癌症2001，Vol.20Issue(1)：57-60,4.
介入导向下Ad-p53基因治疗晚期恶性肿瘤的临床安全性初步观察
Safety Evaluation of CT-guided Gene Therapy by Ad-p53 Artery Infusion in Patients with Advanced Malignant Tumor
罗沛宏 1罗慧玲 1刘然义 1黄金华 1蔡体育 1张福君 1张彦娜 1曾益新1
作者信息
摘要
Abstract
Objective： The current study was designed to test the safety of CT-guided gene therapy by Ad-p53 artery infusion in the patients with advanced malignant tumors.Methods： Fifteen patients with advanced malignant tumor,who had failed in chemotherapy and/or radiotherapy, or who were unable to be administered routine treatment for some special reasons, were administered artery infusion with adenovirus-mediated p53 gene at the doses ranging from 1.5× 1010 to 2.8× 1011 pfu/dose (total dosage from 9.5× 1010 to 1.40× 1012 pfu/person). Among them, 5 patients with cervical carcinoma were treated in combination with chemotherapy. All patients were monitored for adverse events that would appeare in treatment procedures. Results： During the treatment period, fever was observed in 8 patients and faint flu-like symptoms in 2 cases, and gastric malaise,diarrhea,and tachycardia in 1 case; Additionally, leukocytopenia and thrombocytopenia was observed in one case in blood routine examination, decrease of hemoglobin in blood routine examination, and amino-transferase in liver function examination was observed in 2 patients each. All side-effects were very mild except that WHO Grade Ⅱ fever was observed in 3 patients. No evident ECG changes were observed in the treatment. Conclusion： Ranging the doses assessed in this study, CT-guided gene therapy by Ad-p53 artery infusion in the patients with advanced malignant tumor is safe and feasible.关键词
肿瘤/基因疗法/输注,动脉内/临床试验/安全性分类
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罗沛宏,罗慧玲,刘然义,黄金华,蔡体育,张福君,张彦娜,曾益新..介入导向下Ad-p53基因治疗晚期恶性肿瘤的临床安全性初步观察[J].癌症,2001,20(1):57-60,4.
