The Study Of Zishen Yutai Pill On Intervention Of Kidney Deficiency Type PCOS Patients With Infertility Ovulation

ObjectiveTo discuss the pathogenesis of Polycystic ovary syndrome (PCOS) ovulation inhibition, analysis of endometrial thickness and morphology, serum sex hormone level, Anti-Mullerian hormone (AMH), uterine artery blood flow index, body mass index factors such as the influence of the pregnancy outcome in patients with PCOS infertility, as well as the correlation of AMH and serum levels of Testosterone (T), Luteinzing hormone (LH). To investigate intervention effect about ovulation induction of Zishen Yutai pill.which affected PCOS infertile patients of kidney deficiency type. Then expanded cinical eff ecacy about "kidney dominating reproduction" of Zishen Yutai pill. The subject provided the clinical evidence and research approach that using tradictional Chinese medicine of tonifying kidney to treat PCOS infertile patients who has ovulation inhibition for further study.Method1. Retrospective cohort study:Reasearcher inquiried the outpatient electronic medical records which were illed with "irregular menstruation" "Polycystic ovarian syndrome", "female infertility", accroding to the outpatient electronic medical record system of information section in gynecology of traditional Chinese medicine department, Western medicine gynecology department and reproductive department, from He Xian Memorial Hospital Affiliated to Southern Medical University. In strict accordance with the inclusion criteria and exclusion criteria to collect medical records which contained ill with PCOS infertile patients who has ovulation inhibition between January 2010 and December 2013. Then these patients have induced ovulation 1～6 menstrual cycle treatment by two groups, and there are 395 cases. The patients who in first group had 186 people by oralling clomifene crtrate, the patients who in second group had 209 people by oralling clomifene crtrate combination Zishen Yutai pill. The reasearcher adapted retrospectie cohort study, designed information Excel table and filled the information as required, made Excel worksheet, data inputting and created statistical database,used statistical software SPSS22.0 for analysis.Data collection:The content of information included age, menstrual history, reproductive history, infertility time, infertility type, endometrial thickness when Human chronic gonadotropin(HCG) was intramusculared, endometrial morphology of ovulatory time, treatment of the cycle of induced ovulation, the total mumber of optimal follicle in the cycle of induced ovulation, the total mumber of ovulation in the cycle of induced ovulation, the mumber of Luteinized unruptured follicle syndrome (LUFS), the mumber and clinical manifestations of Ovarian hyper-stimulation syndrome (OHSS), the number of pregnancies, the number of twins or multiple births, times of abortion, mumber of live birth, ect.2. Prospective study:By adopting the method of clinical case randomized controlled study, according to the principle of simple digital random, put the PCOS infertile patients of kidney deficiency type that 60 people who accordanced with the inclusive criteria divided into two groups, that one group was clomifene crtrate, another group was clomifene crtrate combination Zishen Yutai pill, from Affilicted He Xian Memroial Hospital, Southern Medical University, between June 2014 and May 2015. Then these patients have induced ovulation 3 menstrual cycle treatment by two groups. Observed the following index changes before and after treatment of two groups of patients:body mass index(BMI), serum sex hormone level, AMH, TCM syndrome score, endometrial morphology, change about pulsatility index(PI)and Resistance index of the uterine artery blood(RI), and after treatment the following index changes: endometrial thickness when HCG was intramusculared, cycle follicle-stimulating rate, cycle ovulation rate, incidence rate of LUFS, incidence rate of OHSS, pregnancy rate, twin or multiple pregnancy rate, first trimester abortion rate.Result1. Retrospective study:1.1 Average endometrial thickness when HCG was intramusculared:The endometrial thickness of treatment group (clomifene crtrate combination Zishen Yutai pill) was superior to control group (clomifene crtrate) after treatment, difference had statistical sence (P<0.05)1.2 Ovulatory period of morphology of endometrium:type A endometrium of treatment group was superior to control group, difference had statistical sence(P< 0.05). There was no statistically significant difference in treatment group and control group about type B endometrium (P>0.05). type C endometrium of treatment group significantly lower than the control group, difference had statistical sence(P<0.05).1.3 Stimulate ovulation aspects:In the aspect of cycle follicle-stimulating rate, cycle ovulation rate and incidence rate of LUFS, treatment group significantly lower than the control group, difference had statistical sence(P<0.05).1.4 Pregnancy:The pregnancy rate of treatment group was superior to control group, difference had statistical sence(P<0.05). The abortion rate of treatment group was lower than the control group, the live birth rate of treatment group was superior to control group, difference had statistical sence (P<0.05). Twin or multiple pregnancy rate of treatment group was lower than the control group, but there was no statistically difference (P>0.05).2. Prospective study:2.1 BMI:There has statistically significant difference in treatment group and control group in comparison before and after treatment(P< 0.05). The treatment group and control group in comparison after treatment, there was no statistically significant difference(P>0.05).2.2 Sex hormone:The treatment group and control group of serum T、LH、 LH/FSH after treatment compared with before treatment, difference had statistical sense(P<0.05). The treatment group and control group of serum FSH level increased after treatment, and there were statistically significant difference about FSH before and after treatment (P<0.05). The treatment group and control group of serum LHn LH/FSH after treatment, difference had statistical sense(P< 0.05). And there were no statistically significant difference about T, FSH after treatment (P>0.05).The treatment group and control group of serum AMH after treatment compared with before treatment, difference had statistical sense(P< 0.05).The treatment group and control group in comparison after treatment, there was statistically significant difference(P<0.05). Treatment group and control group about AMH with T, LH before treatment was significant correlation. Treatment group after treatment AMH with T was weak correlation, and no correlation with LH. The control group after treatment AMH and T, LH still was significant correlation.2.3 TCM syndrome score:The treatment group compared before and after treatment, the difference was statistically significant(P<0.05). There was no statistically significant difference about the control group compared before and after treatment (P> 0.05). The difference was statistically significant about the treatment group and control group after treatment(P <0.05).2.4 The uterine artery blood flow parameters:The treatment group of uterine artery PI-. RI after treatment compared with before treatment, difference had statistical sense(P< 0.05). There was no statistically significant difference before and after treatment about the control group of uterine artery PI..RI(P>0.05). The difference was statistically significant after treatment about the treatment group and control group of uterine artery PI、RI(P<0.05).2.5 Endometrial thickness when HCG was intramusculared:The average endometrial thickness of treatment group was superior to control group after treatment, difference had statistical sence (P<0.05)2.6 Endometrial morphology:Two groups of cases before treatment were priority to with type B endometrium. After treatment, the treatment group with type A endometrium was priority to, the control group was priority to with C endometrium. Treatment group and control group in the treatment of type A, C endometrium compared after the treatment, the difference was statistically significant(P<0.05). Treatment group and control group in the treatment of type B endometrium compared after the treatment, the difference was no statistically significant (P>0.05).2.7 Stimulate ovulation aspects:In the aspect of cycle follicle-stimulating rate and cycle ovulation rate, treatment group slightly lower than the control group,but there was no statistically significant difference (P>0.05). In the aspect of incidence rate of LUFS, treatment group lower than the control group, difference had statistical sence(P<0.05).2.8 Pregnancy:The pregnancy rate of treatment group was superior to control group, but there was no statistical difference (P>0.05). The abortion rate and twin or multiple pregnancy rate of treatment group were significantly lower than the control group, but there were no statistical difference (P >0.05).Conelusion1. Zishen Yutai pill can improve PCOS infertility abnormal serum sex hormone and AMH level. Effectively reduced the serum LH, T and AMH level, and improved the FSH level, adjusted the LH/FSH ratio.AMH could also be one of the predictors about PCOS stimulate ovulation infertility treatment effect.2. Zishen Yutai pill can make the thin endometrium thick ing, and increase the proportion of the treatment cycle type A endometrial, thus improve the endometrial morphology, increase uterine blood flow perfusion, to improve the receptivity of endometrium.3. Zishen Yutai pill in improving patients with PCOS infertility had advantages in the respect of kidney deficiency syndrome of TCM and BMI.4. There were synergies effect that treating PCOS infertile patients by clomifene crtrate combination Zishen Yutai pill. To improve the quality of the ovum, and promote a single ovulation. The rates of LUFS and abortion were reduced. And the rates of pregnancy and live birth were increased significantly. The total effect of treatment group was better than that of control group.