国产重组人红细胞生成素治疗肾性贫血的疗效和安全性

Treatment of renal anemia with recombinant human erythropoietin:a multicentre clinical study

目的比较国产与进口注射用重组人红细胞生成素(rhEPO)治疗肾性贫血的疗效及其安全性.方法采用前瞻性、随机、对照、多中心研究方法,选取肾性贫血患者134例,随机分为2组.试验组和对照组分别给予国产或进口(rhEPO)治疗,初始剂量为6 000 U·wk-1(100～150 U·kg-1·wk-1),分2次皮下注射.治疗前后监测Hb、HCT、肝肾功能、血电解质等水平的变化.结果共完成130例,退出4例.治疗结束时,试验组与对照组有效率分别为93.8%(61/65)与89.2%(58/65),P＞0.05.国产rhEPO主要不良反应为高血压和注射部位疼痛,但均能耐受,无需停药.结论国产rEPO治疗肾性贫血疗效显著、安全性高,与进口同类产品相似.

AIM To evaluate the safety and efficacy of domestically manufactured recombinant human erythropoietin（rhEPO）in the treatment of renal anemia and compare with imported rhEPO. METHODS One hundred and thirtyfour renal anemia patients with chronic renal failure were divided into two groups randomly. All patients were given with domestically manufactured rhEPO or imported rhEPO at dosages of 100- 150 U＂ kg-1. wk-1by subcutaneous injection. RESULTS One hundred and thirty patients completed the study and four withdrawed. At the end of the trial, the proportions of the patients whose serum hemoglobin elevated no less than 15 g· L^-1, or whose hematocrit rose 5 % in the domestically manufactured rhEPO group and in the control group were 93.8% （61/65） and 89.2% （58/65）respectively. Rank sum test showed that there was no statistic significance between the domestically manufactured rhEPO group and the control as for the clinical efficacy（ P 〉 0.05）, The main adverse drug reactions of domestically manufactured rhEPO were hypertension and pain in the injection site. Hypertension induced by the domestically manufactured rhEPO can be controlled without drug withdrawal and pain was mild. The incidence of the episode of adverse drug reactions in the domestically manufactured rhEPO group was similar to that in the control. CONCLUSION Domestically manufactured rhEPO is safe and effective in treating renal anemia, having the similar property of imported rhEPO.