| ObjectiveBy comparing the outcome indexes and safety indexes of Bushen Jieyu Tiaochong formula,letrozole and combined Chinese and Western medicine in the treatment of infertility of polycystic ovary syndrome(PCOS)with kidney deficiency and liver depression,the clinical efficacy of Bushen Jieyu Tiaochong formula in the treatment of infertility of PCOS with kidney deficiency and liver depression was evaluated,providing clinical trial support for TCM treatment of infertility of PCOS with kidney deficiency and liver depression.MethodsA total of 81 PCOS infertility patients with syndrome differentiation as kidney deficiency and liver depression were collected from September 2020 to March 2023 in the outpatient department of Professor Liu Yanfeng of the Department of Gynecology,Dongzhimen Hospital of Beijing University of Chinese Medicine and the Department of Traditional Chinese Medicine,Beijing Maternal and Child Health Hospital Affiliated to Capital Medical University.They were divided into three groups according to the patients’ will.The western medicine group was treated with conventional Western medicine,and the combined Chinese and Western medicine group was treated with supplementing kidney Jieyu Tiaochong formula on the basis of conventional Western medicine treatment.The treatment course of the three groups was 3 menstrual cycles.The differences of clinical pregnancy rate,periodic ovulation rate,female hormone six items,TCM syndrome score and other indicators among the three groups before and after treatment were compared,and SPSS26.0 was used for statistical analysis to evaluate the efficacy of the three groups.Results1 Pregnancy rate the clinical pregnancy rate was 18.5%(5/27)in the Chinese medicine group,3.7%(1/27)in the western medicine group,and 29.6%(8/27)in the combined Chinese medicine group.Statistical analysis showed that the clinical pregnancy rate in the combined Chinese medicine group was better than that in the traditional Chinese medicine group and the Western medicine group,and there was a statistical difference between the two groups(P=0.011,P<0.0125).2 Ovulation rate the ovulation rate was 43.9%in the Chinese medicine group,75.6%in the western medicine group and 93%in the combined Chinese and Western medicine group.Statistical analysis showed that the three groups had statistical differences in the combined Chinese and Western medicine group,and the combined Chinese and Western medicine group was the best,followed by the Western medicine(P=0.000,P<0.01).The ovulation rate was 43.9%in the Chinese medicine group,75.6%in the western medicine group and 93%in the combined Chinese and Western medicine group.Statistical analysis showed that the three groups had statistical differences in the combined Chinese and Western medicine group,and the combined Chinese and Western medicine group was the best,followed by the Western medicine(P=0.000,P<0.01).3 Serum sex hormone ①LH:The mean value of LH in the TCM group was 10.56 ± 8.59 mIU/mL before treatment and 8.20 ± 5.86 mIU/mL after treatment,with no statistical significance(P=0.063,P>0.05).The mean value of LH in western medicine group was 8.52± 3.40 mIU/mL before treatment and 6.70 ± 3.32 mIU/mL after treatment,and the difference was statistically significant(P=0.044,P<0.05).The mean value of LH in the combination group was 5.66 ±3.74 mIU/mL before treatment and 6.22 ± mIU/mL after treatment,with no statistical significance(P=0.520,P>0.05).There was no significant difference in the difference between the three groups of LH after treatment and before treatment(P=0.207,P>0.05).②FSH:The mean value of FSH in TCM group was 7.18±2.17 mIU/mL before treatment and 7.08±2.06 mIU/mL after treatment,and the difference was not statistically significant(P=0.685,P>0.05).The mean value of FSH in the western medicine group was 6.29± 1.69 mIU/mL before treatment and 5.99 ± 1.90 mIU/mL after treatment,with no statistical significance(P=0.426,P>0.05).The mean value of FSH in the combination group was 5.95 ± 1.98 mIU/mL before treatment and 6.01 ± 1.84 mIU/mL after treatment,and the difference was not statistically significant(P=0 777,P>0.05)There was no significant difference in the difference of FSH between the three groups after treatment and before treatment(P=0.826,P>0.05).③T:The mean T of the TCM group was 0.66±0.41 ng/L before treatment and 0.43±0.23 ng/L after treatment,and the difference was statistically significant(P=0.044,P<0.05).The T mean of western medicine group was 0.43 ± 0,16 ng/L before treatment and 0.36 ± 0.11 ng/L after treatment,and the difference was not statistically significant(P=0.088,P>0.05).The T mean of the combined group was 0.55 ± 0.46 ng/L before treatment and 0.45 ± 0.16 ng/L after treatment,and the difference was not statistically significant(P=0.888,P>0.05).There was no significant difference in T between the three groups after treatment and before treatment(P=0.327,P>0.05).④LH/FSH:The mean value of LH/FSH in TCM group was 1.59 ± 1.54 before treatment and 1.20±0.71 after treatment,with no statistical significance(P=0.191,P>0.05).The mean value of LH/FSH in the western medicine group was 1.42 ± 0.65 before treatment and 1.10± 0.48 after treatment,with no statistical significance(P=0.091,P>0.05).The mean value of LH/FSH in the combination group was 0.90 ± 0.41 before treatment and 0.99 ± 0.63 after treatment,and the difference was not statistically significant(P=0.494,P>0.05).There was no significant difference in LH/FSH between the three groups after treatment and before treatment(P=0.156,P>0.05).4 TCM syndrome scoring ①Total score:the mean score of TCM syndrome in the TCM group was 17.64±5.18 before treatment and 9.23±4.73 after treatment,the difference was statistically significant(P=0.000,P<0.01).The mean TCM syndrome score of the western medicine group was 15.62 ± 4.60 before treatment and 11.54±4.31 after treatment,and the difference was statistically significant(P=0.002,P<0.01).The mean TCM syndrome score of the combined group was 16.37± 5.11 before treatment and 8.74± 4.38 after treatment,and the difference was statistically significant(P=0.000,P<0.01).The results of comparison among the three groups showed that the difference values of TCM syndrome scores in the TCM group and the TCM combination group were significantly greater than those in the western medicine group(P<0.05).② Main symptoms(menstrual score):the menstrual cycle,menstrual volume and blood clot score in the TCM group were decreased after treatment compared with before treatment(P<0.05);The transchromatic score decreased slightly after treatment compared with before treatment,but the difference was not statistically significant(P=0.052,P>0.05)The scores of menstrual cycle and menstrual volume in western medicine group were decreased after treatment compared with before treatment(P<0.05).Menstrual color and blood clot score decreased slightly after treatment compared with before treatment,but the difference was not statistically significant(P>0.05).In the combination group,the menstrual cycle and menstrual color score were decreased after treatment compared with before treatment(P<0.05).Menstrual volume and blood clot score decreased slightly after treatment compared with before treatment,but the difference was not statistically significant(P>0.05).There were no significant differences in menstrual cycle,menstrual volume,menstrual color and blood clot score among the three groups(P>0.05).③ Secondary symptoms(symptoms of kidney deficiency and liver depression):lumbosacral soreness,tibia acid knee weakness or heel pain,dizziness,hypolibido,frequent nocturnal urination,irritability and irritability or emotional depression,chest and hypochondriac discomfort or belching sighing scores in the TCM group were all decreased after treatment compared with before treatment(P<0.05);Tinnitus and milk distension scores decreased slightly after treatment compared with before treatment,but the difference was not statistically significant(P>0.05).The scores of lumbosacral soreness,tibia acid knee weakness or heel pain,tinnitus,hypolibido,frequent nocturnal urination,irritability and irritability or emotional depression,chest and stomach discomfort or belching in western medicine group decreased slightly after treatment compared with before treatment,but the difference was not statistically significant(P>0.05).The milk distension score was higher after treatment than before treatment,and the difference was statistcally significant(P<0.05).The score of emotion after treatment was higher than that before treatment,and the difference was not statistically significant(P>0.05).The scores of lumbosacral soreness,tibial acid knee weakness or heel pain,tinnitus,hypolibido,milk distension,chest and stomach discomfort or belching were decreased after treatment compared with before treatment in TCM and Western medicine combination group(P<0.05).Dizziness,nocturnal frequent urination,irritability and emotional depression scores decreased slightly after treatment compared with before treatment,but the difference was not statistically significant(P>0.05).There were no significant differences in the scores of tibia acid,knee weakness or heel pain,dizziness,tinnitus,bypolibido frequent nocturnal urination,chest and stomach discomfort or belching(P>0.05)The differences of lumbosacral soreness,irritability and depression scores in TCM group were higher than those in western medicine group(P<0.05).The difference of milk distension score between TCM group and TCM combined group was higher than that of western medicine group(P<0.05).5 The total effective rate was 88.9%in the Chinese medicine group,55.6%in the western medicine group and 81.5%in the combined Chinese and Western medicine group.The curative effect of the Chinese medicine group and the combined TCM group was significantly better than that of the western medicine group(P<0.01),but there was no difference between the Chinese medicine group and the combined TCM group(P>0.05).6 Safety evaluation No adverse reactions such as rash,nausea,diarrhea and vomiting were observed during medication.7 Observation of complications During treatment,the incidence of LUFS of unruptured follicles was 0%in the Chinese medicine group,3.5%in the combined Chinese and Western medicine group,and 17.9%in the western medicine group.Statistical analysis showed that the incidence of LUFS in the Chinese medicine group and the combined Chinese and Western medicine group was lower than that in the Western medicine group(P<0.0125).There was no significant difference between the two groups(P=0.125,P>0.0125).No ovarian hyperstimulation syndrome(OHSS)was observed during treatment.During treatment,1 case of biochemical pregnancy was observed in the western medicine group,while no biochemical pregnancy was observed in the Chinese medicine group and the combined Chinese and Western medicine group.ConclusionsBushen jieyu Tiaochong formula has definite clinical effect PCOS infertility patients with kidney deficiency and liver depression.It can reduce serum testosterone level,improve the menstrual condition of patients,and alleviate the clinical manifestations of kidney deficiency and liver depression.On the basis af combined letrozole for excretion promotion,it can obtain better clinical pregnancy rate and cycle ovulation rate,and reduce the occurrence of follicular luteinization,with good safety.It provides a certain idea for clinical diagnosis and treatment of PCOS infertility,and is worth further popularization and application. |
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