Agnihotri Parag, Telfer Margaret, Butt Zeeshan, Jella Abhay, Cella David, Kozma Chris M, Ahuja Mukesh, Riaz Shahbaz, Akamah Joseph
Division of Geriatrics, Department of Medicine, Mercy Medical Group, Sacramento, California 95816, USA.
J Am Geriatr Soc. 2007 Oct;55(10):1557-65. doi: 10.1111/j.1532-5415.2007.01357.x. Epub 2007 Aug 14.
To evaluate the effect of epoetin alfa treatment on hemoglobin (Hb), fatigue, quality of life (QOL), and mobility in elderly patients with chronic anemia.
An exploratory, 32 week, randomized, double-blind, crossover treatment trial.
Sixty-two community-dwelling individuals aged 65 and older with chronic anemia (Hb < or =11.5 g/dL).
Subcutaneous epoetin alfa or placebo weekly for 16 weeks (Phase I) with crossover to the opposite treatment (Phase II).
Hb and QOL scores from the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Mobility was assessed as a secondary outcome using the Timed Up and Go (TUG) test.
Of the 62 subjects enrolled, complete data were analyzed for 58 in Phase I and 54 participants in Phase II. Of those enrolled, most were African American (95%) and female (85%) and had multiple comorbidities and a mean age+/-standard deviation of 76.1+/-7.2. Mean baseline Hb was 10.5+/-0.9 g/dL (7.3-11.5). In Phase I, 67% of those taking epoetin alfa, and in Phase II, 69% of those taking epoetin alfa had an increase in Hb of more than 2 g/dL, significantly more than those taking placebo (P<.001). Similarly, elderly participants significantly improved on the fatigue and anemia subscales of the FACIT across phases (all P<.05). No significant differences were found between treatment and placebo on TUG scores. Epoetin alfa was well tolerated.
In this trial involving predominantly older African-American women with anemia, a direct relationship existed between increases in Hb during epoetin alfa therapy and improvements in fatigue and QOL.
评估促红细胞生成素α治疗对老年慢性贫血患者血红蛋白（Hb）、疲劳、生活质量（QOL）及活动能力的影响。
一项为期32周的探索性随机双盲交叉治疗试验。
62名年龄在65岁及以上的社区慢性贫血患者（Hb≤11.5 g/dL）。
皮下注射促红细胞生成素α或安慰剂，每周一次，共16周（第一阶段），然后交叉接受相反治疗（第二阶段）。
采用慢性病治疗功能评估（FACIT）测量系统评估Hb和QOL得分。使用定时起立行走（TUG）测试评估活动能力作为次要结果。
62名受试者中，58名在第一阶段和54名在第二阶段的完整数据进行了分析。入组者中，大多数为非裔美国人（95%）和女性（85%），有多种合并症，平均年龄±标准差为76.1±7.2。平均基线Hb为10.5±0.9 g/dL（7.3 - 11.5）。在第一阶段，接受促红细胞生成素α治疗的患者中有67%，在第二阶段，接受促红细胞生成素α治疗的患者中有69%，Hb升高超过2 g/dL，显著高于接受安慰剂治疗者（P<0.001）。同样，老年参与者在各阶段FACIT的疲劳和贫血子量表上有显著改善（所有P<0.05）。治疗组和安慰剂组在TUG得分上无显著差异。促红细胞生成素α耐受性良好。
在这项主要涉及老年贫血非裔美国女性的试验中，促红细胞生成素α治疗期间Hb升高与疲劳和QOL改善之间存在直接关系。
