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贝达喹啉方案对埃及耐多药结核病患者治疗成功率的影响。

Impact of bedaquiline regimen on the treatment success rates of multidrug-resistant tuberculosis patients in Egypt.

机构信息

General Administration of Chest Diseases, MoHP, Cairo, Egypt.

Chest Diseases Consultant and MDR Coordinator/NTP, Cairo, Egypt.

出版信息

Sci Rep. 2024 Jul 15;14(1):16247. doi: 10.1038/s41598-024-65063-8.

Abstract

Bedaquiline (BDQ), an innovative anti-tuberculous (TB) agent, has attracted attention for its potential effectiveness against drug-resistant TB. This study investigated the impact of BDQ-containing regimens on treatment success rates among multi-drug resistant tuberculosis (MDR-TB) patients in Egypt. We conducted a prospective cohort study that included all adult non-pregnant patients treated in MDR-TB centers in Egypt from April 1, 2020, to June 30, 2021, with follow-up extended until December 31, 2022. The study compared patients prescribed BDQ according to national protocols with those receiving conventional treatments for MDR-TB. Treatment success rates, mortality rates, and adverse events were analyzed using descriptive statistics, chi-square tests, logistic regression, and Kaplan-Meier survival curves. Adjustment for potential confounders was conducted using propensity score matching and Cox-hazard regressions. A total of 84 patients were included in this study. The median age of the study participants was 39 years; 22.6% were women, 57.1% were unemployed or housewives, and 1.2% had human immunodeficiency virus (HIV). Regarding the treatment regimen, 67.8% were exposed to BDQ-based treatment. Among the 55 patients (65.5%) with treatment success, a significantly higher success rate was observed in the BDQ group (73.7%) compared to the conventional group (48.1%), P = 0.042. Additionally, the incidence of skin discoloration was significantly higher in the BDQ group compared to the conventional group (38.6% versus 0.0%, P < 0.001). Despite the lower mortality incidence in the BDQ-group (14.0% versus 22.2% in the conventional group), the Kaplan-Meier survival analysis revealed no excess mortality associated with the BDQ-group, with a hazard ratio (HR) of 0.62 (95% CI 0.21-1.78, P = 0.372). Propensity score matching, while considering factors such as lesion site, diabetes mellitus, hepatitis C virus, and smoking, revealed a significant increase in the success rate associated with BDQ inclusion, with an HR of 6.79 (95% CI 1.8-25.8). In conclusion, BDQ is an effective and tolerable medication for treating MDR-TB, associated with lower mortality rates compared to conventional treatment.

摘要

贝达喹啉(BDQ)是一种创新的抗结核药物,因其对耐药结核病的潜在疗效而备受关注。本研究旨在探讨含贝达喹啉方案对埃及耐多药结核病(MDR-TB)患者治疗成功率的影响。

我们开展了一项前瞻性队列研究,纳入 2020 年 4 月 1 日至 2021 年 6 月 30 日期间在埃及 MDR-TB 中心接受治疗的所有成年非妊娠患者,并随访至 2022 年 12 月 31 日。该研究比较了按照国家方案接受贝达喹啉治疗的患者与接受常规 MDR-TB 治疗的患者。采用描述性统计、卡方检验、逻辑回归和 Kaplan-Meier 生存曲线分析治疗成功率、死亡率和不良事件。采用倾向评分匹配和 Cox 风险回归调整潜在混杂因素。

共纳入 84 例患者。研究参与者的中位年龄为 39 岁;22.6%为女性,57.1%为失业或家庭主妇,1.2%患有人类免疫缺陷病毒(HIV)。在治疗方案方面,67.8%的患者接受了基于贝达喹啉的治疗。在 55 例(65.5%)治疗成功的患者中,贝达喹啉组的成功率(73.7%)明显高于常规组(48.1%),P=0.042。此外,贝达喹啉组皮肤变色的发生率明显高于常规组(38.6%对 0.0%,P<0.001)。尽管贝达喹啉组的死亡率较低(14.0%对常规组的 22.2%),但 Kaplan-Meier 生存分析显示,贝达喹啉组与死亡率升高无关,风险比(HR)为 0.62(95%CI 0.21-1.78,P=0.372)。在考虑病变部位、糖尿病、丙型肝炎病毒和吸烟等因素进行倾向评分匹配后,发现纳入贝达喹啉与治疗成功率显著增加相关,HR 为 6.79(95%CI 1.8-25.8)。

综上所述,贝达喹啉是一种治疗耐多药结核病的有效且耐受良好的药物,与常规治疗相比,死亡率较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/560a/11250779/24ad566123fe/41598_2024_65063_Fig1_HTML.jpg

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本文引用的文献

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