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目的:沙铂是第一个在体外被证实与顺铂有同样抗肿瘤活性的口服铂类药物。本剂量递增(20,40,70,80,100 m.gm-2.d-1)Ⅰ期临床研究目的是评价人体对沙铂胶囊的耐受性,确定其在人体的最大耐受剂量(MTD)。方法:共纳入21例晚期恶性肿瘤患者。所有患者均可进行安全性分析。给予口服沙铂胶囊,qd,连续5 d,每21 d重复。结果:MTD为100 m.gm-2.d-1,剂量限制性毒性为呕吐、腹泻和血小板下降。其他常见不良反应还包括白细胞下降、中性粒细胞下降、疲乏、蛋白尿。结论:推荐Ⅱ期临床给药剂量为80 m.gm-2.d-1,连用5 d,每28～35 d为1周期。
AIM: SABA is the first oral platinum-based drug that has been demonstrated to have the same antitumor activity as cisplatin in vitro. The purpose of this Phase I clinical trial was to assess the human tolerance to satraplatin and to determine its maximum tolerated dose (MTD) in the human body at 20,40,70,80,100 m.gm-2.d-1. . Methods: A total of 21 patients with advanced malignant tumors were enrolled. All patients can carry out safety analysis. Give oral Shaba capsule, qd, continuous 5 d, repeated every 21 d. RESULTS: The MTD was 100 m.gm-2.d-1 with dose-limiting toxicities of vomiting, diarrhea and thrombocytopenia. Other common adverse reactions include leukopenia, neutropenia, fatigue, proteinuria. Conclusion: The recommended dosage of Phase Ⅱ clinical trial is 80 m.gm-2.d-1 for 5 days, and every 28-35 days is one cycle.