| BackgroundDecreased ovarian function can cause menstrual disorders,low fertility,and increased risk of long-term cardiovascular disease.Its prevention and treatment has always been a hot and difficult point in the field of reproductive medicine.A number of clinical studies have shown that TCM treatment has advantages in improving ovarian function and increasing pregnancy rate.However,most of the current Chinese medicine researches set the treatment time at 3 months(3 menstrual cycles),to a certain extent,it is difficult to reflect the clinical characteristics of traditional Chinese medicine intervention time in improving ovarian function and improving pregnancy rate in different stages of the disease and rules.On the basis of inheriting the "Essence and Blood Theory" of Professor Cai Lianxiang,a famous Chinese doctor in the capital,my tutor Dr Huang Yuxiao has been using Bushenjing and Tianjing Therapy to treat ovarian function decline in recent years,and has achieved better clinical outcomes.While working,we discovered that patients with this disease have high disease heterogeneity due to different degrees of ovarian dysfunction.Patients with different stages of ovarian function decline have different therapeutic effects after treatment with traditional Chinese medicine.With the increase of treatment time of traditional Chinese medicine,the improvement of ovarian function and fertility may be more obvious.Based on the real-world data of the tutor’s outpatient medical records,this study will use a retrospective research method to analyze the dynamic changes of ovarian function outcome indicators,pregnancy outcomes and influencing factors in patients who with decreased ovarian reserve and treated by Bushenjing and Tianjing Therapy.In addition,this study used the Generalized Additive Mixed Model(GAMM)to explore the relationship between the treatment time of traditional Chinese medicine and related meaningful variables,in order to play a guiding role in the clinical application of traditional Chinese medicine in the treatment of ovarian reserve function decline.Objective1.Through the outpatient information service platform of our hospital,this research retrospectively studied the clinical data of patients with decreased ovarian reserve diagnosed and treated by Dr Huang,analyzed the clinical characteristics of patients with decreased ovarian function,and preliminarily explored the related outcome indicators of ovarian function and menstruation after different intervention time,and the dynamic changes of DOR/POI and the influencing factors of the treatment of DOR/POI were also analyzed.2.Through the outpatient information service platform of our hospital,this research retrospectively studied the clinical data of patients who had reduced ovarian reserve,wishsd to become pregnant and treated by Dr Huang,analyzed the pregnancy rates of those patients after treatment of Bushenjing and Tianjing Therapy,and comprehensively evaluated The effect and influencing factors of Bushenjing and Tianjing Therapy on pregnancy rates in patients with ovarian function decline.Methods1.A retrospective study on the effect of Bushenjing and Tianjing Therapy on ovarian function in patients with decreased ovarian functionWe will collect medical records of patients who diagnosed decreased ovarian reserve and treated by Dr Huang from January 2019 to January 2022.Patients who met the inclusion and exclusion criteria will be divided into the early group(meeting the DOR diagnostic criteria but not the Premature Ovarian Insufficiency(POI)diagnostic criteria)and the POI group(meeting the POI diagnostic criteria).The GAMM model will be used to explore the relationship between Chinese medicine treatment time and meaningful variables,IPTW will be used to control potential confounding factors,and analyze the dynamic changes of ovarian function outcome indicators related to different stages of ovarian function decline in patients with different intervention times.The patients with different curative effects after treatment in the two groups were grouped for analysis,and the univariate and univariate logistic regression analysis was used to preliminarily explore the influencing factors of the curative effect of Bushenjing and Tianjing Therapy in the treatment of DOR and POI.2.A retrospective study on the effect of Bushenjing and Tianjing Therapy on ovarian function in patients with decreased ovarian functionCollecting the medical records of outpatient who had ovarian function decline and wanted to have a baby from January 2019 to January 2022,and analyzing the pregnancy rates after treatment with the Bushenjing and Tianjing Therapy at different intervention times.Patients who meeted the inclusion and exclusion criteria were divided into pregnant group and non-pregnant group.Monofactor analysis and Multiplefactor binary logistic regression analysis were used to analyze the data.Results1.A retrospective study on the effect of Bushenjing and Tianjing Therapy on ovarian function in patients with decreased ovarian function1.1 General situationThe average age of the 140 patients included in the study was 35.26±4.00 years old,and 69.29%of the patients had a disease course of more than 2 years.The stratified study found that 93.83%of the patients in the early group had a disease course of less than 5 years,and 52.54%of the patients in the POI group had a disease course of more than 5 years.In the early group,58 cases(71.60%)had normal menstrual cycle,19 cases(23.46%)had normal menstrual flow,and 70 cases(86.40%)had normal menstrual period.In the POI group,40 patients(67.80%)had late menstruation,19 patients(32.20%)had amenorrhea,19 patients(32.20%)had normal menstrual flow,and 28 patients(47.46%)had normal menstrual periods.In the early group,51(62.96%)basal follicle-stimulating hormone(bFSH)<25IU/L,37(45.68%)anti-Müllerian hormone(AMH)≥0.5ng/mL,61 cases(72.31%)of antral follicle count(Antral follicle count,AFC)≥3,POI group 46 cases(77.97%)bFSH>40IU/L,57 cases(96.61%)AMH<0.2ng/ml,26 cases(44.07%)AFC>3.The average treatment time of 140 patients was 4.43±2.04 months,of which the shortest treatment time was 2 months and the longest treatment time was 12 months.There was no significant difference in age,pregnancy times,delivery times,past history,age at menarche,and treatment time between the two groups.There were significant differences between the two groups in disease course,menstrual cycle,menstrual period,menstrual volume,and baseline ovarian function-related indicators(bFSH,AMH,AFC)(P<0.05).1.2Influence of Bushenjing and Tianjing Therapy on Ovarian Function(1)Impact on MenstruationThere were significant differences in menstrual scores and syndrome scores between the two groups of treatment time ≤3 months,3-6 months,and>6 months(P<0.05).In the early group,after at least 2 months of Bushenjing and Tianjing Therapy,the menstrual cycle of the early menstrual patients returned to normal,and the menstrual cycle of 9 patients(47.37%)of the late menstrual cycle returned to normal.In the POI group,26 cases(65.00%)of late menstrual period returned to normal menstrual cycle,and 15 cases of amenorrhea(35.00%)had menstrual recurrence at least once.(2)Impact on Ovarian FunctionThere were significant differences in bFSH,AMH and AFC levels between the two groups before and after treatment with traditional Chinese medicine(P<0.01).GAMM model was used to explore the relationship between TCM treatment time and meaningful variables.With the increase of TCM treatment time,the level of FSH gradually decreased,and the decreasing rate of FSH slowed down after 6 months of treatment.By analyzing the change trend of bFSH according to the stage of disease development,it was found that the bFSH level of the patients in the early group showed a downward trend,and dropped to the normal range(bFSH<10 IU/L)after 5 months of treatment,and then maintained until 12 months.The decreasing trend of bFSH level in POI group was rapid before 5 months of Chinese medicine treatment,and basically maintained at 20 IU/L level after 5 months.With the increase of traditional Chinese medicine treatment time,the change trend of AMH level first increased,then decreased,and finally increased again.The increase rate of AMH reached the highest after 5 months of treatment,and the lowest increase rate at 9 months.Analyzing the change trend of AMH according to the stage of disease development,it was found that AMH in the early group was positively correlated with the increase in treatment time.After 6 months of treatment,the change in AMH was small and maintained above 1.Ong/mL;the AMH level in the POI group increased first After 5 months of treatment,it remained stable,rose to the highest point after 5 months of treatment,and maintained a fluctuation below 0.2 ng/ml after 5 months of treatment.With the increase of traditional Chinese medicine treatment time,the AFC level first increased,then decreased,and finally increased again.The increase rate of AFC reached the highest after 5 months of treatment,and the lowest rate at 9 months.Analyzing the change trend of AFC according to the stage of disease development,it was found that the AFC of the patients in the early group was positively correlated with the increase of the treatment time.After 7 months of treatment,the number of AFC changed little and maintained at about 7;the AFC of the POI group increased first and then remained stable.It rose to the highest point after 5 months of treatment,and remained at about 3 after 5 months.1.3Analysis of Influencing Factors on treatment effects of Bushenjing and Tianjing Therapy(1)Analysis of the influencing factors on treatment effects of the early group with Bushenjing and Tianjing TherapyIn the study,among the 81 patients in the early group,23 patients had AMH returned to normal(>1.1ng/mL),accounting for 28.4%,and 58 patients had not returned to normal(≤1.1ng/mL),accounting for 71.6%.After logistic univariate regression analysis,it was found that the course of disease,menstrual cycle,AMH,AFC and treatment time were the influencing factors of the curative effect of the early group that treated by Bushenjing and Tianjing Therapy.(2)Analysis of the influencing factors on treatment effects of the POI group with Bushenjing and Tianjing TherapyAmong the 59 POI patients included in the analysis,19 cases had FSH decreased to below 15IU/L,accounting for 32.20%,and 40 cases did not decrease to 15IU/L,accounting for 67.80%.After logistic univariate regression analysis,it was found that whether amenorrhea was an influencing factor for the efficacy of Bushenjing and Tianjing Therapy for the POIgroup.(P<0.05).2.A retrospective study on the effect of Bushenjing and Tianjing Therapy on ovarian function in patients with decreased ovarian function2.1 General situationOf the 164 patients included in the analysis,the average age was 34.12±3.21 years old,87.2%of the patients were older than 30 years,65.24%of the disease duration was longer than 2 years,70.12%were infertile,and 81.10%of the patients never gave birth.Forty-three patients(26.22%)received assisted reproductive intervention in the past,but none of them became pregnant.The number of assisted reproductive interventions was at least 1 and at most 5.81.09%of patients had FSH distributed between 10-25 IU/L,39.02%of patients had AMH≥0.5 ng/mL,and 50.00%of patients had AFC between 3-5.The average intervention duration was 4.5±2.46 months,the shortest intervention duration was 2 months,and the longest intervention duration was 12 months.The intervention duration of 89 patients(54.27%)was within 3 months.2.2Pregnancy rate of patients with decreased ovarian function after the treatment of Bushenjing and Tianjing TherapyThere were 42 cases of pregnancy after the treatment of Bushenjing and Tianjing Therapy,accounting for 25.61%,36 cases of natural pregnancy and 6 cases of assisted reproductive pregnancy.The pregnant 6 patients who received assisted reproductive pregnancy were also patients who had failed assisted reproductive pregnancy in the past.Among the pregnant patients,14 cases were treated within 3 months,19 cases were treated within 3 to 6 months,and 10 cases were treated for more than 6 months.Among the 36 patients with natural pregnancy,13 cases(36.11%)were alive,12 cases(33.34%)were still pregnant,and 11 cases(30.55%)resulted in miscarriage.Among the 6 pregnant cases who had assisted reproductive treatment,1 case(16.67%)gave birth,3 cases(50.00%)were still pregnant,and 2 cases(33.33%)resulted in miscarriage.2.3Univariate factor analysis of the effect of Bushenjing and Tianjing Therapy on patients with decreased ovarian functionAfter monofactor analysis,it was found that there were significant differencesj in the course of disease,menstrual cycle,menstrual period,bFSH,AMH,AFC and treatment time between the pregnant group and the non-pregnant group(P<0.05).2.4Multi-factor analysis of the effect of Bushenjing and Tianjing Therapy on patients with decreased ovarian functionThe course of disease,menstrual cycle,FSH,AMH,AFC,and treatment time were included in Multi-factor analysis,and the results showed that the length of treatment time(3-6 months OR value=5.474,95%Cl=2.124-14.109,P=0.000<0.001,>6 months OR=5.474,95%Cl=1.162-10.957,P=0.026<0.05),normal menstrual cycle(OR=3.626,95%Cl=1.207-10.897,P=0.022<0.05),AFC≥6(OR=0.369,95%Cl=0.138-0.990,P=0.048<0.05),AMH≥0.3ng/mL(OR=4.709,95%Cl=1.637-13.546,P=0.004<0.05)were the factors that influencing pregnancy rate.Conclusion1.It is preliminarily confirmed that the treatment of Bushenjing and Tianjing Therapy can not only improve scores of menstruation and syndrome in patients with DOR/POI,menstrual regularity rate in patients with late menstrual period,menstrual recovery rate in patients with amenorrhea,and increase AMH and AFC levels,but also reduce the level of FSH.2.With the prolongation of the intervention time of Bushenjing and Tianjing Therapy,the levels of FSH,AMH,and AFC gradually improved,and the improvement trend gradually slowed down after 6 months of intervention.3.Patients with normal menstrual cycle,AFC,disease duration ≤2 years,and AMH≥0.5ng/mL maybe the dominant group for early stage of DOR patients who treated with Bushenjing and Tianjing Therapy.Menstrual oligomenorrhea may be the dominant group for the treatment of POI patients who treated with Bushenjing and Tianjing Therapy.4.It is preliminarily confirmed that Bushenjing and Tianjing Therapy can improve the pregnancy rate of patients with decreased ovarian function,and Pregnancy rates will increase with longer treatment time.5.Treatment time>3 months,normal menstrual cycle and AMH≥0.3ng/mL are the influencing factors of pregnancy in patients with ovarian function decline treated by Bushenjing and Tianjing Therapy. |
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