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目的：观察奥沙利铂治疗晚期大肠癌的临床疗效和安全性。方法：根据ＧＣＰ指导原则开展多中心Ⅱ期随机临床研究：Ａ组奥沙利铂单药１３０ｍｇ／ｍ２静脉滴注２ｈ，每３周一次；Ｂ组奥沙利铂１３０ｍｇ／ｍ２静脉滴注２ｈＤ１，加甲酰四氢叶酸钙（ＣＦ）２００ｍｇ／ｍ２＋５氟尿嘧啶３００ｍｇ／ｍ２静脉滴注４ｈＤ１到Ｄ５，每３周一次。治疗３周期后评定疗效，有效病例在４周后确认疗效。结果：共收入１１４例，在可统计近期疗效的１００例中，ＣＲ１例，ＰＲ２６例，ＳＤ３２例，ＰＤ４１例，总有效率２７０％。Ａ组３６例单药治疗有效率为１３９％；Ｂ组６４例有效率为３４４％。不良反应主要为恶心、呕吐、贫血和感觉神经毒性。对白细胞和血小板影响较小。结论：经考核奥沙利铂对大肠癌疗效和不良反应与欧洲的结果相近，和氟尿嘧啶合用疗效突出；多数病人耐受良好，是一治疗大肠癌有希望的新药。进一步考核，奥沙利铂和氟尿嘧啶联合有望成为治疗晚期大肠癌的首选方法。
Objective: To observe the clinical efficacy and safety of oxaliplatin in the treatment of advanced colorectal cancer. METHODS: A multicenter, phase II, randomized clinical study was performed according to the guidelines of GCP: Group A oxaliplatin 130 mg/m2 was administered intravenously every 2 weeks; Group B oxaliplatin 130 mg/m2 was intravenously administered 2 hD1. Intravenous infusion of calcium folinate (CF) 200 mg/m 2 +5-fluorouracil 300 mg/m 2 for 4 h from D1 to D5 every 3 weeks. The curative effect was evaluated after 3 cycles of treatment, and the effective case was confirmed after 4 weeks. RESULTS: A total of 114 cases were included in the study. Of the 100 cases that could be evaluated for short-term efficacy, CR1 cases, PR 26 cases, SD 32 cases, PD 41 cases, and total effective rate of 27%. The effective rate of single-agent treatment was 36.9% in group A and 34.4% in group B. Adverse reactions were mainly nausea, vomiting, anemia and sensory neurotoxicity. Little effect on white blood cells and platelets. Conclusion: The efficacy and adverse reactions of oxaliplatin on colorectal cancer are similar to those in Europe. The efficacy of oxaliplatin in combination with fluorouracil is outstanding. Most patients are well tolerated and it is a promising new drug for colorectal cancer. Further evaluation, oxaliplatin and fluorouracil combination is expected to become the preferred method for the treatment of advanced colorectal cancer.