| Objective:To observe the efficacy and safety of Modified Qingxin Zishen decoction on the treatment of perimenopausal syndrome after endocrine therapy for hormone receptor-positive breast cancer patients.Methods:According to the random number table method,60 patients meeting the inclusion criteria were divided into the experimental group(30 cases)and the control group(30 cases).The control group received endocrine treatment.The experimental group was given Modified Qingxin Zishen decoction on the basis of the control group’s treatment.The TCM symptom score,improved KI,FACT-B score and safety evaluation index were detected after 3 months.Statistical analysis was performed by SPSS 25.0 software.Results:Finally,56 subjects including 28 in the experimental group and 28 in the control group were included.(1)There was no statistical difference between the two groups among the age,breast cancer clinical stage,pathological type,hormone receptors,endocrine drugs,duration of endocrine treatment,radiotherapy and chemotherapy(P>0.05).The baseline was comparable;(2)The TCM symptom score:The total TCM symptom score in the two groups were getting lower after the treatment,and the difference in the experimental group was statistically significant(P<0.05);The experimental group was better than the control group in improving the total TCM symptom score(P<0.05);The experimental group was better than the control group in improving hot flashes,sweating,irritability,emotional depression,fatigue,insomnia and dreaminess,soreness and weakness of waist and knees,and dryness of the oropharynx,skin,and vagina.The difference is statistically significant(P<0.05);In terms of the TCM clinical efficacy,the effective rate of the experimental group is 53.6%,and the effective rate of the control group is 25%.The difference between the two groups was statistically significant(P<0.05).(3)Improved KI:The improved KI in the two groups were getting lower after the treatment,and the difference in the experimental group was statistically significant(P<0.05);The experimental group was better than the control group in improving the improved KI(P<0.05);(4)FACT-B score:The FACT-B score in the experimental group was improved after the treatment,and the difference was statistically significant(P<0.05);The experimental group is better than the control group in improving physiological conditions,emotional conditions and additional conditions.The difference is statistically significant(P<0.05).(5)Safety evaluation:there was no significant difference between two groups among the blood routine,liver and kidney function,tumor indicators,sex hormones and gynecological color Doppler ultrasound(P>0.05);There was no significant statistical difference between before and after treatment in each group among these safety evaluation index(P>0.05);The adverse reactions were mild,and no adverse events were observed.The safety of this prescription is satisfactory.Conclusions:Modified Qingxin Zishen decoction can improve the TCM symptoms,perimenopausal symptoms and the quality of life among the patients with breast cancer after endocrine therapy.The safety of it is satisfactory and worth promoting clinically. |