Article record

注射剂与耐利福平结核病患者治疗中的听力损失：一项全国性多中心前瞻性研究

Injectable agents and hearing loss in the treatment of patients with rifampicin-resistant tuberculosis: a nationwide multicenter prospective study.

临床研究耳科IF 3.5Q2

文献信息

PMID	42763278
原文	在 PubMed 查看原文 ↗
发表日期	2026
作者	Chou-Jui Lin 查看其他 8 位作者 Chi-Jung Chiang；Shun-Tien Chien；Yi-Wen Huang；Chih-Bin Lin；Jen-Jyh Lee；Chih-Hsin Lee；Ming-Chih Yu；Chen-Yuan Chiang
作者单位	Tao-Yuan General Hospital, Ministry of Health and Welfare, 1492, Zhongshan Road, Taoyuan District, Taoyuan City, 330, Taiwan. 查看其他 8 条单位信息 Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, No.291, Zhongzheng Rd., Zhonghe District, New Taipei City, 235, Taiwan.；Chest Hospital, Ministry of Health and Welfare, 864 Zhongshan Road, Rende District, Tainan City, 717, Taiwan.；Chang-Hua Hospital, Ministry of Health and Welfare, 80 Zhongzheng Road, Section 2, Puxin Township, Changhua County, 513, Taiwan; Institute of Medicine, Chang Shan Medical University, 110 Jianguo North Road, Section 1, Taichung City, 402, Taiwan.；Division of Chest Medicine, Department of Internal Medicine, Tzu Chi General Hospital, Tzu Chi University, 707 Chung-Yang Road, Section 3, Hualien, 970, Taiwan; School of Medicine, Tzu Chi University, 701 Zhongyang Road, Section 3, Hualien, 970, Taiwan.；Division of Chest Medicine, Department of Internal Medicine, Tzu Chi General Hospital, Tzu Chi University, 707 Chung-Yang Road, Section 3, Hualien, 970, Taiwan.；Division of Pulmonary Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, 111 Hsin-Long Road, Section 3, Taipei City, 116, Taiwan; Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, 250 Wuxing Street, Xinyi District, Taipei City, 110, Taiwan.；Division of Pulmonary Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, 111 Hsin-Long Road, Section 3, Taipei City, 116, Taiwan; School of Respiratory Therapy, College of Medicine, Taipei Medical University, 250 Wuxing Street, Xinyi District, Taipei City, 110, Taiwan.；Division of Pulmonary Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, 111 Hsin-Long Road, Section 3, Taipei City, 116, Taiwan; Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, 250 Wuxing Street, Xinyi District, Taipei City, 110, Taiwan. Electronic address: cychiang@theunion.org.
期刊	Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi
SCI 分区	Q2
IF	3.5
研究类型	临床研究 · 临床
所属专科	耳科

中文摘要

背景： 听力损失监测是活动性结核病药物安全性监测与管理的重要组成部分，有助于评估注射药物剂量及与治疗所致听力损失相关的危险因素。
方法： 在基线和每月进行纯音测听。采用Brock分类对听力损失的严重程度进行分级。对累积剂量和按体重标准化的累积剂量进行量化。构建Cox比例风险模型以评估与治疗所致听力损失相关的因素。
结果： 在基线时无严重听力损失的196例患者中，89例（45.4%）出现治疗所致听力损失，46例（23.5%）出现治疗所致严重听力损失。在多变量分析中，年龄大于65岁（adjHR 13.31，95% CI 3.78-46.85）和基线时轻度听力损失（adjHR 2.98，95% CI 1.12-7.96）与治疗所致严重听力损失显著相关。在无可分级治疗所致听力损失者中，所用注射药物的最低累积剂量为3.2 g；在轻度治疗所致听力损失者为11.6 g；在中度听力损失者为32.4 g；在严重听力损失者为9.8 g（Kruskal-Wallis秩和检验，p值=1.00）；按体重标准化的最低累积剂量分别为100、200、500和100 mg/kg（Kruskal-Wallis秩和检验：p值=0.84）。
结论： 治疗所致听力损失较为常见，且可能在所用注射药物累积剂量相对较低时发生。只要有必要使用注射剂，结核病规划就必须建立完善的耳毒性监测方案。

英文摘要

BACKGROUND: Monitoring for hearing loss is an integral component of active tuberculosis drug-safety monitoring and management, enabling the evaluation of injectable drug doses and risk factors associated with treatment-emergent hearing loss.
METHODS: Pure-tone audiometry was performed at baseline and monthly. Brock classification was used to classify the severity of hearing loss. The cumulative doses and body weight standardized cumulative doses was quantified. Cox proportional hazards models were constructed for assessment of factors associated with treatment-emergent hearing loss.
RESULTS: Of the 196 patients without severe hearing loss at baseline, 89 (45.4%) had treatment-emergent hearing loss and 46 (23.5%) had treatment-emergent severe hearing loss. In multivariable analysis, aged more than 65 years old (adjHR 13.31, 95% CI 3.78-46.85) and mild hearing loss at baseline (adjHR 2.98, 95% CI 1.12-7.96) were significantly associated with treatment-emergent severe hearing loss. The minimum cumulative doses of injectable agents used was 3.2 g in those without gradable treatment-emergent hearing loss, 11.6 g in those with mild treatment-emergent hearing loss, 32.4 g in those with moderate hearing loss was, and 9.8 g in those with severe hearing loss (Kruskal-Wallis rank sum test, p-value = 1.00); and the minimum body weight standardized cumulative doses were 100, 200, 500, and 100 mg/kg, respectively (Kruskal-Wallis rank sum test: p-value = 0.84).
CONCLUSION: Treatment-emergent hearing loss was common and may occur at relatively low cumulative doses of injectable agents used. Whenever injectables are indicated, it is pivotal for TB programmes to establish robust protocols for monitoring ototoxicity.