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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
Objective: To observe the short-term efficacy and adverse reactions of intratumoral injection of E1B-deleted adenovirus injection (H10 1) in the treatment of malignant tumors. METHODS: A multicenter open-label study was conducted. In line with the inclusion criteria of a total of 53 cases were given H 10 1 intratumoral injection, once a day, each time (5 × 10 11 virus particles / 0 5ml) for 5 days for a course of treatment. During treatment and after treatment observe and record the efficacy and adverse reactions. Results: Of the 49 evaluable patients, CR 2, PR 9, MR 8, SD 19 and PD 11 had a total effective rate of 22.4% (11/49). According to the ITT population The effective rate of analysis was 20.8% (11/53), and 77.6% (38/49) of patients with clinical benefit (CR + PR + MR + SD). The main adverse reactions were local pain (57 4%) and fever (35 2%), with no serious adverse events. Conclusion: E1B deletion adenovirus (H10 1) intratumoral injection of different types of malignancies have a certain effect, its toxicity is low, easy for patients to accept