CAJ | 학술논문

目的：观察介入导向下经动脉导管系统灌注p53重组腺病毒(Ad-p53)进行恶性肿瘤基因治疗的安全性。方法：选择经放化疗无效或复发及因故不能进行常规治疗的中晚期肿瘤患者15例，经瘤组织主要供血动脉进行1.5×1010～2.8×1011pfu/次、累积剂量为9.5×1010～1.40×1012pfu/例的Adp53基因治疗(其中5例宫颈癌病人联合化疗)，并观察出现的副作用。结果：临床观察发现以发热、流感样症状为主的5种不良反应，其中发热8例，流感样症状2例，胃不适、腹泻及心动过速各1例；血常规检查发现白细胞和血小板减少各1例，血红蛋白减少2例；肝肾功能检查发现转氨酶CGT、AST升高2例；治疗前后未见心电图改变(只有1例在化疗开始当天出现心动过速，第2天又恢复正常)。与化疗联合治疗未产生强于单纯化疗的副作用。上述毒副反应以Ⅰ级反应为主(占86.8％)，无Ⅲ、Ⅳ级反应。结论：在所用试剂量范围内Ad-p53经动脉局部用药及与化疗联合治疗是安全可行的。
목적：관찰개입도향하경동맥도관계통관주p53중조선병독(Ad-p53)진행악성종류기인치료적안전성。방법：선택경방화료무효혹복발급인고불능진행상규치료적중만기종류환자15례，경류조직주요공혈동맥진행1.5×1010～2.8×1011pfu/차、루적제량위9.5×1010～1.40×1012pfu/례적Adp53기인치료(기중5례궁경암병인연합화료)，병관찰출현적부작용。결과：림상관찰발현이발열、류감양증상위주적5충불량반응，기중발열8례，류감양증상2례，위불괄、복사급심동과속각1례；혈상규검사발현백세포화혈소판감소각1례，혈홍단백감소2례；간신공능검사발현전안매CGT、AST승고2례；치료전후미견심전도개변(지유1례재화료개시당천출현심동과속，제2천우회복정상)。여화료연합치료미산생강우단순화료적부작용。상술독부반응이Ⅰ급반응위주(점86.8％)，무Ⅲ、Ⅳ급반응。결론：재소용시제량범위내Ad-p53경동맥국부용약급여화료연합치료시안전가행적。
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.