绿茶茶多酚胶囊联合化疗治疗晚期非小细胞肺癌的临床疗效观察
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摘要
1目的
以既往基础与临床实验研究为基础,选择非小细胞肺癌Ⅲb、Ⅳ期患者为研究对象,以已经上市的绿茶茶多酚胶囊为观察药物,通过随机分组、对照观察的临床研究,重点观察茶多酚胶囊配合化疗治疗晚期非小细胞肺癌临床疗效的观察,同时,对中医症状疗效与患者生活质量进行评价,并结合治疗前后肿瘤标志物(CEA、 Cyfra211、CA125)、肿瘤新生血管相关因子(VEGF、 bFGF、 TIMP-2)表达水平的测定、免疫功能的测定,研究绿茶茶多酚胶囊联合化疗治疗晚期非小细胞肺癌的临床疗效,并对其抑制肺癌新生血管生成机制进行初步探索性研究。
2方法
收集有效NSCLC病例61例,采用简单随机法进行随机分组,试验组31例,对照组30例。61例病例均进行常规化疗,试验组除化疗外,在化疗的同时给予口服茶多酚胶囊,每天2次,每次2粒。化疗2周期后进行疗效评价,指标包括肿瘤瘤体大小、KPS评分、中医症状评分、新生血管生成因子等指标、免疫功能、肿瘤标志物。
3结果
①肿瘤疗效评价：试验组总有效率(CR+PR+SD)80%,对照组总有效率(CR+PR+SD)73%(P>0.05),差异无统计学意义。②中医症状评分：治疗后试验组的中医症状评分平均值为10.36分,对照组平均值为14.76分,高于试验组,且P<0.05,差异有统计学意义,说明茶多酚能改善化疗患者的中医临床症状。③KPS评分：治疗后试验组KPS平均评分为81.39,对照组KPS平均评分为73.47,治疗后试验组和对照组KPS评分比较有统计学意义(P<0.05),说明茶多酚能舒缓肿瘤化疗期间KPS评分的下降,提高患者生活质量。④免疫功能：对照组治疗前后Foxp3、CD4+/CD8+的变化均无统计学意义(P>0.05)；试验组治疗前后Foxp3的变化值无统计学意义(P>0.05),而CD4+/CD8+的变化有统计学意义(P<0.05),提示茶多酚胶囊具有调整免疫抑制状态的作用。⑤肿瘤标志物：治疗后两组肿瘤标志物的变化均无统计学意义(P>0.05)。
4结论
茶多酚胶囊联合化疗能改善晚期非小细胞肺癌患者化疗期间的中医症状,舒缓患者化疗期间KPS的下降,提高患者生存质量,并具有调整免疫抑制状态的作用。
1Purpose
Clinical study based on the previous basic and clinical trials, to select non-small cell lung cancer Ⅲ b, Ⅳ patients for the study observed drugs already on the market capsules of green tea polyphenols, randomized, controlled observation, focused observation tea polyphenol capsule with the observation of the clinical efficacy of chemotherapy in advanced non-small cell lung cancer, at the same time, clinical symptoms and patient quality of life evaluation, combined wi th before and after treatment of tumor markers (CEA, Cyfra211, CA125), tumor neovascularization factor (VEGF, bFGF, and TIMP-2) expression levels of determination, determination of immune function, studies of green tea polyphenols capsule combined with chemotherapy in advanced non-small cell lung cancer clinical efficacy, and inhibition of lung cancer angiogenesis mechanisms preliminary exploration study.
2Methods
Collected61cases of effective NSCLC cases, simple random randomized trial,31patients in the control group of30cases.61cases underwent conventional chemotherapy, the experimental group in addition to chemotherapy in the chemotherapy cycle to give oral tea polyphenol capsules,2times a day, every2. After two cycles of chemotherapy efficacy evaluation, indicators, including tumor size of tumor, KPS score, clinical symptoms score, tumor markers, immune function, angiogenesis factors and other indicators.
3Conclusions
①tumor response assessment:the test group, the total response rate (CR+PR+SD)80%of the control group response rate (CR+PR+SD)73%(P>0.05), the difference was not statistically significant.②The TCM symptom score: the test group after the treatment of TCM symptom score averaged10.36points, control group average of14.76points higher than the experimental group (P<0.05) difference was statistically significant, indicating that polyphenols can improve chemotherapy clinical symptoms of patients with Chinese medicine.③KPS score: the experimental group after treatment KPS mean score of81.39, to control the average score of the group KPS KPS score of73.47, after treatment, the experimental group and control group was statistically significant (P<0.05), indicating that polyphenols can relieve the tumor during chemotherapy decline in KPS score, and improve patients'quality of life.④immune function: the control group were Foxp3and CD4/CD8changes were not statistically significant (P>0.05); changes in the value of the experimental group before and after treatment of Foxp3was no significant (P>0.05), while the CD4+/CD8+changes statistically s ignif icant (P<0.05), suggest ing that the polyphenols capsule with adjustment of the immunosuppressive state.⑤The tumor markers:After treatment, the tumor marker changes were not statistically significant(P>0.05).
4Results
The polyphenols capsule combined with chemotherapy can improve the symptoms of advanced non-small cell lung cancer patients during chemotherapy Chinese medicine to relieve the decline of the patients during chemotherapy, KPS, and improve patients'quality of life, and have to adjust the immunosuppressive role of the state.
以既往基础与临床实验研究为基础,选择非小细胞肺癌Ⅲb、Ⅳ期患者为研究对象,以已经上市的绿茶茶多酚胶囊为观察药物,通过随机分组、对照观察的临床研究,重点观察茶多酚胶囊配合化疗治疗晚期非小细胞肺癌临床疗效的观察,同时,对中医症状疗效与患者生活质量进行评价,并结合治疗前后肿瘤标志物(CEA、 Cyfra211、CA125)、肿瘤新生血管相关因子(VEGF、 bFGF、 TIMP-2)表达水平的测定、免疫功能的测定,研究绿茶茶多酚胶囊联合化疗治疗晚期非小细胞肺癌的临床疗效,并对其抑制肺癌新生血管生成机制进行初步探索性研究。
2方法
收集有效NSCLC病例61例,采用简单随机法进行随机分组,试验组31例,对照组30例。61例病例均进行常规化疗,试验组除化疗外,在化疗的同时给予口服茶多酚胶囊,每天2次,每次2粒。化疗2周期后进行疗效评价,指标包括肿瘤瘤体大小、KPS评分、中医症状评分、新生血管生成因子等指标、免疫功能、肿瘤标志物。
3结果
①肿瘤疗效评价：试验组总有效率(CR+PR+SD)80%,对照组总有效率(CR+PR+SD)73%(P>0.05),差异无统计学意义。②中医症状评分：治疗后试验组的中医症状评分平均值为10.36分,对照组平均值为14.76分,高于试验组,且P<0.05,差异有统计学意义,说明茶多酚能改善化疗患者的中医临床症状。③KPS评分：治疗后试验组KPS平均评分为81.39,对照组KPS平均评分为73.47,治疗后试验组和对照组KPS评分比较有统计学意义(P<0.05),说明茶多酚能舒缓肿瘤化疗期间KPS评分的下降,提高患者生活质量。④免疫功能：对照组治疗前后Foxp3、CD4+/CD8+的变化均无统计学意义(P>0.05)；试验组治疗前后Foxp3的变化值无统计学意义(P>0.05),而CD4+/CD8+的变化有统计学意义(P<0.05),提示茶多酚胶囊具有调整免疫抑制状态的作用。⑤肿瘤标志物：治疗后两组肿瘤标志物的变化均无统计学意义(P>0.05)。
4结论
茶多酚胶囊联合化疗能改善晚期非小细胞肺癌患者化疗期间的中医症状,舒缓患者化疗期间KPS的下降,提高患者生存质量,并具有调整免疫抑制状态的作用。
1Purpose
Clinical study based on the previous basic and clinical trials, to select non-small cell lung cancer Ⅲ b, Ⅳ patients for the study observed drugs already on the market capsules of green tea polyphenols, randomized, controlled observation, focused observation tea polyphenol capsule with the observation of the clinical efficacy of chemotherapy in advanced non-small cell lung cancer, at the same time, clinical symptoms and patient quality of life evaluation, combined wi th before and after treatment of tumor markers (CEA, Cyfra211, CA125), tumor neovascularization factor (VEGF, bFGF, and TIMP-2) expression levels of determination, determination of immune function, studies of green tea polyphenols capsule combined with chemotherapy in advanced non-small cell lung cancer clinical efficacy, and inhibition of lung cancer angiogenesis mechanisms preliminary exploration study.
2Methods
Collected61cases of effective NSCLC cases, simple random randomized trial,31patients in the control group of30cases.61cases underwent conventional chemotherapy, the experimental group in addition to chemotherapy in the chemotherapy cycle to give oral tea polyphenol capsules,2times a day, every2. After two cycles of chemotherapy efficacy evaluation, indicators, including tumor size of tumor, KPS score, clinical symptoms score, tumor markers, immune function, angiogenesis factors and other indicators.
3Conclusions
①tumor response assessment:the test group, the total response rate (CR+PR+SD)80%of the control group response rate (CR+PR+SD)73%(P>0.05), the difference was not statistically significant.②The TCM symptom score: the test group after the treatment of TCM symptom score averaged10.36points, control group average of14.76points higher than the experimental group (P<0.05) difference was statistically significant, indicating that polyphenols can improve chemotherapy clinical symptoms of patients with Chinese medicine.③KPS score: the experimental group after treatment KPS mean score of81.39, to control the average score of the group KPS KPS score of73.47, after treatment, the experimental group and control group was statistically significant (P<0.05), indicating that polyphenols can relieve the tumor during chemotherapy decline in KPS score, and improve patients'quality of life.④immune function: the control group were Foxp3and CD4/CD8changes were not statistically significant (P>0.05); changes in the value of the experimental group before and after treatment of Foxp3was no significant (P>0.05), while the CD4+/CD8+changes statistically s ignif icant (P<0.05), suggest ing that the polyphenols capsule with adjustment of the immunosuppressive state.⑤The tumor markers:After treatment, the tumor marker changes were not statistically significant(P>0.05).
4Results
The polyphenols capsule combined with chemotherapy can improve the symptoms of advanced non-small cell lung cancer patients during chemotherapy Chinese medicine to relieve the decline of the patients during chemotherapy, KPS, and improve patients'quality of life, and have to adjust the immunosuppressive role of the state.
引文
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[1]马成杰,李元青,刘朝阳,等.茶多酚联合易瑞沙抗移植性人肺腺癌效应研究[J].北京中医,2007,26(10)：675-677
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[3]张燕明,陈信义,徐力.茶多酚对乳腺癌组织及重要器官微血管密度影响的研究[J].北京中医,2007,26(8)：532-536
[4]侯丽,姜苗,陈信义.晚期非小细胞肺癌中医证候特征回顾性临床研究[J].中国中医药信息杂志,2007,14(4)：19-21
[5]宋彦,朱喜科.肿瘤免疫逃逸机制的研究新进展[J].现代肿瘤[学,2011,19(6)：1230-1233
[6]侯丽,姜苗,李忠,等.晚期非小细胞肺癌围化疗期中药参与治疗回顾性临床研究[J]中国中医基础医学杂志,2006,12(5)：359-360
[7]Nagaraj S, Gupta K, Pisarev V, et al. Altered recognition of antigen is a mechanism of CD8 T cell tolerance in cancer [J].Nat Med,2007,13,828-835
[8]Shim JH,Choi Hs,Pugliese A, et al. Epigallocatechin gallate regulates CD3-mediated T cell receptor signaling in leukemia through the inhibition of ZAP-70 kinase[J]. Biological Chemister,2008,283:28370-28379
[9]Kang TH, Lee JH, Song CK,et al. Epigallocatechin-3-Gallate enhances CD8+ T cell-mediated antitumor immunity induced by DNA vaccination[J]. Cancer Research,2007,67:802-811
[10]Theurillat JP,Hainfellner J,Maddalena A, et al.Early induction of angiogene ticsignals in gliomas of GFAP-v-src transgenic mice[J].Am J Pathol,1999,154:581-590