【摘要】 目的 探讨新型仿生核壳结构载药微球DiaSphere加载蒽环类药物行药物洗脱微球TACE(drug eluting beads-TACE,DEB-TACE)治疗肝癌的安全性与有效性。方法 选取2022年12月至2023年11月东南大学附属中大医院等8家中心收治的肝癌患者34例，以DiaSphere载药微球加载蒽环类化疗药物行DEB-TACE治疗。治疗后随访3个月，评价抗肿瘤疗效，记录肝功能、并发症及患者预后情况。结果 34例患者均成功实施DEB-TACE治疗，栓塞成功率100%。末次TACE术后1个月、3个月患者客观缓解率分别为67.65%、75.00%。最大靶病灶直径由术前的（31.36±16.72）mm降至末次DEB-TACE术后1个月的（19.73±15.98）mm，差异有统计学意义（P<0.05）。术后30例患者出现不良事件，其中栓塞后综合征27例（79.4%），高血压7例（20.59%），经对症支持治疗后，均在7 d内缓解或消失。未发生与器械相关的不良事件。结论 新型仿生核壳结构载药微球DiaSphere加载蒽环类药物行DEB-TACE治疗肝癌具短期疗效好，安全可行。更多还原

【Abstract】 Objective To investigate the safety and efficacy of transcatheter arterial chemoembolization(TACE) with novel biomimetic core-shell structure DiaSphere drug-eluting microspheres loaded with anthracyclines(DEB-TACE)for the treatment of liver cancer.Methods A total of 34 patients with liver cancer,who were admitted to eight medical centers including Affiliated Zhongda Hospital of Southeast University of China from December 2022 to November 2023,were enrolled in this study.DEB-TACE treatment with DiaSphere drug-eluting microspheres loaded with chemotherapy drug of anthracyclines was performed for all patients.The patients were followed up for 3 months after treatment,and the efficacy was evaluated.The liver functions and complications were recorded,and the prognosis of the patients were statistically analyzed.Results Successful DEB-TACE treatment was accomplished in all the 34 patients,with an embolization success rate of 100%.At one month and 3 months after the last TACE treatment the objective response rate(ORR)was 67.65% and 75.00%respectively.The mean diameter of the largest target lesions decreased from preoperative(31.36±16.72)mm to(19.73±15.98)mm at one month after the last surgery,with a statistically significant difference(P<0.05).Thirty patients experienced adverse events after surgery,mainly including post-embolization syndrome(n=27,79.4%)and hypertension(n=7,20.59%).No device-related adverse events occurred.After symptomatic supportive treatment,all adverse reactions were relieved or disappeared within7 days.Conclusion For the treatment of liver cancer,DEB-TACE using novel biomimetic core-shell structure DiaSphere drug-eluting microspheres loaded with anthracyclines is clinically safe and feasible with satisfactory short-term efficacy.更多还原