养血清脑颗粒预防和治疗偏头痛的临床研究

A clinical study of Yangxueqingnaokeli in preventive treament of migraine

目的 研究养血清脑颗粒 (主要成分为当归、川芎、白芍、细辛等 )治疗偏头痛的疗效及其不良反应。方法 112例偏头痛患者 ,男性 4 2例 ,女性 70例 ,年龄 19～ 75岁 ,平均年龄为 ( 3 8 1±9 8)岁 ,进行了多中心、随机、双盲、安慰剂对照研究。结果 ( 1)养血清脑颗粒对偏头痛的治疗中治疗组比安慰剂组较明显地减少总发作次数 (分别为 3 1± 2 5和 4 2± 2 7,Z =2 16,P =0 0 3 )和总发作时间 (h)分别为 3 1 0± 4 8 0和 5 1 2± 73 8,Z =2 86,P =0 0 0 4。 ( 2 )治疗组和安慰剂组总发作次数减少率 ( % )分别为 4 9± 0 3和 3 0± 0 5 ,两组比较差异有显著意义 (Z =5 76,P <0 0 0 1)。 ( 3 )治疗组和安慰剂组中偏头痛伴随症状 ,如恶心、呕吐、畏光、怕声的观察表明无明显差异。 ( 4 )治疗组发生不良反应 3例 ( 5 4 % ) ,安慰剂组 1例 ( 1 8% )。 ( 5 )血尿常规和血生化检查治疗前后无特殊改变。结论 养血清脑颗粒可用于治疗偏头痛 ,可减少偏头痛的发作次数和缩短发作时间 ,但对偏头痛发作过程中出现的伴随症状的作用不明显。

Objective To investigate the therapeutic efficacy and adverse-events of Yangxueqingnaokel i (main composition includes Chinese angelica, ligusticum wallichii, Paconia lac tiflora, Asarum sieboldii, etc) in patients with migraine. Methods One hundred and twelve patients with migraine with an average age of 38.1±9.8 years( ranging from 19～75) were investigated in a multicenter, doub le-blind, randomized, controlled and perspective study. Results (1) The total number an d total duration of migraine attacks were markedly decreased in therapeutic group of Yangxueqingnaokeli than those in placebo group, 3.1±2.5 and 4.2±2.7 ( Z=2.1 6, P=0.03); 31.0±48.0 and 51.2±73.8(Z=2.86, P=0.004), respe ctively. (2) The to tal decrease rate of migraine attacks (%) of therapeutic group and placebo group were 4.9±0.3 and 3.0±0.5(Z=5.76,P<0.001), respectively. It has marked statist ical difference (P<0.001). (3) There were no significant difference of th erapeu tic effect on associated symptoms of migraine such as nausea, vomiting, photopho bia and phonophobia between the therapeutic group and placebo group. (4) The ad v erse-events occurred in 3 patients of therapeutic group(5.4%) and in one patie nt of placebo group(1.8%). (5) There were no noticeable changes in blood and ur in e routine examination and blood chemistry. Conclusions Yangxueqingnaokeli is an effective drug for therapy of patients with migaine. It can decrease the number of attacks of migraine and also shorten the duration of migraine attacks, but it has no therapeutic effect on the associated symptoms of migraine.