国产CalliSpheres载药微球在原发性肝癌介入治疗中的疗效评估  

Evaluation of the Therapeutic Efficacy of CalliSpheres Drug-eluting Microspheres in the Interventional Treatment of Primary Liver Cancer

作　　者：曾振鹏 刘雨 洪跃飞 杜端明[1] 刘春霖[1] 吴育民[1] ZENG Zhenpeng;LIU Yu;HONG Yuefei;DU Duanming;LIU Chunlin;WU Yumin(Shenzhen Second People’s Hospital,Guangdong Shenzhen 518035)

机构地区：[1]深圳市第二人民医院,广东深圳518035

出　　处：《深圳中西医结合杂志》2024年第6期21-26,共6页Shenzhen Journal of Integrated Traditional Chinese and Western Medicine

摘　　要：目的:探讨国产CalliSpheres载药微球在原发性肝癌介入治疗中的疗效。方法:选取2020年4月至2022年10月深圳市第二人民医院收治的原发性肝癌患者25例,均在首次载药微球经导管动脉化疗栓塞术(DEB-TACE)中应用国产CalliSpheres载药微球。比较治疗前后的实验室检查差异、肿瘤活性病灶大小,记录栓塞后不良反应发生情况,分析中远期预后情况。结果:25例患者治疗后1、3、6个月客观缓解率(ORR)分别为55.56%、61.54%和44.44%,治疗后1、3、6个月疾病控制率(DCR)分别为88.89%、76.92%和55.56%。中位生存时间(mOS)为30.47个月[95%CI(16.02,44.91)],中位无进展生存期(mPFS)为19.21个月[95%CI(7.67,34.24)]。相比于治疗前,治疗后1个月、6个月的血清甲胎蛋白(AFP)水平比较,差异无统计学意义(P>0.05),治疗后3个月的AFP较治疗前明显下降(P<0.05)。22名(88%)患者接受DEB-TACE治疗后出现了栓塞后综合征,其中腹痛18例(72%)、恶心5例(20%)、呕吐4例(16%)、腹泻2例(8%),发热6例(24%)、乏力5例(20%)、头痛1例(4%),骨髓抑制8例(32%),无患者出现消化道大出血、肝脓肿等严重并发症和治疗相关死亡。结论:国产CalliSpheres载药微球在肝癌介入治疗中具有较好的中长期疗效,是不可切除肝癌患者的重要治疗手段。Objective To assess the therapeutic efficacy of CalliSpheres drug-eluting microspheres in the interventional treatment of primary hepatocellular carcinoma.Methods From April 2020 to October 2022,twenty-five patients diagnosed with primary liver cancer admitted to Shenzhen Second People's Hospital underwent their initial Drug-Eluting Beads Transarterial Chemoembolization(DEB-TACE)procedure,utilizing CalliSpheres drug-eluting microspheres.Laboratory test variations,tumor activity lesion sizes before and after treatment,post-embolization adverse reactions,and medium to long-term prognosis were analyzed.Results The objective response rate(ORR)at 1,3,and 6 months post-treatment were 55.56%,61.54%,and 44.44%,respectively.The disease control rate(DCR)at 1,3,and 6 months post-treatment were 88.89%,76.92%,and 55.56%,respectively.The median overall survival(mOS)was 30.47 months[95%CI(16.02,44.91)]and the median progression-free survival(mPFS)was 19.21 months[95%CI(7.67,34.24)].Compared to pre-treatment,there was no statistically significant difference in serumα-fetoprotein(AFP)levesl at 1 and 6 months post-treatment(P>0.05),while AFP level at 3 months post-treatment decreased significantly(P<0.05).After treatment,22 patients(88%)experienced post-embolization syndrome,including abdominal pain in 18 cases(72%),nausea in 5 cases(20%),vomiting in 4 cases(16%),diarrhea in 2 cases(8%),fever in 6 cases(24%),fatigue in 5 cases(20%),headache in 1 case(4%),and bone marrow suppression in 8 cases(32%).No patients experienced severe complications such as gastrointestinal hemorrhage or liver abscess,and there were no treatment-related deaths.Conclusion CalliSpheres drug-eluting microspheres demonstrate favorable medium to long-term efficacy in the interventional treatment of hepatocellular carcinoma,and is an important treatment for patients with unresectable liver cancer patients.

关 键 词：原发性肝癌 肝动脉化疗栓塞术 CalliSpheres载药微球 

分 类 号：R735.7[医药卫生—肿瘤]