CAJ | 학술논문

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.
목적 응용직경350～560 μm명효해면미립(GSMs)연합중조인p53선병독주사액(Gendicine)경도관간동맥전새(TAE)치료만기간암적안전성급료효.방법 수집2009년5월지2012년6월대련대학부속중산의원개입치료과응용상술방법치료만기간암환자24례,균위남성,술후응용실체류료효평개표준(mRECIST)급불량반응평개표준(CTCAE)평개림상료효급안전성.채용SPSS 17.0통계연건진행회고성분석,포괄계수자료채용χ2검험,생존솔채용Kaplan-Meier통계방법등.결과 24례환자공행73차(평균3.0차)TAE.중위수방시간14개월(6～42개월),술후1、6、12개월완전완해솔(CR)분별위25.0%、33.3%화37.5%,유효솔(OR)분별위87.5%、75.0%화75.0%,6개월급1년생존솔분별위100%화91.7%.전조병례균미견급성간쇠갈、간농종、폐전새급담낭염등엄중병발증.결론 응용350～560 μm명효해면미립연합Gendicine TAE치료만기간암구유량호적안전성화료효,위만기간암환자제공료일충량호적치료선택.
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.