Revicki D A, Brown R E, Feeny D H, Henry D, Teehan B P, Rudnick M R, Benz R L
Batelle Medical Technology Assessment Program, Centers for Public Health Research and Evaluation, Arlington, VA 22201, USA.
Am J Kidney Dis. 1995 Apr;25(4):548-54. doi: 10.1016/0272-6386(95)90122-1.
The investigators evaluated the impact of recombinant human erythropoietin (r-HuEPO) therapy on health-related quality of life (HRQL) in predialysis chronic renal disease patients with anemia. Eighty-three patients were entered into a randomized, parallel-group, open-label clinical trial with follow-up evaluations over 48 weeks. Forty-three patients were assigned to r-HuEPO treatment, and 40 patients were assigned to an untreated control group. Hematocrit levels were measured at baseline and monthly. HRQL was assessed at baseline and at weeks 16, 32, and 48. The HRQL assessment included measures of physical function, energy, role function, health distress, cognitive function, social function, home management, sexual dysfunction, depression, and life satisfaction. Significant improvements in hematocrit levels were observed in the r-HuEPO-treated group (P < 0.0001), and no changes were seen in the untreated group. Correction of anemia (hematocrit > or = 36) occurred in 79% of r-HuEPO-treated patients and 0% of control patients. Significant improvements in assessments of energy (P < 0.05), physical function (P < 0.05), home management (P < 0.05), social activity (P < 0.05), and cognitive function (P < 0.05) were found for the r-HuEPO-treated group. No changes were observed in the control group, except for a decrease in physical function (P < 0.05). Between-group differences favoring the r-HuEPO-treated group were found for energy (P < 0.05) and physical functioning (P < 0.05). In patients receiving r-HuEPO, significant improvements were seen in hemotocrit levels, and these increases resulted in improvements in HRQL.
研究人员评估了重组人促红细胞生成素（r-HuEPO）治疗对贫血的透析前慢性肾病患者健康相关生活质量（HRQL）的影响。83名患者进入一项随机、平行组、开放标签的临床试验，并进行了48周的随访评估。43名患者被分配到r-HuEPO治疗组，40名患者被分配到未治疗的对照组。在基线和每月测量血细胞比容水平。在基线以及第16、32和48周评估HRQL。HRQL评估包括身体功能、精力、角色功能、健康困扰、认知功能、社会功能、家庭管理、性功能、抑郁和生活满意度等指标。r-HuEPO治疗组的血细胞比容水平有显著改善（P<0.0001），未治疗组未见变化。79%接受r-HuEPO治疗的患者贫血得到纠正（血细胞比容≥36），而对照组患者这一比例为0%。r-HuEPO治疗组在精力（P<0.05）、身体功能（P<0.05）、家庭管理（P<0.05）、社会活动（P<0.05）和认知功能（P<0.05）评估方面有显著改善。对照组除身体功能有所下降（P<0.05）外未见变化。在精力（P<0.05）和身体功能（P<0.05）方面发现了有利于r-HuEPO治疗组的组间差异。在接受r-HuEPO治疗的患者中，血细胞比容水平有显著改善，这些改善导致了HRQL的提高。
