健脾散結(jié)湯聯(lián)合SOX方案治療晚期胃癌的臨床觀察
本文關(guān)鍵詞: 晚期胃癌 健脾散結(jié)湯 臨床研究 體能狀況 出處:《南京中醫(yī)藥大學(xué)》2017年碩士論文 論文類型:學(xué)位論文
【摘要】:目的:胃癌是臨床常見惡性腫瘤之一,其發(fā)病率以及死亡率在全球都較高,人類健康深受威脅。本研究的目的是通過設(shè)置治療組以及對照組,觀察健脾散結(jié)湯加減聯(lián)合化療與單純化療兩組患者的中醫(yī)證候、生活質(zhì)量、腫瘤標(biāo)志物以及化療不良反應(yīng)等方面,客觀地評價健脾散結(jié)湯加減配合化療對晚期胃癌脾虛痰濕證患者的臨床療效以及安全性,為日后中西醫(yī)辨證治療胃癌晚期提供參照。方法:本次臨床研究采用對照平行的設(shè)計方法將入組的共計45例晚期胃癌患者分為兩組:治療組入組21例,采用健脾散結(jié)湯加減聯(lián)合SOX(替吉奧與奧沙利鉑)方案治療,化療最初即配合中藥治療;對照組納入24例,僅采用SOX方案化療。分別記錄兩組治療前、后的中醫(yī)證候、KPS評分、生活質(zhì)量、腫瘤標(biāo)志物等指標(biāo)以及影像學(xué)資料用以評估實體瘤變化,并評價治療過程中存在的毒副反應(yīng),探討健脾散結(jié)湯加減在晚期胃癌治療中的價值。結(jié)果:對比兩組治療前、后的各項指標(biāo)結(jié)果顯示,中醫(yī)證候的療效方面,治療組的總有效率(80.95%)顯著高于對照組(25.0%)(P0.01),兩組患者經(jīng)治療后臨床癥狀均有不同程度改善,且變化具備統(tǒng)計學(xué)意義(兩組P值均0.05);體能狀況方面,兩組在治療前、后的KPS評分以及生活質(zhì)量評分均有統(tǒng)計差異(P0.01),且治療組較對照組的改善情況好(P0.01);兩組患者經(jīng)過治療后實體瘤客觀療效和腫瘤標(biāo)志物療效均沒有統(tǒng)計學(xué)差別(P0.05),其中治療組在治療后血液腫瘤指標(biāo)CA19-9較治療前有所下降并在統(tǒng)計學(xué)上有意義(P0.05);用藥安全性方面,治療過程中出現(xiàn)的毒副反應(yīng)主要包括:血液毒性、胃腸道反應(yīng)及肝腎功能損害,但兩組受試者的不良事件發(fā)生率沒有明顯的統(tǒng)計學(xué)差別(P0.05)。結(jié)論:健脾散結(jié)湯加減聯(lián)合SOX方案化療在不增加化療毒副反應(yīng)的同時,能夠緩解晚期胃癌患者的臨床癥狀,明顯改善患者的體能狀態(tài),且比之對照組,治療組能夠降低血液腫瘤指標(biāo)CA19-9水平,提高患者的治療耐受性,但在改善實體瘤客觀療效,降低骨髓抑制、消化功能障礙以及肝腎功能損傷等不良事件發(fā)生率方面無明顯優(yōu)勢。本次臨床觀察仍有許多不足之處,有關(guān)胃癌的中西醫(yī)結(jié)合規(guī)范治療仍需進(jìn)一步探究。
[Abstract]:Objective: gastric cancer is one of the common clinical malignant tumors, its morbidity and mortality are high in the world, human health is seriously threatened. The purpose of this study is to set up treatment group and control group. To observe the TCM syndromes, quality of life, tumor markers and adverse reactions of chemotherapy in the two groups. Objective to evaluate the clinical efficacy and safety of Jianpi Sanjie decoction combined with chemotherapy in the treatment of advanced gastric cancer with spleen deficiency and phlegm dampness syndrome. Methods: in this clinical study, a total of 45 patients with advanced gastric cancer were divided into two groups: treatment group (n = 21). Jianpi Sanjie decoction combined with SOX (Tejiao and oxaliplatin) regimen, chemotherapy was initially combined with traditional Chinese medicine treatment; In the control group, 24 cases were treated with SOX regimen only. The scores of TCM syndromes and quality of life were recorded before and after treatment in the two groups. Tumor markers and imaging data were used to evaluate the changes of solid tumors and to evaluate the toxic and side effects in the course of treatment. To explore the value of Jianpi Sanjie decoction in the treatment of advanced gastric cancer. Results: compared with the two groups before and after the treatment of the results of the indicators showed that TCM syndromes curative effect. The total effective rate of the treatment group (80.95) was significantly higher than that of the control group (25.0%). The clinical symptoms of the two groups were improved to some extent after treatment. The changes were statistically significant (P values of both groups were 0.05). In terms of physical condition, the KPS scores and quality of life scores of the two groups were statistically different before and after treatment, and the improvement of the treatment group was better than that of the control group. Two groups of patients after the treatment of solid tumor after the objective efficacy and tumor markers were not statistically significant difference (P0.05). In the treatment group, the blood tumor index (CA19-9) decreased after treatment and had statistical significance (P0.05A). In the aspect of drug safety, the side effects in the course of treatment mainly include: blood toxicity, gastrointestinal reaction and damage of liver and kidney function. Conclusion: Jianpi Sanjie decoction combined with SOX regimen chemotherapy does not increase the side effects of chemotherapy at the same time. Can alleviate the clinical symptoms of patients with advanced gastric cancer, significantly improve the physical condition of patients, and compared with the control group, the treatment group can reduce the level of blood tumor index CA19-9, improve the patient's treatment tolerance. However, there is no significant advantage in improving the objective effect of solid tumor, reducing the incidence of adverse events such as bone marrow suppression, digestive dysfunction and liver and kidney function injury. There are still many deficiencies in this clinical observation. The standardized treatment of gastric cancer with integrated traditional Chinese and western medicine still needs to be further explored.
【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
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