目的 探討參一膠囊聯(lián)合FOLFOX4方案治療索拉非尼耐藥的晚期原發(fā)性肝癌的臨床療效。方法 選取2018年3月-2020年1月南陽醫(yī)學(xué)高等?？茖W(xué)校第一附屬醫(yī)院接收的80例索拉非尼耐藥的晚期原發(fā)性肝癌患者，根據(jù)入院奇偶順序?qū)⒒颊叻譃閷?duì)照組和治療組，每組各40例。兩組均給予FOLFOX4方案化療，以2周為1個(gè)周期，化療4個(gè)周期。第1天靜脈滴注奧沙利鉑注射液，85 mg/m²；第1~2天靜滴注注射用亞葉酸鈣，200 mg/m²；第1~2天靜推氟尿嘧啶注射液，400 mg/m²，同時(shí)持續(xù)靜滴氟尿嘧啶注射液600 mg/m²。治療組在對(duì)照組治療的基礎(chǔ)上飯前0.5 h溫水送服參一膠囊，20 mg/次，2次/d，最少連續(xù)使用8周。觀察兩組療效，比較兩組的生活質(zhì)量、免疫功能和血清腫瘤標(biāo)志物水平。結(jié)果 治療后，治療組的臨床有效率（47.50%）、客觀緩解率（82.50%）高于對(duì)照組的臨床有效率（25.00%）、客觀緩解率（55.00%）（P<0.05）。治療后，兩組SF-36各維度評(píng)分均升高，同組治療前后對(duì)比有差異（P<0.05）；治療后，治療組的SF-36各維度評(píng)分高于對(duì)照組（P<0.05）。治療后，兩組免疫球蛋白（Ig）G、IgA、IgM、CD3⁺、CD4⁺均顯著升高，同組治療前后對(duì)比具有顯著差異（P<0.05）；治療后，治療組IgG、IgA、IgM、CD3⁺、CD4⁺高于對(duì)照組（P<0.05）。治療后，兩組甲胎蛋白（AFP）、癌胚抗原（CEA）、糖類抗原125（CA-125）水平均降低，同組治療前后對(duì)比有顯著差異（P<0.05）；治療后，治療組的AFP、CEA、CA-125水平低于對(duì)照組（P<0.05）。結(jié)論 參一膠囊聯(lián)合FOLFOX4方案治療索拉非尼耐藥的晚期原發(fā)性肝癌可有效延緩疾病進(jìn)展，改善患者生活質(zhì)量和免疫功能，降低血清腫瘤標(biāo)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

河南省醫(yī)學(xué)科技攻關(guān)計(jì)劃項(xiàng)目（201603373）