恩度联合养正消积胶囊治疗晚期消化道恶性肿瘤的临床研究  

Clinical Effect of Yangzheng Xiaoji Capsule Combined with Endostar in Treatment of Advanced Malignant Tumor of Digestive Tract

作　　者：徐红燕[1] 曹琳[2] 高绍荣[1] 李瑞林[2] 王爱蓉[3] 李鲁明[4] 王光明[5] XU Hongyan1, CAO Lin2, GAO Shaorong1, LI Ruilin2, WANG Airong3, LI Luming4 , WANG Guangming5(1. Thrid Department of Chemotherapy, Weihai Municipal Hospital, Weihai 264200, Shandong, China; 2. First Department of Chemotherapy, Weihai Municipal Hospital, Weihai 264200, Shandong, China; 3. Oncology Department, Weihai Municipal Hospital, Weihai 264200, Shandong, China ; 4. Internal Medicine - Cardiovascular Department, Weihai Municipal Hospital, Weihai 264200, Shandong, China; 5. Pharmacy Department, Weihai Municipal Hospital, Weihai 264200, Shandong, Chin)

机构地区：[1]威海市立医院化疗三科,山东威海264200 [2]威海市立医院化疗一科,山东威海264200 [3]威海市立医院肿瘤科,山东威海264200 [4]威海市立医院心内科,山东威海264200 [5]威海市立医院药剂科,山东威海264200

出　　处：《中华中医药学刊》2018年第5期1173-1176,共4页Chinese Archives of Traditional Chinese Medicine

基　　金：山东省医药卫生科技发展计划基金项目(2013BJYB38)

摘　　要：目的：观察恩度联合养正消积胶囊治疗晚期消化道恶性肿瘤的临床治疗效果及其具体的作用机制研究。方法：选取晚期消化道恶性肿瘤患者80例,随机分为对照组及观察组,对照组38例,观察组42例。两组患者前4个周期均采用恩度联合XELOX方案治疗,后4个周期,对照组采用恩度联合卡培他滨维持治疗,观察组采用恩度联合养正消积胶囊治疗,两组均继续治疗4周期。观察比较治疗前后两组患者T细胞的亚群（CD4^＋、CD8^＋、CD4^＋/CD8^＋）的比例,及血清中的炎性因子肿瘤坏死因子-α（TNF-α）、白介素-6（IL-6）和C反应蛋白（CRP）的变化;比较治疗后两组卡式评分（KPS评分）、生存质量评分、无进展生存期（RFS）及总生存期（OS）及不良反应。结果：两组患者治疗后血清中炎性因子TNF-α、IL-6及CRP较治疗前显著改善（P〈0.05）。两组治疗后CD4^＋及CD4^＋/CD8^＋均升高（P〈0.05）,并且观察组较对照组变化更为明显（P〈0.05）。治疗后观察组的KSP评分变化较对照组更为明显（P〈0.05）,观察组患者生存质量评分的功能领域、症状领域及其他均明显优于对照组（P〈0.05）;观察组患者0.5年和1年PFS率J及OS率与对照组患者相比,差异均无统计学意义（P〉0.05）;不良反应明显少于对照组（P〉0.05）。结论：恩度联合养正消积胶囊治疗晚期消化道恶性肿瘤对患者的生存质量具有很大改善,值得在临床上推广。Objective： To study the clinical effect of Yangzheng Xiaoji Capsule combined with Endostar in the treatment of advanced malignant tumor of digestive tract and its specific mechanism of action. Methods： Eighty patients with advanced digestive tract cancer were selected and randomly divided into the control group and the observation group,38 cases in the control group and 42 cases in the observation group. Two groups before 4 cycles were treated by Endostar combined with XELOX regimen. After 4 cycles,the control group used Endostar combined with capecitabine maintenance treatment and observation group were treated with Endostar combined with Yangzheng Xiaoji Capsule. Two groups were treated continuously for 4 cycles. Before and after treatment,we observed two groups＇ T cell subsets（CD4^＋,CD8^＋,CD4^＋/CD8^＋）,the proportion of inflammatory factors in serum and tumor necrosis factor alpha（TNF-alpha） and interleukin-6（IL-6） and C reactive protein（CRP） changes in peripheral blood platelet index（PLT） and the number of white blood cell（WBC） and hemoglobin（Hb）. The two goups＇ KPS score,relapse free survival（RFS） and overall survival（OS）,the clinical efficacy and adverse reactions were comapred after treatment. Results： After treatment,serum inflammatory factor TN-alpha,IL-6 and CRP and peripheral blood indexes of WBC,PLT and Hb in two groups were significantly improved compared with those before treatment（P〈0. 05） and the observation group＇s IL-6,WBC and Hb improved significantly compared with those of the control group（P〈0. 05）. The CD4^＋ and CD4^＋/CD8^＋ of the two groups were increased（P〈0. 05） and the change of the observation group was more obvious than that of the control group（P〈0. 05）. There was no significant difference between the observation group and the control group in the 0. 5 and 1 year RFS rates（P〉0. 05）. The rate of OS in the observation group and the 0. 5 year group and the 1 year group were significantly different

关 键 词：恩度 养正消积胶囊 CD4^+/CD8^+ 生存质量 

分 类 号：R735[医药卫生—肿瘤]