| OBJECTIVE: To observe the clinical efficacy and safety of Shenling Baizhu Powder combined with beinaglutide on polycystic ovary syndrome with spleen deficiency and excessive dampness.METHODS: Using the clinical randomized controlled study method,64 patients who were eligible for spleen deficiency and dampness type PCOS were selected from the endocrine and gynecology outpatient clinics of the Affiliated Hospital of Chengdu University of TCM,and 4 cases were shed.30 cases were divided into treatment group and control group of 30 cases by using the randomized numerical method,and the treatment group was treated with Shenling Baizhu Powder combined with beinaglutide,while the control group was treated with beinaglutide alone.The clinical symptoms,obesity-related indexes,glucose metabolism indexes,blood lipid profile,sex hormone hormone levels and other indexes of patients in both groups were observed.All data were analyzed statistically using SPSS26.0 statistical software.Results: 1.TCM symptoms: the symptom scores of both the treatment and control groups decreased significantly(P<0.05),more significant decrease in the treatment group(P < 0.01).2.Clinical efficacy: the effective rate of the treatment group was 93.33%,and the effective rate of the control group was 83.33%,and the efficacy of the treatment group was better(P < 0.05).3.Weight,BMI,waist circumference,and WHR: The weight,BMI,waist circumference,and WHR of patients in both groups decreased significantly(P<0.05),and more significant decrease in the treatment group(P <0.05).4.Glucose metabolism: both treatment regimens reduced the values of FPG,2h PG,FINS,2h INS,and HOMA-IR after treatment(P<0.05),and the treatment group was more significant in reducing FPG,FINS,and HOMA-IR(P < 0.05).5.As for lipid metabolism: both treatment regimens improved patients’ TC,TG,HDL-C,LDL-C(P<0.05),and the difference was not statistically significant between two groups(P > 0.05).6.Sex hormone levels: FSH,LH,LH/FSH,and T values improved in both groups after treatment;compared between groups,the differences were statistically significant(P < 0.05)in LH,LH/FSH,and T values,and no statistically significant in FSH values(P > 0.05).7.In uterine ultrasound imaging: the number of follicles in the affected sinus decreased in both groups after treatment(P < 0.05);the efficacy was comparable in both groups(P > 0.05).8.Safety analysis: the general vital signs of patients in both groups were stable and liver and kidney functions were normal during treatment;the gastrointestinal reactions in the treatment group were significantly less(P< 0.05).Conclusion: Shenlingbaizhu Powder with beinaglutide can significantly improve the clinical treatment efficiency of patients with PCOS with spleen deficiency and dampness,improve the TCM symptoms and menstrual cycle,reduce body weight and BMI,regulate glucose metabolism,improve insulin resistance and sex hormone levels with no serious adverse effects,and provide a new idea for the clinical treatment of PCOS. |