静脉补铁对肾性贫血促红细胞生成素的治疗效果

目的比较静脉补铁与口服补铁对慢性肾脏疾病患者使用促红细胞生成素（EPO）治疗贫血的效果。方法选择58例初次使用铁剂及EPO治疗慢性肾功不全的透析患者。试验前检查每位患者的血红蛋白（Hb）、红细胞比容（Hct）、血清铁（SI）、血清铁蛋白（SF）、总铁结合力（TIBC）、转铁蛋白饱和度（TSAT）。Hct〈33％作为贫血指标。将患者随机分为静脉补铁组（30例）和口服补铁组（28例），静脉补铁组予以低分子右旋糖酐氢氧化铁复合物注射液（科莫非）100mg，每周2次；口服组予以右旋糖酐铁225mg／d。两组均予以EPO10000单位／周，皮下注射。4周后复查上述指标。结果试验结束时，静脉补铁组各项铁参数指标明显高于口服补铁组；静脉补铁组贫血改善较口服服补铁组好，两组Hb和Hct上升有明显差异。结论在使用EPO的同时，静脉补铁较口服补铁能更快、更好地改善肾性贫血。     

蔗糖铁注射液治疗维持性血液透析患者肾性贫血的前瞻性、随机对照多中心研究

目的比较蔗糖铁(森铁能)与右旋糖酐铁(科莫非)静脉注射液治疗维持性血液透析(MHD)患者缺铁性贫血的疗效与安全性。方法采用前瞻性、随机对照的多中心研究。 80例MHD患者分为试验组(蔗糖铁组)与对照组(右旋糖酐铁组),每组各40例。治疗前,两组患者男女性别比例、年龄、维持透析时间、血红蛋白(Hb)、红细胞比容(Hct)、铁蛋白(SP)和转铁蛋白饱和度(TSAT)等均无显著性差异。将100 mg蔗糖铁和100 mg右旋糖酐铁分别稀释于 100 ml生理盐水,于每次血透时使用。每周治疗2次,治疗时间为5周,观察时间共8周。两组患者的总补铁量均为1000 mg。全部病例都合并使用红细胞生成素(FPO)治疗,剂量为120～150 U·kg-1·周-1,皮下或静脉应用。观察并比较两组患者治疗贫血的效果、铁代谢指标变化及不良反应发生情况。结果经治疗后,试验组与对照组的Hb均较治疗前显著升高,分别为[(98．85± 17．45)g／L比 (75．20±9．66)g／L,P<0．01]和[(94．93±14．03)g／L比(75．53±10．61)g／L,P< 0．01];Hct也较治疗前明显升高(P<0．01),而试验组的上升幅度大于对照组,但差异无统计学意义。治疗后两组铁蛋白和转铁蛋白饱和度均明显高于治疗前,试验组铁蛋白为[(399．92± 200．90)μg／L比(106．61±78．24)μg／L,P<0．01];转铁蛋白饱和度为[(27．28±11．87)μg／L比 (17．95±9．17)μg/L,P<0．01]。试验组的上升幅度大于对照组,但两组相比差异无统计学意义。两组患者血清BUN、Scr、ALT和AST等均无明显变化。两组患者均无严重不良反应发生,对照组有1例发生下肢肌肉酸痛。结论蔗糖铁是治疗伴有缺铁的血液透析患者肾性贫血的一种安全而有效的药物。     

蔗糖铁联合促红细胞生成素治疗血液透析肾性贫血疗效观察

目的:比较静脉应用蔗糖铁联合促红细胞生成素(EPO依倍成都地奥集团九泓制药生产2000iu/支)和口服维铁缓释片联合EPO治疗MHD患者肾性贫血的疗效与安全性.方法:50 例MHD伴肾性贫血患者随机分为静脉组和口服组,两组均给予EPO 治疗,静脉组给予蔗糖铁100mg静脉滴注,口服组给予维铁缓释片(每片含硫酸亚铁525mg)口服,疗程均16周.观察并比较两组患者贫血治疗的效果、铁代谢指标的变化和不良反应发生情况.结果:静脉组Hb、Hct、及TSAT,SF的指标明显高于口服组.结论:静脉注射蔗糖铁可有效地纠正MHD的铁缺乏,提高EPO的疗效,不良反应发生率低,安全性好.     

生血宁与多糖铁治疗血液透析患者肾性贫血的疗效比较

目的比较生血宁片与多糖铁复合物对血液透析患者合并肾性贫血的疗效。方法选取2018年2月至2019年2月在合肥市第五人民医院血液净化中心进行规律性血液透析合并肾性贫血的患者50例,采用随机对照方法将该50例患者随机分为生血宁组(治疗组)和多糖铁组(对照组),每组25例。两组患者均按标准使用促红细胞生成素治疗,疗程12周,对照组在此基础上加用多糖铁复合物胶囊,治疗组在此基础上加用生血宁片。治疗组和对照组在治疗前、治疗12周均监测血红蛋白(Hb)、红细胞压积(hematocrit,Hct)、血清铁蛋白(serum ferritin,SF)、转铁蛋白饱含度(transferrin saturation,TSAT)等指标变化。结果治疗12周后对照组和治疗组分别与治疗前相比,血清Hb、Hct、SF、TAST均有明显升高(P0.05);其中以治疗组升高更为明显,治疗组的血清Hb、Hct、SF、TAST水平显著高于对照组,差异有统计学意义(P0.05)。结论生血宁片能够明显地提高血液透析患者体内的Hb、Hct、SF、TSAT,促进铁的吸收和利用,增加体内铁的储存,减少铁的消耗,其治疗维持性血液透析患者合并肾性贫血效果优于多糖铁复合物组。     

血液透析患者肾性贫血的维持性补铁方式研究

目的比较不同方式补铁治疗对血液透析患者在肾性贫血得以纠正达标后长期维持治疗期间的疗效和安全性,从而选择更佳的维持性治疗方式。方法选择2014年9月至2016年3月在湖北省中医院血液净化中心行维持性血液透析的患者40例,经规范治疗肾性贫血相关指标达标后,随机分为静脉组和口服组,每组20例。静脉组患者每周第一次透析时给予静脉注射蔗糖铁100mg,口服组患者口服多糖铁复合物胶囊150 mg,每日一次。2组患者均合并使用促红细胞生成素(erythropoietin,EPO)治疗,剂量为10 000 U/10d。观察12周后2组患者红细胞数量(red blood cell,RBC)、血红蛋白(hemoglobin,Hb)、红细胞比容(hematocrit,Hct)、血清铁蛋白(serum ferritin,SF)、转铁蛋白饱和度(transferin saturation,TSAT)、C反应蛋白(C reaction protein,CRP)等指标的变化及不良反应。结果治疗前静脉组和口服组患者在Hb、RBC、SF、TSAT和Hct等方面无明显差异(P0.05)。2组患者分别经过12周治疗后,Hb、RBC、SF等水平有下降趋势,口服组患者下降幅度更为明显。静脉组患者无明显不良反应。结论血液透析患者在肾性贫血得以纠正达标后仍维持性补充铁剂是有必要的。维持性静脉注射蔗糖铁与口服多糖铁复合物胶囊联合EPO治疗都能用于稳定大多数患者相关铁参数和Hb水平,但静脉注射蔗糖铁更为安全、有效,且依从性更高。     

静脉铁剂在肾性贫血中的治疗作用

目的观察右旋糖酐铁静脉注射治疗尿毒症致肾性贫血的疗效和不良反应。方法80例尿毒症血液透析病人随机分为两组。对照组：速立菲200mg，每日3次，口服。治疗组：右旋糖酐铁100mg，每周1次，静脉滴注。两组均治疗10周，并同时应用促红细胞生成素（EPO）9000U/周。结果对照组治疗后血红蛋白（Hb）、红细胞压积（Hct）较治疗前有明显升高（P〈0．01），但转铁蛋白饱和度（TSAT）、铁蛋白（FT）与治疗前对比无明显提高（P〉0．05）。治疗组治疗后Hb、Hct、TSAT、FT较治疗前均有显著升高（P〈0．001）。两组治疗后的Hb、Hct、TSAT、FT对比，治疗组比对照组有显著升高（P〈0．001）。结论静脉注射铁剂能有效补充EPO治疗中所需要的铁储备，疗效优于口服，不良反应少。     

静脉补铁对维持性血液透析患者微炎症及氧化应激状态的影响

目的探讨静脉补铁对维持性血液透析(MHD)患者微炎症及氧化应激状态的影响。方法选择MHD患者71例,随机分为静脉组(24例)、口服组(27例)和未补铁组(20例)。观察用药前后血红蛋白(Hb)浓度、红细胞压积(Hct)、血清铁(SI)、血清铁蛋白(SF)、转铁蛋白饱和度(TSAT)等疗效指标以及血清C反应蛋白(CRP)、白介素-1β(IL-1β)、白介素-6(IL-6)、白介素-10(IL-10)、肿瘤坏死因子-α(TNF-α)等炎症指标和血浆及红细胞中丙二醛(MDA)、过氧化物歧化酶(SOD)、谷胱苷肽过氧化物酶(CSH-px)、全血过氧化氢酶(CAT)等氧化应激指标,并监测不良反应。结果8周后,静脉组Hb水平及SF较治疗前明显改善(P<0.01);血浆及红细胞中MDA较治疗前显著升高(P<0.01),SOD、GSH-px和全血中的CAT均较治疗前显著降低(P<0.01或P<0.05);血清CRP、IL-1β、TNF-α均较治疗前显著升高(P<0.01或P<0.05)。相关性分析发现,8周后静脉组血浆MDA与SF呈正相关,MDA与TNF-α呈正相关(P<0.01)。结论静脉补铁可有效改善患者贫血及缺铁,但也加剧了其炎症及氧化应激状态。MHD患者体内炎症及氧化应激之间具有相关性,氧化应激似乎是形成慢性炎症的关键因素之一。     

番茄红素对血液透析患者静脉铁剂诱导氧化应激的影响

目的：观察维持性血液透析（MHD）患者由静脉铁剂诱导的氧化应激状态，探讨番茄红素对其的干预作用。方法：30例MHD患者，随机分为对照组和试验组，各15例。对照组在患者透析时给予蔗糖铁注射液100mg，2次／周，共10次，观察时间8周；试验组除蔗糖铁注射液使用外，同时口服番茄红素胶囊，2粒／次，2次／d。用药8周，观察时间8周，观察并比较两组患者治疗前及治疗8周后的血红蛋白（m）、红细胞比容（Hct）、血清铁（SI）、铁蛋白（SF）、转铁蛋白饱和度（TSAT）以及超氧化物歧化酶（SOD）、谷胱甘肽过氧化物酶（GSH—px）、丙二醛（MDA）等指标的变化。结果：两组患者治疗后SOD和GSH—px水平较治疗前均有显著下降（P〈0．01）；但是试验组下降幅度显著性小于对照组（P〈0．01）。两组患者治疗后MDA水平较治疗前有显著性升高（P〈0．01）；但是试验组升高幅度显著性小于对照组（P〈0.01）。治疗后两组血清MDA水平与SF呈正相关（P〈0.01）。治疗后两组Hb、Hct、SI、SF、TSAT较治疗前均有显著性升高（P〈0．01），并且两组升高幅度相似，无统计学差异。结论：静脉铁剂治疗加剧了MHD患者的氧化应激状态。番茄红素可减轻这种氧化应激状态。     

静脉用蔗糖铁纠正功能性缺铁对血液透析患者贫血的影响

目的：通过比较静脉铁剂蔗糖铁和口服铁剂琥珀酸亚铁分别联合应用基因重组人红细胞生长素（EPO），治疗伴有功能性缺铁的维持性血液透析患者贫血的疗效，探讨对功能性缺铁的补铁途径、安全性和方法。方法：采用前瞻性、随机、对照研究。30例维持性血液透析、存在功能性缺铁和贫血的患者随机分为静脉铁剂和口服铁剂治疗组。静脉铁剂组15例，100mg蔗糖铁溶于100ml生理盐水，静脉滴注，隔日1次，直至完成总预计补铁量；口服铁剂组，琥珀酸亚铁200mg，每日3次，共8周。两组患者均联合应用EFO治疗，剂量为100～180U·kg^-1·周^-1，均皮下注射。每2周检测1次患者的血红蛋白（Hb）、红细胞压积（Hct）和网织红细胞计数（Ret），以及血清铁（SF）和转铁蛋白饱和度（TS）。结果：治疗前静脉铁剂组和口服铁剂组之间在年龄、性别比例、体重、接受治疗前维持性血液透析时间及Hb、Hct、Ret、SF、TS等方面均无明显差异。静脉铁剂组SF和TS在治疗2周后明显升高，Hb、Hct、Ret在治疗4周后明显升高；口服铁剂组Hb、Hct、Ret在治疗6周后明显升高。结论：血液透析患者，即使铁储备正常，若存在功能性缺铁，仍然需要静脉补铁。与口服铁剂比较，静脉铁剂可更好地纠正透析患者的功能性缺铁，增加铁储备，改善EPO的疗效。     

番茄红素对血液透析患者静脉铁剂诱导微炎症状态的影响

目的：观察维持性血液透析（MHD）患者由静脉铁剂诱导的微炎症状态,探讨番茄红素对其的干预作用。方法：60例MHD患者,随机分为对照组和试验组,每组各30例。对照组：在患者透析时给予蔗糖铁注射液100mg,2次／周,共10次,观察时间8周。试验组：除蔗糖铁注射液使用外,同时口服番茄红素胶囊,2粒／次,2次／d,用药8周,观察时间8周。观察并比较两组患者治疗前及治疗8周后的血红蛋白（Hb）、红细胞比容（Hct）、血清铁（SI）、铁蛋白（SF）、转铁蛋白饱和度（TSAT）以及白细胞介素-1β（IL-18）、白细胞介素-6（IL-6）、白细胞介素-10（IL-10）、肿瘤坏死因子（TNF—α）、C反应蛋白（CRP）等指标的变化。结果：两组患者治疗后IL-18、IL-6、TNF—α及CRP水平较治疗前均有显著性升高（P〈0．01或P〈0．05）,但是试验组升高幅度显著性小于对照组（P〈0．01）;试验组患者治疗后IL-10水平较治疗前有显著性升高（P〈0．01）,并且试验组升高幅度显著性大于对照组（P〈0．05）;两组血清IL-6、TNF—α水平均与SF呈正相关（P〈0．01）：两组Hb、Hct、SI、SF、TSAT较治疗前均有显著性升高（P〈0．01）,并且两组升高幅度相似,差异无统计学意义。结论：静脉铁剂治疗加剧了MHD患者的微炎症状态。番茄红素可减轻这种微炎症状态。     

蔗糖铁注射液与琥珀酸亚铁片治疗血液透析患者贫血疗效对比

目的比较蔗糖铁注射液与琥珀酸亚铁片治疗维持性血液透析患者肾性贫血的临床疗效与安全性,探讨补铁的途径和方法。方法选择40例维持性血液透析患者,试验前检测每例患者的血红蛋白、红细胞比容、血清铁蛋白、转铁蛋白饱和度,将患者随机分为静脉补铁组（20例）和口服补铁组（20例）,4、8、12周后复查上述指标。结果两组治疗后血红蛋白、红细胞比容、血清铁蛋白、转铁蛋白饱和度均升高,但静脉组比口服组高,差异有统计学意义,且上升速度快于口服组。治疗前、后两组肝功能、C反应蛋白等指标差异无统计学意义。结论在使用重组人促红细胞生成素的同时,静脉补铁较口服补铁能更快、更好地改善肾性贫血。     

口服与静脉铁剂治疗肾性贫血的对比观察

目的观察口服与静脉铁剂在维持性血液透析患者肾性贫血治疗中的应用。方法选择48例合并肾性贫血的维持性血液透析患者为研究对象,随机分为2组,口服组22例,静脉组26例。2组血液透析方案和红细胞生成素用量相同,口服组口服多糖铁复合物300mg／d,静脉组采用静脉滴注低分子右旋糖酐铁100mg／周,观察时间为6个月。结果6个月后,静脉组总有效率高于口服组（P〈0．01）,血红蛋白和血细胞压积高于口服组（P〈0．05）,2组转铁蛋白饱和度、血清铁蛋白及C反应蛋白无显著差异（P〉0．05）,而整体费用支出无显著差异（P〉0．05）。结论对于肾性贫血患者的长期巩固治疗,静脉补铁较口服补铁效果更好,并发症少,且并不增加治疗费用。     

大黄减轻维持性血液透析患者静脉铁剂诱导的微炎症反应

目的探讨大黄对维持性血液透析（MHD）患者静脉铁剂诱导的微炎症反应的影响。方法选择在我院血液净化中心行MHD治疗的患者50例,随机分为静脉铁剂治疗组（A组）和静脉铁剂＋大黄治疗组（B组）。B组给予大黄泡水饮服8周。分别于治疗前后检测各组患者血红蛋白（Hb）、红细胞压积（Hct）、血清铁（SI）、铁蛋白（SF）、转铁蛋白饱和度（TSAT）,C反应蛋白（CRP）,肿瘤坏死因子α（TNF-α）、白细胞介素（IL）-1β、11710等。结果治疗8周后,A组和B组Hb、Hct、SI、SF、TSAT、CRP、TNF-α、IL-1β较治疗前升高;B组CRP、TNF-α、IL-1β均较A组降低（P〈0．01或P〈0．05）;2组IL-10水平差异无统计学意义（P〉0．05）。结论大黄可以减轻静脉铁剂诱导的微炎症反应。     

Iron therapy in the pediatric hemodialysis population

Iron therapy maintains iron stores and optimizes the response to recombinant human erythropoietin (r-HuEPO) in patients with end-stage renal failure. Information is limited, however, regarding the preferential route of iron administration in pediatric patients receiving hemodialysis. Therefore, we prospectively randomized 35 iron-replete patients (aged >1 to <20 years) to receive up to 16 weeks of maintenance IV (n=17) or daily oral (n=18) iron. Eligible patients had received hemodialysis for >2 months, had a baseline transferrin saturation [TSAT] >20%, and were receiving maintenance r-HuEPO. Treatment arms were evenly distributed with respect to baseline demographic and clinical characteristics, with no statistically significant differences in baseline hemoglobin (Hb), hematocrit (Hct), reticulocyte Hb content (CHr), serum ferritin (SF), TSAT, or r-HuEPO dose. In the 35 patients, IV iron dextran and not oral iron was associated with a significant increase (138.5 to 259.1 ng/ml, P=0.003) in SF. A comparison of the change in SF between the IV iron group and the oral iron group was also significant (P=0.001). Whereas only IV iron was associated with a significant decrease in the dose of r-HuEPO (234.0 to 157.6 U/kg per week, P=0.046) and an increase of the CHr (29.2 to 30.1 pg, P=0.049), these changes were not significantly different from those experienced by patients in the oral iron group. In both groups, the Hct remained stable and in neither group was there a significant change in the TSAT. In summary, although both oral and IV iron maintained patients in an iron-replete state in this short-term study, only IV therapy allowed for a significant improvement in iron stores.     

Soluble transferrin receptors and reticulocyte hemoglobin concentration in the assessment of iron deficiency in hemodialysis patients

BACKGROUND: Diagnosing iron deficiency in hemodialysis (HD) patients is crucial for correct anemia management. Hypochromic erythrocytes appear to be the best available marker, but they are often unavailable. Transferrin saturation (TSAT) and ferritin are also indicated as reference markers by guidelines. We evaluated the usefulness of soluble transferrin receptor (s-TfR) and reticulocyte hemoglobin concentration (CHr), which have been recently proposed as more sensitive functional iron deficiency indicators. METHODS: A single-center unselected cohort of 39 chronic HD patients underwent a cross-sectional determination of hemoglobin (Hb), hematocrit (Hct), CHr, transferrin, iron, TSAT, ferritin, folate, vitamin B12 and s-TfR. Twenty-nine patients (74.4%) were treated with subcutaneous erythropoietin (EPO) at a dose of 122 +/- 98 U/kg/week and 24 patients (61.5%) were treated with intravenous (i.v.) iron gluconate, 62.5 mg/week. RESULTS: Hb was 11.1 +/- 1.2 g/dL, Hct 34.4 +/- 3.7%, CHr 32.7 +/- 3.8 pg, transferrin 170 +/- 31 mg/dL, iron 60.2 +/- 25.9 mg/dL, TSAT 30 +/- 18%; ferritin 204 +/- 219 ng/mL, folate 4.2 +/- 1.0 mcg/L, vitamin B12 0.58 +/- 0.15 mcg/L, and s-TfR 1.94 +/- 0.83 mg/L. Both TSAT and s-TfR significantly correlated with CHr, but no relationship could be found between s-TfR and TSAT or between s-TfR and ferritin. Dividing the population into two groups based on iron repletion (ferritin >100 ng/mL and TSAT >20%) we found no differences for CHr levels and significantly lower levels of s-TfR in the replete group (s-TfR 1.71 +/- 0.70 vs. 2.29 +/- 0.90 mg/L; p=0.033). Analysis of 2x2 tables demonstrated that 44% of patients with TSAT >20% had elevated (>1.5 mg/L) s-TfR, indicating a possible functional iron deficiency, but covariance analysis showed that TSAT had a better correlation to CHr. CONCLUSIONS: No clear-cut advantages in the use of CHr content and s-TfR levels as single diagnostic tests could be demonstrated by this cross-sectional study. However, our results suggest that the combined use of TSAT <20% and s-TfR >1.5 mg/L (therefore, including all patients with low TSAT, but also patients with high s-TfR despite normal TSAT) could improve functional iron deficiency detection in dialysis patients suspected of having inflammatory conditions.     

Effect of an intravenous iron dextran regimen on iron stores, hemoglobin, and erythropoietin requirements in hemodialysis patients

Iron deficiency is a common cause of delayed or diminished response to erythropoietin (EPO) in hemodialysis patients. Although oral iron is often prescribed to replete iron stores, this approach to iron supplementation may not be adequate with chronic EPO therapy. Intravenous (IV) iron dextran may be an effective alternative approach to replete iron stores and may facilitate more cost-effective use of EPO. The purpose of this study was to evaluate an IV iron dextran regimen that consisted of a loading dose phase followed by monthly maintenance doses of iron dextran. The effect of this regimen on iron stores, hemoglobin, and EPO doses was evaluated. This was an open prospective study in adult hemodialysis patients who were iron deficient as defined by a serum ferritin less than 100 ng/mL or transferrin saturation (TSAT) of less than 20%. Patients were loaded with 1 g iron dextran in five divided doses and then received monthly maintenance doses of 100 mg for the 4-month study period. Values of serum ferritin, TSAT, hemoglobin, and EPO dose were followed for the 4-month study period. Thirty hemodialysis patients receiving EPO were identified as being iron deficient and were enrolled in the study. The mean serum ferritin increased significantly from 49 ng/mL at baseline to 225 ng/mL at the end of the study period (P < 0.0001). Mean TSAT also increased significantly from 27% to 33% (P = 0.002). Values for hemoglobin did not change significantly during the study period; however, there was a significant reduction in EPO dose from a mean baseline dose of 112 U/kg/wk to 88 U/kg/wk at the end of the study period (P = 0.009). Seventeen patients experienced an increase in hemoglobin or a decrease in EPO dose. Economic analysis showed that approximately $580 (Cdn) per patient per year could be saved by use of IV iron dextran. The administration of the IV iron dextran regimen in the iron-deficient hemodialysis population was effective at repleting and maintaining iron stores and reducing EPO use.     

生血宁治疗慢性肾脏病患者贫血的疗效观察

目的观察生血宁治疗慢性肾脏病(CKD)3～4期患者肾性贫血的疗效。 方法收集2012年1月至2014年12月在无锡市锡山人民医院肾内科住院治疗的CKD患者的临床资料,根据其使用治疗贫血药物不同将其分为A、B两组,A组予生血宁片口服,B组予右旋糖酐铁片口服,两组同时接受重组人促红细胞生成素(rhEPO)的治疗,疗程12周(随访至12周)。观察治疗前后患者血红蛋白(Hb)、血清铁蛋白(SF)、转铁蛋白饱和度(TSAT)的变化及重组人促红素(rhEPO)的用量,并观察基础指标血清白蛋白(ALB)、尿素氮(BUN)、肌酐(SCr)、C反应蛋白(CRP)的变化。采用SPSS 17.0软件包进行统计学分析。 结果治疗后两组患者的贫血均有改善。A组Hb、SF、TSAT上升的幅度高于B组,差异有统计学意义(P<0.05)。A组rhEPO用量少于B组,差异有统计学意义(Z＝3.058, P<0.05)。治疗后两组肾功能和CRP均无明显变化(P>0.05),A组ALB水平较治疗前明显升高,差异有统计学意义(t＝2.811, P<0.05),A组未见明显不良反应。 结论生血宁可改善铁代谢,治疗CKD患者肾性贫血安全有效,并可以减少rhEPO的用量。     

Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients

Iron deficiency limits the efficacy of recombinant human erythropoietin (rhEPO) therapy in end-stage renal disease (ESRD) patients. Functional iron deficiency occurs with serum ferritin >500 ng/ml and/or transferrin saturation (TSAT) of 20 to 30%. This study examines the effects of a maintenance intravenous iron dextran (ivID) protocol that increased TSAT in ESRD hemodialysis patients from conventional levels of 20 to 30% (control group) to those of 30 to 50% (study group) for a period of 6 mo. Forty-two patients receiving chronic hemodialysis completed a 16- to 20-wk run-in period, during which maintenance ivID and rhEPO were administered in amounts to achieve average TSAT of 20 to 30% and baseline levels of hemoglobin of 9.5 to 12.0 g/dl. After the run-in period, 19 patients randomized to the control group received ivID doses of 25 to 150 mg/wk for 6 mo. Twenty-three patients randomized to the study group received four to six loading doses of ivID, 100 mg each, over a 2-wk period to achieve a TSAT >30% followed by 25 to 150 mg weekly to maintain TSAT between 30 and 50% for 6 mo. Both regimens were effective in maintaining targeted hemoglobin levels. Fifteen patients in the control group and 17 patients in the study group finished the study in which the primary outcome parameter by intention to treat analysis was the rhEPO dose needed to maintain prestudy hemoglobin levels. Maintenance ivID requirements in the study group increased from 176 to 501 mg/mo and were associated with a progressive increase in serum ferritin to 658 ng/ml. Epoetin dose requirements for the study group decreased by the third month and remained 40% lower than for the control group, resulting in an overall cost savings in managing the anemia. Secondary indicators of iron-deficient erythropoiesis were also assessed. Zinc protoporphyrin did not change in either group. Reticulocyte hemoglobin content increased only in the study group from 28.5 to 30.1 pg. It is concluded that maintenance of TSAT between 30 and 50% reduces rhEPO requirements significantly over a 6-mo period.