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马来西亚癌症状况及双参饮对癌症放疗病人免疫调节与生活质量的理论和临床研究

The Efficacy of Shuang-Shen-Yin Regimen on the Immunoresponse and Clinical Well-beings of Cancer Patients Who are Undergoing Radiotherapy in Malaysia

【作者】 杨华祥

【导师】 姜建国;

【作者基本信息】 山东中医药大学 , 中医临床基础, 2011, 博士

【摘要】 目的:癌症是全球的主要疾病负担,每年约发生新病例1100万,癌症的治疗已经成为当今社会关注的焦点。本文从现代、传统两个医学层面梳理癌症的沿革,并在此基础上,探讨分析马来西亚癌症的发病、治疗及预防的现状。近年来,提高癌病患者的生活质量,是肿瘤医学界努力的方向,而中医药在减轻症状、提高生活质量、减轻放化疗毒副反应、延长生存期方面有其明显优势。我们将从临床角度评估自拟双参饮对放射线治疗中癌症患者生活质量、免疫功能的影响以及癌症患者中医证型的变化。方法:本研究采用理论探讨和临床研究相结合的方法,首先进行癌症的文献的梳理,围绕其历史沿革、发生机理、治疗方法与预防措施等方面,从现代医学和传统医学两个层面进行探讨;其次对马来西亚中医药治疗癌症的现状进行研究和归纳,并利用图表将马来西亚癌症的发病状况,结合性别、种族、年龄、发病部位和致病因素做出详细的数据分析;第三针对马来西亚治疗与预防癌症的医疗实践,探索体现益气养阴法的双参饮对癌症病人的放疗过程中的治疗优势,尤其在提高病人生活质量和免疫功能方面的疗效。临床研究则依单盲试验随机分组共收录80例,完成全部疗程且可分析者有60例;其中实验组32例,对照组28例;男:女比为21:39;中位年龄57.5岁,实验组平均服用益气养阴组方——双参饮共11周,对照组服用之安慰剂为乳糖;平均放射线剂量为5440cGy;平均放射线治疗为6.94周;平均化学治疗为4周。结果:传统医学中的藏象理论、治则治法、中药应用与现代免疫学均有着密切的关系,尤其中药的合理应用在恶性肿瘤病人的放疗中具有减毒增敏的作用,具有改善血液循环,加快血液流速,降低肿瘤细胞的氧耗量,增强对肿瘤细胞DNA的辐射损伤作用及抑制受损DNA的修复,降低肿瘤谷胱甘肽含量,增强机体的免疫功能,杀伤放疗后残存的癌细胞,明显改善患者的生活质量的多重功效。传统中药分类法的清热解毒药、健脾益气药、活血化瘀药、软坚散结药都在抗癌过程中多靶点的发挥治疗及预防作用。临床研究中,我们应用自拟双参饮对放疗病人做出评估并得出结论:1.在免疫功能评估的变项中,计有实验组Lymphocyte count(p=0.002)、B cellcount(p=0.005)的改变有统计上的显著差异。实验组之NK cell count(p=0.098)的p值介于0.05-0.10之间,为统计显著性边缘。2.在生活质量方面:本研究根据EORTC QLQ-C30作生活质量评估,实验组优于对照组(p=0.046)。在核心问卷中发现情绪功能(p=0.050)、认知功能(p=0.017)、社会功能(p=0.001)、疲倦(p=0.005)、恶心呕吐(p=0.006)、失眠(p=0.031)、食欲不振(p=0.003)、财务功能(p=0.021)、整体生活评估(p=0.016)等指标,有明显统计意义,而以上这些症状是放化疗常见的副作用。3.放射线治疗中癌症患者免疫功能指针、生活质量与“气阴两虚”中医证型的转归呈正相关。结论:现代医学与传统医学两种医学模式虽不相同,但在癌症文献的整理中,并无大异,而中医药学在马来西亚的发展历史悠久,马来西亚在中西医结合治疗癌症方面特点显著、发展迅速。本文在梳理、研究国内外医家应用沙参麦门冬汤的文献的基础上,并根据中医“辨证论治”的原则,运用自拟双参饮在对癌症放射线治疗病人的治疗的观察中,发现能明显提高淋巴细胞数目、B细胞数目;改善生活质量,如情绪功能、认知功能、社会功能、疲倦、恶心呕吐、失眠、食欲不振、财务困难、整体生活。我们认为用现代医学理论阐明复方中药的作用机理不仅对于促进中医药的现代化和国际化具有重要意义,而且对于复方中药的作用靶点和物质基础等的研究也具有重要的理论指导作用和价值。

【Abstract】 Objective: Cancer is a major concern worldwide. There are about11million newcases of cancer annually, thus cancer treatment has become the focal point of theglobal medical community. In this research, the combination of modern andtraditional Chinese medicine was used to study and analyze cancer development,treatment, and prevention in Malaysia. For cancer treatment in recent years, the goalof medical profession is to reduce the clinical symptoms, improve quality of life, andprolong the lifespan of cancer patients.This study has shown that the efficacy oftraditional Chinese medicine has an advantage in reducing clinical symptoms,improving quality of life, reducing the side effects of chemotherapy, and increasingthe survival rate of cancer patients.The main purpose of this study is to evaluate andcompare the efficacy of Shuang-Shen-Yin of traditional Chinese medicine to radiationtherapy of modern medicine base on the differentiation of the clinical symptoms, theimmunity and the quality of life of cancer patients. Method: In this research bothmodern and traditional Chinese medicine were used to study the historical evolution,pathogenesis, treatment, and prevention of cancer patients in Malaysia. Investigate theMalaysia Chinese medical treatment of cancer research and summarized the currentstatus. Cancer patients were grouped and category into different gender, race, age, andtheir disease sites and etiology with figure and table analysis. This study has shownthat the invigorating Qi and nourishing Yin of Shuang-Shen-Yin regimen is superioradvantage to the process of radiotherapy; especially in improving the quality of lifeand efficacy of immunity of cancer patients. Clinical studies were done byrandomized single-blind trial with a total of80test subjects, only60test subjectscompleted all the processes.21of them were male and39female.They were testedrandomly and underwent single-blind experiment,32of them in experimental group,and28in control group. The average age of the test subjects was60. and the medianage was57.5.The average course of therapy with prescription invigorating Qi andnourishing Yin of Shuang-Shen-Yiin regimen was11weeks. In radiation therapy, theaverage radiation dose was5440cGy, and the average treatment-cycle was6.94 weeks. The average treatment-cycle of chemotherapy was4weeks. Results: Base onthe principles of traditional Tibetan medicine, traditional Chinese medicine is closelyrelated to study of modern immunology in particular to the rational application oftraditional Chinese medicine in cancer patients. This study has shown that traditionalChinese medicine has attenuated toxification and modulated synergistic effect,improves blood circulation, speeds up blood flow,and reduces oxygen consumptionof tumor cells. It enhances DNA damage of tumor cells induced by radiation damage,inhibits DNA repair of injured tumor cells. and helps to reduce tumorglutathione.Furthermore, it continues to kill the remaining radiation resistant tumorcells, and enhances the immune function of cancer patients thus improving theirquality of life. The different drug classification of traditional Chinese medicine aredetoxification model, strengthens the spleen “Qi”, promoting blood circulation toremove stasis drugs, and softening the hard to dissolve nodules drugs. These differentregimens prove to be beneficial in the treatment and prevention of multi-target cancer.There is a significant difference in the count of lymphocyte (p=0.002) and the countof B cell (p=0.005) for the before and after treatments of the experimental group. Inour clinical studies, when using Shuang-Shen-Yin to assess patients for radiotherapy,a conclusion was reached:1.Comparing before and after treatments, there is asignificant change in the Lymphocyte count (p=0.002), and B cell count (p=0.005)of the experimental group in the immune function assessment. The p-value of NK cellcount (p=0.098) is in the range of0.05-0.10in experimental group which shownborderline significant difference in the evaluation of immune modulation.2. Based onthe study of EORTC QLQ-C30questionnaire for the quality of life assessment, theexperimental group was better than the control group significantly (p=0.046) inevaluating the quality of life. The items in EORTC QLQ-30included emotionalfunctioning(p=0.050)、cognitive functioning(p=0.017)、social functions(p=0.001)、fatigue(p=0.005)、nausea&vomiting(p=0.006)、insomnia(p=0.031)、anorexia(p=0.003)、economic functions(p=0.021)、and the overall lifeassessment/quality of life (p=0.016)。The results of the assessment have shown thattreatment with “Shuang-Shen-Yin” was improved significantly.3.There is a positivecorrelation in immune function indicators, quality of life, and the outcome of "YinDeficiency" syndromes in cancer patients of radiotherapy. Conclusion: Thoughmodern medicine and traditional Chinese medicine are based on two different models,medically there is no great difference in their philosophy. Traditional Chinesemedicine has a long history in Malaysia. It has significant development, and achievedgreat progress in cancer treatment in Malaysia. After studying the practice of“Shuang-Shen-Yin” inside and outside of Malaysia, traditional Chinese medicine hasshown to be an “immuno-potentiator” in cancer patients treated with radiotherapy. It increases the production of lymphocytes, and B-cells in cancer patients consequentlyimproving their emotional functioning, cognitive functioning, and social functioning.It also reduces fatigue, nausea, vomiting, insomnia, loss of appetite, and financialdifficulties of cancer patients thus improving the overall quality of life. With thepositive influence of integrating modern medicine in traditional Chinese medicine,and using the principles of modern medicine to understand traditional Chinesemedicine can help to promote, modernize, provide positive guidance, and leadtraditional Chinese medicine to a greater significance.

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