【摘要】 目的 :观察瘤内注射E1B缺失腺病毒注射液 (H10 1)治疗恶性肿瘤的近期疗效和不良反应。方法 :采用多中心开放式研究。符合入选标准共 53例 ,给予H 10 1瘤内注射 ,每天一次 ,每次一支 (5× 10 11病毒颗粒数 /0 5ml) ,连续 5天为一疗程。治疗期间及治疗后观察并记录疗效和不良反应。结果 :在可评价疗效的 49例患者中 ,CR 2例 ,PR 9例 ,MR 8例 ,SD 19例 ,PD 11例 ,总有效率为 2 2 .4% (11/49) ,按ITT人群分析有效率为 2 0 .8%(11/53 ) ,临床获益患者 (CR +PR +MR +SD)占 77.6% (3 8/49)。主要不良反应为注射局部疼痛 (57 4% )和发热(3 5 2 % ) ,未见严重不良事件。结论 :E1B缺失腺病毒 (H10 1)瘤内注射对不同类型的恶性肿瘤具有一定疗效 ,其毒副作用较低 ,易为病人接受更多还原

【Abstract】 Purpose:To evaluate the efficacy and toxicity o f intratumoral H101, an E1B deleted oncolytic adenovires. Methods :A total of 53 patients with malignant tumors from multiple centers were treated with H101, 5×10 11 viral particle (VP) per day for 5 consecutive days ever y three weeks. The efficacy and toxicity were evaluated. Results :Among 49 evaluable cases, complete response 2, partial response 9, minimal respo nse 8, stable disease 19, progressive disease 11, overall response rate was 22.4 %. In the 56 ITT population the response rate was 19.6%, including 2 CR and 9 PR . The rate of clinical benefit response (CR+PR+MR+SD) was 77.6% (38/49). Main si de effects were injection site pain (57.4%) and fever (35.2%). No serious advers e events developed. Conclusions:The study showed that genetical ly E1B-deleted adenovirus (H101) showed some efficacy in some refractory malign ant tumors, and was well tolerated.更多还原