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与每周皮下注射两到三次促红细胞生成素β相比,每周一次的疗效:一项随机对照多中心试验的结果。瑞典研究小组。

The efficacy of once weekly compared with two or three times weekly subcutaneous epoetin beta: results from a randomized controlled multicentre trial. Swedish Study Group.

作者信息

Weiss L G, Clyne N, Divino Fihlho J, Frisenette-Fich C, Kurkus J, Svensson B

机构信息

Department of Nephrology, Centralsjukhuset, Karlstad, Sweden.

出版信息

Nephrol Dial Transplant. 2000 Dec;15(12):2014-9. doi: 10.1093/ndt/15.12.2014.

DOI:10.1093/ndt/15.12.2014
PMID:11096148
Abstract

BACKGROUND

Anaemia in haemodialysis patients can be effectively treated with erythropoietin. We investigated whether subcutaneous (SC) epoetin ss administered once weekly was as effective as the same weekly dosage given in two to three divided doses.

METHODS

One hundred and fifty-eight patients (delivered Kt/V >1.0, where K=dialyser-renal urea clearance, t=dialysis time and V=filtration volume, obtained by urea kinetic modelling) were randomized to treatment with SC epoetin beta either once weekly (n=118), or to their original dosage two or three times weekly (control group, n=40) for 24 weeks. All patients received intravenous iron supplementation when necessary.

RESULTS

Eight-eight patients in the once weekly group and 30 patients in the control group were treated for at least 16 weeks and are included in the analysis. Stable haemoglobin levels were maintained without epoetin dose increases in 73% of patients in both groups. Mean haemoglobin levels at randomization and after 16 and 24 weeks were 11.4, 11.1 and 11.1 g/dl, respectively, in the once weekly group compared with 11.2, 11.3 and 11.2 g/dl, respectively, in the control group. The mean weekly epoetin beta dosages at randomization and after 16 and 24 weeks were 102, 103 and 106 IU/kg bodyweight, respectively, in the once weekly group compared with 109, 109 and 115 IU/kg bodyweight, respectively, in the control group. No statistically significant between-group differences were apparent for changes in haemoglobin levels or epoetin beta dosages at week 24.

CONCLUSIONS

Once weekly SC administration of epoetin beta is as safe and effective in maintaining haemoglobin levels in stable haemodialysis patients as two or three times weekly administration of the same total dose. By using the once weekly regimen, patients can avoid up to 104 injections per year. This would reduce clinic time for patients who do not self administer, and may also encourage self-administration and improve overall compliance.

摘要

背景

血液透析患者的贫血可用促红细胞生成素有效治疗。我们研究了每周一次皮下注射促红细胞生成素β单剂量与每周相同剂量分两到三次注射是否具有相同疗效。

方法

158例患者(通过尿素动力学模型得出透析器肾尿素清除率K、透析时间t和超滤量V,计算得出Kt/V>1.0)被随机分为两组,一组118例患者接受每周一次皮下注射促红细胞生成素β治疗,另一组40例患者作为对照组,接受原每周两到三次的剂量治疗,为期24周。所有患者必要时均接受静脉补铁。

结果

每周一次治疗组的88例患者和对照组的30例患者接受了至少16周的治疗并纳入分析。两组中73%的患者在未增加促红细胞生成素剂量的情况下维持了稳定的血红蛋白水平。每周一次治疗组随机分组时、16周和24周后的平均血红蛋白水平分别为11.4、11.1和11.1 g/dl,而对照组分别为11.2、11.3和11.2 g/dl。每周一次治疗组随机分组时、16周和24周后的促红细胞生成素β平均每周剂量分别为102、103和106 IU/kg体重,而对照组分别为109、109和115 IU/kg体重。在第24周时,血红蛋白水平变化或促红细胞生成素β剂量方面,两组间无统计学显著差异。

结论

对于维持稳定血液透析患者的血红蛋白水平,每周一次皮下注射促红细胞生成素β与每周两到三次注射相同总剂量一样安全有效。采用每周一次的治疗方案,患者每年可避免多达104次注射。这将减少非自行注射患者的门诊时间,还可能鼓励患者自行注射并提高总体依从性。

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