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预测初次接受唑来膦酸治疗的骨质疏松症患者的急性期反应发热风险。

Predicting the acute-phase response fever risk in bisphosphonate-naive osteoporotic patients receiving their first dose of zoledronate.

机构信息

Department of Orthopedics, Affiliated Kunshan Hospital of Jiangsu University, Gusu School, Nanjing Medical University, No. 91 West of Qianjin Road, Suzhou, 215300, Jiangsu, China.

Department of Orthopedics, the First Affiliated Hospital of Soochow University, Orthopedic Institute of Soochow University, Suzhou, 215031, Jiangsu, China.

出版信息

Osteoporos Int. 2022 Nov;33(11):2381-2396. doi: 10.1007/s00198-022-06493-w. Epub 2022 Aug 3.

Abstract

INTRODUCTION

To devise a precise and efficient tool for predicting the individualized risk of acute-phase response (APR) in bisphosphonate (BP)-naive osteoporotic (OP) patients, receiving their first intravenous dose of zoledronate (ZOL).

METHODS

The baseline clinical and laboratory data of 475 consecutive BP-naive OP patients, who received their first intravenous dose of ZOL between March 2016 and March 2021 in the Affiliated Kunshan Hospital of Jiangsu University, were chosen for analysis. Univariate and multivariable logistic regression models were generated to establish candidate predictors of APR fever risk, using three distinct fever thresholds, namely, 37.3 °C (model A), 38.0 °C (model B), and 38.5 °C (model C). Next, using predictor regression coefficients, three fever-threshold nomograms were developed. Discrimination, calibration, and clinical usefulness of each predicting models were then assessed using the area under the curve (AUC), calibration curve (CC), and decision curve analysis (DCA). The internal and external model validations were then performed.

RESULTS

The stable predictors were age, serum 25-hydroxy vitamin D, serum total calcium, and peripheral blood erythrocytes count. These were negatively associated with the APR fever risk. The AUCs of models A, B, and C were 0.828 (95% confidence intervals [CI], 0.782 to 0.874), 0.825 (95% CI, 0.767 to 0.883), and 0.879 (95% CI, 0.824 to 0.934), respectively. Good agreement was observed between the predictions and observations in the CCs of all three nomograms.

CONCLUSIONS

This study developed and validated nomogram prediction models that can predict APR fever risk in BP-naive OP patients receiving their first infusion of ZOL.

摘要

简介

为了设计一种精确、高效的工具,以预测接受唑来膦酸(ZOL)首剂静脉注射的初治双膦酸盐(BP)骨质疏松症(OP)患者的急性期反应(APR)的个体化风险,我们分析了 2016 年 3 月至 2021 年 3 月期间在江苏大学附属昆山医院接受 ZOL 首剂静脉注射的 475 例连续初治 BP-OP 患者的基线临床和实验室数据。使用三个不同的发热阈值(37.3°C 模型 A、38.0°C 模型 B 和 38.5°C 模型 C),建立 APR 发热风险的候选预测因子的单变量和多变量逻辑回归模型。然后,使用预测因子回归系数,开发了三个发热阈值列线图。使用曲线下面积(AUC)、校准曲线(CC)和决策曲线分析(DCA)评估每个预测模型的区分度、校准度和临床实用性。然后进行内部和外部模型验证。

结果

稳定的预测因子是年龄、血清 25-羟维生素 D、血清总钙和外周血红细胞计数。这些因素与 APR 发热风险呈负相关。模型 A、B 和 C 的 AUC 分别为 0.828(95%可信区间[CI],0.782 至 0.874)、0.825(95%CI,0.767 至 0.883)和 0.879(95%CI,0.824 至 0.934)。所有三个列线图的 CC 均显示预测值与观察值之间具有良好的一致性。

结论

本研究开发和验证了预测初治 OP 患者接受 ZOL 首剂静脉输注后 APR 发热风险的列线图预测模型。

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