[关键词]
[摘要]
目的 观察舒脑欣滴丸治疗偏头痛(血虚血瘀证)的临床疗效和安全性。方法 240例来源于6家医疗机构的符合西医诊断偏头痛、中医辨证血虚血瘀证患者随机分为试验组和对照组,各120例。对照组口服天舒胶囊4粒/次、3次/d,试验组口服舒脑欣滴丸,4粒/次、3次/d,疗程均12周。观察患者治疗前后头痛月发作天数、头痛程度、中医证候疗效、头痛持续时间、偏头痛残疾程度评估问卷(MIDAS)、头痛影响测评量表-6(HIT-6)、单项症状(每次头痛持续时间、头痛发作次数、头痛程度、伴随症状、头晕、善忘、失眠、面色苍白、唇甲紫暗)疗效;观察患者的不良事件和生命体征。结果 两组患者治疗后偏头痛发作天数、头痛程度、头痛持续时间均较治疗前明显改善(P<0.01),且试验组头痛程度、头痛持续时间低于对照组(P<0.05);两组患者治疗后MIDAS积分、HIT-6积分均较治疗前明显降低(P<0.01、0.5),但治疗后两组患者MIDAS积分、HIT-6积分比较均无统计学差异。治疗后,试验组中医证候疗效优于对照组(P<0.05);单项症状中“头痛发作次数”“头痛程度”“伴随症状”“头晕”“失眠”“唇甲紫暗”组间比较差异具有统计学意义(P<0.05);单项症状中“每次头痛持续时间”“善忘”“面色苍白”组间比较差异无统计学意义。试验组和对照组不良事件发生率分别为8.33%和6.67%,组间比较,差异无统计学意义;试验期间无严重不良事件发生。结论 舒脑欣滴丸治疗偏头痛(血虚血瘀证)的临床疗效确切,安全性较好,具有较好的临床应用前景。
[Key word]
[Abstract]
Objective To analyze clinical effect and safety of Shunaoxin Dropping Pills treating migraine (blood deficiency and stasis type). Methods The research is a large samples, multi-center, double-blind RCT. From 6 medical institutions 240 cases of migraine (blood deficiency and stasis type) was randomly divided into experimental group and control group, each group has 120 cases. Experimental group were given Shunaoxin Dropping Pills, 4 pills each time, 3 times daily and control group were given Tianshu Capsules 4 pills each time, 3 times daily for 12 weeks as one course. The effect was analyzed before and after treatment with the indexes days of headache, headache degree. clinical efficacy of Traditional Chinese Medicine (TCM) symptoms, duration time, MIDAS, HIT-6, single therapy effectiveness. To observe adverse event and vital signs. Results The number of migraine attack days, headache degree and headache duration of the two groups were significantly improved after treatment compared with before treatment (P<0.01), the degree and duration of headache in the experimental group were lower than those in the control group (P<0.05). After treatment, MIDAS score and hit-6 score of patients in both groups were significantly lower than before treatment (P<0.01, 0.5). After treatment, there was no significant difference in MIDAS score and hit-6 score between the two groups. After treatment, the curative effect of TCM syndrome in the experimental group was better than that in the control group (P<0.05). After treatment, there was statistical significance compared between these groups about the number of headache attacks, headache degree, associated symptoms, dizziness, insomnia (P<0.05). There was no statistical significance compared between these groups about duration of headache, forgetful, palefaced. The incidence of adverse events in the experimental group and the control group were 8.33% and 6.67%, respectively, with no statistically significant difference. No serious adverse events occurred during the study period. Conclusion Shunaoxin Dropping Pills treating migraine (blood deficiency and stasis type) has exact effect and with good safety.
[中图分类号]
R286.1;R971
[基金项目]
国家科技重大专项(2018ZX09734-002-004);黑龙江中医药大学工程中心建设资助项目(2017SEC01)