仙蟾片联合曲妥珠单抗和mFOLFOX6方案治疗老年HER2阳性晚期胃癌的临床研究

Clinical study on Xianchan Tablets combined with trastuzumab and mFOLFOX6 regimen in treatment of elderly with advanced gastric cancer of HER2 positive

目的观察仙蟾片联合曲妥珠单抗和mFOLFOX6方案治疗老年表皮生长因子受体-2(HER2)阳性晚期胃癌的临床疗效。方法选取2011年1月—2014年1月在延安市人民医院就诊的老年HER2阳性晚期胃癌患者212例,随机分为对照组和治疗组,每组各106例。两组患者均给予mFOLFOX6方案化疗,每个治疗周期为21 d。对照组在此基础上于第1天静脉滴注注射用曲妥珠单抗8 mg/kg,然后每个周期第1天给予6 mg/kg。治疗组在对照组的基础上口服给予仙蟾片,4片/次,3次/d。两组患者均治疗6个周期。观察两组患者近期和远期疗效,同时比较治疗前后两组患者血清生化指标和不良反应。结果治疗后,对照组临床有效率和控制率分别为60.3%、78.3%,均显著低于治疗组的73.5%、89.6%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者血清纤维母细胞特异性蛋白-1(FSP-l)、骨髓相关蛋白-14(MRP-l4)、趋化因子受体-4(CXCR4)和基质衍生因子-1(SDF-1)均明显降低(P<0.05),且治疗组上述血清生化指标明显低于对照组(P<0.05)。远期疗效结果显示,对照组有效病例中平均无疾病进展生存时间(PFS)和总生存时间(OS)均分别明显小于治疗组患者,两组比较差异具有统计学意义(P<0.05)。治疗期间,治疗组的不良反应发生率均明显低于对照组,两组比较差异具有统计学意义(P<0.05)。结论仙蟾片联合曲妥珠单抗和mFOLFOX6方案治疗老年人表皮生长因子受体-2(HER2)阳性晚期胃癌患者临床疗效较好,能够有效延长生存时间,具有一定的临床推广应用价值。

Objective To observe the clinical effects of Xianchan Tablets combined with trastuzumab and mFOLFOX6 in treatment of elderly with advanced gastric cancer of HER2 positive. Methods Patients（212 cases） with advanced gastric cancer of HER2 positive in Yan＇an People＇s Hospital from January 2011 to January 2014 were randomly divided into control and treatment groups, and each group had 106 cases. All patients were given mFOLFOX6 chemotherapy, and each treatment cycle was 21 d. Patients in the control group were iv administered with Trastuzumab Injection for the first day of each cycle, and the 1 st time was 8 mg/kg, then 6 mg/kg. Patients in the treatment group were po administered with Xianchan Tablets on the basis of the control group, 4 tablets/time, three times daily. Patients in two groups were treated for 6 cycles. After treatment, the short-term and long-term efficacy was evaluated, the serum biochemical indexes and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical efficacy and the clinical control rate were 60.3% and 78.3%, which were significantly lower than 73.5% and 89.6% in the treatment group, respectively, and there were differences between two groups（P〈0.05）.After treatment, the FSP-l, MRP-l4, CXCR4 and SDF-1 in two groups were significantly decreased（P〈0.05）, and the serum biochemical indexes in the treatment group after treatment was significantly lower than those in the control group（P〈0.05）. Long-term efficacy result showed that the PFS and OS of valid cases in the control group were lower than those in the treatment group, with significant difference between two groups（P〈0.05）. During the treatment, the adverse reactions rates in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. Conclusion Xianchan Tablets combined with trastuzumab and mFOLFOX6 in treatment of elderly with advanced gastric cancer of HER2 positive has good effect, and can effectively prolong the survival time, which has a certain clinical application value.