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中国防痨杂志 ›› 2022, Vol. 44 ›› Issue (6): 582-586.doi: 10.19982/j.issn.1000-6621.20220019

• 论著 • 上一篇    下一篇

含贝达喹啉方案治疗老年耐药肺结核患者的有效性及安全性

薛玉1, 张静1, 聂文娟2()   

  1. 1首都医科大学附属北京胸科医院急诊科,北京 101149
    2首都医科大学附属北京胸科医院结核一科,北京 101149
  • 收稿日期:2022-01-30 出版日期:2022-06-10 发布日期:2022-06-01
  • 通信作者: 聂文娟 E-mail:wenjuan.nie@outlook.com
  • 基金资助:
    国家自然科学基金(82100002);通州“运河”两高人才(YH2019-11)

The efficacy and safety of regimen containing bedaquiline in the treatment of elderly drug-resistant tuberculosis patients

XUE Yu1, ZHANG Jing1, NIE Wen-juan2()   

  1. 1Department of Emergency,Beijing Chest Hospital, Capital Medical University,Beijing 101149,China
    2The First Department of Tuberculosis,Beijing Chest Hospital, Capital Medical University,Beijing 101149,China
  • Received:2022-01-30 Online:2022-06-10 Published:2022-06-01
  • Contact: NIE Wen-juan E-mail:wenjuan.nie@outlook.com
  • Supported by:
    National Natural Science Foundation of China(82100002);Tongzhou “Canal” Two Talents Project(YH2019-11)

摘要:

目的: 回顾性分析贝达喹啉联合常规抗结核药物治疗老年耐药肺结核患者的有效性及安全性。 方法: 收集2020年4月至2021年7月期间首都医科大学附属北京胸科医院使用含贝达喹啉方案治疗的20例65周岁以上老年耐药肺结核患者作为研究对象,其中利福平耐药肺结核患者2例,耐多药肺结核患者6例,准广泛耐药肺结核患者11例,广泛耐药肺结核患者1例。分析治疗24周患者的痰培养阴转率和病灶吸收好转情况以评估治疗的有效性,分析心电图QTc(按Fridericia法校正的QT间期)的变化等不良反应发生情况以评估安全性。 结果: 共有12例患者完成了24周的疗程及各指标监测,均实现培养阴转,胸部CT扫描显示7例显效、5例有效,6例存在肺部空洞的患者中5例空洞缩小或空洞数量减少、1例空洞闭合。4例患者死亡,死亡原因均为重症感染导致呼吸衰竭。1例患者因新发左前束支传导阻滞停用,5例出现QTc间期>450ms,其中1例QTc间期>500ms停药,2例因家属顾虑风险要求停药,停药前QTc分别为473ms和490ms,另外2例QTc间期分别为479ms和452ms,坚持服用至强化期治疗结束。2例患者出现胃肠道反应,其中1例合并肝功能损伤,调整背景方案后坚持服药至疗程结束。 结论: 含贝达喹啉的组合方案治疗老年耐药肺结核患者24周时的结核分枝杆菌培养阴转率较高,患者耐受性相对良好。

关键词: 结核, 抗多种药物性, 抗结核药, 药物评价

Abstract:

Objective: To evaluate the early efficacy and safety of regimen containing bedaquiline in the treatment of elderly drug-resistant tuberculosis (TB) patients. Methods: From April 2020 to July 2021, 20 elderly patients over 65 years old with drug-resistant TB who used bedaquiline regimen in Beijing Chest Hospital were enrolled, including 2 (10.0%) with rifampicin-resistant (RR), 6 (30.0%) with multidrug-resistant (MDR), 11 (55.0%) with pre-extensively drug-resistant (pre-XDR) and 1 (5.0%) with extensively drug-resistant TB (XDR-TB), respectively. TB culture conversion rate and lesions absorption within 24 weeks were analyzed to assess the early treatment efficacy. The adverse events and QTc were recorded to assess the treatment safety. Results: Twelve (60.0%) cases achieved culture conversion within 24 weeks, 7 showed significant absorption in Chest CT scan, 5 showed partial absorption. Among 6 patients with lung cavities, 5 showed cavities reducing and 1 showed cavity closing, 4 (20.0%) cases died, and the reason of death was respiratory failure caused by severe infection, 1 (5.0%) patient stopped bedaquiline due to the happening of left anterior bundle branch block. QTc value >450 ms was found in 5 (25.0%) patients, with 1 (5.0%) >500 ms, 2 (10.0%) were 473 ms and 490 ms, respectively, and bedaquiline was stopped. The other 2 patients with QTc 479 ms and 452 ms persisted took bedaquiline until the end of 24 weeks. 2 patients (10.0%) with gastrointestinal reactions continuing regimen until the end of 24 weeks, including 1 (5.0%) with liver injury. Conclusion: The regimen containing bedaquiline can achieve high culture conversion rates in patients with drug-resistant TB, and the safety is also well in the elderly TB patients.

Key words: Tuberculosis, multidrug-resistant, Antitubercular agents, Drug evaluation

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