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.
Abstract
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 serum α-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.
维普
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