| Purpose:To study the availability and security of Xuefu Zhuyu capsule in treating primary dysmenorrhea of Qi stagnation and blood stasis syndrome,and to watch the influence of Xuefu Zhuyu capsule on uterine artery blood flow velocity of patients with primary dysmenorrhea of Qi stagnation and blood stasis syndrome,evaluate objectively the curative effect ’ s difference,and supply new ideas and basis for TCM treatment of primary dysmenorrhea.Materials and Methods:Adopt parallel randomized,placebo controlled,double-blind clinical trial method,included 70 patients with PD of qi and blood stasis syndrome,35 cases in therapeutic capsule intervention group,control group of 35 cases with placebo,two groups of treatment methods are on an empty stomach for two weeks before menstruation to begin oral,6 grain each time,2 times a day,from taking a treatment until the end of the menstrual cycle,A total of 3 menstrual cycles were treated.TCM syndrome score McGill pain score and uterine arterial blood flow dynamics velocity were used as clinical observation indexes.Results:1 Before treatment,baseline data such as age,height,weight,marital status,menstrual cycle and disease course were comparable between the experimental group and the control group.2 TCM syndrome score: there was no marked difference in TCM syndrome score between the experimental group and the control group before treatment(P>0.05).Through treatment,there were statistically marked differences within the experimental group and between the two groups(P<0.01),but no statistically significant differences within the control group(P>0.05).3 McGill pain score: there were no significant differences between the experimental group and the control group in VAS score,PRI single item and total score,PPI score and SF-MPQ total score before treatment(P>0.05).After treatment,VAS score,PRI single component and total score,PPI score and SF-MPQ total score of the experimental group were significantly decreased compared with those before treatment,and the decrease degree of the experimental group was better than that of the control group,the difference was statistically significant (P<0.01),but there was no significant difference within the control group(P>0.05).4 Uterine artery flow velocity: peak uterine systolic flow velocity(PSV)and end diastolic flow velocity before treatment in experimental group and control group Blood flow velocity(EDV)and mean blood flow velocity(VM)showed no significant difference(P>0.05).After treatment,PSV,EDV and VM of experimental group were significantly increased within the group and between the groups compared with the control group,and the differences were statistically significant(P<0.01).There was no significant difference within the control group(P>0.05).5 Total clinical efficacy: experimental group’s total effective rate was 94.12%.control group’s total effective rate was 20.59%.There was marked difference in total clinical efficacy between the experimental group and the control group(P<0.01).6 Safety assessment: No adverse reactions or adverse events occurred during the treatment.Conclusion:1 Xuefu Zhuyu capsule can reduce the TCM syndrome score of patients with primary dysmenorrhea of qi stagnation and blood stasis,and improve the degree of dysmenorrhea and related symptoms;2 Xuefu Zhuyu capsule can improve the pain sensation of patients with primary dysmenorrhea of qi stagnation and blood stasis syndrome from physiological sensation,emotional factors,cognitive ability and other aspects,and improve the quality of life;3 Xuefu Zhuyu capsule can improve the high resistance and low speed of uterine blood flow in patients with primary dyspenorrhea of qi stagnation and blood stasis syndrome,thus improving blood perfusion,relieving uterine muscle spasm and relieving pain;4 Xuefu Zhuyu capsule has no adverse events in the treatment of primary dysmenorrhea of Qi stagnation and blood stasis syndrome,and the medication is safe and reliable. |
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