基于真实世界数据的一次性使用血液灌流器安全性评估与风险管理建议

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【中图分类号】R197.39 【文献标识码】A

【Abstract】 Objective To analyze the characteristics of adverse events of disposable hemoperfusion devices in real-world clinical practice using multicenter data，and to investigate the influencing factors of hypotension，providing evidence for the safe clinical use of these devices.Methods An observational study was conducted involving patients who received disposable hemoperfusion therapy across 17 sentinel hospitals in China from June 2022 to July 2024.Device-related adverse events were monitored and analyzed.Descriptive statistics，Firth's Logistic regresson model，and balanced random forest model wereapplied to systematically evaluate the manifestations of adverse events and the risk factors for the occurrence of hypotension.ResultsA total of 17，824 usage records were included. In the sentinel hospital data， hypotension 0.19% 95%CI （ 0.14% 0 0.27% ] and hemoperfusion occlusion [0.13% 95%CI （0.09%，0.19%） ] occupied the highest incidence rate. The Firth's Logistic regressionanalysis revealed that end-stage renal disease with comorbidities significantly increased hypotension risk OR=77.324. ），while no prior medical history was protective （ ）. Stepwise blood purification modalities （hemoperfusion alone or sequential hemoperfusion-hemodialysis） significantly reduced the hypotension risk compared with simultaneous hemoperfusion and hemodialysis （ OR=0.003 ） The random forest model further confirmed that blood purification modality was the strongest influencing factor for hypotension. Conclusion In real-world clinical settings，hypotension and device occlusion were the predominant adverse events， with blood purification modality criticall influencing hypotension risk.Stepwise blood purification is recommended to mitigate this risk. Enhancing clinical operating procedures and device design is essential to improve overall treatment safety.

【Keywords】Disposable hemoperfusion devices; Adverse events; Hypotension; Hemoperfusior occlusion; Influencing factors

一次性使用血液灌流器是实施血液灌流治疗不可或缺的关键医疗器械。（剩余14307字）