摘要
目的:前瞻性研究重组人p53腺病毒注射液(重组人p53腺病毒)在肝癌介入化疗中的应用价值.方法:分析2008-01-01/2010-12-31期间在上海长海医院和中国人民解放军第113医院行肝癌介入治疗的162例肝癌,随机分为A实验组(n=56)采用重组人p53腺病毒注射液瘤体内注射加肝动脉介入化疗、B实验组(n=62)采用重组人p53腺病毒注射液亦经肝动脉灌注和C对照组(n=44)单纯肝动脉介入化疗,随访24mo观察其疗效及不良反应发生情况.结果:近期疗效1mo后评估A实验组完全缓解6例,部分缓解42例,稳定5例,进展3例;B实验组完全缓解7例,部分缓解42例,稳定8例,进展5例;C对照组完全缓解1例,部分缓解22例,稳定13例,进展8例;就有效率来评估,A、B实验组之间无明显差异(P>0.05),2个实验组疗效均明显优于对照组(P<0.01).远期疗效6、12、24mo生存率分别为:A实验组:80.4%、72.7%和23.6%;B实验组:77.4%、67.7%和21.3%;C对照组:56.8%、47.7%和14%;每个观察点的生存率,A、B实验组之间无明显差异(P>0.05),2个实验组在6和12mo生存率均明显优于对照组(P<0.05),在24mo时生存率之间无明显差异.实验组均未发生严重不良反应.结论:重组人p53腺病毒注射液可以增强肝癌介入化疗的疗效,没有严重不良反应发生;瘤体内注射疗效要并不优于肝动脉灌注,但仍需进一步的研究评估.
AIM： To prospectively evaluate the value of Gendicine （recombinant human adenovirus p53 injection） in interventional chemotherapy of primary hepatocarcinoma. METHODS： A total of 162 patients with primary hepatocarcinoma who were treated from January 2008 to December 2010 at Shanghai Changhai Hospital and the 113^rd Hospital of PLA were recruited in the study. They were randomly divided into three groups： an intratumoral injection group, a hepatic artery perfusion group, and a control group. The intratumoral injection group （n = 56） underwent intratumoral injection of Gendicine plus hepatic arterial infusion chemotherapy. The hepatic artery perfusion group （n = 62） underwent hepatic artery perfusion of Gendicine and hepatic arterial infusion chemotherapy. The control group （n = 44） underwent simple hepatic arterial infusion chemotherapy. Follow-up period was 24 mo. The efficacy and adverse reactions were observed. RESULTS： The short-term effects were assessed at one month. In the intratumoral injection group, complete remission was achieved in 6 cases, partial remission in 42 cases, stable disease in 5 cases, and progressive disease in 3 cases. The corresponding figures in hepatic artery perfusion group were 7, 42, 8 and 5, and 1, 22, 13, and 8, respectively. The efficacy was significant better in the two experimental groups than in the control group （both P 〈 0.01）, although no significant difference was noted between the two experimental groups. The 6-, 12-, and 24-month survival rates were 80.4%, 72.7% and 23.6% in the intratumoral injection group, 77.4%, 67.7% and 21.3% in the hepatic artery perfusion group, and 56.8%, 47.7% and 14% in the control group. Although there was no significant difference in survival rates between the two experimental groups, the 6- and 12-month survival rates were significantly better in the two experimental groups than in the control group （all P 〈 0.05）. However, there was no significant difference in the 24-month survival rate between the three
出处
《世界华人消化杂志》
CAS
北大核心
2013年第15期1437-1441,共5页
World Chinese Journal of Digestology
