目的 觀察舒腦欣滴丸治療偏頭痛（血虛血瘀證）的臨床療效和安全性。方法 240例來源于6家醫(yī)療機構(gòu)的符合西醫(yī)診斷偏頭痛、中醫(yī)辨證血虛血瘀證患者隨機分為試驗組和對照組，各120例。對照組口服天舒膠囊4粒/次、3次/d，試驗組口服舒腦欣滴丸，4粒/次、3次/d，療程均12周。觀察患者治療前后頭痛月發(fā)作天數(shù)、頭痛程度、中醫(yī)證候療效、頭痛持續(xù)時間、偏頭痛殘疾程度評估問卷（MIDAS）、頭痛影響測評量表-6（HIT-6）、單項癥狀（每次頭痛持續(xù)時間、頭痛發(fā)作次數(shù)、頭痛程度、伴隨癥狀、頭暈、善忘、失眠、面色蒼白、唇甲紫暗）療效；觀察患者的不良事件和生命體征。結(jié)果 兩組患者治療后偏頭痛發(fā)作天數(shù)、頭痛程度、頭痛持續(xù)時間均較治療前明顯改善（P<0.01），且試驗組頭痛程度、頭痛持續(xù)時間低于對照組（P<0.05）；兩組患者治療后MIDAS積分、HIT-6積分均較治療前明顯降低（P<0.01、0.5），但治療后兩組患者MIDAS積分、HIT-6積分比較均無統(tǒng)計學(xué)差異。治療后，試驗組中醫(yī)證候療效優(yōu)于對照組（P<0.05）；單項癥狀中“頭痛發(fā)作次數(shù)”“頭痛程度”“伴隨癥狀”“頭暈”“失眠”“唇甲紫暗”組間比較差異具有統(tǒng)計學(xué)意義（P<0.05）；單項癥狀中“每次頭痛持續(xù)時間”“善忘”“面色蒼白”組間比較差異無統(tǒng)計學(xué)意義。試驗組和對照組不良事件發(fā)生率分別為8.33%和6.67%，組間比較，差異無統(tǒng)計學(xué)意義；試驗期間無嚴重不良事件發(fā)生。結(jié)論 舒腦欣滴丸治療偏頭痛（血虛血瘀證）的臨床療效確切，安全性較好，具有較好的臨床應(yīng)用前景。

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.

R286.1;R971

國家科技重大專項（2018ZX09734-002-004）；黑龍江中醫(yī)藥大學(xué)工程中心建設(shè)資助項目（2017SEC01）