重组人5型腺病毒注射液局部瘤内注射治疗晚期肝癌的临床研究  

Clinical research on topical intratumoral injection of recombinant human adenovirus type 5 in the treatment of advanced liver cancer

作　　者：陆吉麟 张浩 石伟 崔小红 岳增辉 王永勇 伊萌 LU Jilin;ZHANG Hao;SHI Wei;CUI Xiaohong;YUE Zenghui;WANG Yongyong;YI Meng(Department of General Surgery,Huashan Hospital Affiliated to Fudan University,Shanghai 200050,China;Department of General Surgery,Shanghai Electric Power Hospital,Shanghai 200031,China;Shanghai Sunway Biotech Co.,LTD,Shanghai 200052,China)

机构地区：[1]复旦大学附属华山医院普外科,上海200050 [2]上海电力医院普外科,上海200031 [3]上海三维生物技术有限公司,上海200052

出　　处：《中国现代医生》2021年第12期10-15,F0003,共7页China Modern Doctor

摘　　要：目的探讨重组人5型腺病毒注射液局部瘤内注射治疗晚期肝癌的临床疗效及安全性。方法选择2009年1月至2013年1月来自复旦大学附属华山医院的80例晚期肝癌患者,分为对照组(n=40)和观察组(n=40),对照组患者只给予顺铂及5-氟尿嘧啶化疗,观察组患者在化疗基础上联合B超引导下经皮瘤内注射重组人5型腺病毒注射液,连续使用两个周期。比较两组患者肿瘤客观有效率、肿瘤进展时间及不良反应。结果观察组的客观有效率为22.50%,高于对照组的5.00%,差异有统计学意义(P<0.05)。观察组的平均肿瘤进展时间为(11.93±2.54)周,高于对照组的(8.06±2.21)周,差异有统计学意义(P<0.05)。局部瘤内注射后48 h观察组血液中IFN-γ、IL-1α、IL-6及TNF-α显著高于治疗前,差异有统计学意义(P<0.05)。两组患者治疗后ALT、AST、ALP、TBIL及AFP指标均有所下降,而观察组下降幅度大于对照组,差异有统计学意义(P<0.05)。观察组患者不良反应主要为发热、局部反应及流感样症状,均为Ⅰ/Ⅱ级。观察组患者生活质量提高率为55.00%,高于对照组的22.50%,差异有统计学意义(P<0.05)。结论晚期肝癌患者在化疗基础上局部瘤内注射重组人5型腺病毒注射液,可提高客观有效率和患者生存期,且安全性及耐受性好。Objective To investigate the clinical efficacy and safety of intratumoral injection of recombinant human adenovirus type 5 in the treatment of advanced liver cancer.Methods A total of 80 patients with advanced liver cancer admitted to Huashan Hospital Affiliated to Fudan University from January 2009 to January 2013 were selected,and they were divided into the control group(n=40)and the observation group(n=40).The patients in the control group were only treated with cisplatin and fluorouracil chemotherapy,while those in the observation group were treated with recombinant human adenovirus type 5 injection on the basis of chemotherapy combined with B-ultrasound guided percutaneous injection for two consecutive cycles.The objective efficacy rate,tumor progression time and adverse reactions(ADRs)of the two groups of tumors were compared.Results The objective efficacy rate in the observation group was 22.50%,which was higher than that of 5.00% in the control group,with statistically significant difference(P<0.05).The tumor progression time in the observation group was(11.93±2.54)weeks,which was higher than that of(8.06±2.21)weeks in the control group,with statistically significant difference(P<0.05).The blood levels of IFN-γ,IL-1α,IL-6 and TNF-α in the observation group 48 h after topical intratumoral injection were significantly higher than those before injection(P<0.05).After treatment,the index levels of ALT,AST,ALP,TBIL and AFP all decreased in both groups,while the decrease in the observation group was greater than that in the control group,with statistically significant difference(P<0.05).The main ADRs in the observation group were fever,topical reactions and influenza like symptoms,all of which were gradeⅠ/Ⅱ.The improvement rate of quality of life in the observation group was 55.00%,which was higher than that of 22.50% in the control group,with statistically significant difference(P<0.05).Conclusion Topical intratumoral injection of recombinant human adenovirus type 5 on the basis of chemotherapy for pa

关 键 词：肝癌 腺病毒 重组人5型腺病毒 基因疗法 

分 类 号：R738.6[医药卫生—肿瘤] R730.5[医药卫生—临床医学]