头痛宁胶囊联合利扎曲普坦治疗偏头痛的临床研究

Clinical study on Toutongning Capsules combined with rizatriptan in teatment of migraine

目的探讨头痛宁胶囊联合利扎曲普坦治疗偏头痛的临床效果和安全性。方法选取2013年3月—2017年3月在中国人民解放军第二五四医院就诊的偏头痛患者91例,随机分成对照组(45例)和治疗组(46例)。对照组患者口服苯甲酸利扎曲普坦片,2片/次,1次/d;治疗组患者在对照组基础上口服头痛宁胶囊,3片/次,3次/d。两组患者均连续治疗20 d。观察两组患者临床疗效,同时比较治疗前后两组患者头痛症状和程度及视觉模拟疼痛评分(VAS),5-羟色胺(5-HT)、基质金属蛋白酶-9(MMP-9)和溶血磷脂酸(LPA)水平及不良反应情况。结果治疗后,对照组和治疗组的总有效率分别为80.00%、95.65%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者的头痛发作次数、头痛持续时间及VAS评分均显著降低(P<0.05),且治疗后治疗组上述指标比对照组降低更明显(P<0.05)。治疗后,两组患者5-HT水平显著升高(P<0.05),MMP-9及LPA水平均显著降低(P<0.05),且治疗组5-HT、MMP-9和LPA治疗后水平明显优于对照组(P<0.05)。治疗期间,治疗组不良反应发生率为4.35%,显著低于对照组的20.00%,两组比较差异具有统计学意义(P<0.05)。结论头痛宁胶囊联合苯甲酸利扎曲普坦片治疗偏头痛临床效果好,安全性高,具有一定的临床推广应用价值。

Objective To explore the clinical efficacy and safety of Toutongning Capsules combined with rizatriptan in teatment of migraine. Methods Patients（91 cases） with migraine in PLA 254 Hospital from March 2013 to March 2017 were randomly divided into control（45 cases） and treatment（46 cases） groups. Patients in the control group were po administered with Rizatriptan Benzoate Tablets, 2 tablets/time, once daily. Patients in the treatment group were po administered with Toutongning Capsules on the basis of the control group, 3 tablets/time, three times daily. Patients in two groups were treated for 20 d After treatment, the clinical efficacy was evaluated, and the VAS scores, 5-HT, MMP-9 and LPA levels and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups was 80.00% and 95.65% respectively, and there were differences between two groups（P 〈 0.05）. After treatment, the headache attack frequency, headache duration and VAS scores in two groups were significantly decreased（P 〈 0.05）, and these indicators in the treatment group after treatment were significantly lower than those in the control group（P 〈 0.05）. After treatment, the 5-HT levels in two groups were significantly increased（P 〈 0.05）, MMP-9 and LPA levels were significantly decreased（P 〈 0.05）, and the 5-HT, MMP-9 and LPA levels in the treatment group after treatment were significantly better than those in the control group（P 〈 0.05）. During the treatment, the adverse reactions rate in the treatment group was 4.35%, which was significantly lower than 20.00% in the control group, with significant difference between two groups（P 〈 0.05）. Conclusion Toutongning Capsules combined with rizatriptan has good clinical efficacy and safety in teatment of migraine, which has a certain clinical application value.