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日本非透析依赖型慢性肾脏病患者贫血起始治疗的特征:一项回顾性真实世界数据库研究。

Characteristics of Japanese patients with non-dialysis-dependent chronic kidney disease initiating treatment for anemia: a retrospective real-world database study.

机构信息

Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.

Department of Health Policy and Management, School of Medicine, Keio University, Tokyo, Japan.

出版信息

Curr Med Res Opin. 2022 Dec;38(12):2175-2182. doi: 10.1080/03007995.2022.2125256. Epub 2022 Oct 11.

Abstract

OBJECTIVE

Anemia is a common complication of chronic kidney disease (CKD). The aim of this study was to evaluate hemoglobin levels at the initiation of erythropoiesis stimulating agent (ESA) therapy in patients with non-dialysis-dependent CKD (NDD-CKD) and anemia using a large-scale administrative database in Japan.

METHODS

The longitudinal data of adult patients who initiated ESA therapy between April 2008 and December 2018 were extracted from a hospital-based administrative database. The primary outcome was hemoglobin level at the initiation of ESA therapy, whereas the exploratory outcome was hemoglobin level recorded 6 months after the onset of the ESA therapy.

RESULTS

A total of 4939 patients were included in the primary analysis. The mean hemoglobin level at the initiation of ESA therapy was 9.1 g/dL, which was lower than the level (11 g/dL) recommended for the initiation of treatment by the current Japanese treatment guidelines. Moreover, 42.1% and 15.0% of the patients had hemoglobin levels <9.0 and <8.0 g/dL, respectively, at the initiation of ESA therapy. In 2964 patients for whom hemoglobin levels at 6 months after the initiation of ESA therapy were available, the mean hemoglobin level increased to 10.3 g/dL, and 61.9% and 31.1% of these patients had hemoglobin levels ≥10.0 and ≥11.0 g/dL, respectively.

CONCLUSION

This real-world database study revealed that hemoglobin levels at the initiation of ESA therapy in new users of ESA were lower than those recommended by treatment guidelines in Japan.

摘要

目的

贫血是慢性肾脏病(CKD)的常见并发症。本研究旨在使用日本大型行政数据库评估非透析依赖性慢性肾脏病(NDD-CKD)伴贫血患者开始使用促红细胞生成刺激剂(ESA)治疗时的血红蛋白水平。

方法

从医院行政数据库中提取 2008 年 4 月至 2018 年 12 月期间开始接受 ESA 治疗的成年患者的纵向数据。主要结局为 ESA 治疗开始时的血红蛋白水平,探索性结局为 ESA 治疗开始后 6 个月时记录的血红蛋白水平。

结果

共有 4939 例患者纳入主要分析。ESA 治疗开始时的平均血红蛋白水平为 9.1g/dL,低于当前日本治疗指南推荐的治疗起始水平(11g/dL)。此外,42.1%和 15.0%的患者在开始 ESA 治疗时血红蛋白水平<9.0 和<8.0g/dL。在 2964 例可获得 ESA 治疗开始后 6 个月时血红蛋白水平的患者中,平均血红蛋白水平增加至 10.3g/dL,其中 61.9%和 31.1%的患者血红蛋白水平分别≥10.0 和≥11.0g/dL。

结论

本真实世界数据库研究表明,ESA 新使用者开始 ESA 治疗时的血红蛋白水平低于日本治疗指南推荐的水平。

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