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维持性血液透析患者促红细胞生成素刺激剂的计算机辅助处方:人工智能模型选择的随机对照试验

Computer-assisted prescription of erythropoiesis-stimulating agents in patients undergoing maintenance hemodialysis: a randomized control trial for artificial intelligence model selection.

作者信息

Lim Lee-Moay, Lin Ming-Yen, Hsu Chan, Ku Chantung, Chen Yi-Pei, Kang Yihuang, Chiu Yi-Wen

机构信息

Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 80708, Taiwan.

Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 80708, Taiwan.

出版信息

JAMIA Open. 2025 Mar 27;8(2):ooaf020. doi: 10.1093/jamiaopen/ooaf020. eCollection 2025 Apr.

Abstract

OBJECTIVE

Machine learning (ML) algorithms are promising tools for managing anemia in hemodialysis (HD) patients. However, their efficacy in predicting erythropoiesis-stimulating agents (ESAs) doses remains uncertain. This study aimed to evaluate the effectiveness of a contemporary artificial intelligence (AI) model in prescribing ESA doses compared to physicians for HD patients.

MATERIALS AND METHODS

This double-blinded control trial randomized participants into traditional doctor (Dr) and AI groups. In the Dr group, doses of ESA were determined by following clinical guideline recommendations, while in the AI group, they were predicted by the developed models named Random effects (REEM) trees, Mixed-effect random forest (MERF), Long short-term memory (LSTM) networks-I, and LSTM-II. The primary outcome was the capability to maintain patients' hemoglobin (Hb) value near 11 g/dL with a margin of 0.25 g/dL after treating the suggested ESA, with the secondary outcome being Hb value between 10 and 12 g/dL.

RESULTS

A total of 124 participants were enrolled, with 104 completing the study. The mean Hb values were 10.8 and 10.9 g/dL in the AI and Dr groups, respectively, with 69.7% and 73.5% of participants in the respective groups maintaining Hb levels between 10 and 12 g/dL. Only the REEM trees model passed the non-inferiority test for the primary outcome with a margin of 0.25 g/dL and the secondary outcome with a margin of 15%. There was no difference in severe adverse events between the 2 groups.

CONCLUSION

The REEM trees AI model demonstrated non-inferiority to physicians in prescribing ESA doses for HD patients, maintaining Hb levels within the therapeutic target.

CLINICALTRIALSGOV IDENTIFIER

NCT04185519.

摘要

目的

机器学习(ML)算法是管理血液透析(HD)患者贫血的有前景的工具。然而,其在预测促红细胞生成素(ESA)剂量方面的疗效仍不确定。本研究旨在评估一种当代人工智能(AI)模型与医生相比在为HD患者开具ESA剂量方面的有效性。

材料与方法

这项双盲对照试验将参与者随机分为传统医生(Dr)组和AI组。在Dr组中,ESA剂量根据临床指南建议确定,而在AI组中,由名为随机效应(REEM)树、混合效应随机森林(MERF)、长短期记忆(LSTM)网络-I和LSTM-II的开发模型预测。主要结局是在使用建议的ESA治疗后将患者血红蛋白(Hb)值维持在11 g/dL附近且波动范围为0.25 g/dL的能力,次要结局是Hb值在10至12 g/dL之间。

结果

共招募了124名参与者,其中104名完成了研究。AI组和Dr组的平均Hb值分别为10.8和10.9 g/dL,各组分别有69.7%和73.5%的参与者Hb水平维持在10至12 g/dL之间。只有REEM树模型在主要结局波动范围为0.25 g/dL和次要结局波动范围为15%时通过了非劣效性检验。两组之间严重不良事件无差异。

结论

REEM树AI模型在为HD患者开具ESA剂量方面显示出不劣于医生的效果,能将Hb水平维持在治疗目标范围内。

临床试验注册标识符

NCT04185519。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba26/11950923/0419c4ae0f1c/ooaf020f1.jpg

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