Health care

发布时间:2006-12-12    发布人:    来源:

Anemic children with cancer benefit from erythropoietin
Clinical trial led by St. Jude shows treatment with drug increases hemoglobin  levels, reduces need for transfusions and improves quality of life
Children with cancer who develop anemia during chemotherapy can benefit from  a weekly dose of erythropoietin (EPO), according to researchers at St. Jude Children''s Research Hospital. The drug reduces the need for red blood cell transfusions and improves quality of life in children whose anemia is corrected   by this treatment, according to results of a Phase III clinical trial at St. Jude.

Anemia is an abnormally low level of hemoglobin (Hb), the oxygen-carrying protein in red blood cells; EPO is a natural hormone that stimulates production of the Hb-containing red blood cells.

This is the first large-scale study of anemic children with cancer that randomly assigned patients to receive either EPO or a placebo (inactive "drug") intravenously, and the first to measure the effect of EPO on quality of life in children, according to Bassem Razzouk, M.D., an associate member of the Department of Oncology at St. Jude. Razzouk is the lead author of a report on this study that appears in the August 1 issue of the Journal of Clinical Oncology.

"EPO was already known to benefit adults with cancer by increasing their hemoglobin level and improving their quality of life," Razzouk said. "But even though many children with cancer are anemic, there has been little evidence to support the use of EPO in such children who are receiving chemotherapy." Chemotherapy can suppress the production of red blood cells and cause anemia. "Our study showed that EPO not only improves the child''s condition, but is also well tolerated, which makes it more acceptable to the patient," he added. The study was also significant because a smaller clinical trial at another institution included three subcutaneous injections per week of EPO, while children in the current study received EPO only once a week intravenously. "Our use of intravenous administration of EPO instead of subcutaneous injections reduced the suffering of children and allowed us to complete a major clinical trial that demonstrated the effectiveness of this treatment," Razzouk said.

The study, which was led by St. Jude, was conducted at 26 sites in the United Statesand included anemic patients 5 to 18 years of age who were receiving chemotherapy for solid tumors (excluding brain tumors), lymphoma and leukemia. A total of 111 patients received EPO and 111 received a placebo.

The researchers studied the effect of EPO treatment on quality of life using a test called the Pediatric Quality of Life InventoryTM 4.0 Generic Core Scales (PedsQLTM-GCS), a survey that includes questions on physical, emotional and social functioning as well as school performance.

The team concluded that EPO increases Hb levels in children with anemia, reduces their need for transfusions and improves the quality of life in those who have an increase in Hb.


St. Jude领导的临床研究显示药物治疗可以升高血红蛋白水平,降低输血的需要并且改善生活质量。
根据St. Jude儿童医院的研究人员的研究,在化疗过程中发生贫血的儿童癌症患者可以从每周剂量的促红细胞生成素治疗中获益。St. Jude第三阶段临床研究的结果显示这一药物可以降低对红细胞的需求,且由这一治疗纠正了贫血的儿童患者的生活质量也得以提高。

据医学博士Bassem RazzoukSt. Jude儿童医院肿瘤中心的合作人之一)所说,这是第一次通过随机的安排孩子的父母接受对孩子进行促红细胞生成素或安慰剂(无活性的“药物”)静脉用药治疗,对儿童癌症患者贫血情况进行的大规模研究,并且是第一次来研究促红细胞生成素对儿童生活质量的影响。以Bassem Razzouk为第一作者的关于这一研究的一篇报告刊登在8月份第一期的临床肿瘤杂志上。
“我们已经知道促红细胞生成素通过提高血红蛋白的水平、改善患者的生活质量而使成年肿瘤患者获益。”Razzouk说,“虽然很多儿童癌症患者也有贫血,但是现在还没有证据支持促红细胞生成素可以用于接受化疗的儿童。”化疗可以抑制红细胞的生成从而导致贫血。Razzouk还说 “我们的研究显示促红细胞生成素不仅仅可以改善儿童的一般情况,还可以使他们对化疗具有更好的耐受性,从而使家长更容易接受化疗”。另一家机构采用每周三次皮下注射促红细胞生成素的一项小规模临床实验,使这一研究更有意义,因为参与我们目前的实验的孩子只需接受每周一次的促红细胞生成素的治疗。“我们采用每周一次静脉注射促红细胞生成素可以减少孩子们的痛苦,有利于整个临床实验的完成,从而可以证实这一治疗方案的有效性。”Razzouk说。
St. Jude领导的这一研究在美国26个调查点进行,包括年龄在518岁之间因患有实体瘤(不包括脑瘤)、淋巴瘤或白血病而接受化疗的贫血患者。其中111位患者接受了促红细胞生成素的治疗,111位患者接受安慰剂治疗。




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