中文摘要：

目的：观察p53基因治疗药物“今又生”对晚期恶性肿瘤患者的临床疗效。方法：自2004年5月到2005年6月，用静脉滴注、肿瘤局部注射等方法共治疗晚期肿瘤患者23例。其中10例单用“今又生”进行基因治疗，13例接受“今又生”治疗并联合化疗。用CT观察肿瘤大小改变，卡氏评分评估体力状态的变化，综合评估患者的临床受益。结果：单用”今又生”治疗的患者，无CR患者，PR3例（30％），SD4例（40％），PD3例（30％），该组的临床获益率为70％。接受“今又生”和化疗组，无CR患者，PR6例（46．2％），SD4例（30．8％），PD3例（23．1％），该组的临床获益率为76．9％。“今又生”治疗后总的临床获益率为72．7％。两组的卡氏评分平均提高〉10分。“今又生”对头颈部癌，肺癌，胰腺癌及胃癌均显示出较好疗效。未观察到与“今又生”相关的严重副反应。结论：“今又生”的应用能让晚期恶性肿瘤患者临床获益同时无严重并发症。

英文摘要：

Objective：To evaluate the efficacy and toxicity of recombinant adenovirus p53 injection （Gendicine） in patients with advanced cancer. Methods： From august 2004 to June 2005, we treated 23 advanced cancer patients with Gendicine by methods of intravenous drip, intratumoral injection. 10 patients were treated by Gendicine gene therpy only; other 13 patients were treated by Gendicine combined with chemotherapy. According to WHO criteria, we judged the curative effect by using CT to compare the change in tumor size; and evaluated clinical benefit response by change of Karnofsky Peformance Score. Results： The 10 patients treated by Gendicine only revealed partial response （3 of 10 patients, 30% ） , stable disease （4 of 10 patients, 40% ）, progressive disease （3 of 10 patients, 30% ）. Total clinical benefit response was 70%. The other 13 patients treated by Gendicine combined with chemotherapy revealed partial response （6 of 13 patients, 46.2% ）, stable disease （4 of 13 patients, 30.8% ）, progressive disease （3 of 13 patients, 23.1% ）. Karnofsky Peformance Score average of two groups were increased over 10. Total clinical benefit response was 76.9%. In patients treated with Gendicine there was no severe side effect. Conclusion： Both gendicine and combined with chemotherapy are effective and safe to most patients with advanced cancer.