溶瘤病毒类药物腔内给药临床研究进展  

Progress in clinical study of intra-cavity administration of oncolytic virus

作　　者：刘晓 黄云虹 高晨燕 LIU Xiao;HUANG Yun-hong;GAO Chen-yan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2021年第19期1814-1818,共5页Chinese Journal of New Drugs

摘　　要：近年来,越来越多的溶瘤病毒类药物进入临床研究,涉及给药方式主要有瘤内注射、静脉注射、腔内注射、颅内注射和动脉注射等。其中,腔内注射溶瘤病毒目标适应证多为恶性胸腹腔积液、恶性胸膜间皮瘤、胸腹腔部位的肿瘤,由于给药方式本身的特点,溶瘤病毒腔内给药的吸收速度比静脉注射慢,且胸腔注射需要置留管。腔内给药的疗效在不同的溶瘤病毒产品和适应证间差异较大,其中,胸腔注射治疗恶性胸腔积液显现出较好疗效,而腔内注射治疗间皮瘤、卵巢癌疗效尚不明确。由于相关临床研究入组人数均较少,安全性和有效性还需确证性临床试验进一步验证。In recent years,increasing number of oncolytic virus drugs have entered clinical study.Administration approach mainly involves intratumoral,intravenous,intracranial intra-arberial,and so on.Among them,indications for intraperitoneal administration of oncolytic virus mostly include malignant pleural effusion,malignant pleural mesothelioma,and thoracic/abdominal cancer.Due to the inherent characteristics of the administration approach,the absorption of intra-cavity administration is slower than that by intravenous,and the pleural injection requires an indwelling catheter.The efficacy of intraperitoneal administration greatly varies among different oncolytic virus products and indications.Among them,pleural administration for malignant pleural effusion shows good efficacy,while the efficacy of intra-cavity administration for malignant pleural mesothelioma and ovarian cancer is unclear.Due to limited participants in relevant clinical study,the safety and efficacy need further verification by confirming clinical trials.

关 键 词：腔内给药 溶瘤病毒 肿瘤 胸腔注射 腹腔注射 临床研究 

分 类 号：R969.4[医药卫生—药理学] R979.1[医药卫生—药学]