【摘要】 目的 探讨TraSphere显影栓塞微球用于经动脉化疗栓塞治疗肝癌的安全性、有效性。方法 选取2023年9月至2023年11月丽水市中心医院收治的肝癌患者5例，以TraSphere显影栓塞微球加载表阿霉素行载药微球经动脉化疗栓塞(drug-eluting bead transarterial chemoembolization,DEBTACE)治疗。治疗后随访1个月，根据改良实体瘤疗效评价标准(mRECIST)评价抗肿瘤疗效，记录栓塞区域可视化情况、肝功能及并发症。结果 5例患者均成功进行DEB-TACE治疗。治疗后1个月，5例患者病灶评价为PR。术后即刻锥形束CT扫描与术后1个月CT对栓塞区域的可视化评价中，100%病灶可达到25%～100%区域显影；术后4例患者出现不良反应，其中栓塞后综合征3例，未发生3级以上不良反应，不良反应在给予对症支持治疗后，1～2 d内症状消失。结论 TraSphere显影栓塞微球用于DEB-TACE治疗肝癌安全可行，具有一定的短期疗效与较好的显影性能，远期疗效需大样本、多中心、随机对照研究进一步确证。更多还原

【Abstract】 Objective This prospective,single-center,open-label First-in-Man(FIM)study aimed to evaluate the safety and efficacy of TraSphere embolic microspheres for transcatheter arterial chemoembolization(TACE)in the treatment of hepatocellular carcinoma(HCC).Methods Five patients with HCC at Lishui Municipal Central Hospital between September 2023 and November 2023 were enrolled in this study.Drug-eluting bead TACE(DEB-TACE)was performed using TraSphere embolic microspheres loaded with epirubicin.Patients were followed up for one month post-treatment.Anti-tumor efficacy was assessed according to the modified Response Evaluation Criteria in Solid Tumors(mRECIST).The degree of visualization of the embolized area,liver function changes,and complications were recorded.Additionally,patient prognosis was calculated.Results All five patients successfully underwent DEB-TACE treatment,achieving a success rate of 100%.One month after treatment,all five patients were evaluated as having partial remission(PR),resulting in a partial remission rate of100.00%.In terms of visualization evaluation,CBCT imaging immediately post-surgery and CT imaging one month later revealed that 100% of lesions achieved 25% to 100% regional visualization.Adverse reactions occurred in four patients,with the primary adverse reaction being post-embolization syndrome in three cases(3/5,60%).No grade 3 or higher adverse reactions were observed.Symptomatic treatment effectively managed adverse reactions,and symptoms resolved within one to two days following supportive care.Conclusion Preliminary findings indicate that TraSphere embolic microspheres are safe and effective for transarterial chemoembolization in treating HCC,demonstrating short-term efficacy and good imaging performance.However,long-term efficacy requires further validation through large-scale,multicenter,randomized controlled trials.更多还原