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透析液酸成分对血液透析死亡率的影响。

Impact of the dialysate acid component on haemodialysis mortality rates.

机构信息

Renal Epidemiology and Information Network registry, Agence de la biomédecine, Saint-Denis La Plaine, France.

Laboratoire Biostatistique Santé Université Claude Bernard Lyon I, Villeurbanne, France.

出版信息

Nephrol Dial Transplant. 2020 Jul 1;35(7):1244-1249. doi: 10.1093/ndt/gfaa168.

Abstract

BACKGROUND

No prospective study has evaluated the long-term effect on mortality of the new acid concentrates added to bicarbonate dialysate. The aim of this pharmacoepidemiological study was to evaluate the association between hydrochloric or citric acid-based dialysate and mortality on haemodialysis (HD).

METHODS

This study included 117 796 patients with 3 723 887 months on HD recorded in the national French Renal Epidemiology and Information Network registry. Dialysate acid components were retrospectively reconstructed for each facility. All patients on HD were associated each month with an exposure based on that at their facility of treatment. We took each patient's time-varying exposure into account to calculate the monthly mortality rates for each exposure. Incidence rate ratios (IRRs) for mortality were calculated with a Poisson regression, with acetic acid as the reference. Regressions were adjusted for initial clinical characteristics (age, gender, previous cardiovascular events, active malignancy, diabetes, pulmonary disease, mobility), dialysis technique and location (in-centre, outpatient centre, self-care unit) and ESRD vintage, updated monthly.

RESULTS

The crude mortality rate per 1000 patient-months with citric acid {11.5 [95% confidence interval (CI) 11.1-12.0]} was lower than with either acetic acid [12.9 (95% CI 12.8-13.1)] or hydrochloric acid [12.8 (95% CI 12.2-13.5)]. For the 2014-17 period, the IRR for mortality with citric acid [adjusted IRR 0.94 (95% CI 0.90-0.99)] and with hydrochloric acid [adjusted IRR 0.86 (95% CI 0.79-0.94)] were significantly lower than with acetic acid.

CONCLUSION

This post-marketing study of long-term exposure to dialysate acidifiers at the patient level found the use of citric and hydrochloric acid-based dialysates, compared with acetic acid, was associated with lower mortality.

摘要

背景

尚无前瞻性研究评估添加到碳酸氢盐透析液中的新型酸浓缩物对死亡率的长期影响。本药代动力学研究的目的是评估盐酸或柠檬酸基透析液与血液透析(HD)患者死亡率之间的关系。

方法

本研究纳入了法国全国肾脏流行病学和信息网络登记处记录的 117796 例患者,共 3723887 个月的 HD 治疗。回顾性重建了每个中心的透析液酸成分。将每位 HD 患者的每月暴露情况与治疗中心的暴露情况进行关联。我们考虑了每位患者的时间变化暴露情况,以计算每种暴露的每月死亡率。使用泊松回归计算死亡率的发病率比(IRR),以醋酸盐为参考。调整初始临床特征(年龄、性别、既往心血管事件、活动性恶性肿瘤、糖尿病、肺部疾病、活动能力)、透析技术和地点(中心内、门诊中心、自我护理单元)和 ESRD 年龄,每月更新。

结果

柠檬酸组每 1000 患者-月的粗死亡率为 11.5[95%置信区间(CI)11.1-12.0],低于醋酸盐组[12.9(95%CI 12.8-13.1)]或盐酸盐组[12.8(95%CI 12.2-13.5)]。在 2014-17 年期间,柠檬酸[调整后的 IRR 0.94(95%CI 0.90-0.99)]和盐酸[调整后的 IRR 0.86(95%CI 0.79-0.94)]的死亡率 IRR 明显低于醋酸盐。

结论

本研究对患者水平长期暴露于透析液酸化剂进行了上市后研究,发现与醋酸盐相比,使用柠檬酸和盐酸基透析液与死亡率降低相关。

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