参莲胶囊联合曲妥珠单抗对人表皮生长因子受体2阳性晚期胃癌化疗患者毒副作用及临床疗效的影响  

The clinical effects of Shenlian capsule, trastuzumab combined with SOX regimen in the treatment for HER-2 positive advanced gastric carcinoma

作　　者：刁卓[1] 王成[1] 刘晓超[1] 唐玉虎[1] Diao Zhuo;Wang Cheng;Liu Xiaochao;Tang Yuhu(Department of Gastroenterology,Hanzhong Central Hospital of Shaanxi,Hanzhong 723000,China)

机构地区：[1]陕西省汉中市中心医院消化内科,723000

出　　处：《国际中医中药杂志》2018年第11期1020-1024,共5页International Journal of Traditional Chinese Medicine

摘　　要：目的 探讨参莲胶囊联合曲妥珠单抗对人表皮生长因子受体2（human epidermal growth factor receptor-2, HER-2）阳性晚期胃癌化疗患者毒副作用及临床疗效的影响。方法 将符合入选标准的314例HER-2阳性晚期胃癌患者采用随机数字表法分为2组，每组157例。2组均采用SOX化疗方案（替吉奥＋奥沙利铂）治疗，对照组在此基础上加用曲妥珠单抗，治疗组在对照组基础上加服参莲胶囊。2组均以21 d为1个周期，共治疗6个周期，随访3年。采用双抗体夹心法检测基质衍生因子-1（stromal-derived factor-1, SDF-1）、趋化因子受体-4 （chemokine receptor-4, CXCR4）、纤维母细胞特异性蛋白-1（fibroblast specific protein-1, FSP-l）及骨髓相关蛋白-14（marrow related protein -14, MRP-l4）含量；观察治疗期间的毒副作用及随访期间患者生存率、总生存时间（overall survival, OS）、无疾病进展生存时间（progression- freely-survival, PFS），评价临床疗效。结果 治疗组临床有效率为78.1%（118/151）、疾病控制率为92.7%（140/151），对照组分别为66.4%（99/149）、79.9%（119/149），2组有效率与疾病控制率比较，差异有统计学意义（Z值分别为3.712、3.812，P值分别为0.039、0.037）。治疗后，治疗组血清SDF-1、CXCR4、FSP-l及MRP-l4含量低于对照组（t值分别为4.091、4.310、3.972、3.821，P值均＜0.01）。治疗期间，治疗组神经毒性、胃肠道反应、肝功能损伤、肾功能损伤、皮疹及骨髓抑制等毒副作用发生率低于对照组（χ2值分别为5.182、4.671、4.491、5.091、5.204、4.925，P＜0.05或P＜0.01）。随访期间，治疗组3年生存率高于对照组（χ2＝3.105，P＝0.043），PFS、OS高于对照组（t值分别为3.714、3.612，P＜0.05）。结论 参莲胶囊联合曲妥珠单抗可降低HER-2阳性晚期胃癌患者化疗后的毒副作用，延长患者生存时间。Objective To investigate the clinical effects of Shenlian capsule, trastuzumab combined with SOX regimen in the treatment for HER-2 positive advanced gastric carcinoma. Methods A total of 314 patients with HER-2 positive advanced gastric carcinoma in our hospital were randomly divided observation group and control group, 157 cases in each group. The observation group was treated by SOX regimen and trastuzumab, while the control group was given Shenlian capsule on the base of control group. After treatment, the short-term effects in the 2 groups were evaluated. Before and after the treatment, the levels of SDF-1, CXCR4, FSP-l and MRP-l4 in the 2 groups were detected. During the treatment, the rates of neurotoxicity, gastrointestinal reaction, liver function injury, renal function injury, rashes and bone marrow suppression were observed in the 2 groups. After the treatment, 3 years follow-up was performed, the 1 year survival rate, 3 year survival rate, overall survival （OS） and progression-free survival （PFS） were observed. Results After the treatment, the control rate （92.7% vs. 79.9%; Z=3.812, P=0.037） and efficiency rate （78.1% vs. 66.4%; Z=3.712, P=0.039） were significantly higher in treatment group than which in the control group （P〈0.05）. After the treatment, the levels of SDF-1, CXCR4, FSP-l, MRP-l4 in treatment group were significantly lower than control group （t=4.091, 4.310, 3.972, 3.821, P〈0.05）. During the treatment, the rates of neurotoxicity, gastrointestinal reaction, liver function injury, renal function injury, rashes, bone marrow suppression were significantly lower in treatment group than control group （χ2=5.182, 4.671, 4.491, 5.091, 5.204, 4.925, P〈0.05 or P〈0.01）. After the treatment, the PFS, OS （t=3.714, 3.612, P〈0.05）, 3 year survival rate （χ2=3.105, P=0.043） were significantly higher in treatment group than the control group. Conclusions The Shenlian capsule, trastuzumab combined with SOX regimen has a good effect and low toxic effects in the

关 键 词：胃肿瘤 人表皮生长因子受体2 曲妥珠单抗 参莲胶囊 药物相关副作用及不良反应 疗效比较研究 

分 类 号：R735.2[医药卫生—肿瘤]