Clinical Study Of Zichong Prescription In Treating Decreasing Ovarian Reservation

Objective:On the basis of previous studies on Zichong Decoction Promoting Follicular development,To further carry out the clinical study of Zichong Decoction in the treatment of Decreasing Ovarian Reservation（DOR）.Method:1、Source of cases:Patients with DOR diagnosed in the tutor clinic of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from May2018 to January 2020 were collected.Conduct retrospective study2、Diagnostic criteria:according to《the expert consensus on ovarian hyporesponsiveness》^[13]（2015 reproductive medicine branch of Chinese Medical Association）and《practical gynaecological endocrinology》^[14]（2nd Edition）,the diagnostic criteria of DOR were:18 years old≤age<40 years old;clinical manifestations were decreased menstrual volume or delayed cycle or no pregnancy;10 m IU/ml<basal serum FSH≤40 m IU/ml,AMH<1.1ng/ml,or AFC<6.Inclusion criteria:（1）18 years old≤age<40 years old;（2）Dor meeting the inclusion criteria of Western Medicine（decreased ovarian reserve function）;（3）Not taking any hormones and drugs having impact on reproductive endocrine（3 months before treatment）.3、Methods:the general data（age,course of disease,history of gynecological operation,height and weight,BMI）of the patients were collected retrospectively.Patients were given zichong Decoction:prepared rehmannia,dodder,wolfberry and other drugs.Decoction,one dose a day,three doses a day,about 200ml each time,menstruation stop taking.3 months（or 3 menstrual cycles）is a course of treatment.Using the self before and after control research method in the matching design,analyze and compare the scores of TCM syndrome,menstruation,AMH,FSH,AFC,and the calorific value of reproductive location（non menstruation）before and after treatment.If there is a menstrual cycle,the blood hormone should be measured 2-3days after menstruation.Patients with amenorrhea were measured before and after treatment.Using the medical infrared imaging system（adt-yl-100a）to measure the metabolic calorific value of Shenque,Dumai,lower abdomen,uterus,left and right appendages.Then according to the FSH value stratification,the patients were divided into low FSH group（10 m IU/ml<FSH≤25 m IU/ml）and high FSH group（25m IU/ml<FSH≤40 m IU/ml）to observe the AMH,FSH and AFC before and after treatment,without comparison between the two groups.According to the AMH value,41 patients were divided into three groups:AMH≤0.1 m IU/ml,0.1 m IU/ml<AMH≤0.5 m IU/ml,0.5 m IU/ml<AMH≤1 m IU/ml.AMH,FSH and AFC were observed before and after treatment in each group.4、Evaluation criteria:observation indexes:TCM syndrome score,menstruation score,AMH,FSH,AFC,and calorific value of reproductive location（Shenque,Dumai,lower abdomen,uterus,left and right appendages）of infrared scanning.According to the《guiding principles for clinical research of new drugs of traditional Chinese medicine》^[15],the clinical comprehensive efficacy evaluation standard is formulated to calculate the efficacy index"n"according to the nimodipine method.Recovery:FSH and AMH basically return to normal or increase with AFC,and TCM syndrome score is reduced by≥90%;significant effect:FSH and AMH are significantly improved after treatment or increase with AFC,90%>TCM syndrome score is reduced by≥75%;effective:FSH and AMH are improved after treatment or increase with AFC,75%>TCM syndrome score is reduced by≥30%;ineffective:There was no improvement or aggravation of FSH and AMH or no improvement of AFC,and the TCM syndrome score decreased<30%.5、Statistical methods:the information was input into the database and analyzed by SPSS 22.0.Result:41 eligible patients were included,with an average age of 35.4±4.1 years;30patients with ovarian,fallopian tube,uterus and other related gynaecological operation history,accounting for 73.2%;the average course of disease was 12.4±9.4months;the average BMI was 21.9±2.2;the number of people with menarche age at the stage of 13-14 years was 21,accounting for 51.2%;（1）The comprehensive curative effect rate was 14.63%,significant effect was19.51%,effective rate was 43.9%,total effective rate was 78.04%.AMH was 0.07（0.01-0.39）ng/ml before treatment and 0.24（0.04-0.07）ng/ml after treatment,and the level of AMH increased after treatment（P<0.01）;The level of FSH was 23.27（15.48-32.54）miu/ml before treatment and 13.03（8.70-23.67）miu/ml after treatment（P<0.01）;AFC increased 2（0-3）before treatment and 3（0-5）after treatment（P<0.01）.（1）FSH stratification:no matter high FSH group or low FSH group,there were differences in AMH and FSH before and after treatment.There was no statistical significance in AFC after treatment in high FSH group（P>0.05）.In the low FSH group,AMH was 0.26（0.07-0.66）ng/ml before treatment and0.56（0.23-1.10）ng/ml after treatment,which increased after treatment（P<0.01）;FSH was 16.62（13.01-22.69）m IU/ml before treatment and 8.9（7.90-14.20）m IU/ml after treatment,which decreased significantly（P<0.01）;after treatment,AFC was 4（1-6）after AFC 3（0-5）,which increased after AFC treatment（P<0.01）.In the high FSH group,AMH was 0.01（0.01-0.06）ng/ml before treatment and0.05（0.01-0.08）ng/ml after treatment,which increased after treatment（P<0.01）;FSH was 33.8±4.93 before treatment and 26.98±11.24 after treatment,which decreased significantly（P<0.05）;AFC was 0.00（0.00-1.75）before treatment and1.00（0.00-2.80）after treatment（P>0.05）.（2）AMH segment:23 persons in low AMH group:AMH before treatment 0.01（0.01-0.06）ng/ml,after treatment 0.05（0.02-0.12）、FSH before treatment 29.54±7.96 m IU/ml after treatment 23.22±11.50 m IU/ml,there was significant difference before and after treatment（P<0.01）;AFC before treatment 0.00（0.00-1.00）after treatment 0.00（0.00-2.00）,there was no significant difference before and after treatment（P>0.05）;11 persons in middle AMH group:AMH before treatment0.29±0.11ng/ml ng/ml,after treatment0.58±0.25 ng/ml、FSH before treatment17.98±5.44 m IU/ml after treatment 10.46±3.45 m IU/ml,there was significant difference before and after treatment（P<0.01）;AFC before treatment 2.91±1.81 after treatment 4.00±2.10,the difference was statistically significant before and after treatment,P<0.05;7 persons in high AMH group:AMH before treatment0.82±0.15ng/ml ng/ml,after treatment1.20±0.16 ng/ml、FSH before treatment13.69±3.57 m IU/ml after treatment 7.67±1.78 m IU/ml,there was significant difference before and after treatment（P<0.01）;AFC before treatment 4.43±1.40 after treatment 7.14±1.68,the difference was statistically significant before and after treatment,P<0.05。（2）Before treatment,the total score of TCM syndrome was 12.00（8.00-17.00）,after treatment,4.00（2.00-11.00）,after treatment,the score decreased significantly（P<0.01）;before treatment,the score of menstruation was 6.00（4.00-10.00）,after treatment,2.00（0.00-6.00）,after treatment,the score decreased significantly（P<0.01）;（3）A total of 16 patients completed infrared thermal imaging scanning before and after treatment,and 96 regional calorific values were measured.The results showed that:after treatment,the calorific value of reproductive location of all patients was higher than that before treatment,Shenque:31.11（30.78-31.46）before treatment,31.26（30.73-31.67）after treatment;Dumai calorific value:31.17±0.58before treatment,31.54±0.58 after treatment;Calorific value of lower abdomen:29.76±0.39 before treatment,29.83±0.26 after treatment;Calorific value of uterus:29.29±0.53 before treatment,29.29±0.53 after treatment;Left adnexa calorific value:29.68±0.32 before treatment,29.82±0.42;Right adnexa calorific value:29.58±0.42before treatment,29.71±0.53;There was no statistical significance in the above regional differences（P>0.05）.Conclusion:Zichong decoction can improve the clinical symptoms of DOR patients,increase the number of sinus follicles,improve the level of AMH,reduce the level of FSH,and regulate endocrine.Zichong decoction can improve the hormone levels of DOR patients in different AMH and FSH stages,and Zichong decoction is an effective drug for the treatment of mild and moderate DOR.