摘要
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.
作者
李怡帆
李春蕊
王泊宁
黎明全
许予明
吴大胜
傅志俭
陈应柱
毛鹏
樊碧发
LI Yi-Fan;LI Chun-Rui;WANG Bo-Ning;LI Ming-Quan;XU Yu-Ming;WU Da-Sheng;FU Zhi-Jian;CHEN Ying-Zhu;MAO Peng;FAN Bi-Fa(Graduate School of Beijing University of Chinese Medicine,Beijing 100029,China;Department of Pain Medicine;Center of Day Surgery,China-Japan Friendship Hospital,Beijing 100029,China;Department of Encephalopathy,the Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130021,China;Department of Neurology,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Department of Pain Medicine,People's Hospital of Jilin Province,Changchun 130400,China;Department of Pain Medicine,Shandong Provincial Hospital Affiliated to Shandong University,Jinan 250021,China;Department of Neurology,Subei People's Hospital,Yangzhou 225001,China)
出处
《中国疼痛医学杂志》
CAS
CSCD
北大核心
2019年第10期739-743,748,共6页
Chinese Journal of Pain Medicine
基金
中央高校基本科研业务费专项资金
中日友好医院生物医学转化工程系列研究项目(PYBZ1840)
关键词
川芎清脑颗粒
偏头痛
疼痛
多中心
前瞻性临床试验
Chuanxiong Qingnao Granule
Migraine
Pain
Multicenter
Prospective clinical trial