| Objectives:To explore the possible mechanisms of Qingxin Zishen method(clearing heart fire and nourishing kidney),and lay the foundation for the standardized treatment of traditional Chinese medicine in patients with Diminished Ovarian Reserve(DOR).Methods:We randomized 60 women diagnosed as DOR with syndrome of disharmony between heart and kidney into two groups,according to the Western Medicine and the TCM syndrome diagnostic criteria,with 30 in each one,who were treated in gynecology clinic of Jiangsu Province Hospital of Chinese Medicine from January 2018 to December 2018.The treatment group were treated with modified Qingxin Zishen Decoction,and the control group were treated with Kun Tai capsules.The changes of menstruation,clinical symptoms,FSH,LH,FSH/LH,E2,Anti-Mullerian Hormone(AMH)and Antral Follicle Count(AFC)were observed in the two groups of patients before and after treatment.The statistical analysis was applied to the results,in order to evaluate the clinical efficacy and safety of Qingxin Zishen method in the treatment of DOR.Results:1)Total effective rate:The treatment group’s the total effective rate was 86.67%,while the control group was 70.00%.The total effective rate of the treatment group was statistically higher than the control group(P<0.05).2)TCM syndrome effective rate:The treatment group’s effective effect was 90.00%,while the control group was 76.67%.Compared with the control group,the treatment group was superior to the control group in improving clinical symptoms(P<0.05).3)TCM symptom scores:The TCM syndrome scores of the two groups were significantly lower than before(P<0.01)and the improvement of the treatment group was more obvious compared with the control group(P<0.05),4)Serum sex hormone levels:After treatment,serum sex hormone levels were improved in both groups(P<0.01).Compared with the control group,the treatment group had a significant advantage in lowering serum FSH level and increasing E2 level(P<0.05),but no significant advantage in reducing serum LH(P>0.05).5)AMH level:After treatment,serum AMH level in both groups were higher than before(P<0.01),and the treatment effect of the two groups was similar(P>0.05).6)AFC:After treatment,the AFC of the two groups were both increased(P<0.01)and two groups had the similar effects(P>0.05).7)Safety observation:There were no obvious abnormalities in the safety indexes before and after treatment in the two groups,and no adverse events occurred during the treatment.Conclusions:The Qinxin Zishen method has excellent clinical effects on DOR patients with syndrome of disharmony between heart and kidney.Compared with Kuntai Capsule,Qingxin Zishen decoction can significantly improve the clinical symptoms,serum sex hormone levels,AMH level and AFC of patients with DOR.The Qinxin Zishen method can improve ovarian function effectively and safely,which is worthy of clinical promotion. |