ABSTRACT
Objective:To observe the effect of syndrome differentiation and treatment with Wandaitang on symptoms, quality of life and function of immunologic after operation of endometrial carcinoma (EC), in order to discuss the mechanism of action according to regulation of microenvironment of EC. Method:The 109 patients were divided into control group (54 cases) and observation group (55 cases) by random number table. Patients in control group got radiotherapy and/or chemotherapy according to different stages after operation. Patients in observation group were additionally given syndrome differentiation and treatment with Wandaitang, 1 dose/day. And a course of treatment was 3 months. Before and after treatment, symptoms, sign, functional assessment of cancer therapy-general (FACT-G) were scored. And levels of T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+/CD8+), natural killer cell (NK), vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), insulin-like growth factor-1(IGF-1), interleukin-17 (IL-17) and IL-10 were detected. Result:After treatment, the scores of symptoms, signs and total scores of the patients in the observation group were lower than the control group (PP+, CD4 + and CD4 +/CD8 + in the observation group were higher than those in the control group(PPβ, IGF-1, IL-17 and IL-10 in the observation group were lower than those in the control group. Conclusion:Wandaitang can ameliorate clinical symptoms, improve quality of life of patients and immune function of organism, regulate multiple cytokines, change the tumor microenvironment of endometrial carcinoma.
ABSTRACT
BACKGROUND: Alendronate sodium is a commonly used western medicine for the treatment of osteoporosis, but it has many adverse reactions.The main component of the traditional Chinese medicine,known as the Bushen Tiaochong recipe,is Epimedium brevicornu Maxim. (epimedium).Pharmacological studies have shown that the main active ingredient of Epimedium is icariin.Icariin has an estrogen-like effect, can prevent against bone loss and improve bone strength, and has a definite effect on the treatment of postmenopausal senile degenerative osteoporosis. OBJECTIVE:To testify the hypothesis that the Bushen Tiaochong recipe combined with alendronate sodium will be more effective,as well as safer and more reliable than alendronate sodium alone for the treatment of postmenopausal senile degenerative osteoporosis. METHODS: Two hundred patients with postmenopausal senile degenerative osteoporosis will be randomly assigned to an observation group and a control group. In the control group, patients will be given alendronate sodium tablets 10 mg/d and calcium carbonate D3 chewable tablets 0.6 g/d.In the observation group,patients will receive the same treatment as the control group and the Bushen Tiaochong recipe,simmering,twice per day(once in the morning and once in the evening).The duration of treatment will be 6 months in both groups. The primary outcome measure is the overall efficacy 6 months after treatment in both groups. The secondary outcome measures are Visual Analogue Scale scores for waist and back pain; lumbar spine (L2–4) bone mineral density; serum levels of calcium, phosphorus, alkaline phosphatase, osteocalcin, estradiol, follicle stimulating hormone, luteinizing hormone, interleukin-1, and interleukin-6 before and 6 months after treatment; and incidence of adverse reactions 6 months after treatment. This trial has been approved by the Ethics Committee of the Affiliated Hospital of Qinghai University of China (approval number: QHY1703F). The study protocol will be conducted in accordance with the Declaration of Helsinki,formulated by the World Medical Association.Written informed consent will be obtained from all participants. The recruitment of subjects will begin in January 2018. Samples and data will be collected from January to December 2018. Outcome measures will be analyzed in March 2019. This trial will be completed in April 2019. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17013947). DISCUSSION: We hope to verify that the Bushen Tiaochong recipe combined with alendronate sodium provides better results than alendronate sodium alone for the treatment of postmenopausal senile degenerative osteoporosis.