| ObjectiveTo observe the clinical effect of modified Danggui Shaoyao San on endometriosis dysmenorrhea and explore its mechanism.MethodsFrom January 2019 to December 2020,the patients suffering from endometriosis dysmenorrhea were selected in Guangdong Hospital of Chinese Medicine.Patients will be randomly assigned to modified Danggui Shaoyao San group and Marvelon group.They will be treated with modified Danggui Shaoyao San and Marvelon,respectively for three menstrual cycles.The changes of Visual Analog Scale(VAS),dysmenorrhea symptom score,Traditional Chinese Medicine(TCM)syndrome score,CA125,CD4+T lymphocytes,CD8+T lymphocytes and CD4+/CD8+T lymphocytes will be observed,comparing before and after treatment.Serum of patients before and after treatment were collected to examine the serum levels of NGF,TNF-α,TGF-β1 and VEGF by ELISA.The variation of each index within and between groups will be recorded and analyzed.Results1.In terms of baseline data,there were no significant difference between modified Danggui Shaoyao San group and Marvelon group in age,duration of dysmenorrhea,history of dysmenorrhea,VAS,dysmenorrhea symptom score,TCM syndrome score,CA125,CD4+T lymphocytes,CD8+T lymphocytes,CD4+/CD8+T lymphocytes,NGF,TNF-α,TGF-β1 and VEGF before treatment(P>0.05),indicating comparability.2.Compared with before treatment,VAS and dysmenorrhea symptom score in modified Danggui Shaoyao San group and Marvelon group decreased after treatment,with statistical significance(P<0.05).There was no significant difference in VAS and dysmenorrhea symptom score in two groups after treatment(P>0.05).After patients followed up in three mentrual cycles,the VAS in the Chinese medicine group was lower than the Western medicine group,with statistical significance(P<0.05).Compared with before treatment,TCM syndrome score in two groups reduced after treatment,with statistical significance(P<0.05).After treatment,TCM syndrome score in TCM group was lower than western medicine group,with significant difference(P<0.05).3.Compared with before treatment,there was no significant difference in serum level of CA125 in two groups after treatment(P>0.05).The serum level of CD4+T lymphocytes in modified Danggui Shaoyao San group and Marvelon group increased after treatment compared with before treatment,with statistical significance(P<0.05).After treatment,the serum CD4+T lymphocytes level in the modified Danggui Shaoyao San group was higher than the Marvelon group,and the difference was statistically significant(P<0.05).Compared with before treatment,the serum level of CD8+T lymphocytes in modified Danggui Shaoyao San group and Marvelon group reduced after treatment,with statistical significance(P<0.05).There was no significant difference in serum level of CD8+T lymphocytes between two groups after treatment(P>0.05).The serum CD4+/CD8+T lymphocytes level in modified Danggui Shaoyao San group and Marvelon group rose after treatment compared with before treatment,with statistical significance(P<0.05).No significant difference was observed in serum level of CD4+/CD8+T lymphocytes between two groups after treatment(P>0.05).4.Compared with before treatment,the serum level of NGF in modified Danggui Shaoyao San group and Marvelon group decreased after treatment,with statistical significance(P<0.05).After treatment,the serum NGF level in modified Danggui Shaoyao San group was lower than the Marvelon group,and the difference was statistically significant(P<0.05).The serum level of TNF-α,TGF-β1 and VEGF in modified Danggui Shaoyao San group and Marvelon group reduced after treatment compared with before treatment,with statistical significance(P<0.05).There was no significant difference in serum level of TNF-α,TGF-β1 and VEGF between two groups after treatment(P>0.05).Conclusion1.Modified Danggui Shaoyao San and Marvelon had similar efficacy in alleviating VAS and dysmenorrhea symptom score.Modified Danggui Shaoyao San was more effective than Marvelon in reducing TCM syndrome score.In terms of long-term efficacy in treatment of dysmenorrhea,modified Danggui Shaoyao San was better than Marvelon.2.Modified Danggui Shaoyao San and Marvelon had no significant effect on serum CA125 level.Modified Danggui Shaoyao San was more effective than Marvelon in increasing serum CD4+T lymphocytes level.Both modified Danggui Shaoyao San and Marvelon could decrease serum CD8+T lymphocytes level and increase serum level of CD4+/CD8+T lymphocytes,and the two treatments had similar efficacy.3.Modified Danggui Shaoyao San decreased serum NGF level more significantly than Marvelon.Both modified Danggui Shaoyao San and Marvelon could reduce serum level of TNF-α、TGF-β1 and VEGF,and the two were equivalent. |