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目的 为进一步验证重组人红细胞生成素注射液(宁红欣)对肾性贫血的疗效,并观察可能出现的不良反应。方法 我们组织69家医院对1115例慢性肾衰肾性贫血患者进行了多中心临床研究,采用自身对照,应用皮下及静脉方式给药进行治疗。结果 完成试验疗程者共1079例,其中显效734例(68％);有效303例(28.1％);无效42例(3.89％);总有效率为96.1％。36例患者中途退出试验。宁红欣主要不良反应有血压升高、头痛等,多数不需停药即可好转。未发现严重不良反应。非透析治疗病例用药期间未见肾功能明显变化。结论 宁红欣治疗肾性贫血安全、有效,与Ⅱ期临床试验结果相似。
Objective To further verify the efficacy of recombinant human erythropoietin injection (Ning Hongxin) on renal anemia and to observe the possible adverse reactions. METHODS: We conducted a multicenter clinical trial of 1115 patients with chronic renal failure and renal anemia at 69 hospitals using self-control and subcutaneous and intravenous administration. Results A total of 1079 patients completed the trial, of which 734 (68%) were markedly effective; 303 (28.1%) were effective; 42 (3.89%) were ineffective; and the total effective rate was 96.1%. Thirty-six patients dropped out of the trial. Ning Hongxin major adverse reactions are blood pressure, headache, etc., most do not need to stop the drug can be improved. No serious adverse reactions were found. No significant changes in renal function were observed during non-dialysis treatment. Conclusion Ning Hongxin treatment of renal anemia is safe and effective, similar to the results of phase Ⅱ clinical trials.