具有肾脏剂量调整的临床决策支持系统并未改善住院患者的后续肾脏和肝功能：日本药物不良事件研究。

Clinical Decision Support System with Renal Dose Adjustment Did Not Improve Subsequent Renal and Hepatic Function among Inpatients: The Japan Adverse Drug Event Study.

机构信息

Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.

Department of Infectious Diseases, Shimane Prefectural Central Hospital, Izumo, Shimane, Japan.

出版信息

Appl Clin Inform. 2020 Oct;11(5):846-856. doi: 10.1055/s-0040-1721056. Epub 2020 Dec 23.

DOI:10.1055/s-0040-1721056

PMID:33368060

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7758157/

Abstract

BACKGROUND

Medication dose adjustment is crucial for patients with renal dysfunction (RD). The assessment of renal function is generally mandatory; however, the renal function may change during the hospital stay and the manual assessment is sometimes challenging.

OBJECTIVE

We developed the clinical decision support system (CDSS) that provided a recommended dose based on automated calculated renal function.

METHODS

We conducted a prospective cohort study in a single teaching hospital in Japan. All hospitalized patients were included except for obstetrics/gynecology and pediatric wards between September 2013 and February 2015. The CDSS was implemented on December 2013. Renal and hepatic dysfunction (HD) were defined as changes in the estimated glomerular filtration rate (eGFR) and alanine aminotransferase or alkaline phosphatase levels based on these measurements during hospital stay. These measurements were obtained before (phase I), after (phase II), and 1 year after (phase III) the CDSS implementation.

RESULTS

We included 6,767 patients (phase I: 2,205; phase II: 2,279; phase III: 2,283). The patients' characteristics were similar among phases. Changes in eGFR were similar among phases, but the incidence of RD increased in phase III (phase I: 228 [10.3%]; phase II: 260 [11.4%]; phase III: 296 [13.0%], = 0.02). However, the differences in incidences of RD were not statistically significant after adjusting for eGFR at baseline and age. The incidences of HD were also similar among phases (phase I: 175 [13.2%]; phase II: 171 [12.9%]; phase III: 167 [12.2%], = 0.72).

CONCLUSION

The CDSS implementation did not affect the incidence of renal and HD and changes in renal and hepatic function among hospitalized patients. The effectiveness of the CDSS with renal-guided doses should be investigated with respect to other endpoints.

摘要

背景

对于肾功能障碍（RD）患者，调整药物剂量至关重要。通常需要评估肾功能；但是，肾功能可能会在住院期间发生变化，手动评估有时具有挑战性。

目的

我们开发了一种临床决策支持系统（CDSS），该系统可根据自动计算的肾功能提供推荐剂量。

方法

我们在日本的一家教学医院进行了一项前瞻性队列研究。除妇产科和儿科病房外，所有住院患者均包括在内，时间为 2013 年 9 月至 2015 年 2 月。CDSS 于 2013 年 12 月实施。住院期间基于这些测量值，将肾功能和肝功能障碍（HD）定义为估算肾小球滤过率（eGFR）和丙氨酸氨基转移酶或碱性磷酸酶水平的变化。这些测量值在 CDSS 实施之前（阶段 I）、之后（阶段 II）和 1 年后（阶段 III）获得。

结果

我们纳入了 6767 名患者（阶段 I：2205 名；阶段 II：2279 名；阶段 III：2283 名）。各阶段患者的特征相似。eGFR 的变化在各阶段相似，但在阶段 III 中 RD 的发生率增加（阶段 I：228 [10.3%]；阶段 II：260 [11.4%]；阶段 III：296 [13.0%]，= 0.02）。但是，在调整基线 eGFR 和年龄后，RD 发生率的差异无统计学意义。各阶段 HD 的发生率也相似（阶段 I：175 [13.2%]；阶段 II：171 [12.9%]；阶段 III：167 [12.2%]，= 0.72）。