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免疫球蛋白治疗后川崎病患者血红蛋白浓度的变化:利用日本索赔数据库进行的基于人群的研究。

Changes in Hemoglobin Concentrations Post-immunoglobulin Therapy in Patients with Kawasaki Disease: A Population-Based Study Using a Claims Database in Japan.

机构信息

Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.

Department of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.

出版信息

Paediatr Drugs. 2018 Dec;20(6):585-591. doi: 10.1007/s40272-018-0316-y.

Abstract

BACKGROUND

We sought to quantify the degree of anemia after high-dose intravenous immunoglobulin (IVIG) therapy in patients with Kawasaki disease (KD) by assessing hemoglobin (Hb) dynamics and determining the risk of transfusion.

METHODS

We analyzed data from a database containing inpatient data collected from 230 hospitals in Japan. In addition to administrative records, this database included laboratory results for some patients. We searched for individuals aged ≤ 18 years with a diagnosis of KD (International Statistical Classification of Diseases and Related Health Problems, 10th revision, code M30.3) who had received high-dose (≥ 1 g/kg) IVIG therapy. The primary outcome measure was post-IVIG therapy Hb dynamics in patients for whom laboratory findings were available. Secondary outcomes included the proportion of patients whose Hb value decreased below a specified threshold (e.g., 1 g/dL) and the number who received red blood cell transfusions, identified by a Japanese administrative code, in the whole cohort.

RESULTS

Laboratory data were available for 979 of 8262 patients with KD receiving high-dose IVIG. Hb dynamics assessed on spline curves showed that mild anemia commonly occurred 1-2 days after IVIG infusion and returned to the baseline thereafter. Declines of Hb > 1 g/dL and > 2 g/dL were found in 21.8% and 4.3% of patients, respectively. Two of the 8262 individuals with KD had received transfusions after IVIG therapy (incidence rate 0.024%; 95% confidence interval 0.003-0.087), but the indication for transfusion could not be determined from our records.

CONCLUSIONS

Although mild anemia commonly occurred post-IVIG therapy in Japanese individuals with KD, severe anemia necessitating transfusion was rare in these patients.

摘要

背景

我们通过评估血红蛋白(Hb)动态变化并确定输血风险,来量化川崎病(KD)患者接受大剂量静脉注射免疫球蛋白(IVIG)治疗后的贫血程度。

方法

我们分析了一个数据库中的数据,该数据库包含了来自日本 230 家医院的住院患者数据。除了行政记录外,该数据库还包括了部分患者的实验室结果。我们搜索了年龄≤18 岁、患有 KD(国际疾病分类第十版,M30.3 编码)并接受大剂量(≥1g/kg)IVIG 治疗的患者。主要结局指标是有实验室检查结果的患者接受 IVIG 治疗后的 Hb 动态变化。次要结局包括 Hb 值下降到特定阈值(如 1g/dL)以下的患者比例,以及通过日本行政代码确定的整个队列中接受红细胞输注的患者数量。

结果

在 8262 名接受大剂量 IVIG 的 KD 患者中,有 979 名患者的实验室数据可用。基于样条曲线的 Hb 动态变化显示,轻度贫血通常在 IVIG 输注后 1-2 天发生,此后恢复到基线水平。Hb 下降>1g/dL 和>2g/dL 的患者分别占 21.8%和 4.3%。8262 名 KD 患者中有 2 名在接受 IVIG 治疗后接受了输血(发生率 0.024%;95%置信区间 0.003-0.087),但我们的记录无法确定输血的指征。

结论

尽管日本 KD 患者接受 IVIG 治疗后常出现轻度贫血,但这些患者需要输血的严重贫血很少见。

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