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

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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 a common complication of chronic renal failure (CRF), called renal anemia. Recombinant human erythropoietin (rhEPO) is an important treatment for renal anemia. In the past the use of imported rhEPO, and achieved satisfactory results. To compare the efficacy and safety of domestic and imported rhEPO against renal anemia, we conducted a multicenter clinical controlled trial. A total of 199 renal anemia patients were enrolled in the trial, 3 were removed midway, and 196 completed all 12 weeks of treatment. Common domestic drugs for the treatment of renal anemia in 133 cases, of which 63 cases with imported drugs, the control drug used by Japan Kirin Brewery Limonbao injection. The use of subcutaneous injection. 63 of renal anemia in patients with control study showed that domestic rhEPO markedly effective rate of 54.0%, the effective rate was 31.7%, the total effective rate was 85.7%; imported rhEPO markedly effective rate of 50.8%, the effective rate of 36 .5%, the total effective rate was 87.3%; no significant difference between the two groups. Domestic rhEPO treatment of renal anemia in 133 cases markedly effective rate was 50.4%, the effective rate was 38.3%, the total effective rate was 88.7% (118/133). Domestic rhEPO main adverse drug reactions for hypertension and headache, most of the symptomatic treatment, without stopping can be improved, the type and incidence of adverse drug reactions compared with imported similar preparations no significant difference. The efficacy of the test preparation is similar to that of imported similar products, which is safe and effective for treating renal anemia.
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