社團法人臺灣臨床藥學會

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【原著】Ferric Chloride Hexahydrate (Atofen®) 與 Iron Dextran (Desman®) 使用於血液透析患者之臨床療效與安全性比較
Compared the Efficacy and Safety of Ferric Chloride Hexahydrate (Atofen®) vs Iron Dextran (Desman®) in Hemodialysis Patients
鐵劑、貧血、血液透析、紅血球生成素、 iron supplementation, Ferric Chloride Hexahydrate, Iron Dextran, hemodialysis, erythropoietin, rHuEPO, anemia
廖淑貞Shu-Chen Liao1 、楊郁Yu-Yan2 、蔡玉娟Yu-Jang Tsai1 、康宜靜I-Ching Kang3 、簡素玉Su-Yu Chien1
1財團法人彰化基督教醫院藥劑部 、2財團法人彰化基督教醫院腎臟科 、3財團法人彰化基督教醫院洗腎室
貧血是血液透析患者常見之問題,雖然許多因素皆會導致貧血,其主要之原因為腎臟製造紅血球生成素(rHuEPO)不足。使用rHuEPO治療可以改善患者生活品質,降低致死率及住院率。但許多情況會造成rHuEPO治療效果不佳,例如:壓力、感染或發炎、副甲狀腺機能亢進、鋁中毒、鐵缺乏等。其中鐵缺乏是rHuEPO療效不佳的最主要原因,因此鐵劑的補充為血液透析患者使用rHuEPO治療貧血之一部分。
本研究採用前瞻性、隨機方式,比較兩種靜脈注射鐵劑(Atofen® and Desman®)之臨床療效及安全性,將符合條件之患者(ferritin < 200 ng/ml、hemoglobin < 10g/dL and hematocrits < 30%、血液透析大於六個月)以隨機方式分成兩組,第一組:靜脈注射Atofen® 每週100 mg,連續治療八週;第二組:靜脈注射Desman® 每週100 mg,連續治療八週,兩者皆追蹤三個月。
兩組治療後之ferritin,hemoglobin及hematocrit之數值與治療前比較,皆明顯增加(P < 0.005);兩組注射鐵劑次數均為112次,患者可耐受鐵劑注射,只出現輕微不良反應於少數患者,無嚴重之過敏性反應發生。比較兩組治療後ferritin、hemoglobin及hematocrit之改善程度,並無統計學上之意義,藥物成本效益(cost-effectiveness)方面,第二組低於第一組(NT: 140 vs. NT: 778)。研究結果顯示Desman® 之療效與安全性與Atofen® 相似;Desman® 價格較便宜,具經濟效益。
 
Anemia is a common and treatable problem in hemodialysis patients. Although multiple factors can cause the anemia, the main cause is endogenous erythropoietin deficiency. The rHuEPO treatment improved quality of life, reduced mortality and morbidity .The beneficial effects of rHuEPO replacement may be blunted by various conditions, including stress, infection, hyperparaththyroidism, aluminum toxicity, and most important, functional iron deficiency. Iron supplementation becomes an integral part of the management of patients who receiving rHuEPO therapy.    
This research was a prospective randomized study of iron supplementation in hemodialysis treated with erythropoietin. To compare the efficacy and safety of IV iron preparation, all patients (ferritin < 200 ng/ml、hemoglobin <10g/dL、hematocrit <30% and hemodialysis over six months) were divided randomly into two groups with different iron preparations, Atofen® and Desman®. Group I (N=14), IV Atofen 100mg weekly for 8 weeks; Group II (N=14), IV Desman 100mg weekly for 8 weeks. The follow up period was over three months. 
Both groups were increased the level of ferritin, hemoglobin and hematocrit than the level from baseline, that without treatment (p value <0.005). There were totally 112 infusions to each group. All of them were well tolerated. We did not observe any severe anaphylactic reaction. Iron and blood status were no significant difference between Group I and Group II. The treatment in Group II was more cost-effectiveness than Group I, e.g., direct cost of drug, NT$140 vs. NT$778. The data showed that Desman® is as effective and safe as Atofen®, but much less expensive.  
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