National Coordinating Center of Clinical Trials, Havana, Cuba.
MEDICC Rev. 2010 Jul;12(3):27-31. doi: 10.37757/MR2010.V12.N3.7.
Recombinant human erythropoietin (RHuEPO) is an erythropoiesis stimulating agent (ESA) used to treat anemia in patients with total or relative erythropoietin deficit. In cancer patients, it is administered to optimize hemoglobin (Hb) levels, correct anemia and reduce the need for transfusions. Cuba produces a RHuEPO, registered in 1998 as iorEPOCIM, that is widely used in the national public health system, mainly to treat patients with anemia due to chronic kidney disease (CKD).
Evaluate the efficacy and safety of iorEPOCIM in pediatric cancer patients with anemia following chemotherapy or radiotherapy. The working hypothesis posed an Hb increase>or=15 g/l in 70% of patients receiving iorEPOCIM for 8 weeks.
A Phase IV, multicenter, open clinical trial was conducted. Participants were 157 patients aged 1-19 years with anemia and cyto-histological diagnosis of cancer in any location. Patients received either 600 U/kg iorEPOCIM intravenously, once weekly, or 150 U/kg iorEPOCIM subcutaneously, 3 times a week, for 8 weeks. All patients had blood tests every week to determine hemoglobin and hematocrit, and reticulocyte and platelet counts. Mean number of transfusions required by patients during the treatment period was compared to the mean number of transfusions received in the preceding 8 weeks. Adverse events (AE) were recorded at the 4th and 8th weeks and classified by intensity and causality.
Hb levels rose>or=15 g/l in 68.8% of patients, and transfusion requirements decreased 17%. The most frequent adverse events were fever (19.3%), vomiting (10.2%) and flu-like syndrome (9.6%). Intensity of AE was predominantly mild. Only 7 AE were classified as very probably related to the product and none of those was severe.
iorEPOCIM proved to be safe and effective at the doses and frequencies used in this patient population. As a result, this medication was recommended for use in all pediatric oncology and hematology services in the country.
重组人红细胞生成素（rhuepo）是一种促红细胞生成素刺激剂（esa），用于治疗总或相对红细胞生成素缺乏的患者的贫血。在癌症患者中，它被用于优化血红蛋白（hb）水平，纠正贫血并减少输血需求。古巴生产一种 rhuepo，于 1998 年注册为 iorepocim，广泛用于国家公共卫生系统，主要用于治疗因慢性肾病（ckd）导致贫血的患者。
评估 iorepocim 在接受化疗或放疗后患有贫血的儿科癌症患者中的疗效和安全性。工作假设提出，接受 iorepocim 治疗 8 周后，70%的患者 hb 增加>或=15 g/l。
进行了一项四期、多中心、开放性临床试验。参与者为 157 名年龄在 1-19 岁之间的患者，患有任何部位癌症的血液学和组织学诊断，并伴有贫血。患者每周接受一次 600 u/kg 的 iorepocim 静脉注射，或每周三次皮下注射 150 u/kg 的 iorepocim，共 8 周。所有患者每周都进行血液检查，以确定血红蛋白和血细胞比容、网织红细胞和血小板计数。治疗期间患者所需的平均输血次数与前 8 周的平均输血次数进行比较。在第 4 周和第 8 周记录不良事件（ae），并按强度和因果关系进行分类。
68.8%的患者 hb 水平升高>或=15 g/l，输血需求减少 17%。最常见的不良事件是发热（19.3%）、呕吐（10.2%）和流感样综合征（9.6%）。ae 的强度主要为轻度。只有 7 例被归类为极有可能与产品相关，且均不严重。
iorepocim 在该患者人群中使用的剂量和频率下被证明是安全有效的。因此，建议在全国所有儿科肿瘤学和血液学服务中使用该药物。
