Sheashaa Hussein, Abdel-Razek Waleed, El-Husseini Amr, Selim Amal, Hassan Nabil, Abbas Tarek, El-Askalani Hassan, Sobh Mohamed
Nephrology Unit, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Nephron Clin Pract. 2005;99(4):c102-6. doi: 10.1159/000083891. Epub 2005 Feb 8.
BACKGROUND/AIMS: Use of androgen as an adjuvant therapy to treat anemia in patients on hemodialysis is debated. Our target is to assess the safety and the efficacy of nandrolone decanoate (ND) as an effective adjunctive therapy to treat such anemia.
This study included 32 anemic adult hemodialysis patients who had adequate iron stores. They were randomized into two equal groups: the first group received subcutaneously a low dose of erythropoietin (EPO) 1,000 U three times weekly combined with ND, 50 mg intramuscularly twice weekly, and the second group received only the same low dose of EPO for the 6-month study period. All patients were subjected to a serial follow-up of hemoglobin (Hb), hematocrit % (Hct%), iron store indices, serum insulin-like growth factor-1 (IGF-1) concentration and liver function tests.
A significant rise of both Hb and Hct in both groups was found at the end of the study (p < 0.001). Although the rise of both Hb and Hct was higher in the androgen group, it was not rated as being statistically significant. Both groups showed a significant rise of serum IGF-1 concentration at the end of the study in comparison to its initial value. Moreover, the androgen group attained a more statistically significant rise of IGF-1 serum concentration. Four female patients discontinued ND because of related adverse effects, principally distressing hirsutism and hepatic dysfunction.
Addition of ND to a low-dose EPO regimen does not offer a significant benefit. Androgen-related side effects limit its use in female patients.
背景/目的:雄激素作为辅助疗法用于治疗血液透析患者贫血的情况存在争议。我们的目标是评估癸酸诺龙(ND)作为治疗此类贫血的有效辅助疗法的安全性和有效性。
本研究纳入了32名铁储备充足的成年贫血血液透析患者。他们被随机分为两组,每组人数相等:第一组皮下注射低剂量促红细胞生成素(EPO),每周3次,每次1000 U,同时每周2次肌肉注射50 mg ND;第二组在6个月的研究期内仅接受相同低剂量的EPO。所有患者均接受了血红蛋白(Hb)、血细胞比容百分比(Hct%)、铁储备指标、血清胰岛素样生长因子-1(IGF-1)浓度及肝功能检查的系列随访。
研究结束时,两组的Hb和Hct均显著升高(p < 0.001)。虽然雄激素组的Hb和Hct升高幅度更大,但未达到统计学显著差异。与初始值相比,两组在研究结束时血清IGF-1浓度均显著升高。此外,雄激素组的IGF-1血清浓度升高在统计学上更显著。4名女性患者因相关不良反应停用了ND,主要是令人苦恼的多毛症和肝功能障碍。
在低剂量EPO方案中添加ND并无显著益处。雄激素相关的副作用限制了其在女性患者中的应用。