Cotter D J, Thamer M, Kimmel P L, Sadler J H
Medical Technology and Practice Patterns Institute, Bethesda, Maryland, USA.
Kidney Int. 1998 Dec;54(6):2129-39. doi: 10.1046/j.1523-1755.1998.00187.x.
Chronic anemia is a major cause of morbidity among the end-stage renal disease (ESRD) population. Recombinant erythropoietin (rHuEPO) has been recognized as a major advance in the treatment of anemia among the ESRD population. This study examines the secular trends in the use of and response to rHuEPO therapy among severely, moderately and mildly anemic hemodialysis patients.
We designed a cohort analytic study using seven years of claims data. The study population comprised all facility-based adult hemodialysis patients receiving rHuEPO therapy, who were initially reimbursed by Medicare in each of the first quarter of the calendar years 1990 through 1996 (N = 64,957).
Between 1990 and 1996, the mean rHuEPO dose increased by 139% for the patient cohorts with a first observed hematocrit < 0.25, 122% for the 0.25 to 0.29 cohorts, and 107% for the > or = 0.30 cohorts, and produced a 0.02 to 0.03 increase in achieved hematocrit (A-Hct) over this time. Dosing of rHuEPO did not appear to be influenced by patient or provider characteristics, although African-Americans, the elderly, non-diabetics and persons receiving dialysis in a non-profit facility had a larger percent change in hematocrit compared to their counterparts (P < 0.001).
The results of the clinical use of rHuEPO seven years after FDA approval found in the general ESRD hemodialysis population have not equaled the results obtained in the initial clinical trials. Overall, our findings suggest that substantial increases in rHuEPO dose provided to anemic patients have resulted in only modest increases in hematocrit in the seven years since rHuEPO's introduction. Resistance to rHuEPO, prior rHuEPO treatment, inadequate use of supplemental iron, and policy and financial incentives may explain this finding.
慢性贫血是终末期肾病（ESRD）患者发病的主要原因。重组促红细胞生成素（rHuEPO）已被公认为是治疗ESRD患者贫血的一项重大进展。本研究调查了重度、中度和轻度贫血血液透析患者使用rHuEPO治疗的长期趋势及其反应。
我们利用七年的索赔数据设计了一项队列分析研究。研究人群包括所有接受rHuEPO治疗的成年血液透析患者，这些患者在1990年至1996年历年的第一季度首次由医疗保险报销（N = 64,957）。
1990年至1996年期间，首次观察到的血细胞比容<0.25的患者队列中，rHuEPO平均剂量增加了139%，0.25至0.29队列增加了122%，≥0.30队列增加了107%，在此期间达到的血细胞比容（A-Hct）增加了0.02至0.03。rHuEPO的给药似乎不受患者或提供者特征的影响，尽管与其他人群相比，非裔美国人、老年人、非糖尿病患者以及在非营利性机构接受透析的患者血细胞比容的变化百分比更大（P < 0.001）。
在美国食品药品监督管理局（FDA）批准七年后，rHuEPO在一般ESRD血液透析人群中的临床使用结果并未达到最初临床试验的结果。总体而言，我们的研究结果表明，自rHuEPO引入以来的七年中，给予贫血患者的rHuEPO剂量大幅增加，仅使血细胞比容有适度增加。对rHuEPO的抵抗、先前的rHuEPO治疗、补充铁剂使用不足以及政策和经济激励措施可能解释了这一发现。
