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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。
Objective To observe the curative effect and adverse reactions of domestic nida platinum single agent combined with other chemotherapeutic drugs in the treatment of non-small cell lung cancer, esophageal cancer and nasopharyngeal carcinoma. Methods A single-blind randomized controlled phase II study. There were 43 cases in total, 4 cases in monotherapy group and 39 cases in combination chemotherapy group (21 cases in treatment group and 18 cases in control group). Nedaplatin 80 ~ 100mg / m2, added to 500ml normal saline for 2 hours, repeated every 3 to 4 weeks. Results of 43 cases into the group, can evaluate the efficacy of 42 cases. 13 cases of non-small cell lung cancer treatment group, PR 3 cases, the effective rate of 23%; control group of 12 cases, PR 3 cases, the effective rate of 25%, no difference between the two groups. Esophageal cancer treatment group 6 cases, PR 2 cases, the effective rate was 33.3%; control group of 5 cases, PR 1 cases, the effective rate of 20%. One case of nasopharyngeal carcinoma treated group reached SD, and one case of control group received PR. Non-small cell lung cancer in 4 cases, efficacy are SD. Toxic side effects of single drug group slightly, combined with chemotherapy group two similar, but the treatment group without renal toxicity. Conclusion Nedaplatin has a certain curative effect on non-small cell lung cancer and esophageal cancer. It has similar curative effect to cisplatin in non-small cell lung cancer and has better curative effect than cisplatin in esophageal cancer without nephrotoxicity.