| Objective:To observe the efficacy and safety of Yishen Huayu combined with Anshen Dingtong Formula for treating the adenomyosis(AM)with kidney deficiency and blood stasis,and to explore its possible mechanism,so as to provide a new method for the conservative treatment of adenomyosis.Methods:We choose 60 patients diagnosed as adenomyosis with kidney deficiency and blood stasis in Jiangsu Provincial Hospital of Traditional Chinese Medicine from January 2019 to January 2020,and they were randomly divided into two groups,30 patients in treatment group and 30 patients in control group.The treatment group were given Yishen Huayu combined with Anshen Dingtong Formula,while the control group were given Sanjie Zhentong capsule.All patients were treated for three months,and the VAS score of dysmenorrhea,the size of uterus under ultrasound,the uterine arterial resistance index(RI)under ultrasound,carbohydrate antigen 125(CA125),carbohydrate antigen 199(CA199),human epididymal protein 4(HE4),the score of TCM syndrome and safety indicators along with the occurrence of adverse events in the treatment were observed in the two groups before and after treatment,then the results were statistically analyzed.Results:1)Total clinical efficacy:The total effective rate was 80.0%in the treatment group while 66.7%in the control group.Compared with the control group,the total clinical efficacy was better in the treatment group(P<0.05).2)Efficacy of TCM syndrome:The effective rate of TCM syndrome in the treatment group was 90.0%,while that in the control group was 83.3%.The curative effect of TCM syndrome in the treatment group was better than control group(P<0.05).3)VAS score of dysmenorrhea;VAS score decreased significantly in both groups after treatment(P<0.01),but the treatment group had more powerful effect than the control group(P<0.01).4)Score of TCM syndrome:The TCM syndrome score of two group were relieved(P<0.01).Compared with the control group,the treatment group was better in improving TCM syndrome(P<0.01).5)Uterine size and RI:After treatment,the size of the uterus in the two groups did not shrink significantly(P>0.05),and there was no obvious discrepancy between the two groups(P>0.05).RI decreased in both groups after treatment(P<0.01),and the effect was more significant than the treatment group(P<0.05).6)CA125,CA199 and HE4:CA125 decreased significantly in both groups after treatment(P<0.01),and the effect of treatment group was better(P<0.05).Both CA199 and HE4 decreased after treatment(P<0.05),but the curative effect of treatment group is similar to control group(P>0.05).7)Safety observation:There were no any abnormalities in the safety indicators such as hepatorenal function before and after treatment in the two groups,and no adverse events occurred during the treatment.Conclusion:Yishen Huayu along with Anshen Dingtong Formula can effectively relieve dysmenorrhea and reduce TCM syndrome score of AM patients with kidney deficiency and blood stasis,and can cut down the level of CA125 and RI.Compared with Sanjie Zhentong capsule,the effect of decoction is better.The method can also reduce CA199 and HE4 in AM patients,but the effect is similar to that of Sanjie Zhentong capsule.Yishen Huayu combined with Anshen Dingtong Formula has no effect on reducing the size of the uterus.In a word,Yishen Huayu along with Anshen Dingtong Formula has definite efficacy for adenomyosis,it is safe and has no toxic side effects at the same time,providing more effective traditional Chinese medicine conservative treatment programs for patients with adenomyosis,which is worthy of further promotion and application in clinic. |