卢比替康胶囊Ⅰ期临床耐受试验结果分析

The Analysis of Rubitecan in Phase I Tolerance Trial

目的：评价口服卢比替康在治疗恶性肿瘤中的耐受及疗效情况。方法：受试者接受卢比替康单次或连续治疗，观察此过程中患者的生命体征、不良反应及实验室检查（包括血、尿常规，凝血功能，血生化及心电图），并在连续治疗1个周期后行影像学检查以评价疗效。结果：共有30例患者参加单次试验和20例患者参加连续试验，主要不良反应为Ⅰ-Ⅱ度血液学毒性、血尿、蛋白尿、恶心、呕吐及心电图改变。在可评价疗效的13例患者中，PR1例，SD8例，疾病控制率（DCR）为69.2％。结论：晚期耐药的肿瘤患者口服卢比替康耐受良好且有一定疗效。

Objective： To investigate the efficacy of rubitecan for patients with malignant tumor and to observe patients＇ .tolerance to rubitecan. Metheds： The laboratory examinations （including blood and urine routine examination, coagulation test, blood biochemical test and electrocardiogram） were performed in patients treated with rubitecan orally once or continuously. Imaging for efficacy evaluation was carried out after continuous treatment of one cycle. Results： Thirty patients were enrolled into the single experiment and 20 patients were enrolled into the consecutive experiment. The major adverse effects were Ⅰ - Ⅱ hematological toxicity, proteinuria, nausea, vomiting, and electrocardiographic changes. The efficacy could be assessed in 13 patients. PR was obtained in 1 patient and SD was obtained in 8 patients. The disease control rate （DCR） was 69.2%. Conclusion： Oral administration of rubitecan is effective for patients with advanced and drug-resistent malignant tumor and can be well tolerated.