作者：彭翰斐1，周志涛1，范隼1，李庆源1，何伟良1，钟鹏1，卢曼萍1，李华2，关守海3

单位：1.中山大学附属第三医院粤东医院肝胆外科，广东 梅州 514000；2.中山大学附属第三医院肝脏外科，广东 广州 510000；3.中山大学附属第三医院介入科，广东 广州 510000

Authors: Peng Hanfei1, Zhou Zhitao1, Fan Sun1, Li Qingyuan1, He Weiliang1, Zhong Peng1, Lu Manping1, Li Hua2, Guan Shouhai3

Unit: 1.Department of Hepatobiliary Surgery, Yuedong Hospital of the Third Affiliated Hospital of Sun Yat-sen University, Meizhou 514000, Guangdong, China；2.Department of Liver Surgery, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510000, Guangdong, China； 3.Department of Interventional Radiology Program, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510000, Guangdong, China

摘要：

目的 分析药物洗脱微球经动脉化疗栓塞（drug-eluting bead transarterial chemoembolization, DEB-TACE）和传统经导管动脉化疗栓塞（conventional transcatheter arterial chemoembolization, c-TACE）在晚期肝细胞癌患者治疗中的疗效及安全性。方法 回顾性分析中山大学附属第三医院2021年3月至2023年2月收治的79例晚期肝细胞癌患者，其中39例接受DEB-TACE治疗（DEB-TACE组），40例接受c-TACE治疗（c-TACE组）。比较两组治疗后1个月、3个月时的客观缓解率（objective response rate, ORR）和疾病控制率（disease control rate, DCR），比较两组治疗后1周及1个月时的血常规指标（白细胞计数、红细胞计数、血小板计数）及肝功能指标（白蛋白、总胆红素、丙氨酸转氨酶、天冬氨酸转氨酶）的变化情况，观察患者治疗后的不良反应发生情况。比较随访期间两组患者的总生存（overall survival, OS）时间、无进展生存（progression-free survival, PFS）时间。结果 治疗后1个月及3个月时，c-TACE组的ORR分别为2.50%、15.00%，DEB-TACE组分别为7.69%、25.64%，差异无统计学意义（P＞0.05）；DEB-TACE组的DCR分别为97.44%、79.49%，高于c-TACE组的80.00%、55.00%（P＜0.05）。治疗后1周及1个月时，两组天冬氨酸转氨酶、白蛋白、白细胞计数、红细胞计数变化幅度差异无统计学意义（P＞0.05）；治疗后1周，c-TACE组患者丙氨酸转氨酶、总胆红素和血小板计数变化幅度大于DEB-TACE组（P＜0.05）；治疗后1个月时，两组丙氨酸转氨酶、总胆红素和血小板计数变化幅度差异无统计学意义（P＞0.05）。DEB-TACE组轻度胃肠道反应、发热、血液系统反应的发生率均低于c-TACE组（P＜0.05），两组中度胃肠道反应、发热、血液系统反应的发生率，轻度及中度皮肤反应、脱发的发生率差异无统计学意义（P＞0.05）。c-TACE组1年PFS时间和1年OS时间分别为8.5个月（95%CI: 7.7~9.2个月）、10.1个月（95%CI: 9.3~10.7个月），DEB-TACE组分别为9.3个月（95%CI: 8.6~10.1个月）、10.4个月（95%CI: 9.5~10.8个月），差异无统计学意义（P＞0.05）。结论 晚期肝细胞癌患者采用DEB-TACE与c-TACE治疗后的ORR相似，但DEB-TACE 治疗后的DCR高于c-TACE，且DEB-TACE治疗后短期内对肝功能的影响更小，不良反应发生率更低。

关键词： 晚期；肝细胞癌；药物洗脱微球；经导管动脉化疗栓塞

Abstract：

Objective  To analyze the efficacy and safety of drug-eluting bead transarterial chemoembolization (DEB-TACE) and conventional transcatheter arterial chemoembolization (c-TACE) in the treatment of patients with advanced hepatocellular carcinoma. Method  79 patients with advanced hepatocellular carcinoma admitted to the Third Affiliated Hospital of Sun Yat-sen University from March 2021 to February 2023 were analyzed retrospectively, including 39 patients treated with DEB-TACE (DEB-TACE group) and 40 patients treated with c-TACE (c-TACE group). The objective response rate (ORR) and disease control rate (DCR) at 1 month and 3 months after treatment were compared between the two groups. The changes of blood routine index (white blood cells count, red blood cells count and platelets count) and liver function index (albumin, total bilirubin, alanine transaminase and aspartate transaminase) at 1 week and 1 month after treatment were compared between the two groups, and the occurrence of adverse reactions after treatment was observed. The overall survival (OS) time and progression-free survival (PFS) time were compared between the two groups during the follow-up period. Result  At 1 month and 3 months after treatment, the ORR of c-TACE group were 2.50% and 15.00%, while the DEB-TACE group were 7.69% and 25.64%, respectively, and there were no statistical differences (P＞0.05). The DCR of DEB-TACE group were 97.44% and 79.49%, which were higher than those of c-TACE group (80.00% and 55.00%) (P＜0.05). At 1 week and 1 month after treatment, there were no statistical differences in the changes of aspartate transaminase, albumin, white blood cells count and red blood cells count between the two groups (P＞0.05). 1 week after treatment, the changes of alanine transaminase, total bilirubin and platelets count in c-TACE group were greater than those in DEB-TACE group (P＜0.05). 1 month after treatment, there were no statistical differences in the changes of alanine transaminase, total bilirubin and platelets count between the two groups (P＞0.05). The incidences of mild gastrointestinal reaction, fever and blood system reaction in DEB-TACE group were lower than those in c-TACE group (P＜0.05), while the incidences of moderate gastrointestinal reaction, fever and blood system reaction, and the incidences of mild and moderate skin reaction and alopecia were not statistically different between the two groups (P＞0.05). 1-year PFS time and 1-year OS time in c-TACE group were 8.5 months (95%CI: 7.7-9.2 months) and 10.1 months (95%CI: 9.3-10.7 months), while the DEB-TACE group were 9.3 months (95%CI: 8.6-10.1 months) and 10.4 months(95%CI: 9.5-10.8 months), respectively, without statistical differences (P＞0.05). Conclusion  The ORR of patients with advanced hepatocellular carcinoma treated with DEB-TACE or c-TACE is similar, but the DCR of DEB-TACE is higher than that of c-TACE, while the short-term impact on liver function of DEB-TACE is less, and the incidence of adverse reactions of DEB-TACE is lower.

Key Words: Late stage; Hepatocellular carcinoma; Drug-eluting beads; Transcatheter arterial chemoembolization