Pockros Paul J, Shiffman Mitchell L, Schiff Eugene R, Sulkowski Mark S, Younossi Zobair, Dieterich Douglas T, Wright Teresa L, Mody Samir H, Tang K Linda, Goon Betty L, Bowers Peter J, Leitz Gerhard, Afdhal Nezam H
Scripps Clinic, La Jolla, CA 92037, USA.
Hepatology. 2004 Dec;40(6):1450-8. doi: 10.1002/hep.20482.
Anemia and decreased health-related quality of life (HRQL) are common in patients receiving combination therapy of interferon alfa (IFN) and ribavirin (RBV) for chronic hepatitis C virus (HCV) infection. In a randomized, prospective study evaluating the effectiveness of epoetin alfa in maintaining RBV dose, alleviating anemia, and improving HRQL in anemic (Hb < or = 12 g/dL) HCV-infected patients receiving combination therapy, patients receiving epoetin alfa had significant improvements in HRQL compared with placebo. In this study, 185 patients were randomized to 40,000 units of epoetin alfa subcutaneously weekly or placebo for an 8-week double-blind phase (DBP), followed by an 8-week open-label phase during which all patients received epoetin alfa. To further assess the impact of epoetin alfa on HRQL, post hoc analyses were conducted in the same patient population to compare the HRQL of these patients at randomization with norms of other populations, and to determine the critical relationship between hemoglobin (Hb) levels and HRQL. Mean HRQL scores of anemic HCV-infected patients receiving combination therapy at randomization were significantly lower than those of both the general population and patients who had other chronic conditions. Patients receiving epoetin alfa who had the greatest Hb increases from randomization to the end of the DBP also had the largest improvements in HRQL. Hb improvement was an independent predictor of HRQL improvement in these patients. In conclusion, epoetin alfa provided clinically significant HRQL improvement in HCV-infected patients receiving IFN/RBV therapy.
对于接受干扰素α（IFN）和利巴韦林（RBV）联合治疗的慢性丙型肝炎病毒（HCV）感染患者，贫血及健康相关生活质量（HRQL）下降很常见。在一项随机、前瞻性研究中，评估促红细胞生成素α在维持RBV剂量、缓解贫血以及改善接受联合治疗的贫血（血红蛋白<或=12 g/dL）HCV感染患者的HRQL方面的有效性，与安慰剂相比，接受促红细胞生成素α的患者在HRQL方面有显著改善。在这项研究中，185例患者被随机分为皮下注射每周40,000单位促红细胞生成素α组或安慰剂组，进行为期8周的双盲期（DBP），随后是为期8周的开放标签期，在此期间所有患者均接受促红细胞生成素α治疗。为了进一步评估促红细胞生成素α对HRQL的影响，在同一患者群体中进行了事后分析，以比较这些患者在随机分组时的HRQL与其他人群的标准，并确定血红蛋白（Hb）水平与HRQL之间的关键关系。接受联合治疗的贫血HCV感染患者在随机分组时的平均HRQL评分显著低于普通人群和患有其他慢性病的患者。从随机分组到DBP结束时Hb升高幅度最大的接受促红细胞生成素α治疗的患者，其HRQL改善也最大。Hb改善是这些患者HRQL改善的独立预测因素。总之，促红细胞生成素α在接受IFN/RBV治疗的HCV感染患者中使HRQL有临床意义的改善。
