| Objective:To observe the clinical efficacy of Jinlida Granule combined with metformin in the treatment of polycystic ovary syndrome(PCOS)with insulin resistance(IR),and to provide more clinical evidence for the treatment of polycystic ovary syndrome with insulin resistance(PCOSIR)by traditional Chinese medicine.Methods: According to the corresponding inclusion and exclusion criteria,60 patients in the first affiliated hospital of Guang Xi University of Traditional Chinese Medicine from January 2018 to January 2019 were diagnosed with polycystic ovary syndrome with insulin resistance and who met the spleen deficiency and dampness syndrome.Divided into 2 groups of 30 cases each.Both groups received metformin hydrochloride 0.5g Bid oral treatment and received a balanced diet and appropriate exercise as the basic treatment;the observation group was treated with Jinlida Granule 9g Tid orally on the basis of the control group for 3 months.Three months is a course of treatment,followed up once a month.Before treatment and 3 months after treatment,TCM syndrome score,acne score,waist circumference,six sex hormones,fasting insulin(FINS),fasting blood glucose(FPG),blood lipid were measured,BMI and HOMA-IR were calculated,and comprehensive efficacy and safety were analyzed.During monthly follow-up,drug use,diet and exercise,and adverse reactions were recorded.Results:(1)TCM syndrome scores were compared: the syndrome scores of the two groups were lower than those before treatment,and the symptoms were better than before treatment(P<0.05).The syndrome scores of the observation group were more significant than those of the control group(P<0.01).(2)Comprehensive efficacy: the total effective rate of the observation group was 97%,and the total effective rate of the control group was 90%.The observation group was better than that of the control group(P < 0.05).(3)BMI and waist circumference comparison: BMI and waist circumference of the observation group and the control group were lower than those before treatment(P<0.05).The observation group was superior to the control group in reducing BMI and waist circumference(P<0.05).(4)Comparison of acne scores: The acne condition of the two groups was significantly improved compared with that before treatment(P<0.01);the acne in the observation group was better than the control group(P<0.05).(5)FINS,FPG,HOMA-IR comparison: FINS,HOMA-IR decreased before treatment(P<0.05),and the observation group improved the insulin resistance better than the control group(P<0.05).There was no significant difference in the improvement of FPG between the two groups(P>0.05).(6)Comparison of blood lipids: TC,TG,LDL-C values decreased,HDL-C increased in both groups after treatment,compared with before treatment(P<0.05),the observation group was better than the control group(P<0.05).(7)Sex hormone comparison: After treatment,the LH,LH/FSH and T values of the two groups decreased compared with those before treatment(P<0.05),and the effect of the observation group was better than that of the control group(P<0.05);after treatment,the LH,T,LH/FSH values of the two groups had significant differences,and the effect of the observation group was better than that of the control group(P<0.05).The FSH value of the two groups increased slightly after treatment(P < 0.05),and there was no significant difference between the observation group and the control group(P > 0.05).(8)There was no obvious abnormality in safety monitoring of patients in observation group and control group,no adverse events and no obvious adverse reactions occurred.Conclusions: 1.Jinlida Granule combined with metformin tablets can effectively control insulin resistance,significantly alleviate the TCM syndromes of PCOS-IR patients with spleen deficiency and phlegmdampness syndrome in Pregnancy preparation,and improve glycolipid metabolism.The comprehensive effect of Jinlida Granule is better than metformin group.2.Jinlida Granule combined with metformin tablets can effectively regulate hormone levels(decrease total testosterone and luteinizing hormone)and clinical manifestations of hyperandrogenism and hyperandrogenism in pregnant PCOS-IR patients with spleen deficiency and phlegm-dampness syndrome.Its mechanism may be indirect regulation of sex hormone level by improving insulin resistance,reducing glycolipid metabolic disorder and controlling body weight.A deeper mechanism needs to be further studied.3.In the treatment of PCOS-IR patients with spleen deficiency and phlegm-dampness syndrome during pregnancy,there was no obvious abnormal safety index or obvious adverse drug reaction. |
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