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肾替代治疗患者中静脉和皮下途径不同给药频率使用促红细胞生成素的疗效前瞻性研究。

Efficacy prospective study of different frequencies of Epo administration by i.v. and s.c. routes in renal replacement therapy patients.

作者信息

Messa Piergiorgio, Nicolini Maria Angela, Cesana Bruno, Brezzi Brigida, Zattera Tito, Magnasco Alberto, Moroni Gabriella, Campise Mariarosaria

机构信息

Division of Nephrology, Dialysis and Transplantation, Ospedale Maggiore Policlinico, Mangiagalli, e Regina Elena, Fondazione IRCCS, Milan, Italy.

出版信息

Nephrol Dial Transplant. 2006 Feb;21(2):431-6. doi: 10.1093/ndt/gfi216. Epub 2005 Oct 25.

Abstract

BACKGROUND

The problem of pure red cell aplasia (PRCA) prompted nephrologists to revert to a wider intravenous (i.v.) utilization of erythropoeitin (Epo). Once weekly i.v. Epo administration has been suggested to be as effective as the twice/thrice weekly i.v. dose. The aim of the present study was to test whether once weekly i.v. Epo administration is equally as cost-effective as once weekly subcutaneous (s.c.) and 2-3 times weekly i.v. administration.

METHODS

We prospectively studied 41 patients (23 males, aged 28-82 years), on renal replacement therapy for 18-286 months, stabilized on twice or thrice weekly s.c. Epo-alpha (basal). The patients were treated for three consecutive 6 month periods with once weekly s.c. (OWSC), once weekly i.v. (OWIV) and twice/thrice weekly i.v. (TWIV) Epo-alpha. The initial dose for each period was equal to the final dose of the previous one; when necessary, the dose was adjusted according to DOQY guidelines. Iron, folic acid and vitamin B(12) supplementations were given throughout all the study periods. At the end of each of the four study periods, the following parameters were evaluated: haemoglobin, haematocrit, hypochromic red blood cells (RBCs), iron, serum ferritin, transferrin, folate, vitamin B(12), C-reactive protein (CRP), Kt/V, parathyroid hormone (PTH) and weekly dose of Epo-alpha.

RESULTS

Thirty-three out of 41 enrolled patients completed the study (there were five deaths, two renal transplants and one transfer). No significant changes were observed as regards iron, serum ferritin, transferrin, folate, vitamin B(12), CRP, Kt/V or PTH level. Haemoglobin levels were not different at the end of the basal (11.7+/-1.21), OWSC (11.8+/-0.86) and TWIV (12.1+/-1.04) periods, while significantly lower levels were observed after the OWIV period (11.0+/-0.97, P<0.01). Weekly Epo consumption (Epo U/week/kg body weight/g haemoglobin) was: basal 11.57+/-5.96; OWSC 10.22+/-4.53; OWIV 15.99+/-7.7*(a); and TWIV 11.89+/-6.3*(a) (*P<0.01 vs basal; (a)P<0.01 vs OWSC).

CONCLUSIONS

From our results, the OWIV schedule seems to have less efficacy in the control of anaemia of chronic renal failure patients on dialysis treatment than either OWSC or TWIV schedules.

摘要

背景

纯红细胞再生障碍性贫血(PRCA)问题促使肾脏病学家更广泛地采用静脉注射促红细胞生成素(Epo)。有人提出每周一次静脉注射Epo与每周两次/三次静脉注射剂量同样有效。本研究的目的是测试每周一次静脉注射Epo是否与每周一次皮下注射(s.c.)以及每周2 - 3次静脉注射同样具有成本效益。

方法

我们前瞻性地研究了41例患者(23例男性,年龄28 - 82岁),接受肾脏替代治疗18 - 286个月,稳定接受每周两次或三次皮下注射Epo-α(基础治疗)。患者连续三个6个月周期分别接受每周一次皮下注射(OWSC)、每周一次静脉注射(OWIV)和每周两次/三次静脉注射(TWIV)Epo-α治疗。每个周期的初始剂量等于前一周期的最终剂量;必要时,根据DOQY指南调整剂量。在所有研究期间均给予铁、叶酸和维生素B12补充剂。在四个研究周期结束时,评估以下参数:血红蛋白、血细胞比容、低色素红细胞(RBC)、铁、血清铁蛋白、转铁蛋白、叶酸、维生素B12、C反应蛋白(CRP)、Kt/V、甲状旁腺激素(PTH)和每周Epo-α剂量。

结果

41例入选患者中有33例完成了研究(5例死亡、2例肾移植和1例转院)。铁、血清铁蛋白、转铁蛋白、叶酸、维生素B12、CRP、Kt/V或PTH水平未观察到显著变化。基础治疗期(11.7±1.21)、OWSC期(11.8±0.86)和TWIV期结束时血红蛋白水平无差异,而OWIV期后血红蛋白水平显著降低(11.0±0.97,P<0.01)。每周Epo消耗量(Epo U/周/千克体重/克血红蛋白)为:基础治疗期11.57±5.96;OWSC期10.22±4.53;OWIV期15.99±7.7*(a);TWIV期11.89±6.3*(a)(*P<0.01 vs基础治疗期;(a)P<0.01 vs OWSC期)。

结论

从我们的结果来看,对于接受透析治疗的慢性肾衰竭患者,OWIV方案在控制贫血方面似乎不如OWSC或TWIV方案有效。

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