| Research BackgroundBreast cancer, the world’s most common malignancy, has a high mortality and rapid development, known as the "number one killer" that endangers women’s health and health.Breast cancer is also one of the most important causes of female deaths worldwide. According to the pathology ER, PR, HER-2, Ki67 positive rate of the results of breast cancer is divided into four different molecular types, respectively : Luminal A type, Luminal B type, HER-2 overexpression type, basal-like type. Which Luminal A and Luminal B type of treatment is generally given the appropriate chemotherapy, radiotherapy, according to pathology hormone receptor positive need to add endocrine therapy, for HER-2 positive that HER-2 overexpression of patients need to add targeted therapy. However, in China, in addition to the above treatment, the patient will be in the entire disease diagnosis and treatment stage at any time to seek the treatment of Chinese medicine,Chinese medicine can help patients to improve some symptoms, so that the quality of life is improved, which is also one of the purpose of patients seeking Chinese medicine treatment. In previous studies, it has been clear that traditional Chinese medicine treatment of hormone-dependent breast cancer can delay the progression of disease progression, although there is no significant effect on overall survival.Although in previous studies, estrogen levels will affect the incidence of breast cancer, there is no exact answer. The outside world is still on the safety of traditional Chinese medicine,and in the treatment of breast cancer,especially hormone receptor-positive breast cancer treatment has questions, generally around the problem is the role of traditional Chinese medicine phytoestrogen, and liver toxicity. At present, animal time and pharmacological experiments in laboratory studies have proved that some phytoestrogenic components in Chinese herbal medicine have phytoestrogenic effects, but there are few clinical studies on the effect of Chinese medicine on estrogen levels in female patients with estrogen-dependent breast cancer.PurposeTo explore the effect of dialectical Traditional Chinese Medicine (TCM) on estrogen level in female patients with hormone receptor positive breast cancer by observing the changes of Estrogen levels and the changes of Follicle Stimulating Hormone (FSH) before and after treatment. Then to provide the basis for the safety of clinical treatment of Traditional Chinese Medicine. Observing the changes of quality of life before and after treatment to explore the impact of traditional Chinese medicine on the quality of life of patients.MethodsIn this study, according to books and literature about the phytoestrogenic effects of Chinese herbal medicine and the relationship between estrogen levels and breast cancer, we developed Estrogen levels and Follicle Stimulating Hormone as observation items. At the same time, the patient’s name, age, menstrual status, clinical stage, lymph node metastasis,treatment status, endocrine drug application, symptom score, and Traditional Chinese Medicine, tongue and pulse were the basic information. During September 2015 to March 2017,visiting Professor Lu Wenping at the Chinese Academy of Traditional Chinese Medicine, Guang’anmen Hospital Oncology outpatient, there were 313 cases of primary hormone receptor positive breast cancer female patients in line with the proposed diagnosis and treatment criteria, excluding the standard, observed and recorded the relevant information by interviewing, follow-up and other methods.Results1. General situationIn1.1 AgeIn this study, a total of 321 patients, lost to 8 cases, a total of 313 cases completed follow-up. The mean age was 59.6 ± 12.2 years old. The maximum age was 75 years and the minimum age was 30 years. The age span was 45 years. The median age was 63 years and the quartile age was 9 years old.1.2 Menopause/OFSIn this study, a total of 313 patients, of which 236 cases of natural menopause, and there were 13 cases of surgical castration and 64 cases of ovarian inhibitors in patients without menopause.2. Clinical data2.1 Lymph node metastasisPNO (no regional lymph node metastasis, IHC negative) in 123 cases (39.30%), pNl(micrometastasis, or 1-3 axillary lymph node metastases, and / or sentinel lymph node dissection found in endometrial lymph nodes underwent microscopic metastases, (17.57%),pN3 (≥10 axillary lymph node metastasis), pN3 (249.8%), pN2 (4-9 axillary lymph node metastasis, or clinically significant internal lymph node metastasis without axillary lymph node metastasis) , Or subclavian lymph node metastasis, or clinically significant ipsilateral medial lymph node metastasis associated with≥ 1 axillary lymph node metastasis; or ≥ 3 axillary lymph node metastasis with clinically negative but microscopic lymph node metastasis; or ipsilateral clavicle On the lymph node metastasis) in 29 cases (9.27%), lymph node metastasis was unknown in 30 cases (9.58%).2.2 Clinical StagingOf all the patients, there were 79 patients (25.24%) with clinical stage I,118 patients(37.70%) in stage Ⅱ , 52 patients (16.61%) with stage Ⅲ, 34 patients (10.86% ), Staging of 30 patients (9.59%).2.3 TreatmentThere were 284 patients (90.73%) with radical resection and 29 (9.27%) underwent defrosting. 123 cases (39.30%) received radiotherapy and 190 (60.70%) did radiotherapy; 266(84.98% ), 48 patients (15.34%) underwent targeted chemotherapy, 265 (84.66%) did not perform targeted therapy, and 313 (100%) were endocrine therapy.3. Quality of life3.1 The main symptomsThere were 152 cases (48.56%), 142 cases (45.37%) of shortness of breath and shortness,104 cases (33.23%), 96 cases (30.67%) of joint pain, 95 cases of hot flashes (30.35%(17.90%), 56 cases (17.90%) in the morning stiffness, 48 cases (15.34%) at the end of the extremities, and 57 cases (18.21%) without the above eight symptoms.3.2 Evaluation of symptomsThe mean score before treatment was 9.28 ± 3.73,after treatment was 6.02 ± 3.46,p<0.05, statistically significant, before and after treatment differences.3.3 Quality of Life ScaleAfter treatment with traditional Chinese medicine, the quality of life increased by 244 cases (77.95%), stabilized in 46 cases (14.70%) and decreased by 23 cases (7.35%).Traditional Chinese medicine could improve the quality of life of patients.4. Estradiol levelsThe median estradiol level before treatment was 11.88 士 4.56 pg / ml,and the average estradiol level after treatment was 11.81 ±4.50pg / ml , p > 0.05, no statistically significant before and after treatment no significant difference. The median level of estradiol in the treatment group was 7.95 ± 3.91pg / mL,7.89 士 3.90 pg / mL after treatment,p> 0.05, there was no significant difference before and after treatment.5. Follicle stimulating hormone levelsThe mean value of FSH in the presbyopia group was 58.02± 10.42IU/L,the mean value was 58.06 ± 10.43IU/L after treatment,p> 0.05, no statistically significant difference before and after treatment.The mean value of FSH level in the amenorrhea group was 5.16 士1.71IU/L before treatment,5.14 ±1.66IU/L after treatment,p> 0.05, no statistically significant difference before and after treatment.6. Frequent use of traditional Chinese medicine frequencyStatistical tutor commonly used dialectical Chinese medicine in the prescription of patients in the prescription frequency. Among them, the highest frequency of astragalus was found in 275 cases (87.86%), and the lowest frequency of angelica was found in 9 cases(2.88%).7. Adverse eventsDuring the observation period, a total of 2 patients with mild liver function abnormalities,and then returned to normal. I have no obvious adverse events, liver and kidney dysfunction.Conclusions1. The traditional Chinese medicine used in this study had no significant effect on estrogen levels in ER + / PR + breast cancer women. 2. In this study, the traditional Chinese medicine on ER + / PR + breast cancer female FSH levels had no significant effect. 3.Traditional Chinese medicine can improve the symptoms of patients, improve their quality of life. 4. The traditional Chinese medicine in this study is safe and effective. |
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