脑痛宁颗粒治疗气虚血瘀型偏头痛多中心、随机、双盲、双模拟临床对照研究

Clinical study on “Naotongning Granules” in treating migraine of qi deficiency and blood stasis type: A multi-center randomized double-blind and double-dummy controlled trail

目的观察脑痛宁颗粒治疗气虚血瘀型偏头痛的临床疗效及安全性。方法采用多中心、随机、双盲、双模拟临床对照研究方法,将200例病例随机分为2组,每组100例。治疗组予脑痛宁颗粒、晕痛定模拟剂口服,对照组予晕痛定、脑痛宁颗粒模拟剂口服。两组疗程均为28天,观察偏头痛发作频率、持续时间、发作程度、中医证候,以及血液流变学指标、TXB2、6-K-PGF1α水平变化情况,并于治疗后、停药28天时评价临床疗效。结果 1治疗组治疗后及停药28天时偏头痛总有效率分别为97.0%、96.0%,对照组分别为85.0%、87.0%;组间同期比较,疾病疗效差异有统计学意义(P<0.05)。2两组治疗后,头痛发作持续时间、发作频率、疼痛程度及中医证候积分均明显减少(P<0.05),且治疗组的减少幅度大于对照组(P<0.05)。3两组治疗后,全血黏度高切、全血黏度低切、血浆黏度及纤维蛋白原(FIB)水平均明显下降(P<0.05),组间治疗前后差值比较,各指标差异均无统计学意义(P>0.05)。4治疗组治疗后,6-K-PGF1α水平升高,而TXB2及TXB2/6-K-PGF1α明显下降(P<0.05),对照组仅TXB2水平明显下降(P<0.05);组间治疗前后差值比较,TXB2、6-K-PGF1α、TXB2/6-K-PGF1α差异均有统计学意义(P<0.05)。结论脑痛宁颗粒对偏头痛具有良好的近期及远期临床疗效,应用安全。

Objective To observe the clinical efficacy and safety of application of ＂Naotongning Granules＂ in treating migraine of qi deficiency and blood stasis type . Methods A multi-center, randomized, double-blind and double-dummy controlled clinical study was conducted, and 200 patients were randomly divided to 2 groups （ 100 per group）. Patients in treatment group were given ＂Naotongning Granules＂ and ＂Yuntongding＂ analog drug for oral administration, and patients in control group were given Yuntongding and analog drug of ＂Naotongning Granules＂ for oral administration. For both groups, the treatment course was 28 days. The migraine onset frequency, duration, onset degree, TCM symptoms as well as hemorheological indicators and changes in TXB2 and 6-K-PGF1α, levels were observed, and the clinical efficacy was evaluated after treatment and on Day 28 after cessation of administration. Results （1） In treatment group, the total effective rates of after treatment and Day 28 during follow-up period were 97.0% and 96.0%, and the rates in control group were 85.0% and 87.0%. For the same group during the same period, the comparison in terms of efficacy displayed a statistical significance （P 〈 0.05 ）. （2） For both groups, after treatment, the scores of headache onset duration, onset frequency, pain degree and TCM symptoms markedly decreased （ P 〈 0.05 ）, and the decrease rate in treatment group was greater than that of control group （ P 〈 0. 05 ）. （3） For both groups, after treatment the levels of whole blood high shear rate viscosity, whole blood low shear rate viscosity, plasma viscosity and fibrinogen （FIB） markedly decreased （ P 〈 0. 05 ）, and inter-group comparison before and after treatment indicated that all indicators had no statistical difference （ P 〉 0.05 ）. （4） After treatment, the level of 6-K-PGF1α increased and TXB2 and TXB2/6-K-PGF1α decreased markedly （ P 〈 0. 05 ）, while in control group only the level of TXB2 decreased （P 〈0.05） ; inter-group comparison before and after treatment indicated, the difference in TXB2 , 6-K-PGF1α and TXB2/6-K-PGF1α had a statistical significance （P〈0.05）. Conclusion ＂Naotongning Granules＂ has good short-term and long-term clinical efficacy for migraine, and the application is safe.