半夏白术天麻汤加减联合针刺治疗偏头痛风痰上扰证的观察

Modified Banxia Baizhu Tianmatang Combined with Acupuncture for Migraine(Wind-phlegm Upset Syndrome) Observe

目的:观察半夏白术天麻汤加减联合针刺治疗偏头痛风痰上扰证的临床疗效及对神经血管活性肽和血管内皮激活介质的调节效应。方法:将150例患者按随机数字表法分成对照组和观察组各75例,两组采用针刺治疗,1次/d,连续6次,休息1 d。对照组服用半夏白术天麻汤安慰剂颗粒,10 g/次,2次/d。观察组内服半夏白术天麻汤,1剂/d。两组疗程均为治疗4周。记录治疗后0.5,1,2,6,12,24和48 h的疼痛视觉模拟(VAS)评分,并计算6,12,24 h内的疼痛缓解率,72 h内的疼痛消失率和疼痛复发率;记录治疗前4周、治疗4周和治疗后4周偏头痛发作次数、头痛持续时间和头痛程度;进行治疗前后伴随症状、风痰上扰证、头痛影响测定-6(HIT-6)和偏头痛残疾程度评估问卷(MIDAS)评分;检测治疗前后降钙素基因相关肽(CGRP),一氧化氮(NO),内皮素-1(ET-1),垂体腺苷酸环化酶激活肽(PACAP),S100B蛋白,P物质(SP),血管性血友病因子(vWF)和纤维蛋白原(FIB)水平;进行安全性评价。结果:两组患者治疗后各时点VAS评分均逐渐下降(P<0.01),观察组在治疗后6,12,24,48 h的VAS评分均低于同期对照组(P<0.01);观察组治疗后6,12 h的疼痛缓解率为67.14%(47/70),87.14%(61/70),72 h疼痛消失率为92.86%(65/70),分别高于对照组的50.00%(34/68),70.59%(48/68),79.41%(54/68);观察组疼痛复发率为21.43%(15/70),低于对照组的39.71%(27/68)(P<0.05);观察组在用药和停药期间,偏头痛发作次数、头痛持续时间、头痛程度均低于对照组(P<0.01);观察组伴随症状、风痰上扰证,HIT-6和MIDAS评分均低于对照组(P<0.01);观察组患者临床疗效优于对照组(Z=2.106,P<0.05);观察组CGRP,PACAP,S100B蛋白,SP,ET-1,vWF和FIB水平均低于对照组,NO水于高于对照组(P<0.01)。结论:半夏白术天麻汤加减联合针刺治疗风痰上扰偏头痛患者具有较好的即时镇痛效应,在持续镇痛和减少头痛再发生方面效果显著,并可减轻偏头痛症状和伴随症状,减轻偏头痛对日常生活的影响和残疾程度,其作用机制可能与调节神经血管活性肽类物和血管内皮物质有关。

Objective:To observe theclinical efficacy of modified Banxia Baizhu Tianmatang combined with acupuncture on migraine with wind phlegm disturbance syndrome, and the regulatory effect on neurovasoactive peptide and vascular endothelial activator. Method: Two hundred and fifty patients were randomly divided into control group(75 cases)and observation group(75 cases). Patients in Two group got acupuncture for 6 times,1 time/day,after a day of rest,they got placebogranules of Banxia Baizhu Tianmatang,10 g/time,2 times/day. Patients in observation group got Banxia Baizhu Tianmatang,1 dose/day,and also the same acupuncture with the therapyof control group. And the treatment lasted for 4 weeks. At the half,1 st,2 nd,6 th,12 th,24 th,and 48 thhour after treatment,VAS were scored,rate of pain relief within 6,12,and 24 hours,disappearance rate and recurrence rate of pain within 72 hours,migraine attack times,headache duration and headache degree before 4 weeks of treatment,during the treatment and after the treatment were recorded. Before and after treatment,accompanying symptoms,wind phlegm disturbance syndrome,headache impact test version-6(HIT-6)and the migraine disability assessment questionnaire(MIDAS)were scored. And levels of calcitonin gene-related peptide(CGRP),nitric oxide(NO),endothelin-1(ET-1),pituitary adenylate cyclase activating peptide(PACAP),S100 B protein,substance P(SP),von Willebrand factor(vWF)and fibrinogen(FIB)were detected. And safety was evaluated. Result:VAS in two groups decreased at different time points(P<0.01),and VAS in observation group at6 th,12 th,24 thand 48 thhour after treatment were lower than those in control group(P<0.01). The rate of pain relief in observation group at 6 thand 12 thhours after treatment and the disappearance rate of pain at 72 thhour were 67.14%(47/70),87.14%(61/70)and 92.86%(65/70),which were higher than 50.00%(34/68),70.59%(48/68)and79.41%(54/68)in control group. The recurrence rate of pain in observation group was 21.43%(15/70),which was lower than 39.71%(27/68)in control group(P<0.05). During the treatment and drug withdrawal,times of migraine attack,headache duration and headache degree were all less than those in control group(P<0.01).Scores of accompanying symptoms,wind phlegm disturbance syndrome,HIT-6 and MIDAS were all lower than those in control group(P<0.01). The clinical effect was better than that in control group(Z=2.106,P<0.05).Levels of CGRP,PACAP,S100 B protein,SP,ET-1,vWF and FIB were lower than those in control group,while level of NO was higher than control group(P<0.01). Conclusion: Modified Banxia Baizhu Tianmatang combined with acupuncture had a better instant analgesic effect,with a significant effect on continuing analgesia and reducing headache recurrence. It can also alleviate migraine symptoms and accompanying symptoms,andreduce the impact of migraine on daily life and the degree of disability. Its mechanism may be related to the regulation of neurovasoactive peptides and vascular endothelial substances. It is worth for further study.