微粒联合重组人p53腺病毒注射液栓塞治疗晚期肝癌疗效观察  

The preliminary study of recombinant adenovirus p53 combined with transarterial embolization with particles for advanced hepatocellular carcinoma

作　　者：周军[1] 张跃伟[1] 赵广生[1] 刘影[1] 李闯[1] 唐顺雄[1] 刘松[1] 袁琳[1] 

机构地区：[1]大连大学附属中山医院介入治疗科,116001

出　　处：《中华医学杂志》2014年第9期660-663,共4页National Medical Journal of China

基　　金：辽宁省社会发展科技攻关项目（2012225020）

摘　　要：目的 应用直径350～560 μm明胶海绵微粒（GSMs）联合重组人p53腺病毒注射液（Gendicine）经导管肝动脉栓塞（TAE）治疗晚期肝癌的安全性及疗效.方法 收集2009年5月至2012年6月大连大学附属中山医院介入治疗科应用上述方法治疗晚期肝癌患者24例,均为男性,术后应用实体瘤疗效评价标准（mRECIST）及不良反应评价标准（CTCAE）评价临床疗效及安全性.采用SPSS 17.0统计软件进行回顾性分析,包括计数资料采用χ2检验,生存率采用Kaplan-Meier统计方法等.结果 24例患者共行73次（平均3.0次）TAE.中位随访时间14个月（6～42个月）,术后1、6、12个月完全缓解率（CR）分别为25.0%、33.3%和37.5%,有效率（OR）分别为87.5%、75.0%和75.0%,6个月及1年生存率分别为100%和91.7%.全组病例均未见急性肝衰竭、肝脓肿、肺栓塞及胆囊炎等严重并发症.结论 应用350～560 μm明胶海绵微粒联合Gendicine TAE治疗晚期肝癌具有良好的安全性和疗效,为晚期肝癌患者提供了一种良好的治疗选择.Objective To evaluate the safety and efficacy of transarterial embolization with 350-560 μm Gelatin sponge microspheres （GSMs-TAE） mixed with recombinant adenovirus p53 （rAd-p53, trademarked as Gendicine） in patients with advanced hepatocellular carcinoma （HCC）.Methods The study was designed as a case-control, single-institution clinical trial. 24 male patients with advanced HCC were included in this study. Tumor response was evaluated by contrast enhanced CT using modified Response Evaluation Criteria in Solid Tumors （mRECIST） after 1-, 6- and 12-month of initial rAd-p53 combined with GSMs -TAE. Adverse events were evaluated by the Common Terminology Criteria for Adverse Effects （CTCAE）. Overall survival of all the patients was calculated from the date of initial rAd-p53 combined with GSMs -TAE using the Kaplan-Meier method. Results GSMs -TAE was performed 73 times （mean 3.0） in total on 24 patients. All procedures were performed successfully. The mean follow-up period was 14 （range 6-42） months. Complete response （CR） rate after 1-, 6- and 12-month was25.0%, 33.3% and 37.5% respectively. Objective response （OR） rate was 87.5% ,75.0% and 75.0% after 1-, 6- and 12-month respectively. There were no serious complications such as acute liver failure, liver abscess and pulmonary embolism. Conclusions Recombinant adenovirus p53 combined with transarterial embolization with 350-560 μm Gelatin sponge particles for hepatocellular carcinoma is safe and effective.

关 键 词：基因 p53 肝肿瘤 明胶海绵 吸收性 栓塞 治疗性 Genes p53 

分 类 号：R735.7[医药卫生—肿瘤]