Balan Vijayan, Schwartz David, Wu George Y, Muir Andrew J, Ghalib Reem, Jackson John, Keeffe Emmet B, Rossaro Lorenzo, Burnett Alfreda, Goon Betty L, Bowers Peter J, Leitz Gerhard J
Division of Transplantation Medicine, Mayo Clinic Hospital, 5777 E. Mayo Boulevard, Phoenix, AZ 85054, USA.
Am J Gastroenterol. 2005 Feb;100(2):299-307. doi: 10.1111/j.1572-0241.2005.40757.x.
In hepatitis C virus (HCV)-infected patients receiving pegylated interferon (PEG-IFN)/ribavirin (RBV) combination therapy, anemia is a well-known side effect. The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV-induced anemia.
In this multicenter, observational, 8-wk study, laboratory parameters were measured weekly for 8 wk or until early withdrawal. Primary endpoints included changes in Hb and serum erythropoietin (sEPO) from baseline to week 8; other measures were changes in reticulocytes and RBV dose. The predictive value of baseline factors for maximum Hb decline was assessed.
In the 97 evaluable patients, mean Hb decreased from 14.4 +/- 1.4 g/dl (baseline) to 11.9 +/- 1.3 g/dl (week 8). Twenty-one percent of patients withdrew before week 8. The estimated erythropoietic response was lower than that seen in two historic control populations of iron deficiency anemia patients. Mean RBV dose decreased from 986 +/- 190 mg/day (baseline) to 913 +/- 228 mg/day (week 8). Fifty-seven out of 77 (74%) patients who completed the study maintained their initial prescribed RBV dose. Patients maintained on the initial dose of RBV who had a higher baseline Hb and viral load showed a trend toward larger Hb declines. Platelets and white blood cells (WBCs) also declined during the study.
HCV-infected patients receiving PEG-IFN/RBV therapy have reductions in Hb, platelets, and WBCs, possibly due to bone marrow suppression. They also have diminished endogenous sEPO production for their degree of anemia.
在接受聚乙二醇干扰素(PEG - IFN)/利巴韦林(RBV)联合治疗的丙型肝炎病毒(HCV)感染患者中,贫血是一种众所周知的副作用。本研究的目的是描述血红蛋白(Hb)变化的时间进程和程度以及对PEG - IFN/RBV诱导的贫血的红细胞生成反应。
在这项多中心、观察性、为期8周的研究中,每周测量实验室参数,持续8周或直至提前退出。主要终点包括从基线到第8周时Hb和血清促红细胞生成素(sEPO)的变化;其他指标为网织红细胞和RBV剂量的变化。评估了基线因素对最大Hb下降的预测价值。
在97例可评估患者中,平均Hb从14.4±1.4 g/dl(基线)降至11.9±1.3 g/dl(第8周)。21%的患者在第8周前退出。估计的红细胞生成反应低于两个缺铁性贫血患者的历史对照人群。平均RBV剂量从986±190 mg/天(基线)降至913±228 mg/天(第8周)。在完成研究的77例患者中,有57例(74%)维持了最初规定的RBV剂量。维持初始RBV剂量且基线Hb和病毒载量较高的患者显示出Hb下降幅度更大的趋势。在研究期间血小板和白细胞(WBC)也有所下降。
接受PEG - IFN/RBV治疗的HCV感染患者的Hb、血小板和WBC减少可能是由于骨髓抑制。对于其贫血程度,内源性sEPO产生也减少。