| Objective:To systematically summarize the clinical efficacy and safety of Wenjing Nuangong Decoction in the treatment of Primary dysmenorrhea(PD)with cold coagulation and blood stasis,and its influence on pelvic blood flow.Methods:A total of 66 PD patients with cold coagulation and blood stasis who met the exclusion criteria in the gynecological outpatient department of Wangjing Hospital of China Academy of Chinese Medical Sciences from November 2021 to August 2022 were selected and divided into observation group and control group with 33 cases in each group by random number table method.The observation group received Wenjing Nuangong Decoction orally,starting from 14 days before menstruation,divided into morning and evening,a total of 14 doses;The control group was given ibuprofen sustained-release capsules orally,0.3g/time when abdominal pain could not be tolerated during and around the menstrual period,until the abdominal pain was relieved.Both groups were treated continuously for 3 menstrual cycles continuously.Visual analogue scale(VAS)score,pain duration score,dysmenorrhea symptom score,and TCM syndrome score of the two groups were observed before and after treatment and 3 months after drug withdrawal,and uterine artery blood flow pulsation Index(Pulsitility Index)was recorded before and after treatment.PI)and Resistance Index(Resistance Index,RI),the ratio of Systolic Peak velocity to Diastolic Peak velocity(End Systolic Peak/End Diastolic Peak velocity,S/D),the mean peak velocity of uterine vein and ovarian vein(V1max,V2max),the values of uterine vein internal diameter(R)and ovarian vein internal diameter(r),At the same time,safety evaluation was carried out.Statistical analysis was carried out to evaluate the effectiveness,safety and influence of Wenjing Nuangong Decoction on PD with cold coagulation and blood stasis.Results:During the study,3 cases fell off in the observation group and control group,and 30 cases were included in each group.Three months after drug withdrawal,27 cases were followed up in the observation group and 3 cases were lost to follow-up.In the control group,26 cases were followed up and 4 cases were lost to follow-up.(1)Baseline comparison of general conditions:before treatment,there were no statistical differences in age,course of disease,pain related scores,TCM syndrome scores and pelvic blood flow related indicators between the two groups(P>0.05);(2)Pain related scores:After treatment,the pain severity scale,VAS score,pain duration score and dysmenorrhea symptom score were significantly decreased in 2 groups compared with before treatment(P<0.05);After 3 months of drug withdrawal,there was no significant difference in the observation group after treatment(P>0.05),while the pain scores of the control group were higher than those of the treatment(P<0.05).(3)TCM syndrome score:TCM syndrome score of observation group was significantly decreased after treatment compared with before treatment(P<0.05),and was similar to that after treatment 3 months after withdrawal(P>0.05);There was no significant difference in TCM syndrome score of control group after treatment compared with before treatment(P>0.05).(4)Pelvic blood flow related indexes:PI,RI,S/D,etc.,were decreased in the observation group after treatment compared with before treatment,while V1max,V2max,R,r were increased(P<0.05),and there were no significant differences in the control group after treatment compared with before treatment(P>0.05).(5)Efficacy evaluation:the total effective rate of the observation group was 83.3%and that of the control group was 80.0%(P>0.05).After 3 months of drug withdrawal,the total effective rate of observation group was 74.1%,which was better than that of control group 46.1%(P<0.05).(6)In the observation group,there was 1 patient with dizziness,the incidence was 3.3%;In the control group,4 patients developed nausea,vomiting and other reactions,with an incidence of 13.3%.Conclusions:(1)Wenjing Nuangong Decoction can significantly improve the pain related scores and TCM syndroms of PD patients with cold coagulation and blood stasis.(2)Warm meridian and Warm Palace decoction can reduce the blood flow PI,RI and S/D of uterine artery in PD patients with cold coagulation and blood stasis,accelerate the blood flow velocity of uterine and ovarian veins,expand the internal diameter of veins,and improve the state of pelvic high resistance and low blood flow.(3)Wenjing Nuangong Decoction has better clinical safety,more stable long-term efficacy and is not easy to relapse. |