Clinical Study Of Zishen Kangshuai Formula Combined With Phenolactone In The Treatment Of Early-onset Ovarian Insufficiency

Objective:Aim to study the clinical efficacy and safety of professor Zhang Shufen in the treatment of early ovarian dysfunction of deficiency of kidney yin and yang with combination of prescription of nourishing kidney and resisting failure,and to provide a theoretical basis for clinical popularization.Methods : According to the inclusion and exclusion criteria,72 patients with deficiency of kidney yin and yang were collected from August 2017 to October 2018 in Shanxi Provincial Hospital of traditional Chinese Medicine.(Primary ovarian insufficiency,POI was diagnosed as early ovarian insufficiency by western medicine.According to the methods of random,single blind and parallel controlled trial,they were divided into treatment group(n = 36)and control group(n = 36).Continuous treatment for3 months was a course of treatment,followed up for 6 months after treatment,and non-drug meridians were performed after treatment.Serum follicular stimulating hormone(Follicle-stimulating hormone,FSH),estrogen(Estradiol,E2),anti-Mueller tube hormone(Anti-Mullerian hormone,AMH),bilateral ovarian volume,sinus follicular number(Antral follicle count,AFC)were examined for 2 days after the first menstruation.Three months after the end of the treatment,the efficacy of the two groups was evaluated.Using SPSS22.0 software to treat comprehensive curative effect,TCM syndrome curative effect,traditional Chinese medicine(TCM).Symptom score,laboratory indexes: serum follicular hormone(FSH),estrogen(E2),anti-Muller's tube hormone(AMH),bilateral ovarian volume,sinus follicular number(AFC),data analysis.Results:72 cases were included in the experiment,4 cases in the treatment group and4 cases in the control group.The total effective rate was 84.38% in the treatment group and59.38% in the control group,which was more effective than that in the control group(P=0.026<0.05).The therapeutic effect of TCM syndrome in the treatment group was better than that in the control group(P<0.05).The total score of TCM symptoms in the two groups after treatment was significantly lower than that before treatment(P<0.05),and the total score of TCM symptoms in the treatment group was significantly lower than that in the control group after treatment(P <0.01).After treatment,the menstrual cycle,menstrual volume,waist and knee acid cold,frequent nocturnal urination,white or dark complexion,cold and cold shape,decreased libido,low back pain,dizziness and tinnitus,hot flushing and sweating,five upset heat,The score of insomnia amnesia was significantly lower than that before treatment(P<0.05).After treatment,the menstrual volume,waist and knee acid cold,frequent nocturnal urination,white or dark complexion,cold shape and cold,sex were compared between the two groups.Compared with the control group,the scores of low back acid and pain,dizziness and tinnitus,hot flushing and sweating,five upset heat and insomnia amnesia score in the treatment group were significantly lower than those in the control group(P<0.05).In the basic serum sex hormone level,the FSH value of the two groups after treatment was significantly lower than that before treatment(P< 0.01),and the E2 AMH value of the two groups was significantly higher than that before treatment(P< 0.01).After treatment,the FSH value of the treatment group was significantly lower than that of the control group,and the E2 AMH value of the treatment group was significantly higher than that of the control group(P< 0.05).The ovarian volume and the number of sinus follicles in(AFC),group after treatment were significantly higher than those before treatment(P< 0.01),and the number of sinus follicles after treatment was significantly higher than that before treatment(P< 0.01).After treatment,the number of sinus follicles in the treatment group was significantly higher than that in the control group(P< 0.05),but there was no significant difference in ovarian volume between the two groups(P> 0.05).Conclusion:The clinical effect of Zishen Kangshuang combined with fengmotong in the treatment of early ovarian insufficiency(POI)is accurate.It is in improving the score of TCM symptoms(menstrual cycle,menstrual volume,waist and knee acid cold,frequent nocturnal urination,white or dark complexion,cold in shape and afraid of cold).Decreased libido,low back acid and pain,dizziness and tinnitus,hot flushing and sweating,five upset heat,insomnia amnesia),serum FSH,E2,AMH value,bilateral ovarian volume,sinus follicles number were effective.Zishen Kangshuang recipe combined with Finmotong in TCM symptom score(menstrual volume,waist and knee acid cold,frequent nocturnal urination,white or dark complexion,cold shape and fear of cold,decreased libido,low back acid and pain,dizziness and tinnitus,hot tide and sweat,five upset heat,insomnia and forgetfulness),The improvement of serum FSH,E2,AMH value and sinus follicular number was better than that of single drug Femotong.In this study,there were no obvious adverse reactions and toxic and side effects in the clinical application of Zishen Kangshuang combined with fengmotong.It can be considered that the combination of the two drugs is safe and effective in the treatment of early ovarian insufficiency(deficiency of kidney yin and yang)and is worthy of clinical promotion.