肿瘤患者医疗器械相关不良事件的模式和预测因素评估:三级医院的横断面研究

Expert review of medical devices Pub Date : 2025-05-01 Epub Date: 2025-04-03 DOI:10.1080/17434440.2025.2486471
Ashutosh Bhosale, Sarasa Meenakshi, Pavan Kumar Narapaka, Chauhan Richa, V Kalaiselvan, Sameer Dhingra, Nitesh Kumar, Radhakrishnan Rajesh, Krishna Murti
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引用次数: 0

摘要

背景:本研究旨在确定放射治疗患者医疗器械相关不良事件(MDAEs)的模式和预测因素。了解MDAEs对于优化放疗期间患者的安全至关重要。方法:一项观察性研究于2023年8月至12月进行,纳入139例放疗患者。从患者数据表中收集人口统计学、临床特征和AE报告,并使用SPSS Version 28进行分析。结果:研究结果显示,头颈癌患者的皮肤(OR: 3.56, CI: 1.59-7.96)和粘膜反应发生率较高。特定剂量范围,特别是800-2800 cGy,也可以预测粘膜反应(OR: 11.12, CI: 3.42-36.1)。此外,无烟习惯显著影响皮肤反应(OR: 6.04, CI: 1.99-18.3)和粘膜反应(OR: 8.77, CI: 2.57-29.9)。相比之下,头颈癌患者咽部反应的可能性降低(OR: 0.37, CI: 0.13-1.00),特别是剂量在2801-4800 cGy之间(OR: 0.45, CI: 0.96-21.6)。结论:本研究确定了放疗患者中不同类型MDAEs发生的一些重要预测因素。报告MDAEs可以预防医疗器械造成的不良影响,提高放射治疗的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital.

Background: This study aims to identify patterns and predictors of medical device-related adverse events (MDAEs) among radiotherapy patients. Understanding MDAEs is crucial for optimizing patient safety during radiotherapy.

Methodology: An observational study conducted from August to December 2023 involved 139 patients undergoing radiotherapy. Demographics, clinical characteristics, and AE reports were collected from patient datasheets and analyzed using SPSS Version 28.

Results: Study findings revealed that patients with head and neck cancer were significantly associated with higher rates of skin (OR: 3.56, CI: 1.59-7.96) and mucous membrane reactions. Specific dose ranges, particularly 800-2800 cGy, also predict mucous membrane reactions (OR: 11.12, CI: 3.42-36.1). Furthermore, smokeless habits significantly influenced both skin (OR: 6.04, CI: 1.99-18.3) and mucous membrane reactions (OR: 8.77, CI: 2.57-29.9). In contrast, head and neck cancer patients had reduced likelihoods of pharynx reactions (OR: 0.37, CI: 0.13-1.00), particularly with doses between 2801 and 4800 cGy (OR: 0.45, CI: 0.96-21.6).

Conclusion: This study identified a few significant predictors for the occurrence of various types of MDAEs among patients undergoing radiotherapy. Reporting MDAEs can prevent adverse effects caused by medical devices and enhance radiotherapy safety.

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