| Purpose: Through a small sample clinical trial to observe the effect of Xuefu Zhuyu decoction on primary dysmenorrhea(PD)of qi stagnation and blood stasis syndrome,in order to provide ideas and basis for TCM drug treatment of PD.Material and method:This study is a prospective,intervention,blind randomized controlled trial.According to the inclusion and exclusion criteria,a total of 60 outpatients were collected from the TCM of Liaoning Hospital.The patients were randomly divided into two groups: the experimental group(n = 30)and the control group(n = 30).The experimental group was treated with Xuefuzhuyu oral liquid,and the control group was treated with placebo 3 times a day,2 drugs each time.Each menstrual cycle was taken on an empty stomach for two weeks before the menstrual cycle to zhe start of the menstruation,and there was one observation cycle from the medication to the end of menstruation.A total of 3 cycles were observed.The observation indicators included the changes of TCM syndromes,pain,clinical efficacy of TCM,symptoms related to dysmenorrhea and uterine artery hemodynamics.The body temperature,pulse,blood pressure,respiration and all adverse events and adverse reactions during the study period were recorded before treatment and 1cycle,2 cycle and 3 cycle after treatment.SPSS25.0 software was used to process the data.Results:1.Clinical efficacy of traditional Chinese medicine: after 3 cycles of treatment,18 patients in the experimental group were cured with qi stagnation and blood stasis syndrome,accounting for 60%;7 cases were markedly effective,accounting for 23.3%;5 cases were effective,accounting for 16.7%;and 0 cases were ineffective.In the control group,the syndrome of qi stagnation and blood stasis was cured in 0 cases,markedly effective in 2 cases,accounting for6.7%,effective in 2 cases,accounting for 6.7%,and ineffective in 26 cases,accounting for86.7%.There was significant difference in clinical curative effect of TCM syndrome between the two groups(P < 0.001).2.VAS score and CMSS score: there was no significant difference in VAS score between the test group and the control group before treatment(P = 0.857),but after 1 cycle,2 cycles and 3cycles of treatment,the VAS score of the test group was significantly lower than that of the control group,and the difference was statistically significant(P < 0.001).The VAS scores of the experimental group were significantly different before treatment,after 1 cycle,2 cycles and 3 cycles of treatment(P<0.05),and decreased gradually with the passage of time,while there was no significant difference in the VAS score of the control group at 4 time points before treatment,after 1 cycle,2 cycles and 3 cycles(P>0.05).There were significant differences in CMSS scores between the two groups after 2 and 3 cycles of treatment(P <0.001).The CMSS score of the experimental group decreased gradually with the passage of time,while that of the control group increased.3.Uterine artery hemodynamics: before treatment,there was no significant difference in uterine artery systolic blood flow velocity(PSV),diastolic blood flow velocity(EDV),mean blood flow velocity(Vm),blood pulsation index(PI),resistance index(RI)and peak systolic /diastolic peak(S/D)between the control group and the experimental group before treatment.After treatment,the Vp,EDV and Vm of the test group were significantly higher than those of the control group,while the levels of PI,RI and S/D of the test group were significantly lower than those of the control group(P < 0.001).4.Safety indicators: during the trial study,there were no adverse events and adverse reactions in the two groups,and the test was safe and reliable.Conclusion:1.For primary dysmenorrhea of qi stagnation and blood stasis type,Xuefu Zhuyu decoction can effectively improve the manifestation of qi stagnation and blood stasis.2.Using Xuefu Zhuyu oral liquid to treat primary dysmenorrhea with qi stagnation and blood stasis syndrome can significantly improve the VAS score and CMSS score and improve the quality of life of the patients.3.Xuefu Zhuyu oral liquid can significantly change the uterine artery hemodynamics of patients with primary dysmenorrhea with qi stagnation and blood stasis syndrome,increase uterine artery systolic blood flow velocity(PSV),diastolic blood flow velocity(EDV)and mean blood flow velocity(Vm),decrease blood pulsation index(PI),resistance index(RI) and systolic / diastolic peak(S/D).It is suggested that the change of uterine artery hemodynamics may be one of the mechanisms of Xuefu Zhuyu decoction in the treatment of primary dysmenorrhea with qi stagnation and blood stasis. |
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