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生血宁片治疗维持性血液透析患者肾性贫血的多中心前瞻性随机对照研究

Effect of Sheng Xue Ning Tablets on Renal Anemia in Patients Subject to Maintenance Hemodialysis and Safety Evaluation: A Multi-setting Prospective Randomized Study.

机构信息

Department of Nephrology, Changzheng Hospital, the Second Military Medical University, Shanghai, 20003, China.

Department of Nephrology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China.

出版信息

Curr Med Sci. 2020 Apr;40(2):327-331. doi: 10.1007/s11596-020-2179-z. Epub 2020 Apr 26.

DOI:10.1007/s11596-020-2179-z
PMID:32337693
Abstract

This study compared Sheng Xue Ning (SXN) tablets with ferrous succinate (FS) tablets in terms of their efficacy for the treatment of iron-deficient renal anemia and safety in patients subject to maintenance hemodialysis (MHD). A total of 94 patients undergoing MHD were randomly assigned to an experiment group (receiving oral SXN tablets, SXN group) and a control group (orally given FS tablets, FS group) and followed up for 12 weeks. Erythropoietin (EPO) was used in both groups. The efficacy was assessed by detecting the subsequent changes in hemoglobin (Hb), serum iron (SI), SF and transferrin saturation (TSAT). At the 12th week, Hb and TSAT levels in both groups were significantly increased compared to those in the screening period (P<0.05). However, no significant difference in Hb and TSAT was found between the two groups. The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week. Our study showed that SXN tablets can effectively ameliorate renal anemia and keep iron metabolism stable in MHD patients, and its efficacy is virtually close to that of FS tablets. Meanwhile, SXN tablets can reduce the dosage of EPO and have a good safety profile.

摘要

本研究比较了生血宁片(SXN)和琥珀酸亚铁(FS)片在治疗维持性血液透析(MHD)患者缺铁性肾性贫血的疗效和安全性。94 例 MHD 患者随机分为实验组(口服 SXN 片,SXN 组)和对照组(口服 FS 片,FS 组),随访 12 周。两组均使用促红细胞生成素(EPO)。通过检测血红蛋白(Hb)、血清铁(SI)、SF 和转铁蛋白饱和度(TSAT)的后续变化来评估疗效。第 12 周时,两组的 Hb 和 TSAT 水平均较筛选期显著升高(P<0.05)。然而,两组间 Hb 和 TSAT 无显著差异。第 10 周和第 12 周时,SXN 组的平均每周 EPO 用量均低于 FS 组(P<0.05)。本研究表明,生血宁片能有效改善 MHD 患者的肾性贫血,维持铁代谢稳定,其疗效与 FS 片相当。同时,生血宁片可减少 EPO 用量,安全性良好。

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本文引用的文献

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Efficacy of SXN in the Treatment of Iron Deficiency Anemia: A Phase IV Clinical Trial.SXN治疗缺铁性贫血的疗效:一项IV期临床试验。
Evid Based Complement Alternat Med. 2019 Mar 3;2019:8796234. doi: 10.1155/2019/8796234. eCollection 2019.
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Anemia Management in the China Dialysis Outcomes and Practice Patterns Study.
生血宁作为一种新型促造血细胞因子刺激因子,促进造血干细胞/祖细胞增殖,促进红细胞生成。
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PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
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Effect of aggressively driven intravenous iron therapy on infectious complications in end-stage renal disease patients on maintenance hemodialysis.积极静脉补铁治疗对维持性血液透析终末期肾病患者感染并发症的影响。
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