| ObjectiveA prospective and randomized controlled clinical research to discuss the influence of ovarian function on the breast cancer patients with hormone dependent, who were treated by Ru’ai Fang adding and subtracting with the certificate, during the treatment of endocrine therapy after the treated by surgery and chemotherapy, through the observation of the menopausal syndrome symptoms and sex hormone level change in breast cancer patients with hormone dependent.MethodsCollect 50 patients from April 2014 to February 2016 in Guangdong Province Hospital of Integrated Traditional Chinese and Western Medicine, combined medical oncology patients and breast surgery patients of outpatient and inpatient, who were diagnosed with hormone dependent breast cancer by pathology, and met the inclusion criteria and exclusion criteria. Randomly divided into control group (Tamoxifen group) and treatment group (Tamoxifen group and Ruai Fang),25 cases in each group. Control group:Keep tamoxifen tablets 10mg each time, two times a day. Treatment groups:Keep tamoxifen tablets 10mg each time, two times a day, and add Ru ai Fang 1 agent daily, water decoction,2 times a day after breakfast and dinner 30 minutes. To collect and analysis the subjects of E2 (Estradiol)、FSH (Follicle-stimulating hormone)、LH(Luteinizing hormone)、P(Progesterone)、T(Testosterone)、 PRL(Prolactin)before the treatment and after the treatment of the third month and sixth month,and record the subjects of general situation、 menstruation status and Hamilton Anxiety Scale(HAMA scale) score on the first day and the sixth month. To make a detailed record of all data and a statistical analysis.Results1. No statistical significance was found in the two groups’patients with HAMA scale score difference before treatment. After the treatment of six months, comparison of the clinical curative effect of HAMA scale scores showed that, the control group were 25cases,1 case was significant effect (4.00%),10 cases were effective (40.00%),14 cases were invalid(56.00%), the total efficiency was 44.00%; the treatment group were 25 cases,9 cases were significant effect (36.00%),10 cases were effective (40.00%),6 cases were invalid(24.00%), the total efficiency was 66.00%. The patients’TCM syndrome of the two groups were improved after treatment, treatment group had a better efficacy than the control group, which showed a statistically significant difference between two groups (P<0.05). In the course of treatment, there were 5 cases of patients with total symptom score appeared relatively heavier in the control group, but did not have a significantly affect on the quality of life, and total symptom score of other patients in the control group relative improved; All of the total symptom in the treatment groups patients improved after the treatment of Ru’ai fang and Tamoxifen, meaning that the symptom of climacteric syndrome in the treatment group was improved better than the control group of hormone dependent breast cancer patients, and the difference has statistical significance (P<0.05).2. There was no significant difference in the serum levels of E2/FSH/ LH/P/T or PRL before treatment in two groups. No significant change in serum sex hormone level was observed after the treatment of 3 months and 6 months in two groups (P>0.05), and there was no significant difference between the two groups(P>0.05).3. In the course of treatment and long term follow-up, no adverse reactions that was completely unable to tolerate and must terminate the study after taking the drug was found in two groups of patients.ConclusionThe two groups of patients had good long-term prognosis, and in the course of treatment and long term follow-up, there were no adverse reactions that was completely unable to tolerate and must terminate the study after taking the drug was found in two groups of patients. During the treatment of endocrine therapy after the treatment of surgery and chemotherapy, the Ru ai Fang can effectively improve the symptom of climacteric syndrome of breast cancer patients with hormone dependence, without obvious influence on the patient’s serum sex hormone levels. Data is intuitive, and can be used for clinical reference. |
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