of pain was reduced and the pain degree was alleviated. The differences in those indicators were not significant statistically in the 8th week of medication compared with those before treatment in the same group（ P 〉0. 05）. But,the indicators were improved apparently in the trial group since the 4^（th） week of medication as compared with those in the control group（ P〈 0. 05）,indicating that the onset time of zhennaoning capsules was earlier than zhengtian pills. In the 8the week of medication,except the score of pain degree,the results of the rest indicators in the trial group were similar to those of the control group,without significant difference（ P 〉0. 05）. Conclusion Zhennaoning capsules have the definite therapeutic effects on chronic tension-type headache. It is safe in clinical practice and deserves to be promoted.

关 键 词：慢性紧张型头痛 风邪上扰 镇脑宁胶囊 正天丸 

分 类 号：R741.041[医药卫生—神经病学与精神病学]