参一胶囊联合FOLFOX4方案治疗胃癌的临床研究

Clinical study on Shenyi Capsules combined with FOLFOX4 regimen in treatment of gastric cancer

目的探讨参一胶囊联合FOLFOX4方案治疗胃癌的临床疗效。方法选取2013年2月—2016年5月在江汉大学附属医院诊治的胃癌患者89例,按治疗方法不同分为对照组(37例)和治疗组(52例)。对照组给予FOLFOX4方案化疗:第1天静脉滴注注射用奥沙利铂130 mg/m^2,滴注时间2 h;第1天静脉滴注亚叶酸钙注射液200 mg/m^2,滴注时间2 h,尔后先静脉推注氟尿嘧啶注射液300 mg/m^2,然后改为静脉滴注600 mg/m^2,滴注时间22 h;2周为1个化疗周期,肿瘤明显缩小的患者继续1个周期化疗。治疗组患者在对照组基础上口服参一胶囊,20 mg/次,2次/d,连续服用28 d。观察两组的临床疗效,比较两组的免疫功能、血清血管内皮生长因子(VEGF)水平和不良反应情况。结果治疗后,对照组和治疗组的有效率分别为48.6%、71.2%,临床受益率分别为83.8%、96.2%,两组比较差异有统计学意义(P<0.05)。治疗后,对照组CD^(3+)、CD^(4+)、CD^(8+)、CD^(4+)/CD^(8+)明显降低,而治疗组这些指标明显升高,两组比较差异具有统计学意义(P<0.05)。治疗后及术后3个月,两组血清VEGF水平均明显下降,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组血清VEGF水平明显低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗组白细胞减少、血小板减少、消化系统反应、周围神经毒性发生率明显少于对照组,两组比较差异有统计学意义(P<0.05)。结论参一胶囊联合FOLFOX4方案治疗胃癌具有较好的临床疗效,可降低血清VEGF水平,增强免疫功能,安全性较好,具有一定的临床推广应用价值。

Objective To study the clinical efficacy of Shenyi Capsules combined with FOLFOX4 regimen in treatment of gastric cancer.Methods Patients （89 cases） with gastric cancer in Affiliated Hospital of Jianghan University from January 2013 to February 2015 were enrolled in this study. According to the difference treatment plan, patients were divided into the control group （37 cases） and treatment group （52 cases）. Patients in the control group were given chemotherapy with FOLFOX4 regimen： Patients were iv administered with Oxaliplatin for injection on day 1, 130 mg/m2, infusion time of 2 h; Patients were iv administered with Calcium Folinate Injection on day 1, 200 mg/m2, infusion time of 2 h. At the same time, patients were iv administered with Fluorouracil Injection on day 1, 300 mg/m2, then changed to iv drip, 600 mg/m2, infusion time of 22 h, 2 weeks for one chemotherapy cycle. Patients with significantly reduced tumors continued one cycle of chemotherapy. Patients in the treatment group werepo administered with Shenyi Capsules on the basis of the control group, 20 mg/time, twice daily, treated for 28 d. After treatment, the clinical efficacies were evaluated, and immune function, serum VEGF levels, and adverse reactions in two groups were compared.Results After treatment, the clinical efficacies in the control and treatment groups were 48.6% and 71.2%, clinical benefit rates were 83.8% and 96.2%, respectively, and there was difference between two groups （P 〈 0.05）. After treatment, CD3＋, CD4＋, CD8＋, and CD4＋/CD8＋ in the control group were significantly decreased, but the observational indexes in the treatment group were significantly increased, and there was difference between two groups （P 〈 0.05）. After treatment and 3 months after operation, the serum VEGF levels in two groups were significantly decreased, and the difference was statistically significant in the same group （P〈0.05）. And the serum VEGF level in the treatment group was significantly lower than that in the control group, with significant difference between two groups （P〈0.05）. The incidence rates of leukopenia, thrombocytopenia, digestive system reaction, and peripheral neurotoxicity in the treatment group were significantly less than those in the control group, and there was difference between two groups （P 〈 0.05）.Conclusion Shenyi Capsules combined with FOLFOX4 regimen has clinical curative effect in the treatment of gastric cancer, and can decrease serum VEGF level, enhance immune function, with good safety, which has a certain clinical application value.