Research purpose:Through clinical randomized controlled study,the Yishen Jianpi Ointment and Fenmotong Tablets were compared.The clinical data of TCM symptoms,E2,FSH,LH,FSH/LH,AMH,OV,AFC,clinical total effective rate and pregnancy rate before and after treatment were analyzed.The clinical efficacy of Yishen Jianpi Ointment in the treatment of DOR patients was observed,and the clinical basis for the treatment of DOR was provided.Research method:A total of 60 patients diagnosed as DOR and in line with the syndrome of spleen and kidney deficiency in TCM were collected from the department of gynaecology of Changzhou Hospital of Traditional Chinese Medicine.According to the random number table method,they were randomly divided into the experimental group(Yishen Jianpi Ointment)and the control group(Fenmotong Tablets).The patients were treated for three menstrual cycles.The TCM symptom scores,E2,FSH,LH,FSH/LH,AMH,OV,AFC,clinical total effective rate,and pregnancy after treatment and three months of follow-up were compared between the two groups,and the adverse reactions of the two groups were observed.Research results:(1)TCM syndrome scores:After three menstrual cycles,the comparison between the two groups showed that the main TCM symptoms,secondary TCM symptoms and total TCM symptoms were significantly lower than those before treatment,and the differences were statistically significant(P<0.01).The comparison between the two groups showed that the main TCM symptoms,secondary TCM symptoms and total TCM symptoms in the experimental group were significantly lower than those in the control group,and the differences were statistically significant(P<0.05).Statistical analysis of the main symptoms of TCM in the two groups showed that menstrual cycle,menstrual volume,menstrual color quality,lumbar and knee weakness and fatigue were improved compared with those before treatment,and the difference was statistically significant(P<0.05).Compared between the two groups,the improvement of TCM symptoms in the experimental group was better than that in the control group,and the difference was statistically significant(P<0.05).(2)Comparison of the levels of sex hormones and AMH between the two groups:Comparison of the two groups after treatment,the E2 group after treatment was higher than before treatment,the difference was statistically significant(P<0.01),the FSH,FSH/LH two groups after treatment were lower than before treatment,the difference was statistically significant(P<0.01).After treatment,both groups of AMH were higher than before treatment,the difference was statistically significant(P<0.01),but there was no significant change between the two groups of LH treatment compared with before treatment,and the difference was not statistically significant(P>0.01).After treatment,there was no statistically significant difference between the two groups in terms of FSH,FSH/LH,and LH(P>0.05).The E2 test group was lower than the control group,and the difference was statistically significant(P<0.05).AMH test The group was higher than the control group,the difference was statistically significant(P<0.05).(3)Comparison of ovarian parameters:Comparing the two groups after treatment,the AFC of the two groups was improved compared with that before treatment,and the difference was statistically significant(P<0.01).The OV of the two groups was not significantly improved compared with before treatment,and the difference was not statistically significant(P>0.01);In comparison between groups,the experimental group was better than the control group in terms of the increase in the number of AFCs,and the difference was statistically significant(P<0.05).The overall experimental group was more than the control group in terms of the increase in the volume of OV,but the difference was not statistically significant(P>0.05).(4)Comparison of clinical efficacy and pregnancy rate:After the treatment of the two groups of patients,the efficacy analysis found that the total clinical effective rate of the experimental group was 89.3%,which was higher than 81.5%of the control group.However,a statistical analysis of the two groups found that the comparison between the two groups was χ2=4,507,P=0.212,which was not statistically significant(P>0.05).Comparing the pregnancy status of the two groups of patients after treatment for 3 menstrual cycles and follow-up for 3 months,it was found that the pregnancy rate of the test group after treatment for 3 menstrual cycles was 10.7%(3/28),and the pregnancy rate of the control group was 3.7 after treatment.%(1/27);After 3 months of follow-up,it was found that the pregnancy rate in the test group was 17.9%(5/28),and the pregnancy rate in the control group was 7.4%(2/27).However,a statistical analysis of the two groups found that the comparison between the two groups after treatment was χ2=1.002,P=0.317,followed up for 3 months χ2=1.351,P=0.245,which was not statistically significant(P>0.05).Research conclusion:Yishen Jianpi ointment was better than the control group in terms of improving TCM symptoms,AMH and AFC.There was no statistical difference between the two groups in terms of FSH,LH,FSH/LH,OV,clinical total effective rate and improvement of pregnancy rate,indicating that Yishen Jianpi ointment is better than the control group in clinically improving the TCM symptoms,AMH and AFC of patients with DOR,and is equivalent to Fenton tablets in terms of FSH,LH,FSH/LH,OV,clinical total effective rate and pregnancy rate.In addition,the Yishen Jianpi ointment has good safety and no obvious side effects. |