目的 探讨参一胶囊联合FOLFOX4方案治疗索拉非尼耐药的晚期原发性肝癌的临床疗效。方法 选取2018年3月-2020年1月南阳医学高等专科学校第一附属医院接收的80例索拉非尼耐药的晚期原发性肝癌患者，根据入院奇偶顺序将患者分为对照组和治疗组，每组各40例。两组均给予FOLFOX4方案化疗，以2周为1个周期，化疗4个周期。第1天静脉滴注奥沙利铂注射液，85 mg/m²；第1~2天静滴注注射用亚叶酸钙，200 mg/m²；第1~2天静推氟尿嘧啶注射液，400 mg/m²，同时持续静滴氟尿嘧啶注射液600 mg/m²。治疗组在对照组治疗的基础上饭前0.5 h温水送服参一胶囊，20 mg/次，2次/d，最少连续使用8周。观察两组疗效，比较两组的生活质量、免疫功能和血清肿瘤标志物水平。结果 治疗后，治疗组的临床有效率（47.50%）、客观缓解率（82.50%）高于对照组的临床有效率（25.00%）、客观缓解率（55.00%）（P<0.05）。治疗后，两组SF-36各维度评分均升高，同组治疗前后对比有差异（P<0.05）；治疗后，治疗组的SF-36各维度评分高于对照组（P<0.05）。治疗后，两组免疫球蛋白（Ig）G、IgA、IgM、CD3⁺、CD4⁺均显著升高，同组治疗前后对比具有显著差异（P<0.05）；治疗后，治疗组IgG、IgA、IgM、CD3⁺、CD4⁺高于对照组（P<0.05）。治疗后，两组甲胎蛋白（AFP）、癌胚抗原（CEA）、糖类抗原125（CA-125）水平均降低，同组治疗前后对比有显著差异（P<0.05）；治疗后，治疗组的AFP、CEA、CA-125水平低于对照组（P<0.05）。结论 参一胶囊联合FOLFOX4方案治疗索拉非尼耐药的晚期原发性肝癌可有效延缓疾病进展，改善患者生活质量和免疫功能，降低血清肿瘤标志物水平。

Objective To investigate the clinical effect of Shenyi Capsules combined with FOLFOX4 chemotherapy regimen in treatment of sorafenib resistant advanced primary liver cancer. Methods Patients (80 cases) with sorafenib resistant advanced primary liver cancer in the First Affiliated Hospital of Nanyang Medical College from March 2018 to January 2020 were divided into control and treatment groups according to admission parity order, and each group had 40 cases. Patients in the control group were given FOLFOX4 chemotherapy regimen, took 2 weeks as a cycle, treated for 4 cycles:Patients in the control group were intravenous infusion administered with Oxaliplatin Injection on the first day, 85 mg/m², were intravenous infusion administered with Calcium Folinate for injection on the first to second day, 200 mg/m², and were intravenous infusion administered with Fluorouracil Injection on the first to second day, 400 mg/m², continuous intravenous drip administered with Fluorouracil Injection of 600 mg/m². Patients in the treatment group were po administered with Shenyi Capsules on the basis of the control group at 0.5 h before meals, 20 mg/time, twice daily, treated for 8 weeks. After treatment, the clinical efficacies were evaluated, and the quality of life, the immune function, and the serum levels of tumor markers in two groups were compared. Results After treatment, the clinical effective rate (47.50%) and objective remission rate (82.50%) in the treatment group were higher than those in the control group (25.00%) and objective remission rate (55.00%) (P<0.05). After treatment, the each dimension scores of SF-36 in two groups were increased, and there was a difference between the same group before and after treatment (P<0.05). After treatment, the each dimension scores of SF-36 in the treatment group were higher than those in the control group (P<0.05). After treatment, the IgG, IgA, IgM, CD3⁺, and CD4⁺ in two groups were increased, and there was a difference before and after treatment in the same group (P<0.05). After treatment, the IgG, IgA, IgM, CD3⁺, and CD4⁺ in the treatment group were higher than those in the control group (P<0.05). After treatment, the levels of AFP, CEA, and CA-125 in two groups were decreased, and there was a difference between the same group before and after treatment (P<0.05). After treatment, the levels of AFP, CEA, and CA-125 in the treatment group were lower than those in the control group (P<0.05). Conclusion Shenyi Capsules combined with FOLFOX4 chemotherapy regimen in treatment of sorafenib resistant advanced primary liver cancer can effectively delay disease progression, improve patients' quality of life and immune function, and reduce the serum level of tumor markers.

R979.1

河南省医学科技攻关计划项目（201603373）