| Objective: 1.To evaluate the clinical effect of supplementing Qi and activating blood circulation on adenomyosis with Qi deficiency and blood stasis by using prospective randomized controlled observation method.2.To explore the mechanism of Jiawei Tongmai Huazheng Decoction regulating Wnt/β-catenin pathway and promoting ectopic cell apoptosis in mouse model of adenomyosis.Methods: 1.Clinical trial study: Patients with adenomyosis of Qi deficiency and blood stasis in Department of Gynecology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine were selected as research objects and randomly divided into experimental group and control group.The experimental group was given Jiawei Tongmai Huazheng Decoction,and the control group was given San Jie Zhen Tong Jiao Nang combined with Buzhong Yiqi granules.Traditional Chinese Medicine(TCM)syndrome score,Pictorial Blood Loss Assessment Chart(PBAC)score,uterine volume,CA125,dysmenorrhea VAS score changes before and after treatment were recorded to evaluate clinical efficacy.2.In animal experiments,the model of adenomyosis was established by oral tamoxifen in mice,and the model was determined according to the results of hematoxylin-eosin(HE)staining.The experimental groups were control group,model group,Jiawei Tongmai huazheng decoction group and gestrinone group.After 2 months of drug treatment,serum CA125 and PRL levels of mice were detected by Elisa.The expressions of Wnt,β-catenin,Bax and Bcl-2 were detected by Real-Time PCR and Western Blot.Results: 1.Clinical studies:(1)Baseline data: there were no statistical differences between the experimental group and the control group in age,menstrual cycle,menstrual period,pregnancy number,birth number,abortion number,uterine operation history(P>0.05),which was comparable.(2)TCM syndrome: Compared within the group,TCM syndrome scores of the two groups were decreased after treatment,and the difference was statistically significant(P<0.05);Compared between groups,TCM syndrome scores of test group were lower than control group,and the difference between the two groups was statistically significant(P<0.05).In terms of the curative effect of TCM syndrome,the effective rate of experimental group and control group were 93.33% and 70.97%,respectively,and the difference between the two groups was significant(P<0.05).(3)VAS score of dysmenorrhea: VAS score of both groups was significantly decreased after treatment compared within the group(P < 0.05).The difference between the two groups was significant(P<0.05).(4)PBAC score:Compared within the group,PBAC score decreased in both groups after treatment,and their differences were statistically significant(P<0.05);After treatment,PBAC score in experimental group was lower than that in control group,and the difference between the two groups was statistically significant(P<0.05).(5)Uterine volume: After treatment,uterine volume in both groups decreased,but the difference was not significant(P>0.05).(6)Serum CA125: After treatment,CA125 was decreased in both groups,and the difference was statistically significant(P<0.05);And CA125 in experimental group was lower than that in control group,and the difference was significant(P < 0.05).(7)Clinical comprehensive efficacy: The effective rates of the experimental group and the control group were 90%and 64.52%,respectively,with significant difference between the two groups(P<0.05).2.Animal experiments:(1)HE staining: In the control group,the uterus was intact with continuous muscle layer,and no glandular or interstitial cell invasion was observed.In the model group,the boundary between endometrium and myometrium was blurred,myometrium was hypertrophic,continuity was interrupted,there were membrane glands and interstitial invasion.The muscular layer of Jiawei Tongmai Huazheng Decoction group and gestrinone group was continuous,the boundary between the muscular layer and the intima was basically clear,and no obvious glandular and interstitial cells invaded.(2)Serum CA125 and PRL levels:Elisa results showed that the levels of CA125 and PRL in the model group were higher than those in the control group(P<0.05).Compared with model group,CA125 and PRL levels in Jiawei Tongmai Huazheng Decoction group and gestrinone group were significantly decreased,with statistical significance(P<0.05),but there was no significant difference between the two treatment groups(P>0.05).(3)Expression of wnt3 a and β-catenin:Real-Time PCR and Western Blot results showed that compared with the control group,wnt3 a and β-catenin gene and protein expressions in the model group were up-regulated,while the expressions of Wnt3 a and β-catenin in the Jiawei Tongmai Huazheng Decoction group were down-regulated.(4)Expression of Bax and Bcl-2: Western Blot results showed that the expression of Bax was decreased in the model group,but increased in the Jiawei Tongmai huazheng decoction group.The expression of Bcl-2 was opposite to that of Bax.Conclusions: 1.Clinical research: Jiawei Tongmai Huazheng Decoction can reduce the serum CA125 level and TCM syndrome score of patients with adenomyosis of Qi deficiency and blood stasis,reduce menstrual volume and alleviate dysmenorrhea,and is better than the control group.In addition,Jiawei Tongmai Huazheng Decoction has a significant effect on TCM syndromic efficacy and clinical comprehensive efficacy.It is an effective treatment plan for patients with adenomyosis of Qi deficiency and blood stasis.Although the short-term effect of reducing the size of the uterus is not significant,adenomyosis is a chronic disease that requires long-term management and deserves further study.2.Animal experiments: Jiawei Tongmai huazheng Decoction can reduce the levels of serum CA125 and PRL in adenomyosis model mice and alleviate the progression of lesions.By downregulating the expressions of wnt3 a and β-catenin,the expression of wnt/β-catenin pathway in adenomyosis mice was inhibited,and the apoptosis of ectopic cells in mice was promoted by decreasing the expression of Bcl-2 and enhancing the expression of Bax. |