| Purpose: To study the efficacy and safety of Xuefu Zhuyu Capsule in the treatment of primary dysmenorrhea with qi stagnation and blood stasis syndrome,and to observe the effect of Xuefu Zhuyu Capsule on uterine microcirculation of primary dysmenorrhea with qi stagnation and blood stasis syndrome,so as to lay a practical foundation for the clinical application of classic prescriptions.Materials and Methods:60 patients with primary dysmenorrhea with qi stagnation and blood stasis syndrome were randomly divided into experimental group and control group,with 30 cases in each group.The experimental group was treated with Xuefu Zhuyu Capsule and the control group was treated with placebo for 3 menstrual cycles and followed up for 3menstrual cycles.The score of uterine syndrome and vas were compared between the two groups before and after treatment.Results:1.Baseline comparison: the baseline data such as age and course of disease of the two groups before treatment are comparable;2.Comparison of VAS score and TCM syndrome score: after treatment,the score in the experimental group was lower than that before treatment,and the difference was statistically significant(P < 0.05),but there was no statistical significance in the control group before and after treatment(P > 0.05);There was no significant difference between the experimental group and the control group before treatment(P > 0.05),and the experimental group was lower than the control group after treatment(P < 0.05);3.Comparison of parameters of uterine artery blood flow resistance: PI,RI and A/B in the experimental group were lower than those before ipsilateral treatment,which was statistically significant(P < 0.05);In the control group,the left PI,RI,A/B and right A/B were less than those before ipsilateral treatment,the difference was not statistically significant(P > 0.05),and the right PI and RI were greater than those before ipsilateral treatment,the difference was not statistically significant(P > 0.05);After treatment,the experimental group was lower than the control group(P < 0.05);4.Comparison of single symptom scores of traditional Chinese medicine: compared within the group,the single symptoms of the experimental group were improved after treatment.Except for the one symptom of obstructed menstruation,the rest were P < 0.05,and the difference was statistically significant;The symptoms of the control group were not significantly improved after treatment,and the difference was not statistically significant(P >0.05);Before treatment,there was no significant difference in each single symptom of traditional Chinese medicine between the groups;After treatment,the improvement of single syndrome in the experimental group was better than that in the control group(P < 0.05).5.Comparison of clinical efficacy: the effective rate of VAS pain was 93.10% in the experimental group and 13.79% in the control group.After treatment,the effective rate of the experimental group was higher than that of the control group(P = 0.000 < 0.05);The effective rate of the experimental group was 72.41% and that of the control group was10.34%.The difference was statistically significant.The clinical effect of Xuefu Zhuyu Capsule was obvious.6.Safety evaluation: no obvious adverse reactions occurred in both groups.Conclusion:1.Xuefu Zhuyu Capsule can significantly reduce the pain degree of PD patients with qi stagnation and blood stasis syndrome;2.Xuefu Zhuyu Capsule significantly reduces the TCM syndrome score of primary dysmenorrhea(qi stagnation and blood stasis syndrome)and reduces the clinical symptoms of PD patients with qi stagnation and blood stasis syndrome;3.Xuefu Zhuyu Capsule can significantly reduce the blood flow resistance of uterine artery in PD patients with qi stagnation and blood stasis syndrome;4.There were no toxic and side effects and adverse events during the test,indicating that Xuefu Zhuyu Capsule is safe and effective. |