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目的评估肝动脉化疗栓塞术(TACE)后联合索拉非尼治疗非手术切除的中期肝细胞癌(HCC)患者的安全性及临床疗效。方法 2009年7月至2011年7月,我院共38例中期HCC患者(试验组)行TACE后索拉非尼联合治疗。根据试验组患者的基本属性及肿瘤特性,从同期选取38例单纯行TACE治疗的中期HCC患者作为对照组进行回顾性研究,所有患者为巴塞罗那肝癌临床分期(BCLC)B期。分析试验组药物相关不良反应及两组总体生存期的差异。结果所有试验组患者都发生了至少1种药物相关的不良反应,7例(18.4%)患者出现了3级药物相关的不良反应,未见4级及更高的不良反应出现。对照组的中位生存期为11个月(95%CI:7.4～14.6个月),试验组的中位生存期为15个月(95%CI:8.4～21.6个月),两组生存期的差异有统计学意义(P=0.019)。结论非手术切除的中期HCC患者接受TACE后联合索拉非尼治疗,未见严重不良反应发生且能有效提高患者的总体生存期。
Objective To evaluate the safety and clinical efficacy of combined sorafenib in patients with non-resected metaphase hepatocellular carcinoma (HCC) after transcatheter arterial chemoembolization (TACE). Methods From July 2009 to July 2011, a total of 38 patients with HCC in our hospital (experimental group) underwent TACE combined with sorafenib. According to the basic attributes and tumor characteristics of the patients in the experimental group, 38 patients with simple HCC who underwent TACE alone were enrolled as the control group. All patients were in stage B BCLC. Analysis of test group drug-related adverse reactions and overall survival difference between the two groups. Results All patients in the test group experienced at least 1 drug-related adverse event. Grade 7 drug-related adverse events were reported in 7 patients (18.4%), and no grade 4 or higher adverse reactions occurred. The median survival time in the control group was 11 months (95% CI 7.4 to 14.6 months) and the median survival time in the experimental group was 15 months (95% CI 8.4-21.6 months) The difference was statistically significant (P = 0.019). Conclusion Non-surgical resection of medium-term HCC patients receiving TACE combined with sorafenib treatment, no serious adverse reactions occurred and can effectively improve the overall survival of patients.