Objective:Based on the theory of "tongbu qijing",the clinical efficacy of acupuncture and Traditional Chinese Medicine(TCM)in the treatment of PCOS-IR patients with kidney deficiency and phlegm dampness was observed,and the idea and mechanism of its effect was discussed,so as to provide a more effective and convenient treatment method for PCOS-IR.Methods:In this study,98 PCOS-IR patients who met the inclusion criteria were enrolled from the Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital from August 2019 to March 2021 were selected as the research objects,and a randomized controlled clinical design was adopted.According to the inclusion criteria,the patients were randomly divided into treatment group(acupuncture and TCM group)and control group(metformin group).The treatment group was treated with TCM and acupuncture under the guidance of the theory of "tongbu qijing",while the control group was treated with metformin.The treatment time of the two groups was 3 menstrual cycles.The main therapeutic indicators included TCM syndrome score,menstrual condition(cycle,menstrual period),ovulation rate,pregnancy rate;The effect indicators included BMI,WHR,hirsute,acne,sex hormone levels(LH,FSH,LH/FSH,T),insulin resistance indexes(FPG,FTNS,HOMA-IR),bilateral ovarian volume,number of small follicles in early follicular stage.The clinical possible adverse events and drug reactions,such as nausea,vomiting,diarrhea,hematoma,etc.,were closely observed and recorded during the study period.Safety indicators,such as blood pressure,pulse,liver and kidney function,were measured before and after treatment.The above indicators were evaluated at observation points before enrollment and after 3 menstrual cycles of treatment,and the data obtained were statistically analyzed by SPSS 24.0.Results:1.After treatment,the total effective rate of the treatment group was 88.9%,and the total effective rate of the control group was 66%,the treatment group was better than the control group,the difference was statistically significant(P < 0.05).The ovulation rate(80.31%)and pregnancy rate(50%)in treatment group were significantly higher than ovulation rate(62.02%)and pregnancy rate(17.64%)in control group,and the difference was statistically significant(P < 0.05).2.The comparison within the two groups showed that the scores of TCM symptoms,menstrual status(period,menstrual volume),insulin resistance indexes(FPG,FTNS,HOMA-IR),bilateral ovarian volume and the number of small follicles in the early follicular stage were significantly decreased in the two groups after treatment compared with before treatment,the differences within the groups were statistically significant(P < 0.05).The physical sign(BMI,WHR,hirsutism,acne)and the early follicular sex hormone levels(LH,FSH,LH/FSH,T)in the treatment group were decreased significantly after treatment,and the differences within the groups were statistically significant(P < 0.05).The BMI,WHR,LH,LH/FSH and T in the control group decreased significantly after treatment,and the differences within the groups were statistically significant(P < 0.05),while there were no significant abnormality in the improvement of hirsutism,acne and FSH,the difference within the groups were not statistically significant(P > 0.05).3.The comparison between groups showed that the differences of the TCM symptom score,the menstruation situation(cycle,the amount),hairy,acne,early follicular phase sex hormone levels(LH,FSH,LH/FSH,T),a small number of follicle,ovulation rate and pregnancy rate in the treatment group were significantly higher than that in the control group.The difference between the two groups were statistically significant(P < 0.05).while there was no significant improvement in the signs of BMI,WHR,insulin resistance index(FPG,FTNS,HOMA-IR)and bilateral ovarian volume in early follicular stage between the two groups.The difference between the two groups were not significant(P > 0.05).Conclusion:1.Based on the theory of "tongbu qijing",the combination of acupuncture and TCM can effectively improve the TCM symptoms of PCOS-IR patients with kidney deficiency and dampness,adjust the menstrual cycle and menstrual volume.2.Based on the theory of "tongbu qijing",the combination of acupuncture and TCM can effectively improve the ovulation rate and pregnancy rate of PCOS-IR patients with kidney deficiency and phlegm-dampness,and the mechanism is considered to be related to the improvement of reproductive endocrine and IR of patients,thereby improving patients’ obesity and kaohsien signs,reducing ovarian volume and promoting follicle growth.3.Based on the theory of "tongbu qijing",the combination of acupuncture and TCM showed no obvious abnormalities were observed in the safety indicators,with low adverse reactions and clinical loss rate,high safety and good patient compliance.4.Based on the theory of "tongbu qijing",the combination of acupuncture and TCM in the treatment of PCOS-IR with deficiency of kidney and dampness of phlegm is effective and worthy of promotion. |