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中国临床研究英文版:2026,39(7):1067-1070
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含贝达喹啉四联方案与传统二线方案治疗耐药肺结核的短期及中长期疗效比较
(1. 呼和浩特市第二医院药剂部,内蒙古 呼和浩特 010030;2. 呼和浩特市职业病防治所,内蒙古 呼和浩特 010010)
Comparison of short-term and medium-to-long-term efficacy between a bedaquiline-containing quadruple regimen and a conventional second-line regimen for drug-resistant pulmonary tuberculosis
摘要
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Received:October 22, 2025   Published Online:July 30, 2026
中文摘要: 目的  分析含贝达喹啉四联方案与传统二线方案治疗耐药肺结核的短期及中长期疗效与安全性,为临床个体化方案选择提供真实世界数据支持。方法  回顾性纳入2022年1月至2023年6月呼和浩特市第二医院收治的30例耐药肺结核患者,按治疗方案分为观察组(15例,贝达喹啉+环丝氨酸+氯法齐明+莫西沙星)与对照组(15例,环丝氨酸+氯法齐明+莫西沙星+阿米卡星)。所有病例以入组日期为起点,按统一标准完成随访(随访6个月、12个月、24个月者分别记录对应指标),比较两组不同随访节点的痰菌转阴率、胸部影像改善率、不良反应发生率及肝肾功能变化。结果  观察组15例完成6个月随访,12例完成12个月随访,5例完成24个月随访;对照组15例完成6个月随访,12例完成12个月随访,3例完成24个月随访。观察组随访6个月、12个月、24个月时的痰菌转阴率分别为86.67%(13/15)、83.33%(10/12)、80.00%(4/5),均略高于对照组同期的53.33%(8/15)、50.00%(6/12)、33.33%(1/3),但差异均无统计学意义(P=0.109,P=0.193,P=0.464);观察组治疗6 个月胸部影像改善率为80.00%(12/15),略高于对照组的46.67%(7/15),但差异无统计学意义(P=0.128)。观察组和对照组不良反应发生率(26.67% vs 33.33%,P=1.000)及各随访节点肝肾功能(丙氨酸氨基转移酶、血肌酐)指标比较,差异均无统计学意义(P>0.05)。结论  含贝达喹啉四联方案治疗耐药肺结核的短期疗效呈较好趋势,可一定程度促进痰菌转阴与病灶吸收,且中长期疗效稳定,安全性良好,能否取得有统计学意义的获益,有待进一步研究。
Abstract:Objective To analyze the short - term and medium - to - long - term efficacy and safety of a bedaquiline -containing quadruple regimen versus a conventional second-line regimen in the treatment of drug-resistant pulmonary tuberculosis(DR-pTB),and to provide real-world data to support individualized clinical treatment selection. Methods A retrospective analysis was conducted on 30 patients with DR-pTB admitted to Hohhot Second Hospital from January 2022 to June 2023. Patients were divided according to treatment regimen into an observation group (15 cases,bedaquiline + cycloserine + clofazimine + moxifloxacin)and a control group(15 cases,cycloserine + clofazimine +moxifloxacin + amikacin). Using the enrollment date as the starting point,all patients were followed up according to a standardized protocol(with corresponding indicators recorded at 6,12,and 24 months). The sputum bacterial negative conversion rate,chest imaging improvement rate,adverse reaction rate,and changes in liver and kidney function at different follow-up time points were compared between the two groups. Results In the observation group,15 patients completed the 6-month follow-up,12 completed the 12-month follow-up,and 5 completed the 24-month follow-up. In the control group,15 patients completed the 6 - month follow - up,12 completed the 12 - month follow - up,and 3 completed the 24-month follow-up. The sputum bacterial negative conversion rates in the observation group at 6,12,and 24 months were 86.67%(13/15),83.33%(10/12),and 80.00%(4/5),respectively,all slightly higher than those in the control group at the corresponding time points[53.33%(8/15),50.00%(6/12),33.33%(1/3)],but the differences were not statistically significant(P=0.109,P=0.193,P=0.464). The chest imaging improvement rate at 6 months in the observation group was 80.00%(12/15),slightly higher than that in the control group(46.67%,7/15),but the difference was not statistically significant(P=0.128). There was no statistically significant difference between the observation group and the control group in terms of adverse reaction rate(26.67% vs 33.33%,P=1.000)or liver and kidney function parameters (alanine aminotransferase,serum creatinine)at any follow - up time point (P>0.05).Conclusion The bedaquiline-containing quadruple regimen demonstrates a favourable trend in short-term efficacy in the treatment of DR - pTB,promoting sputum bacterial conversion and lesion absorption to a certain extent,while maintaining stable medium - to - long - term efficacy and a favorable safety profile. Whether it can obtain statistically significant benefits needs further study.
文章编号:     中图分类号:R521    文献标志码:A
基金项目:内蒙古医学科学院公立医院科研联合基金项目(2023GLLH0179)
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