本文選題：胃癌 + 益氣健脾化積方　； 參考：《南京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：背景:胃癌(gastriccancer,GC)指起源于胃黏膜上皮細(xì)胞的惡性腫瘤,以胃腺癌多見,其發(fā)病率與死亡率均高居我國惡性腫瘤行列的前三位。目前化療治療胃癌為臨床常用的治療手段之一。但化療伴隨的臨床不適癥狀和免疫功能的減低成為影響療效和降低患者生存質(zhì)量的重要因素。益氣健脾化積方為劉沈林教授治療胃癌的經(jīng)驗(yàn)效方,臨床運(yùn)用多年療效肯定,與化療藥物連用可減輕患者化療不適癥狀,提高療效。為進(jìn)一步評估本方在聯(lián)合化療治療GC中的臨床綜合療效,并探討其效應(yīng)是否與調(diào)節(jié)免疫功能相關(guān),本研究將遵循GCP規(guī)范,采用隨機(jī)雙盲、單模擬和平行對照的設(shè)計(jì)方法,采用DC化療方案治療聯(lián)合益氣健脾化積方的治療方法,客觀評價其療效差異及對免疫功能的影響,為臨床推廣應(yīng)用提供客觀證據(jù)。目的:觀察評價益氣健脾化積方聯(lián)合化療與單純化療為對照治療胃癌患者,對改善患者的臨床癥狀及免疫功能的影響。方法:按藥物臨床實(shí)驗(yàn)規(guī)范(GCP)進(jìn)行試驗(yàn)設(shè)計(jì),采用隨機(jī)雙盲、單模擬的平行對照方法,運(yùn)用計(jì)算機(jī)按隨機(jī)盲法將40例符合標(biāo)準(zhǔn)的GC患者分為兩組,治療組(DC化療方案加益氣健脾化積方免煎顆粒)和對照組(DC化療方案加益氣健脾化積方模擬顆粒),化療2個療程(56天)后,觀察比較兩組患者中醫(yī)癥狀體征狀態(tài)、細(xì)胞免疫功能指標(biāo)(CD4、CD8、CD4/CD8、NK細(xì)胞數(shù)值)的變化,檢測分析兩組治療前后對外周血中腫瘤壞死因子-α(TNF-α)和干擾素-γ(IFN-γ)含量的影響;觀察血常規(guī)、肝腎功能(ALT、AST、Cr、BUN)等變化的安全性。結(jié)果:①治療組在胃癌患者中醫(yī)癥狀體征分級積分等方面均優(yōu)于對照組(P0.05),尤其在癥狀體征改善方面具有顯著優(yōu)勢。②細(xì)胞免疫功能指標(biāo)檢測中,治療組益氣健脾化積方干預(yù)后,CD4、CD4/CD8、NK細(xì)胞的數(shù)值顯著上升、CD8細(xì)胞數(shù)值明顯下降,自身前后對比具有統(tǒng)計(jì)學(xué)意義(P0.05);治療后兩組間比較具有顯著差異(P0.05),表明治療組在改善細(xì)胞免疫功能明顯優(yōu)于對照組。③治療組在益氣健脾化積方干預(yù)后,TNF-α數(shù)值明顯下降,而IFN-γ明顯升高,治療前后自身對照具有明顯統(tǒng)計(jì)學(xué)意義(P0.05);而治療后兩組間比較,益氣健脾化積方組顯示出明顯優(yōu)勢(P0.05)。④兩組治療后對血常規(guī)、肝腎功能影響(ALT、AST、Cr、BUN)的影響變化未顯示出規(guī)律性改變,兩組治療前后及兩組間比較均未顯示出明顯著差異(P0.05)。結(jié)論:接受DC方案化療的胃癌患者聯(lián)合運(yùn)用益氣健脾化積方后,其改善不適癥狀及提高免疫功能的療效優(yōu)于單純DC方案組,在改善化療后不適癥狀、提高細(xì)胞免疫功能等方面顯示出優(yōu)勢,考慮其增效的療效作用與調(diào)節(jié)CD4、CD4/CD8、NK細(xì)胞數(shù)和TNF-α、IFN-y含量變化、從而改善患者機(jī)體的免疫功能相關(guān)。
[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- 偽 (TNF- 偽) and interferon- 緯 (IFN- 緯) 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- 偽 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- 緯 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- 偽 -IFN-y in CD4 / CD4 / CD8 / CD8, so as to improve the immune function of the patients.
【學(xué)位授予單位】：南京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R735.2

【參考文獻(xiàn)】

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1 楚瑞閣;郭紅飛;謝含;吳璐;吳輝淵;施e，

本文編號：1826127