rAd-p53联合TACE治疗原发性肝癌有效性和安全性的Meta分析  

Efficacy and Safety of Recombinant Human Adenovirus-p53 Combined with TACE in the Treatment of Primary Liver Cancer:a Meta-Analysis

作　　者：李代龙 庞雅琪 许新华[1] Li Dailong;Pang Yaqi;Xu Xinhua(Department of Oncology,Yichang Central Peoples'Hospital,The First College of Clinical Medical Science,China Three Gorges University&Tumor Prevention and Treatment Center,China Three Gorges University,Yichang 443003,China)

机构地区：[1]三峡大学第一临床医学院[宜昌市中心人民医院]肿瘤科&三峡大学肿瘤防治中心,湖北宜昌443003

出　　处：《巴楚医学》2022年第1期91-98,共8页Bachu Medical Journal

基　　金：湖北省卫生和计划生育委员会重大项目(No:WJ2017Z026)。

摘　　要：目的:系统评价重组人p53腺病毒(rAd-p53)联合肝动脉化疗栓塞术(TACE)治疗原发性肝癌(PLC)的有效性和安全性。方法:计算机检索PubMed、EMBASE、Cochrane Library、CNKI、万方数据库,收集有关rAd-p53联合TACE(实验组)和单纯TACE(对照组)治疗PLC的临床研究文献。检索时限为建库至2021年5月5日。采用RevMan 5.4软件进行Meta分析。结果:共纳入10项研究,其中随机对照试验3项,前瞻性队列研究7项。共计684例患者,其中rAd-p53联合TACE组311例,单纯TACE组373例。Meta分析结果显示,rAd-p53联合TACE组客观缓解率(RR=1.48,95%CI:1.29~1.69,P<0.00001)、疾病控制率(RR=1.14,95%CI:1.07~1.22,P=0.0001)、体力状况评分(KPS评分)(MD=5.85,95%CI:0.37~11.32,P=0.04)均高于单纯TACE组,两组间6个月、1年和2年生存率差异无统计学意义(均P>0.05)。与单纯TACE组相比,rAd-p53联合TACE组发热发生率较高(P=0.03),恶心呕吐、腹痛、乏力、肝功能损害、白细胞减少、血小板减少和胃肠道反应的发生率未见明显增加(均P>0.05)。结论:rAd-p53联合TACE较单纯TACE治疗PLC临床获益高,且安全性尚可,但中远期临床疗效未见明显改善,尚需更多高质量临床研究进一步验证。Objective:To evaluate the efficacy and safety of recombinant human adenovirus-p53(rAd-p53)combined with transcatheter arterial chemoembolization(TACE)in the treatment of primary liver cancer(PLC).Methods:The databases of PubMed,EMBASE,Cochrane Library,CNKI,and Wanfang were searched up to May 5,2021.The clinical literature about treatment of PLC using rAd-p53 combined with TACE(experimental group)and TACE alone(control group)were collected.RevMan 5.4 software was used for meta-analysis.Results:A total of 10 studies were enrolled,including 3 randomized controlled trials and 7 prospective cohort studies.There were 684 patients,including 311 cases in the rAd-p53 combined with TACE group,and 373 cases in the TACE group.The results of meta-analysis indicated that the objective response rate(RR=1.48,95%CI:1.29-1.69,P<0.00001),the disease control rate(RR=1.14,95%CI:1.07-1.22,P=0.0001)and Karnofsky Performance Status(KPS)score(MD=5.85,95%CI:0.37-11.32,P=0.04)in the rAd-p53 combined with TACE group were higher than those in the TACE alone group,while there was no significant difference in 6-month,1-year,and 2-year survival rates between the two groups(all P>0.05).Compared to the TACE group,the incidence of fever in the rAd-p53 combined with TACE group was higher(P=0.03).However,there was no significant difference in the incidence of nausea and vomiting,abdominal pain,fatigue,liver function damage,leukopenia,thrombocytopenia,and gastrointestinal reaction between the two groups(all P>0.05).Conclusion:Compared to TACE alone in the treatment of PLC,rAd-p53 combined with TACE may have better clinical benefits and acceptable safety,without significant improvement in medium and long-term clinical efficacy,which needs more high-quality clinical trails to verify.

关 键 词：原发性肝癌 重组人P53腺病毒 肝动脉化疗栓塞术 META分析 

分 类 号：R735.7[医药卫生—肿瘤]