川芎清脑颗粒治疗偏头痛的多中心随机对照双盲研究

EFFICACY AND SAFETY OF CHUANXIONG QINGNAO GRANULE FOR THE TREATMENT OF MIGRAINE: A MULTICENTER RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROSPECTIVE CLINICAL TRIAL

目的:观察川芎清脑颗粒治疗慢性偏头痛的临床疗效和安全性。方法:采用多中心、随机、双盲、安慰剂对照、前瞻性试验设计,纳入偏头痛病人214例,采用数字随机表法分为川芎清脑颗粒治疗组(治疗组,n=107)和安慰剂对照组(对照组,n=107),服药4周,比较两组病人服药4周和停药4周时的头痛评分,采用疼痛数字评分法(numeric rating scales, NRS)、头痛月发作次数,记录药物的不良反应。结果:两组病人治疗前头痛的NRS评分和头痛月发作次数无明显差异(P> 0.05)。治疗组服药4周时的头痛NRS评分明显低于治疗前基础值(3.75 vs. 4.49,P <0.05),头痛月发作次数明显少于治疗前(2.80 vs. 7.51, P <0.001);停药4周时,头痛NRS评分进一步降低,明显低于服药4周时的头痛NRS评分(1.65 vs. 3.75, P <0.001),头痛月发作次数也进一步降低,明显低于服药4周时(1.50 vs.2.80, P <0.001);对照组服药4周和停药4周时的NRS评分和头痛月发作次数较治疗前无明显变化(P> 0.05)。治疗组服药4周时的头痛NRS评分明显低于对照组(3.75 vs. 4.34,P <0.001),头痛月发作次数明显少于对照组(2.80 vs.6.09,P <0.001);停药4周时,治疗组的头痛NRS评分显著低于对照组(1.65 vs. 4.16,P <0.001),头痛月发作次数显著少于对照组(1.50 vs. 6.45,P <0.001)。服药过程中及停药后4周,两组病人的血常规、肝肾功、心电图均未见显著异常改变,未发生不良事件。结论:川芎清脑颗粒可明显降低轻中度偏头痛病人的疼痛程度和发作次数,无明显不良反应。

Objective: To evaluate the efficacy and safety of Chuanxiong Qingnao Granule compared with placebo for the treatment of chronic migraine. Methods: A multicenter randomized, double-blind, placebocontrolled prospective trial was conducted. A total of 214 patients with migraine were randomly allocated to either Chuanxiong Qingnao Granule group(treatment, n = 107) or placebo control group(control, n = 107) and took the drug or placebo for 4 weeks. NRS scores, the number of episodes and adverse reactions, if any, at pretreatment, 4 weeks during treatment and 4 weeks after treatment in both groups were evaluated. Results: There was no signicant difference in numeric rating scales(NRS) score and number of episodes between both groups before treatment(P > 0.05). The NRS scores and the number of episodes in the treatment group were signicantly lower than baseline at 4 weeks during treatment(3.75 vs. 4.49, P < 0.05 and 2.80 vs. 7.51, P < 0.001, respectively). After the four-week treatment, the NRS scores and the number of episodes were further reduced, which were considerably lower than those at 4 weeks during treatment(1.65 vs. 3.75, P < 0.001 and 1.50 vs. 2.80, P < 0.001, respectively). However, there was no signicant difference in the NRS scores and the number of episodes in the control group at 4 weeks during treatment and 4 weeks after treatment(P > 0.05). The NRS scores and the number of episodes in the treatment group were signicantly lower than those in the control group at 4 weeks during treatment(3.75 vs. 4.34, P < 0.001 and 2.80 vs. 6.09, P < 0.001, respectively). After the four-week treatment, the NRS scores and the number of episodes in the treatment group were also significantly lower than those in the control group(1.65 vs. 4.16, P < 0.001 and 1.50 vs. 6.45, P < 0.001, respectively). During the whole treatment and 4 weeks after treatment, there was no signicant difference in the blood test, liver and kidney function, and electrocardiogram in both groups, and no adverse events occurred. Conclusion: Chuanxiong Qingnao Granule can significantly reduce pain and the number of episodes of moderate migraine without obvious adverse reactions.