国产去氧氟尿苷胶囊治疗恶性肿瘤的临床验证

Clinical trial of domestic doxifluridine(5'-DFUR) capsule in treatment of malignancies

目的 :比较国产去氧氟尿苷胶囊与进口去氧氟尿苷胶囊 (商品名 :氟铁龙 )的临床疗效和不良反应。方法 :多个中心应用单药国产去氧氟尿苷和与阿霉素、顺铂联合方案 (治疗组 )治疗乳腺癌和胃癌 ,并与氟铁龙加阿霉素和顺铂方案 (对照组 )相比较。结果 :单药组共 5 1例 ,总有效率 2 1.6 %。乳腺癌 30例 ,有效率 2 3.3% ;胃癌 2 1例 ,有效率 19.0 %。联合用药治疗组乳腺癌 2 4例 ,有效率 5 4.2 % ;胃癌 2 3例 ,有效率 34 .8%。对照组乳腺癌 2 7例 ,有效率 5 1.9% ;胃癌 2 7例 ,有效率 2 9.6 %。不良反应主要为恶心、呕吐和骨髓抑制 ,治疗组和对照组不良反应发生率相近。结论 :国产去氧氟尿苷胶囊单药有效 ,联合用药与氟铁龙的疗效和不良反应相近。

ObjectiveTo compare the clinical efficacy and ADR s of domestic and imported 5' DFUR in treatment of breast and gastric cancers.Methods:In the multicenter clinical trial,the patients with breast can cer or gastric cancer were treated with single domestic 5' DFUR or imported 5' DFUR in combination with adriamycin and cisplatin.Results:The total RR in single domestic 5' DFUR group ( n =51) was 21.6% including the RR of 23.3%(7/30) for breast cancer,and the RR of 19.0% (4/ 21) for gastric cancer.In combination group,the RR for breast cancer was 54.2%( 13/24)and 51.9% (14/27)respectively in active and control group,and th e RR for gastric cancer was 34.8% (8/23) and 29.6%(8/27)respectively in active and control group.The main side effects were nausea,vomitting and marrow suppression with similar incidence rate in both the active and control combinat ion groups.Conclusion:In treatment of breast and gastric cancer,domestic 5' DFUR is effective in single regimen and has a RR and ADRs incidence rate compa rable to that of the imported one in combination regimen.