滋肾健脾祛瘀方治疗肾虚血瘀型无先兆偏头痛的疗效观察

Observation on the Therapeutic Effect of Zishen Jianpi Quyu Formula in the Treatment of Migraine Without Aura of Kidney Deficiency and Blood Stasis Type

【目的】探讨滋肾健脾祛瘀方在经后期治疗肾虚血瘀型无先兆偏头痛的临床疗效及安全性。【方法】将104例肾虚血瘀型无先兆偏头痛患者随机分为对照组和试验组,每组各52例。对照组给予盐酸氟桂利嗪胶囊治疗,试验组在对照组基础上给予滋肾健脾祛瘀方治疗,以1个月经周期为1个疗程,共治疗2个疗程(共8周)。观察2组患者治疗前后中医证候积分、偏头痛发作频率、持续时间、疼痛程度视觉模拟量表(VAS)评分、头痛影响测量量表-6(HIT-6)积分及血液流变学指标的变化情况,并评价2组患者的中医证候疗效和用药安全性。【结果】(1)疗效方面,治疗2个疗程后,试验组的总有效率为90.38%(47/52),对照组为69.23%(36/52),组间比较(χ^(2)检验),试验组的中医证候疗效明显优于对照组(P<0.05)。(2)中医证候积分方面,治疗后,2组患者的中医证候积分均较治疗前明显降低(P<0.05),且试验组对中医证候积分的降低幅度明显优于对照组(P<0.05)。(3)偏头痛发作情况方面,治疗后,2组患者的偏头痛发作频率、发作时间、疼痛程度VAS评分均较治疗前明显改善(P<0.05),且试验组对偏头痛发作频率、发作时间、疼痛程度VAS评分的改善幅度均明显优于对照组(P<0.05)。(4)HIT-6积分方面,治疗后,2组患者的HIT-6积分均较治疗前明显下降(P<0.05),且试验组对HIT-6积分的下降幅度明显优于对照组(P<0.05)。(5)血液流变学方面,治疗后,2组患者的各项血液流变学指标(包括血浆黏度、全血高切黏度、全血低切黏度、纤维蛋白原、红细胞压积)均较治疗前改善(P<0.05),且试验组对各项血液流变学指标的改善幅度均明显优于对照组(P<0.05)。(6)治疗过程中,2组患者均未发生严重不良反应事件,具有较高的安全性。【结论】滋肾健脾祛瘀方在经后期治疗肾虚血瘀型无先兆偏头痛患者临床疗效显著,能有效改善患者的中医证候及偏头痛发作情况,患者的头痛程度更轻,发作频率更低,持续时间更短,血液流变学指标更稳定,且安全性高。

Objective To investigate the clinical efficacy and safety of Zishen Jianpi Quyu Formula in treating patients with migraine without aura in the postmenstrual period of kidney deficiency and blood stasis type.Methods A total of 104 patients with migraine without aura of kidney deficiency and blood stasis type were randomly divided into the control group and the trial group,with 52 cases in each group.The control group was treated with Flunarizine Hydrochloride Capsules,and the trial group was treated with Zishen Jianpi Quyu Formula on the basis of treatment for the control group.One menstrual cycle constituted a course of treatment,and the treatment covered a total of two courses(eight weeks).The changes of traditional Chinese medicine(TCM)syndrome score,migraine attack frequency,duration of migraine headaches,visual analogue scale(VAS)score of migraine headache intensity,Headache Impact Test-6(HIT-6)score and hemorheology indexes in the two groups before and after treatment were observed.Moreover,the efficacy for TCM syndrome and clinical safety in the two groups were evaluated.Results(1)After two courses of treatment,the total effective rate of the trial group was 90.38%(47/52),and that of the control group was 69.23%(36/52),the intergroup comparison(by chi-square test)showed that the efficacy for TCM syndrome in the trial group was significantly superior to that of the control group(P<0.05).(2)After treatment,the TCM syndrome scores of the patients in both groups were significantly lower than those before treatment(P<0.05),and the reduction of TCM syndrome score in the trial group was significantly superior to that in the control group(P<0.05).(3)After treatment,the migraine attack frequency,duration of migraine headaches,VAS scores of migraine headache intensity in the two groups of patients were significantly improved compared with those before treatment(P<0.05),and the improvement of migraine headache parameters in the trial group was significantly superior to that in the control group(P<0.05).(4)After treatment,the HIT-6 score in the two groups was decreased significantly compared with those before treatment(P<0.05),and the decrease of HIT-6 score in the trial group was significantly superior to that in the control group(P<0.05).(5)After treatment,hemorheology indexes(including plasma viscosity,whole blood high-shear viscosity,whole blood low-shear viscosity,fibrinogen,and hematocrit)in the two groups were improved compared with those before treatment(P<0.05),and the improvement of each of hemorheology indexes in the trial group was significantly superior to that in the control group(P<0.05).(6)During treatment,no serious adverse events occurred in the two groups,which was of high safety.Conclusion Zishen Jianpi Quyu Formula exerts remarkable clinical efficacy in treating patients of migraine without aura in the postmenstrual period of kidney deficiency and blood stasis type.The formula is effective on improving the TCM syndromes and migraine attacks of the patients,achieving the efficacy of milder headache,lower attack frequency and shorter duration,more stability hemorheology indexes and higher safety.