Clinical Safety Study Of Treatment Of Polycystic Ovary Syndrome(including Aconite And Pinellia)

Objective To evaluate the clinical safety and effectiveness of wenyang huatan decoction containing aconite and pinellia in the treatment of spleen-kidney Yang deficiency and phlegm-dampness blocking collaterals type polycystic ovary syndrome,and to provide a new idea for the treatment of PCOS.Subjects PCOS patients with spleen-kidney Yang deficiency and phlegm-dampness obstruction syndrome differentiation were selected according to inclusion criteria.After signing the informed consent,they were given Wenyang Huatan decoction.Blood routine tests(WBC,RBC,HB,PLT,NEUT),liver and kidney function(ALT,AST,CR,BUN),myocardial enzymes(CK-MB,LDH)were taken before treatment,3-7 days after treatment and 30 days after treatment,respectively.To determine their own basic conditions and assess whether there are side effects;before and at least 1month after treatment,patients' TCM syndrome score,uterine accessory color doppler ultrasound and sex hormones(LH,T,LH/FSH)were observed,and paired t-test(or paired symbolic rank sum test)was used to evaluate the efficacy after comparison.Result From October 2017 to October 2018,37 patients with polycystic ovary syndrome(pcos)whose syndrome differentiation is characterized by spleen-kidney Yang deficiency and phlegm-dampness blocking collaterals were collected from our hospital.During the treatment period,3 cases(4.11%)had post-drug reactions,mainly manifested as hand anesthesia,irritability and nausea.The symptoms were mild,and the patients could tolerate and relieve themselves in a short time,and all of the related safety indexes were within the normal range.Comparing the changes of blood,heart,liver and kidney toxicity of Wenyang Huatan Decoction with Aconite and Pinellia ternata before and after taking medicine in PCOS patients,the results showed that WBC,RBC,HB,PLT,NEUT,ALT,AST,Cr,BUN,CK-MB,LDH and electrocardiogram of PCOS patients had no obvious abnormalities in both mean value and numerical value(P> 0.05),and had no obvious abnormalities before taking medicine.Abnormal P LT and ALT also play a therapeutic role(P< 0.05).Comparing the changes of sex hormone,color Doppler ultrasonography of uterine appendages and symptoms of patients with PCOS before and after treatment with Wenyang Huatan Decoction containing aconite and Pinellia ternata,the results showed that T,LH and LH/FSH of patients with PCOS after treatment had statistical significance(P<0.05)in both mean value and normal value(P=0.01<0.05),and there was a uniform difference in the normal value of uterine appendages before and after treatment with color Doppler ultrasonography(P=0.01<0.05).The symptoms of the patients were significantly improved before and after treatment,and the effective rate was 91.7%.The menstrual cycle and cold limb symptomswere the most obvious improvement.The overall effective rate was78.4% according to the evaluation criteria formulated after referring to the Guiding Principles for Clinical Research of New Chinese Medicines issued by the Ministry of Health.Conclusion The Wenyang Huatan Decoction containing aconite and Pinellia ternata has no obvious toxicity to blood,heart,liver and kidney in PCOS patients with spleen-kidney Yang deficiency and phlegm-dampness obstruction.It has certain effect in regulating menstrual cycle,improving clinical symptoms,reducing androgen T,LH and LH/FSH,and has good clinical application prospects.However,due to the small sample size,incomplete observation indicators,greater flexibility in clinical trials and more influencing factors,its effectiveness and safety deserve further study.