含贝达喹啉的所有口服长程方案治疗巴基斯坦耐多药/利福平结核的疗效。

Effectiveness of bedaquiline containing all oral longer regimens in treating multidrug/rifampicin resistant tuberculosis in Pakistan.

机构信息

Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Pulau Pinang, Malaysia.

出版信息

J Infect Public Health. 2024 Sep;17(9):102522. doi: 10.1016/j.jiph.2024.102522. Epub 2024 Aug 14.

DOI:10.1016/j.jiph.2024.102522

PMID:39173557

Abstract

BACKGROUND

Despite the introduction of bedaquiline (Bdq) containing all-oral regimens for treating patients with rifampicin resistant/multidrug resistant tuberculosis (MDR/RR-TB) in 2019, data on its effectiveness in Pakistan, which has the fifth highest MDR-TB burden, is lacking. This study evaluates treatment outcomes and identifies factors associated with unsuccessful outcomes among MDR/RR-TB patients treated with an all-oral longer treatment regimen (LTR).

METHODS

This retrospective record review included all microbiologically confirmed pulmonary MDR/RR-TB patients treated with an all-oral LTR between August 2019 and February 2021 across nine PMDT centres in Pakistan. Sociodemographic and clinical data were retrieved from the Electronic Nominal Recording and Reporting System. Treatment outcomes, defined by WHO criteria, were analysed using SPSS and multivariate binary logistic regression to identify factors associated with unsuccessful outcomes. A p-value < 0.05 was considered statistically significant.

RESULTS

The final analysis included 644 MDR/RR-TB patients (mean age 37.9 ± 17.6 years), mostly male (53.0 %), underweight (68.0 %), with TB treatment history (66.1 %), MDR-TB (84.9 %), lung cavitation (71.0 %), and no comorbidities (86.4 %). Fluoroquinolone resistance was found in 41.9 %, 16 % had used second-line drugs, and 9.8 % had previous MDR-TB treatment. A total of 400 (62.1 %) patients were declared cured, 53 (8.2 %) treatment completed, 117 (18.2 %) died, 37 (5.7 %) lost to follow-up (LTFU), and 37 (5.7 %) treatment failures. Overall treatment success rate was 70.3 % (n = 453). In multivariate analysis, history of TB treatment (OR:1.63, 95 %CI:1.09-2.64, p = 0.023), previous SLD use (OR:2.09, 95 %CI: 1.20-3.37, p = 0.012), resistance to Z (OR:0.43, 95 %CI: 0.20-0.81, p = 0.023), and resistance to > 5 drugs (OR:3.12, 95 %CI:1.36-11.64, p = 0.013) were significantly associated with death and treatment failure. Whereas, lung cavitation had statistically significant association with LTFU (OR:2.66, 95 %CI:1.10-7.32, p = 0.045).

CONCLUSION

Treatment success rate (70.3 %) in this study fell below the WHO recommended target success rate (>90 %). Enhanced clinical management, coupled with special attention to patients exhibiting identified risk factors could improve treatment outcomes.

摘要

背景

尽管在 2019 年引入了含有贝达喹啉（Bdq）的全口服方案来治疗耐利福平/多药耐药结核病（MDR/RR-TB）患者，但在 MDR-TB 负担位居全球第五的巴基斯坦，缺乏关于其疗效的数据。本研究评估了治疗结果，并确定了在使用全口服长疗程治疗方案（LTR）治疗 MDR/RR-TB 患者中与不成功结果相关的因素。

方法

本回顾性记录研究纳入了 2019 年 8 月至 2021 年 2 月期间在巴基斯坦的 9 个 PMDT 中心接受全口服 LTR 治疗的所有经微生物学证实的肺 MDR/RR-TB 患者。从电子命名记录和报告系统中提取社会人口统计学和临床数据。使用 SPSS 和多变量二分类逻辑回归分析根据世卫组织标准定义的治疗结果，以确定与不成功结果相关的因素。p 值<0.05 被认为具有统计学意义。

结果

最终分析纳入了 644 例 MDR/RR-TB 患者（平均年龄 37.9±17.6 岁），大多数为男性（53.0%）、体重不足（68.0%）、有结核病治疗史（66.1%）、MDR-TB（84.9%）、肺空洞（71.0%），且无合并症（86.4%）。氟喹诺酮类耐药率为 41.9%，16%的患者使用二线药物，9.8%的患者曾接受过 MDR-TB 治疗。共有 400 例（62.1%）患者被宣布治愈，53 例（8.2%）治疗完成，117 例（18.2%）死亡，37 例（5.7%）失访，37 例（5.7%）治疗失败。总体治疗成功率为 70.3%（n=453）。多变量分析显示，有结核病治疗史（OR：1.63，95%CI：1.09-2.64，p=0.023）、既往使用二线药物（OR：2.09，95%CI：1.20-3.37，p=0.012）、对 Z 耐药（OR：0.43，95%CI：0.20-0.81，p=0.023）和耐药≥5 种药物（OR：3.12，95%CI：1.36-11.64，p=0.013）与死亡和治疗失败显著相关。而肺空洞与失访有统计学显著关联（OR：2.66，95%CI：1.10-7.32，p=0.045）。