Clinical Efficacy Of Blood-activating And Anti-Cellulite Granules Combined With Low-Dose Mifepristone In The Treatment Of Adenomyosis With Qi Stagnation And Blood Stasis

ObjectiveThis study is intended to carry out a randomized and controlled study in the department of gynecology of Shanxi Provincial Hospital of Traditional Chinese Medicine with patients with adenomyosis of qi stagnation and blood stasis as the research object.The purpose is to evaluate the efficacy of low-dose mifepristone combined with Huoxue Xiaozheng granules in the treatment of patients with adenomyosis of qi stagnation and blood stasis,as well as the safety and effectiveness of medication,including the improvement of dysmenorrhea symptoms,the change of menstrual volume,the change of uterine volume,And TNF-α、The changes of E₂、serum CA125 levels and the mechanism of action were discussed.MethodsBased on the diagnostic basis of Chinese and Western medicine and inclusion and excluding criteria,73 cases were identified from outpatients and inpatients of gynaecology department of Shanxi Provincial Hospital of Traditional Chinese Medicine from November2021 to October 2022.A randomized trial with control was designed.Patients in the therapeutic group started oral administration of mifepristone tablets（dose:12.5mg/d）on the first day of menstruation and the in-hospital preparations of blood activation and anti-cancer granules（specification:15g/bag,dose:1 bag/time,3 times/d）on the first day after menstruation for 3 months.In the control group,mifepristone tablets（dose:12.5mg/d）were taken orally on the first day of menstruation for 3 months.The clinical curative effects of low-dose mifepristone combined with blood activating and anti-stasis granules in the treatment of adenomyosis with qi stagnation and blood stasis were investigated and evaluated by observing the changes in dysmenorrhea symptom score,menstrual volume,TCM syndrome score,VAS pain scale,uterine volume and serum TNF-α,E2 and CA125 in the two groups before and after medication,and observing the safety indicators during the treatment.Results（1）Menstrual blood loss score（PBAC）:compared with the pre-treatment period,the menstrual blood loss score was significantly reduced in the two groups after therapy（P<0.001）,and the reduction in the score in the experimental group was more apparent than that in the control group（P<0.05）.（2）Serum CA125,TNF-α,E₂:compared to the pre-treatment period,the serum levels of CA125,TNF-α,E₂were significantly reduced in both groups after medical therapy（P<0.001）,and the reduction in E2 was more significant in the pilot group than in the control group（P<0.001）.（3）Pain VAS score:compared to the pre-treatment group,the pain VAS score was significantly reduced in both groups after treatment（P<0.001）,and the experimental group had a significant reduction compared to the control group（P<0.001）.（4）Uterine volume:compared with the pre-treatment period,the uterine volume in the two groups was significantly reduced after treatment（P<0.001）,and there was a statutory discrepancy between the experimental group and the control group in terms of uterine volume reduction（P<0.001）.（5）Dysmenorrhoea symptom score:After receiving treatment,the dysmenorrhoea symptom scores of patients in both groups were significantly lower than before（P<0.001）,and the data in the laboratory group was more prominent than that in the control group（P<0.001）.（6）Chinese medicine certificate points:Before and after receiving treatment,the Chinese medicine symptom points of patients in the two groups have been significantly different（P<0.001）,and the reduction of points in the experimental group was more significant（<0.001）.（7）Integrated curative effect:The general curative effect of the test group tallied91.9%,and that of the control group was 75.1%,with a statistically significant difference in the integrated curative effect of the test group compared with the control（P<0.05）.（8）Adverse reactions:There were 3 negative incidents in the control group,or 8.3%,and 1 negative incident in the experimental group,or 2.7%,with no statistical discrepancy in the adverse drug reactions between the two groups（P=0.587>0.05）.（9）When the patients were followed up after 3 months of medication discontin uation,the menstrual blood loss cycle score（PBAC）,pain VAS score and dysmenor rhoea symptom score were statistically significantly lower in both groups compared t o the pre-treatment period（P<0.001）,and the difference was more significant in the treatment group than in the control group（P<0.001）.ConclusionThe combination of low-dose mifepristone with blood activating and anti-cellulit e granules was superior to low-dose mifepristone in terms of reducing serum E2 an d TNF-αlevels,reducing menstrual flow,lowering pain VAS scores,reducing uterin e volume,improving dysmenorrhea and its related symptoms,improving Chinese me dicine symptoms related to Qi stagnation and blood stasis,and overall efficacy.