| ObjectiveThe study was conducted to abserve the effect of Shuganjiangzhi tablet acting on high risk population with dyslipidemia of postmenopausal women with early breast cancer in the adjuvant setting of nonsteroidal aromatase inhibitors(AIs)(letrozole or anastrozole)through exploratory clinical research,in the case of a lifestyle intervention,in order to evaluate the efficacy of Shuganjiangzhi tablet adjusting lipid levels of high risk population with dyslipidemia of postmenopausal women with early breast cancer in the treatment of nonsteroidal AIs,providing reference for clinical medication.MethodsIn this prospective,randomized,controlled study,33 eligible postmenopausal patients with estrogen and/or progesterone receptor positive early breast cancer were randomly divided into treatment group and control group.17 patients were assigned to control group(blank control),and 16 were assigned to receive shuganjiangzhi tablet,the treatment group,and lifestyle intervention was performed in both groups,with a course of 3 months.The syndromes of Traditional Chinese Medicine(TCM)were evaluated at baseline and the third month,and assessment of total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C)were performed at baseline,the first month and the third month.Results The study enrolled 33 patients,and all of the control group and 13 of the treatment group underdone the course and had data available for analysis.1.Effects on lipid profile:the control group had 12 patients therapeutic among 17 women(70.6%),as compared with 7 patients therapeutic among 13 women(53.8%)in the treatment group,which had no significant difference(P>0.05).There was no significant difference in levels of TC5 TG,LDL-C and HDL-C of the treatnent group at baseline and the third month(P>0.05).There was no significant difference in the change of lipid levels between the treatment group and the control group before and after treatment(P>0.05).2.Effects on TCM syndrome:the TCM syndrome points of the treatment group at baseline and the third month were statistically significantly different(P=0.018).The symptoms,irritability and hot temper,chest tightness and distention changed statistically significantly(P=0.025)of the treatment group before and after treatment.There was statistically significant differences of chest tightness and distention between treatment group and control group(P<0.05).The total response rate of TCM syndromes in the treatment group and the control group was 30.8%(4/13)vs 23.5%(4/17),respectively.The total response rate in the treatment group was slightly better compared with the control group,but with no statistically significant difference(P>0.05).There was no significant difference in the change of TCM syndrome scores between the treatment group and the control group before and after treatment(P>0.05).Cold chills in extremities,soft knees,burning sensation of five centers,chest tightness and distention,nocturnal make water at the third month compared with that at baseline of the treatment group were statistically significant different from the control group(P<0.05).At the third month,there were statistically significant differences between the treatment group and the control group in terms of cold chills in extremities,soft knees,burning sensation of five centers,chest tightness and distention,nocturnal make water(P<0.05).The difference of tiredness and fatigue was,short red urine of the control groups was statistically significant(P<0.05)at the third month compared with that at baseline.Conelusion1.In this study,Shuganjiangzhi tablet did not adjust the lipid levels of high risk population with dyslipidemia of patients with early breast cancer in the treatment of nonsteroidal AIs,which may be associated with the defect of the sample content and research design,as well as syndrome differentiation points of Shuganjiangzhi tablet and the inconsistency of syndrome types of patients of high risk population with dyslipidemia in the treatment of nonsteroidal Als with early breast cancer.According to previous research results,Shuganjiangzhi tablet can reduce TG levels in patients with non-alcoholic fatty liver disease,as a result,the drug may still be studied in this field.2.In this study,Shuganjiangzhi tablet can improve some TCM symptoms of high risk population with dyslipidemia of postmenopausal women with early breast cancer in the treatment of nonsteroidal aromatase inhibitor(AIs)endocrine therapy,which mainly manifested in terms of irritability and hot temper,chest tightness and distention. |
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