Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?
キーワード
概要
説明
Fifty out of 57 hemodialysis anemic patients were finally included. They were assigned to two groups of equal numbers. Oral Pentoxifylline 400mg once daily was added to the treatment group which was compared to the control group over a six months period regarding hemoglobin, hematocrit, serum albumin and CRP.
Inclusion criteria: (Patients with ESRD on HD who have hemoglobin <11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio >65%.). There were 57 patients who met the inclusion criteria out of 158 patients.
Exclusion criteria: Iron deficiency anemia with transferrin saturation <30%, intact PTH>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.
日付
| 最終確認済み: | 10/31/2018 |
| 最初に提出された: | 11/01/2018 |
| 提出された推定登録数: | 11/02/2018 |
| 最初の投稿: | 11/05/2018 |
| 最終更新が送信されました: | 11/05/2018 |
| 最終更新日: | 11/07/2018 |
| 実際の研究開始日: | 10/31/2017 |
| 一次完了予定日: | 05/02/2018 |
| 研究完了予定日: | 05/03/2018 |
状態または病気
介入/治療
Drug: treatment group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: treatment group Group I: 29 patients (25 completed the study) that received the study agent (400mg of oral pentoxifylline daily for 6 months.), besides the appropriate weight-based dose of ESA (60-150I.U/kg/wk). | Drug: treatment group a known drug of xanthine derivatives used in intermittent claudication |
| No Intervention: control group Group II: 28 patients (25 completed the study) who did not receive pentoxifylline but they received the appropriate dose of ESA. They were used as a control group and compared to group1 concerning the primary and the secondary outcomes. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - (Patients with ESRD on HD who have hemoglobin <11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio >65%.). There were 57 patients who met the inclusion criteria out of 158 patients Exclusion Criteria: - Iron deficiency anemia with transferrin saturation <30%, intact PTH>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study. |
結果
主な結果の測定
1. hemoglobin difference [after 6 months from the start]
二次的な結果の測定
1. difference in inflammatory markers [after 6 months from the start]
