头痛合剂联合盐酸氟桂利嗪胶囊治疗偏头痛风痰瘀阻证临床研究

Clinical effect of Toutong Heji combined with flunarizine hydrochloride capsule for migraine of wind-phlegm stasis syndrome

目的观察头痛合剂联合盐酸氟桂利嗪胶囊治疗偏头痛风痰瘀阻证的临床疗效。方法将67例偏头痛风痰瘀阻证患者按照随机数字表法分为2组。对照组32例予盐酸氟桂利嗪胶囊口服治疗,治疗组35例在对照组治疗基础上予头痛合剂治疗。2组均治疗4周。比较2组治疗前后头痛积分、中医证候评分、止痛药使用频率、同型半胱氨酸(Hcy)、C反应蛋白(CRP)和血液流变学指标[全血黏度(高切)、全血黏度(低切)、血浆黏度、纤维蛋白原],并统计2组疗效及不良反应发生情况。结果治疗组总有效率91.4%(32/35),对照组总有效率71.9%(23/32),治疗组疗效优于对照组(P<0.05)。治疗后2组头痛积分均较本组治疗前降低(P<0.05),且治疗后治疗组低于对照组(P<0.05)。治疗后治疗组中医证候各项评分均较本组治疗前降低(P<0.05),对照组痛如针刺、胀痛跳痛、闷痛如裹、面色苍白、畏光畏声、胸膈满闷、心悸心烦、头晕昏沉、口苦口干评分均较本组治疗前降低(P<0.05),且治疗后治疗组痛如针刺、胀痛跳痛、闷痛如裹、面色苍白、畏光畏声、恶心呕吐、胸膈满闷、头晕昏沉、夜寐欠安评分均低于对照组(P<0.05)。治疗后2组止痛药使用频率均较本组治疗前降低(P<0.05),且治疗后治疗组低于对照组(P<0.05)。治疗后治疗组Hcy、CRP水平均较本组治疗前降低(P<0.05),对照组CRP水平降低(P<0.05),且治疗后治疗组Hcy、CRP水平均低于对照组(P<0.05)。治疗后治疗组全血黏度(高切)、全血黏度(低切)、血浆黏度、纤维蛋白原水平均较本组治疗前降低(P<0.05),且治疗后治疗组均低于对照组(P<0.05)。2组治疗期间均未发生严重不良反应。结论头痛合剂联合盐酸氟桂利嗪胶囊治疗偏头痛风痰瘀阻证临床疗效肯定,其机制可能与改善血液黏稠度,降低Hcy含量,调控CRP等炎症相关指标,从而改善血管内皮功能及神经炎症相关。

Objective To observe the clinical effect of Toutong Heji combined with flunarizine hydrochloride capsule for migraine(wind-phlegm stasis syndrome).Methods Totally 67 patients with migraine(wind-phlegm stasis syndrome)were randomly assigned into two groups,35 cases in treatment group were treated with orally administered with Toutong Heji combined with flunarizine hydrochloride capsule,and 32 cases in control group with flunarizine hydrochloride capsule only.The treatment period was 4 weeks,aiming to compare migraine score,traditional Chinese medicine(TCM)syndrome score,frequency of use of analgesics,homocysteine(Hcy),C reactive protein(CRP),hemorheology indexes[whole blood viscosity(WBV)(high shearing),WBV(low shearing),plasma viscosity(PV),fibrinogen];the curative effect and adverse reactions were counted.Results The total response rates in treatment group and control group were 91.4%(32/35)and 71.9%(23/32),respectively,the curative effect being better in treatment group than control group(P<0.05).After treatment,migraine scores in groups were decreased,which wrer lower in treatment group than control group(P<0.05);TCM syndrome scores in treatment group were decreased(P<0.05),TCM syndrome(stabbing ophthalmalgia,tenderness,stuffy pain,pale face,photophobia and phonophobia,chest diaphragm full,palpitations,dizziness,bitter taste and dry mouth)scores in control group were decreased(P<0.05),TCM syndrome(stabbing ophthalmalgia,tenderness,stuffy pain,pale face,photophobia and phonophobia,nausea and vomiting,chest diaphragm full,dizziness,sleepless at night)scores in treatment group were decreased in comparison with those in control group(P<0.05);the utilization frequency of analgesics in groups was decreased(P<0.05),which in treatment group was decreased compared with in cortrol group(P<0.05);Hcy and CRP in treatment group were decreased(P<0.05),which in treatment group were lower than control group(P<0.05);CRP in control group was decreased(P<0.05);hemorheology indexes in groups were decreased(P<0.05),which were lower in treatment group than in control group(P<0.05);with no serious adverse reactions in groups.Conclusion For patients with migraine(syndrome of wind-phlegm stasis),Toutong Heji combined with flunarizine hydrochloride capsule has definite clinical efficacy.The mechanism is likely to associat with improvement of blood viscosity,and then to reduce Hcy content,to regulate CRP and other inflammatory related indicators and to improve of vascular endothelial function and related neuroinflammation.