Evaluation Of The Clinical Efficacy Of "Invigorating The Spleen And Tonifying The Kidney" Method Conbined With Clomiphene Citrate On The Pregnancy Rate Of Infertility PCOS Patients

Objective:The purpose of this study is to observe the clinical efficacy of"Invigorating the spleen and tonifying the kidney" method conbined with Clomiphene Citrate(CC)on the pregnancy rate of Obese PCOS with IR patients,and to evaluate the effectiveness and safety of the treatment plan.Also,by observing the changes in the endocrine hormones,metabolism and inflammatory cytokine,to explore the therapeutic mechanism of the chinese medicine in hope of increasing the pregnancy rate.Method:118 obese PCOS with IR patients were randomly assigned into control group and treatment group,59 cases in each group.The observation period consist of 2 course of treatment,the duration for each course was 3 menstrual cycles.In the first course of treatment,both groups were treated with Clomiphene Citrate,while the treatment group were additionally given "invigorating spleen and tonifying kidney"decoction.In the second course of treatment,the control group entered into observation phase,while the treatment group were given "invigorating spleen and tonifying kidney" decoction.The endocrine hormones,metabolism and inflammatory cytokine were tested before and after confirmed pregnancy or after the treatmentResults:(1)TCM syndrome score:the individual TCM syndrome score and total TCM syndrome score were significantly lower in the treatment group as compared to the control group(P<0.05).The curative rate and total effective rate for the control group were 6.8%and 84.7%,the curative rate and total effective rate for the treatmnet group were23.7%and 96.6%,the difference between both groups were significant(P<0.05)(2)Pregnancy rate:After the treatment,the pregnancy rate of control group was 11.9%,while the pregnancy rate of treatment group was 27.1%,the differences between two groups were significant(P=0.036)(3)Laboratory test index:The levels of E2,FSH,LH,LH/FSH ratio,T and TG were significantly improved in both groups after the treatment,but the differences between the two groupds were insignificant(P>0.05).The levels of DHEAS,AMH,FBG,FINS,HOMA-IR value,TC,LDL-C and TNF-? in the treatment group were significantly reduced as compared to the control group(P<0.05),while the SHBG and HDL-C level were significantly increased in the treatment gorup as compared to the control group(P<0.001).(4)There were no abnormalities in the liver function,kidney function and complete blood count.There were 2 cases of side effects in the treatment group and 4 cases of side effects in the control group.Conclusion:(1)The "invigorating spleen and tonifying kidney" decoction combined with CC can significantly improved the clinical symptoms of the obese PCOS with IR patients.(2)The "invigorating spleen and tonifying kidney" decoction combined with CC can significantly increase the prenancy rate of the obese PCOS with IR patients.(3)The "invigorating spleen and tonifying kidney" decoction combined with CC can significantly regulate the SHBG,AMH and DHEAS levels,improve the glycolipid metabolism and reduce the chronic inflammatory state of the obese PCOS with IR patients.(4)There were no significant hepatorenal toxicity in the use of chinese medicine,thus it is safe and effective to be recommended.