国产奈达铂治疗恶性肿瘤II期临床研究
Phase II clinical study of nedaplatin in treating malignant tumor
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摘要: 目的 观察国产奈达铂单药及联合其他化疗药物治疗非小细胞肺癌、食管癌、鼻咽癌的疗效及不良反应。方法 单盲随机对照II期临床研究。入组共 4 3例, 单药组 4例, 联合化疗组 39例 (治疗组2 1例, 对照组 18例 )。奈达铂 80～ 10 0mg/m2, 加入 5 0 0ml生理盐水中静滴 2小时, 每 3～ 4周重复。结果 入组 4 3例, 能评价疗效的 4 2例。非小细胞肺癌治疗组 13例, PR 3例, 有效率 2 3% ;对照组 12例, PR 3例, 有效率 2 5 %, 二组无差异。食管癌治疗组 6例, PR 2例, 有效率 33.3% ;对照组 5例, PR 1例, 有效率 2 0 %。鼻咽癌治疗组 1例达SD, 对照组 1例达PR。非小细胞肺癌单药 4例, 疗效均为SD。毒副反应单药组轻微, 联合化疗组二组相似, 但治疗组无肾功能毒性。结论 奈达铂对非小细胞肺癌、食管癌有一定疗效, 在非小细胞肺癌疗效与顺铂相近, 在食管癌中疗效优于顺铂, 且无肾毒性。Abstract: Objective We performed this study to assess the therapeutic responses and side effects of domestic nedaplatin in treating non-small-cell lung cancer, esophageal cancer and nasopharyngeal cancer. Methods Randomized controlled phase II clinical study. 43 patients were studied. 4 patients were treated only with nedaplatin. 39 patients were treated with nedaplatin and other drugs (21 patients were in therapy group and 18 patients were in control group). Nedaplatin was administered at a dose of 80～100mg/m 2 w...
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