| ObjectiveThe aim of this study was to observe the clinical effect and safety of Erxian Decoction on the thoroughfare and conception vessels disharmaony’s perimenopausal syndrome caused by breast cancer endocrine therapy and to provide theoretical and clinical evidence to improve the compliance of endocrine therapy.MethodSelf-contrast clinical observation research method was used.Erxian Decoction or decoction granules as well as endocrine therapy were given to the patients who meet the inclusion criteria in order to observe the Erxian Decoction’s effectiveness and safety.The effectiveness was evaluated mainly by Kupperman’s score,Greene scale,TCM syndrome score,and quality of life assessment(KPS).Safety evaluation is mainly through laboratory tests,such as blood routine test,liver function,renal function,blood lipids,estrogen,ECG and adverse events.The treatment cycle was 8 weeks.The the above indicators were observed in the first visit,the fourth week,and the eighth week.Before and after treatment,all laboratory tests were performed.Paired sample t test(or paired sign rank sum test)and repeated measures analysis of variance were used.ResultA total of 55 patients with an average age of 47.02±6.70 years and between 29-60 years old and median age was 48 years old were enrolled in this study.After 1 month and 2 months treatment of Erxian Decoction,the Kupperman total score,Greene score and TCM symptom score were analyzed.The results showed that the total score before and after treatment changed significantly(P < 0.05).In addition,with the extension of treatment,the symptoms improved more obviously.After treatment,the changing rate of each symptom was analyzed by non-parametric wilcoxon test of two related samples.It is indicated that most of the symptoms were significantly changed.The more the treatment circle was,the more obvious improvement were.KPS score didn’t change.Further subgroup analysis of different kind of endocrine drugs and age group suggest that no significant difference of perimenopausal syndrome improvement was found in different groups.ConclusionErxian Decoction is an effective prescription for perimenopausal syndrome caused by breast cancer endocrine therapy.It has good clinical efficacy and good safety and can be applied to all kinds of endocrine drugs and all age groups.It is worth further expanding the sample,a longer period of follow-up,with a view to providing more evidence of clinical support. |