基于真实世界肝动脉化疗栓塞术联合槐耳颗粒治疗肝细胞癌的临床研究

Real-world evidence based clinical research on management of hepatocellular carcinoma treated with TACE combined with Huaier Granules

目的:观察肝动脉化疗栓塞术(TACE)联合槐耳颗粒治疗肝细胞癌(hepatocellular carcinoma,HCC)的有效性和安全性,探索影响预后的相关因素。方法:采用真实世界研究,2014年9月至2016年12月共751例HCC患者入组,实验组行TACE联合槐耳颗粒治疗,对照组行TACE治疗。观察指标为PFS、药物不良反应。结果:截止2017年6月,678例患者可评估,总体中位随访时间为282 d,实验组330例m PFS为381 d,对照组348例m PFS为237 d,Kaplan-Meier法分析有显著统计学差异(P=0.000 3)。COX回归显示ChildPugh分级和有无PVTT是HCC患者TACE术后肿瘤进展的独立风险预测因子。随访期间31例患者出现不良反应,其中以恶心、呕吐多见,均可自行缓解。结论:TACE联合槐耳颗粒治疗HCC具有良好的临床疗效和安全性,值得临床推广。

Objective：To evaluate the efficacy and safety of Huaier Granules combined with TACE in management of hepatocellular carcinoma （HCC） ,and to assess relevant factors affecting prognosis. Methods： A prospective real - world study was carried out in this research. During the period from September 2014 to December 2016, a total of 751 patients diagnosed with HCC were enrolled. Patients in experimental group were treated with TACE combined with Jin Ke Huaier Granules,and patients in control group were treated with TACE. The main observation indexes included progression free survival （PFS） and adverse reactions caused by Huaier Granules. Results：Up to June 2017,678 pa-tients were eligible for evaluation, the overall median follow - up time was 282 days. The median progression free sur-vival of 330 patients in experimental group was 381 days,while the median progression free survival of 348 patients in control group was 237 days. By using Kaplan - Meier analysis,the difference between the two groups was statistically significant （P = Q. 000 3 ） . In experimental group, COX regression analysis showed the independent predictors of tumor progression after TACE were Child - Pugh grade and with or without portal vein tumor thrombus. During the fol-low -up time, different adverse effects occurred in 31 patients using Huaier Granules, which mainly included nausea and vomit. All the adverse effects relieved spontaneously without special treatment. Conclusion： TACE combined with Huaier Granules is effective and safe in management of hepatocellular carcinoma and is worthy of clinical promotion.