Imatoh T, Sai K, Hori K, Segawa K, Kawakami J, Kimura M, Saito Y
Division of Medicinal Safety Science, National Institute of Health Sciences, Tokyo, Japan.
Department of Hospital Pharmacy, Hamamatsu University School of Medicine, Hamamatsu, Japan.
J Clin Pharm Ther. 2017 Apr;42(2):215-220. doi: 10.1111/jcpt.12499. Epub 2017 Jan 18.
Glucocorticoid-induced diabetes mellitus (GIDM) increases the risk of diabetes mellitus (DM)-related complications but is generally difficult to detect in clinical settings. The criteria for diagnosing GIDM have not been established. Recently, medical information databases (MIDs) have been used in post-marketing surveillance (PMS) studies. We conducted a pharmacoepidemiological study to develop an algorithm for detecting GIDM using MID.
We selected 1214 inpatients who were newly prescribed with a typical glucocorticoid, prednisolone, during hospitalization from 2008 to 2014 from an MID of Hamamatsu University Hospital in Japan. GIDM was screened based on fasting blood glucose (FBG) and haemoglobin A1c (HbA1c) levels according to the current Japan Diabetes Society (JDS) DM criteria, and its predictability was evaluated by an expert's review of medical records. We investigated further candidate screening factors using receiver operating characteristics analysis.
Sixty-three inpatients were identified by the JDS DM criteria. Of these, 33 patients were definitely diagnosed as having GIDM by expert's review (positive predictive value = 52·4%). To develop a highly predictive algorithm, we compared the characteristics of inpatients diagnosed with definite GIDM and those diagnosed as non-GIDM. The maximum levels of HbA1c in patients with GIDM were significantly higher than those of patients with non-GIDM (66·9 mmol/mol vs. 58·7 mmol/mol, P < 0·001). The patients with GIDM had significantly higher relative increase in maximum level of HbA1c (RIM-HbA1c) than those with non-GIDM (0·3 vs. 0·03, P < 0·001). However, we did not observe a significant difference in those of fasting blood glucose (FBG) levels. We applied the RIM-HbA1c as a second screening factor to improve the detection of GIDM. It showed that a 13% increase in RIM-HbA1c separated patients with from patients without GIDM.
Patients with GIDM had significantly higher RIM-HbA1c than patients with non-GIDM. There was a 13% increase in RIM-HbA1c in patients with GIDM compared to the others. Our detection algorithm for GIDM using an MID achieved high sensitivity and specificity, and was superior to one based only on the current JDS DM criteria. Our results suggest that monitoring changes in HbA1c levels is important for detecting GIDM and adds to current diagnostic criteria for type 2 DM.
糖皮质激素诱导的糖尿病（GIDM）会增加糖尿病（DM）相关并发症的风险，但在临床环境中通常难以检测。GIDM的诊断标准尚未确立。近年来，医学信息数据库（MIDs）已被用于上市后监测（PMS）研究。我们开展了一项药物流行病学研究，旨在开发一种利用MID检测GIDM的算法。
我们从日本滨松大学医院的MID中选取了2008年至2014年期间住院期间新开具典型糖皮质激素泼尼松龙的1214名住院患者。根据日本糖尿病学会（JDS）现行的DM标准，基于空腹血糖（FBG）和糖化血红蛋白（HbA1c）水平筛查GIDM，并通过专家对病历的审查评估其可预测性。我们使用受试者工作特征分析进一步研究候选筛查因素。
根据JDS DM标准识别出63名住院患者。其中，33名患者经专家审查确诊为GIDM（阳性预测值 = 52.4%）。为开发一种具有高度预测性的算法，我们比较了确诊为GIDM的住院患者和未确诊为GIDM的住院患者的特征。GIDM患者的HbA1c最高水平显著高于非GIDM患者（66.9 mmol/mol对58.7 mmol/mol，P < 0.001）。GIDM患者的HbA1c最高水平相对增加幅度（RIM-HbA1c）显著高于非GIDM患者（0.3对0.03，P < 0.001）。然而，我们未观察到空腹血糖（FBG）水平存在显著差异。我们将RIM-HbA1c作为第二个筛查因素应用于提高GIDM的检测。结果显示，RIM-HbA1c增加13%可区分GIDM患者和非GIDM患者。
GIDM患者的RIM-HbA1c显著高于非GIDM患者。与其他患者相比，GIDM患者的RIM-HbA1c增加了13%。我们利用MID开发的GIDM检测算法具有较高的敏感性和特异性，优于仅基于现行JDS DM标准的算法。我们的结果表明，监测HbA1c水平变化对于检测GIDM很重要，并补充了当前2型糖尿病的诊断标准。
