中国临床药理学杂志2019，Vol.35Issue(7)：620-623,4.DOI:10.13699/j.cnki.1001-6821.2019.07.006
索拉菲尼片联合经肝动脉化疗栓塞术治疗不可手术切除的原发性肝癌的临床研究
Clinical trial of sorafenib tablets combined with transcatheter arterial chemoembolization in the treatment of unresectable liver cancer
摘要
Abstract
Objective To observe the clinical efficacy and safety of sorafenib tablets combined with transcatheter arterial chemoembolization (TACE) in the treatment of unresectable liver cancer. Methods A total of 164 patients with unresectable liver cancer were randomly divided into control and treatment groups with 82 cases per group. Control group was treated with TACE alone, once every 4 weeks. Treatment group was given sorafenib tablets 400 mg per time from 5 d after TACE treatment, bid, orally, on the basis of control group. Two groups were treated for 12 weeks. The clinical efficacy, serum tumor markers, serum vascular endothelial growth factor (VEGF) , levels of basic fibroblast growth factor (bFGF) , and adverse drug reactions were compared between two groups.Results After treatment, the objective remission rates of treatment and control groups were 52. 44％ (43 cases/79 cases) and 28. 05％ (23 cases/79 cases) , the disease control rates were 87. 80％ (72 cases/79 cases) and 68. 29％ (56 cases/79 cases) , the progression free survival time were (15. 32 ± 2. 04) and (10. 83 ± 1. 43) months, the overall survival time were (15. 32 ± 2. 04) and (10. 83 ± 1. 43) months, the differences were statistically significant (all P < 0. 05) . After treatment, the alpha fetoprotein of treatment and control groups were (71. 38 ± 10. 04) and (152. 36 ± 20. 37) ng·m L-1, the carcinoembryonic antigen were (2. 02 ± 0. 27) and (2. 94 ± 0. 34) μg·L-1, the VEGF were (317. 87 ± 32. 76) and (442. 45 ± 35. 09) pg·m L-1, the differences were statistically significant (all P < 0. 05) . The adverse reactions of treatment group and the control group were nausea and vomiting (71. 95％ vs63. 41％) , diarrhea (35. 37％ vs 42. 68％) , myelosuppression (43. 90％ vs 40. 24％) and fever (84. 15％ vs90. 24％) , oral mucositis (32. 93％ vs 6. 10％) , hand-foot skin reaction (69. 51％ vs 2. 44％) , the differences were statistically significant (all P < 0. 05) . Conclusion Sorafenib tablets combined with TACE have a definitive clinical efficacy in the treatment of unresectable liver cancer, which can effectively inhibit the release of tumor markers, decrease the levels of serum VEGF and other cytokines. Although the incidence of adverse drug reactions is high, they can be controlled.关键词
索拉菲尼片/经肝动脉化疗栓塞术/原发性肝癌/安全性评价Key words
sorafenib tablet/transcatheter arterial chemoembolization/primary liver cancer/safety evaluation分类
医药卫生引用本文复制引用
邵宝儿,田炳如,乐凌云,邢士超,鲁文权,林能明..索拉菲尼片联合经肝动脉化疗栓塞术治疗不可手术切除的原发性肝癌的临床研究[J].中国临床药理学杂志,2019,35(7):620-623,4.基金项目
浙江省自然科学基金资助项目 (Y15H310007) （Y15H310007）
