健脾散结汤联合SOX方案治疗晚期胃癌的临床观察

发布时间：2018-02-04 22:27

本文关键词： 晚期胃癌健脾散结汤临床研究体能状况　出处：《南京中医药大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:胃癌是临床常见恶性肿瘤之一,其发病率以及死亡率在全球都较高,人类健康深受威胁。本研究的目的是通过设置治疗组以及对照组,观察健脾散结汤加减联合化疗与单纯化疗两组患者的中医证候、生活质量、肿瘤标志物以及化疗不良反应等方面,客观地评价健脾散结汤加减配合化疗对晚期胃癌脾虚痰湿证患者的临床疗效以及安全性,为日后中西医辨证治疗胃癌晚期提供参照。方法:本次临床研究采用对照平行的设计方法将入组的共计45例晚期胃癌患者分为两组:治疗组入组21例,采用健脾散结汤加减联合SOX(替吉奥与奥沙利铂)方案治疗,化疗最初即配合中药治疗;对照组纳入24例,仅采用SOX方案化疗。分别记录两组治疗前、后的中医证候、KPS评分、生活质量、肿瘤标志物等指标以及影像学资料用以评估实体瘤变化,并评价治疗过程中存在的毒副反应,探讨健脾散结汤加减在晚期胃癌治疗中的价值。结果:对比两组治疗前、后的各项指标结果显示,中医证候的疗效方面,治疗组的总有效率(80.95%)显著高于对照组(25.0%)(P0.01),两组患者经治疗后临床症状均有不同程度改善,且变化具备统计学意义(两组P值均0.05);体能状况方面,两组在治疗前、后的KPS评分以及生活质量评分均有统计差异(P0.01),且治疗组较对照组的改善情况好(P0.01);两组患者经过治疗后实体瘤客观疗效和肿瘤标志物疗效均没有统计学差别(P0.05),其中治疗组在治疗后血液肿瘤指标CA19-9较治疗前有所下降并在统计学上有意义(P0.05);用药安全性方面,治疗过程中出现的毒副反应主要包括:血液毒性、胃肠道反应及肝肾功能损害,但两组受试者的不良事件发生率没有明显的统计学差别(P0.05)。结论:健脾散结汤加减联合SOX方案化疗在不增加化疗毒副反应的同时,能够缓解晚期胃癌患者的临床症状,明显改善患者的体能状态,且比之对照组,治疗组能够降低血液肿瘤指标CA19-9水平,提高患者的治疗耐受性,但在改善实体瘤客观疗效,降低骨髓抑制、消化功能障碍以及肝肾功能损伤等不良事件发生率方面无明显优势。本次临床观察仍有许多不足之处,有关胃癌的中西医结合规范治疗仍需进一步探究。
[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.
【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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