益气健脾化积方对胃癌化疗患者免疫调控作用的临床研究

发布时间：2018-04-30 20:37

本文选题：胃癌 + 益气健脾化积方　；参考：《南京中医药大学》2017年硕士论文

【摘要】：背景:胃癌(gastriccancer,GC)指起源于胃黏膜上皮细胞的恶性肿瘤,以胃腺癌多见,其发病率与死亡率均高居我国恶性肿瘤行列的前三位。目前化疗治疗胃癌为临床常用的治疗手段之一。但化疗伴随的临床不适症状和免疫功能的减低成为影响疗效和降低患者生存质量的重要因素。益气健脾化积方为刘沈林教授治疗胃癌的经验效方,临床运用多年疗效肯定,与化疗药物连用可减轻患者化疗不适症状,提高疗效。为进一步评估本方在联合化疗治疗GC中的临床综合疗效,并探讨其效应是否与调节免疫功能相关,本研究将遵循GCP规范,采用随机双盲、单模拟和平行对照的设计方法,采用DC化疗方案治疗联合益气健脾化积方的治疗方法,客观评价其疗效差异及对免疫功能的影响,为临床推广应用提供客观证据。目的:观察评价益气健脾化积方联合化疗与单纯化疗为对照治疗胃癌患者,对改善患者的临床症状及免疫功能的影响。方法:按药物临床实验规范(GCP)进行试验设计,采用随机双盲、单模拟的平行对照方法,运用计算机按随机盲法将40例符合标准的GC患者分为两组,治疗组(DC化疗方案加益气健脾化积方免煎颗粒)和对照组(DC化疗方案加益气健脾化积方模拟颗粒),化疗2个疗程(56天)后,观察比较两组患者中医症状体征状态、细胞免疫功能指标(CD4、CD8、CD4/CD8、NK细胞数值)的变化,检测分析两组治疗前后对外周血中肿瘤坏死因子-α(TNF-α)和干扰素-γ(IFN-γ)含量的影响;观察血常规、肝肾功能(ALT、AST、Cr、BUN)等变化的安全性。结果:①治疗组在胃癌患者中医症状体征分级积分等方面均优于对照组(P0.05),尤其在症状体征改善方面具有显著优势。②细胞免疫功能指标检测中,治疗组益气健脾化积方干预后,CD4、CD4/CD8、NK细胞的数值显著上升、CD8细胞数值明显下降,自身前后对比具有统计学意义(P0.05);治疗后两组间比较具有显著差异(P0.05),表明治疗组在改善细胞免疫功能明显优于对照组。③治疗组在益气健脾化积方干预后,TNF-α数值明显下降,而IFN-γ明显升高,治疗前后自身对照具有明显统计学意义(P0.05);而治疗后两组间比较,益气健脾化积方组显示出明显优势(P0.05)。④两组治疗后对血常规、肝肾功能影响(ALT、AST、Cr、BUN)的影响变化未显示出规律性改变,两组治疗前后及两组间比较均未显示出明显著差异(P0.05)。结论:接受DC方案化疗的胃癌患者联合运用益气健脾化积方后,其改善不适症状及提高免疫功能的疗效优于单纯DC方案组,在改善化疗后不适症状、提高细胞免疫功能等方面显示出优势,考虑其增效的疗效作用与调节CD4、CD4/CD8、NK细胞数和TNF-α、IFN-y含量变化、从而改善患者机体的免疫功能相关。
[Abstract]:Background: gastric cancer is a malignant tumor originating from gastric mucosal epithelial cells. Gastric adenocarcinoma is the most common cancer. Its morbidity and mortality are among the top three malignant tumors in China. At present, chemotherapy is one of the commonly used methods in the treatment of gastric cancer. However, the clinical symptoms associated with chemotherapy and the reduction of immune function have become important factors affecting the efficacy and quality of life of patients. Yiqi Jianpi Huazhi prescription is Professor Liu Shenlin's experience in treating gastric cancer. It is effective for many years in clinical application. Combined with chemotherapy drugs can alleviate the symptoms of chemotherapy and improve the curative effect. In order to further evaluate the clinical comprehensive efficacy of this prescription in the treatment of GC with combined chemotherapy, and to explore whether its effect is related to the regulation of immune function, this study will follow the GCP standard and adopt a randomized double-blind, single-simulated and parallel control design method. DC chemotherapy regimen was used in combination with Yiqi Jianpi Huazhi recipe to objectively evaluate the difference of curative effect and the effect on immune function, and to provide objective evidence for clinical application. Objective: to observe and evaluate the effect of Yiqi Jianpi Huazhi recipe combined with chemotherapy and chemotherapy alone on the improvement of clinical symptoms and immune function of patients with gastric cancer. Methods: according to the standard of drug clinical trial, 40 patients with GC were divided into two groups by using a randomized double-blind, single-simulated parallel control method, and a randomized blind method was used to divide 40 GC patients into two groups. After two courses of chemotherapy, the treatment group and the control group were treated with the DC chemotherapy regimen plus Yiqi Jianpi Huazhi recipe for 56 days, and the symptoms and signs of traditional Chinese medicine were observed and compared between the two groups. The changes of NK cell number of CD4 / CD8 / CD4 / CD8 +), the changes of tumor necrosis factor- 伪 (TNF- 伪) and interferon- 纬 (IFN- 纬) in peripheral blood before and after treatment, and the safety of the changes of blood routine, liver and kidney function were observed. Results the score of TCM symptoms and signs in the treatment group was better than that in the control group (P 0.05), especially in the improvement of symptoms and signs. After intervention by Yiqi Jianpi Huazhi recipe, the NK cell value of CD4 / CD4 / CD8 + + in the treatment group was significantly increased, and the value of CD8 cell decreased significantly. There was a significant difference between the two groups after treatment, which indicated that the value of TNF- 伪 in the treatment group was significantly lower than that in the control group (3) after the intervention of Yiqi Jianpi Huazhi recipe, the improvement of cellular immune function in the treatment group was obviously superior to that in the control group. But IFN- 纬 was significantly increased, and the self-control had significant statistical significance before and after treatment, while after treatment, the two groups showed obvious advantages in blood routine examination after treatment. The changes of liver and kidney function were not regular, and there was no significant difference between the two groups before and after treatment (P 0.05). Conclusion: after the combination of Yiqi Jianpi Huazhi decoction for gastric cancer patients receiving chemotherapy with DC regimen, the effect of improving discomfort symptoms and improving immune function is better than that of DC regimen alone group, which can improve the symptoms of gastric cancer after chemotherapy. The enhancement of cellular immune function showed advantages. The effect of increasing the efficiency was related to the regulation of the number of NK cells and the content of TNF- 伪 -IFN-y in CD4 / CD4 / CD8 / CD8, so as to improve the immune function of the patients.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.2

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