国产和进口注射用重组人红细胞生成素治疗肾性贫血的疗效比较  

THE EFFICACY COMPARISON OF DOMESTIC AND IMPORTED RECOMBINED HUMAN ERYTHROPOIETIN

作　　者：左力[1,2,3,4,5,6] 潘缉圣[1,2,3,4,5,6] 王梅 吴兆龙[1,2,3,4,5,6] 丁小强 鲍晓荣 陆福明[1,2,3,4,5,6] 丁峰[1,2,3,4,5,6] 曹桂山 汪关煜[1,2,3,4,5,6] 王玮 王献群[1,2,3,4,5,6] 朱永奋 孙建设[1,2,3,4,5,6] 钱家麒 林爱武[1,2,3,4,5,6] 徐莜琪 

机构地区：[1]北京医科大学第一医院肾内科 [2]上海医科大学附属中山医院肾内科 [3]上海医科大学附属华山医院肾内科 [4]上海第二医科大学附属瑞金医院血液透析中心 [5]上海华东医院肾内科 [6]上海第二医科大学附属仁济医院肾内科

出　　处：《中国临床药理学杂志》1998年第3期129-136,共8页The Chinese Journal of Clinical Pharmacology

摘　　要：贫血是慢性肾功能衰竭（ＣＲＦ）的常见并发症，称肾性贫血。补充重组人红细胞生成素（ｒｈＥＰＯ）是治疗肾性贫血的重要手段。过去使用进口ｒｈＥＰＯ，取得了满意的疗效。为了比较国产和进口ｒｈＥＰＯ对肾性贫血的疗效和安全性，我们进行了多中心临床对照试验。进入本试验的肾性贫血患者共１９９例，３例中途剔除，１９６例完成全部１２周疗程。共用国产药物治疗肾性贫血１３３例，其中６３例与进口药物对照，对照药物采用日本麒麟啤酒株式会社生产的利血宝针剂。使用途径均为皮下注射。６３对肾性贫血患者的对照研究结果表明，国产ｒｈＥＰＯ的显效率５４．０％，有效率３１．７％，总有效率８５．７％；进口ｒｈＥＰＯ的显效率５０．８％，有效率３６．５％，总有效率８７．３％；两组疗效比较无明显差异。国产ｒｈＥＰＯ治疗肾性贫血１３３例的显效率５０．４％，有效率３８．３％，总有效率８８．７％（１１８／１３３）。国产ｒｈＥＰＯ主要药物不良反应为高血压和头痛，大多数经对症处理后，不需停药即可好转，药物不良反应的种类和发生率与进口同类制剂相比没有显著差异。受试制剂的疗效与进口同类产品相似，用于治疗肾性贫血是安全和有效的。Anemia is the common complication of chronic renal failure. Recombined human erythropoietin(rhEPO) has been used for years and patients condition has been improved. In order to compare the efficacy of domestic and imported rhEPO, we conducted multicentered controlled clinical trial. PATIENTS: 196 cases studied. 133 cases were treated with domestic rhEPO, among which 63 cases were randomly paired with imported rhEPO, and 70 cases were free of control. RESULT: cure rate of domestic rhEPO is 54.0%(imported 50.8%), excellent rate of domestic rhEPO is 31.7%(im_ ported 36.5%), total cure and excellent rate of domestic rhEPO is 87.3%(imported 88.7%). The common adverse effects of rhEPO is hypertension and headache. The adverse effects of domestic rhEPO is 27.0%(imported 25.0%). There is no statistical difference of efficacy and adverse effects between this two groups.

关 键 词：肾功能衰竭 贫血 RHEPO 药物疗法 

分 类 号：R692.506[医药卫生—泌尿科学] R556.905[医药卫生—外科学]