目的 探讨养血祛风止痛颗粒治疗频发性紧张型头痛（气血两虚证）患者的随机、双盲、安慰剂对照多中心Ⅲ期临床试验。方法 选取2018年5月—2021年3月纳入各研究中心的474例频发性紧张型头痛（气血两虚证）患者为研究对象，采用分层区组随机化方法分为对照组（119例）和治疗组（355例）。对照组给予养血祛风止痛颗粒模拟剂治疗；治疗组给予养血祛风止痛颗粒治疗。2袋/次，2次/d，两组患者治疗周期均为12周。观察比较两组患者头痛发作相关情况、中医证候积分及头痛影响测定量表（HIT-6）评分。结果 治疗后，两组头痛发作天数及次数、头痛的发作持续时间、最痛一次头痛强度均较同组治疗前显著降低（P＜0.05）；治疗后，治疗组头痛发作天数及次数、头痛的发作持续时间、最痛一次头痛强度均低于对照组（P＜0.05）。对照组和治疗组头痛有效率分别是23.70%、87.80%，治疗组高于对照组（P＜0.05）。经治疗后，两组患者中医证候积分均显著下降（P＜0.05），且治疗组低于对照组（P＜0.05）。治疗组头痛、头脑昏沉、记忆力减退、心悸、食少纳呆、自汗、气短、神疲乏力、面色苍白消失率分为33.8%、59.9%、72.0%、82.3%、87.4%、87.8%、83.6%、58.8%、84.2%，对比两组患者上述指标，差异具有统计学意义（P＜0.05）。治疗后，两组HIT-6评分均较同组治疗前显著降低（P＜0.05）；治疗后治疗组HIT-6评分显著低于对照组（P＜0.05）。结论 养血祛风止痛颗粒治疗频发性紧张型头痛（气血两虚证）患者可有效缓解和解决临床症状，疗效明显，不良反应少，安全性高。

Objective To explore a randomized, double-blind, placebo-controlled multicenter phase III clinical trial of Yangxue Qufeng Zhitong Granules in treatment of patients with frequent tension-type headache (qi and blood deficiency syndrome). Methods A total of 474 patients with frequent tension-type headache (qi and blood deficiency syndrome) included in each research center from May 2018 to March 2021 were selected as the research subjects. They were divided into control group (119 cases) and treatment group (355 cases) by stratified block randomization. Patients in control group were treated with the simulation agent of Yangxue Qufeng Zhitong Granules. Patients in treatment group were given Yangxue Qufeng Zhitong Granules for treatment. They were given 2 bags each time, twice daily. The treatment period for both groups of patients was 12 weeks. The conditions related to headache attacks, TCM syndrome scores and HIT-6 scores of two groups were observed and compared. Results After treatment, the number of days and frequency of headache attacks, the duration of headache attacks, and the intensity of the most severe headache in both groups were significantly lower than those before treatment in the same group (P < 0.05). After treatment, the number of days and frequency of headache attacks, the duration of headache attacks, and the intensity of the most severe headache in the treatment group were all lower than those in the control group (P < 0.05). The effective rates of headache in the control group and the treatment group were 23.70% and 87.80% respectively, and the treatment group was higher than the control group (P < 0.05). After treatment, the TCM syndrome scores of both groups of patients decreased significantly (P < 0.05), and those of the treatment group were lower than those of the control group (P < 0.05). The disappearance rates of headache, dizziness, memory loss, palpitations, poor appetite, spontaneous sweating, shortness of breath, fatigue and pale complexion in the treatment group were 33.8%, 59.9%, 72.0%, 82.3%, 87.4%, 87.8%, 83.6%, 58.8%, and 84.2% respectively. The comparison of the above indicators between the two groups showed statistically significant differences (P < 0.05). After treatment, the HIT-6 scores of both groups were significantly lower than those before treatment in the same group (P < 0.05). After treatment, the HIT-6 score of the treatment group was significantly lower than that of the control group (P < 0.05). Conclusion Yangxue Qufeng Zhitong Granules can effectively relieve and solve the clinical symptoms of patients with frequent tension-type headache (qi and blood deficiency syndrome) with obvious therapeutic effect, few adverse reactions and high safety.

R971

长沙市生物医药产业发展专项（2009L02183）