bedaquiline

Bedaquiline
  • 文章类型: Journal Article
    METHODS: Multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) is now endemic in the National Capital District (NCD), Papua New Guinea. Loss to follow-up (LTFU) is a challenge.
    OBJECTIVE: To evaluate and identify risk factors for LTFU, including pre-treatment LTFU, in adults with MDR/RR-TB at Port Moresby General Hospital (PMGH).
    METHODS: A retrospective analysis of treatment initiation in adults diagnosed with MDR/RR-TB (2018-2022) and outcomes for a cohort treated for MDR/RR-TB (2014-2019). We assessed the factors associated with LTFU using multivariate logistic regression.
    RESULTS: Of 95 patients diagnosed with MDR/RR-TB at PMGH from 2018 to 2022, 21 (22%) were lost to follow-up before treatment. Of the 658 adults who initiated treatment for MDR/RR-TB at PMGH from 2014 to 2019, 161 (24%) were lost to follow-up during treatment. A higher proportion of patients on injectable-containing long regimens (110/404, 27%) were lost to follow-up than those on the all-oral regimen containing bedaquiline (13/66, 12%). Treatment loss to follow-up was associated with age (35-54 years age group: aOR 0.49, 95% CI 0.32-0.77; 55-75 years age group: aOR 0.42, 95% CI 0.19-0.90; compared to the 15-34 years age group), residence outside of NCD (aOR 1.79, 95% CI 1.04-3.06), and year of treatment initiation.
    CONCLUSIONS: Pre-treatment LTFU requires programmatic focus. Shorter oral regimens and decentralised services may address the reasons for higher LTFU in younger people and people living outside NCD.
    BACKGROUND: La TB multirésistante/résistante à la rifampicine (MDR-TB/RR-TB, pour l’anglais « multidrug/rifampicin-resistant TB ») est maintenant endémique dans le district de la capitale nationale (NCD, pour l’anglais « National Capital District »), en Papouasie-Nouvelle-Guinée. La perte de suivi (LTFU, pour l’anglais « loss to follow-up ») est un défi.
    OBJECTIVE: Évaluer et identifier les facteurs de risque de LTFU, y compris le LTFU avant le traitement, chez les adultes atteints de MDR-TB/RR-TB à Port Moresby General Hospital (PMGH).
    UNASSIGNED: Une analyse rétrospective de l\'initiation du traitement chez les adultes diagnostiqués avec une MDR-TB/RR-TB (2018–2022) et des résultats pour une cohorte traitée pour la MDR-TB/RR-TB (2014–2019). Nous avons évalué les facteurs associés au LTFU à l\'aide d\'une régression logistique multivariée.
    UNASSIGNED: Sur les 95 patients diagnostiqués avec une MDR-TB/RR-TB à PMGH de 2018 à 2022, 21 (22%) ont été perdus de vue avant le traitement. Sur les 658 adultes qui ont commencé un traitement pour la MDR-TB/RR-TB à PMGH entre 2014 et 2019, 161 (24%) ont été perdus de vue pendant le traitement. Une proportion plus élevée de patients recevant des régimes longs contenant des injectables (110/404 ; 27%) ont été perdus de vue que ceux recevant un régime entièrement oral contenant de la bédaquiline (13/66 ; 12%). La perte de traitement au suivi était associée à l\'âge (groupe d\'âge de 35 à 54 ans : aOR 0,49 ; IC à 95% 0,32 à 0,77 ; groupe d\'âge de 55 à 75 ans : aOR 0,42 ; IC à 95% 0,19 à 0,90 ; par rapport au groupe d\'âge de 15 à 34 ans), à la résidence en dehors des NCD (aOR 1,79 ; IC à 95% 1,04 à 3,06) et à quelques années de début de traitement.
    CONCLUSIONS: Le LTFU avant le traitement nécessite une orientation programmatique. Des régimes oraux plus courts et des services décentralisés peuvent s\'attaquer aux raisons de l\'augmentation du LTFU chez les jeunes et les personnes vivant en dehors des NCD.
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  • 文章类型: Case Reports
    探讨在有多次眼科手术史的患者的眼腔中由脓肿分枝杆菌的多重耐药菌株引起的罕见眼科感染的管理。
    一名60岁女性,有多种眼部并发症史,最终导致眼球摘除和随后的真皮移植植入物,在眼腔中产生了耐药性感染。尽管有各种局部干预措施和广谱全身性抗生素治疗,但感染仍然存在。只有在精确诊断和实施强化治疗后才能解决感染,其中包括特定的抗生素组合和适当的手术清创术。
    该病例突出了管理由非结核分枝杆菌引起的眼科感染的复杂性。它强调了多学科和个性化治疗方法的重要性,以及需要制定针对由快速生长的分枝杆菌引起的眼科感染的具体指南。
    UNASSIGNED: To explore the management of a rare ophthalmic infection caused by a multi-resistant strain of Mycobacterium abscessus in the anophthalmic cavity of a patient with a history of multiple eye surgeries.
    UNASSIGNED: A 60-year-old woman with a history of multiple ocular complications, culminating in the enucleation of the eye and subsequent dermograft implant, developed a resistant infection in the anophthalmic cavity. The infection persisted despite various local interventions and broad-spectrum systemic antibiotic treatments. Resolution of the infection was only achieved after precise diagnosis and the implementation of intensive treatment, which included a specific combination of antibiotics and appropriate surgical debridement of the anophthalmic cavity.
    UNASSIGNED: This case highlights the complexity in managing ophthalmic infections caused by non-tuberculous mycobacteria. It underscores the importance of a multidisciplinary and personalized treatment approach, as well as the need to develop specific guidelines for ophthalmic infections caused by rapidly growing mycobacteria.
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  • 文章类型: Journal Article
    结核分枝杆菌(TB)仍然是全球感染相关死亡的主要原因。耐药性,需要多种抗分枝杆菌药物,延长疗程,与药物相关的副作用是结核病治愈的复杂因素。引入含有新型药物bedaquiline的治疗方案,Pretomanid,和利奈唑胺,有或没有莫西沙星(BPaL-M或BPaL,分别)大大降低了与结核病相关的发病率和死亡率,并与良好的治疗完成率和治愈率相关。这篇综述总结了莫西沙星的药理学和治疗原则的关键信息,bedaquiline,Delamanid,Pretomanid,利奈唑胺,和替地唑胺治疗耐多药结核病,提供了解决和减轻治疗期间常见不良反应的建议。
    Mycobacterium tuberculosis (TB) remains the leading cause of infection-related mortality worldwide. Drug resistance, need for multiple antimycobacterial agents, prolonged treatment courses, and medication-related side effects are complicating factors to TB cure. The introduction of treatment regimens containing the novel agents bedaquiline, pretomanid, and linezolid, with or without moxifloxacin (BPaL-M or BPaL, respectively) have substantially reduced TB-related morbidity and mortality and are associated with favorable rates of treatment completion and cure. This review summarizes key information on the pharmacology and treatment principles for moxifloxacin, bedaquiline, delamanid, pretomanid, linezolid, and tedizolid in the treatment of multi-drug resistant TB, with recommendations provided to address and attenuate common adverse effects during treatment.
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  • 文章类型: Systematic Review
    Bedaquiline(BDQ)用于治疗耐药结核病(DR-TB)的风险和收益尚未确定。我们旨在评估含BDQ方案治疗DR-TB的安全性和有效性,如现有的随机对照试验(RCTs)所证明。在这篇系统综述和荟萃分析中,五个数据库(即,ClinicalTrials.gov,科克伦中部,PubMed,ScienceDirect,和SinoMed)进行了搜索。有控制臂的DR-TB患者的RCT是合格的。安全性终点是全因死亡率和严重不良反应(SAE)。疗效结果为8-12周和24-26周的痰培养转换率,治疗成功,和文化转换的时间。共筛选了476条记录;18条符合资格标准。汇总分析包括2520名参与者(55.8%接受含BDQ的方案,n=1408)。汇总安全性结果显示,BDQ方案组的全因死亡率(相对风险[RR][95%置信区间(CI)]=0.94[0.41-2.20])或SAE(RR[95CI]=0.91[0.67-1.23])没有显著降低。汇总的疗效结果显示,在8-12周(RR[95CI]=1.35[1.10-1.65])和24-26周(RR[95CI]=1.25[1.15-1.36])时,培养物转换率明显较高,更多的治疗成功率(RR[95CI]=1.30[1.17-1.44]),BDQ方案组(参考:非BDQ方案)的培养转化时间减少了17天(标准化平均差[SMD][95CI]=-17.46[-34.82至-0.11])。总的来说,BDQ方案对DR-TB显示出显著的治疗效果,但没有降低死亡率或SAE。
    The risks and benefits of bedaquiline (BDQ) for treatment of drug-resistant tuberculosis (DR-TB) have not been firmly established. We aimed to assess the safety and efficacy of BDQ-containing regimens for the treatment of DR-TB as evidenced in available randomized controlled trials (RCTs). In this systematic review and meta-analysis, five databases (i.e., ClinicalTrials.gov, Cochrane CENTRAL, PubMed, ScienceDirect, and SinoMed) were searched. RCTs among DR-TB patients that had a control arm were eligible. The safety endpoints were all-cause mortality and serious adverse effects (SAEs). Efficacy outcomes were sputum culture conversion rate at 8-12 weeks and 24-26 weeks, treatment success, and time to culture conversion. A total of 476 records were screened; 18 met the eligibility criteria. The pooled analysis included 2520 participants (55.8% received BDQ-containing regimens, n = 1408). Pooled safety outcomes showed no significant reduction in all-cause mortality (relative risk [RR] [95%confidence interval (CI)] = 0.94 [0.41-2.20]) or SAEs (RR [95%CI] = 0.91 [0.67-1.23]) in the BDQ-regimen group. Pooled efficacy outcomes showed significantly superior culture conversion rates at 8-12 weeks (RR [95%CI] = 1.35 [1.10-1.65]) and 24-26 weeks (RR [95%CI] = 1.25 [1.15-1.36]), more treatment success (RR [95%CI] = 1.30 [1.17-1.44]), and a 17-day reduction in the time to culture conversion (standardized mean difference [SMD] [95%CI] = -17.46 [-34.82 to -0.11]) in the BDQ-regimen group (reference: non-BDQ regimen). Overall, BDQ regimens showed significant treatment effect against DR-TB but did not reduce mortality or SAEs.
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  • 文章类型: Journal Article
    结核病(TB)仍然是南非的主要死亡原因。夸祖鲁-纳塔尔省(KZN)是结核病/耐药结核病病例和死亡负担较高的省份之一。我们确定了在KZN省接受治疗的耐药结核病患者死亡率的预测因子。
    我们使用电子耐药结核病登记的次要数据进行了一项回顾性队列研究。我们使用具有稳健标准误差的改良泊松回归模型来确定耐药结核病死亡率的预测因子。
    的7,692名符合条件的患者,1,234(16.0%)死亡。男性占主导地位(707,57.3%),中位年龄为36岁(部门间范围:29-45岁)。大多数(978,79.2%)是HIV-TB与911(93%)共同感染的抗逆转录病毒治疗(ART)。预测因素包括无ART的HIV-TB合并感染(aIRR3.4;95%CI:2.3-5.1),未知ART状态(aIRR:1.8;95%CI:1.4-2.3),年龄≥60岁(aIRR:2.1;95%CI:1.6-2.7),既往耐药结核病(aIRR:1.5;95%CI:1.2-1.8)和二线药物暴露(aIRR:1.7;95%CI:1.4-2.0)。其他预测因素是治疗开始期间住院(aIRR2.5;95%CI2.0-3.1),在其他治疗设施开始(aIRR:2.2;95%CI:1.6-2.9)和利福平耐药(aIRR:1.2;95%CI:1.1-1.4)。富马酸贝达奎林是抗死亡的重要保护因素(aIRR:0.5;95%CI:0.4-0.5)。
    年龄较大,没有ART的HIV共同感染,住院治疗开始治疗,二线药物暴露和之前的耐药结核病发作是DR-TB死亡率的预测因素.为所有合并感染的患者尽早开始治疗和提供抗逆转录病毒治疗可能会降低该省的DR-TB死亡率。
    UNASSIGNED: tuberculosis (TB) remains a leading cause of death in South Africa. KwaZulu-Natal (KZN) is one of the provinces with a high burden of TB/drug-resistant TB cases and deaths. We determined predictors for mortality among drug-resistant TB patients on treatment in KZN province.
    UNASSIGNED: we conducted a retrospective cohort study using secondary data from the Electronic Drug-Resistant Tuberculosis Register. We used a modified Poisson regression model with robust standard errors to determine predictors for drug-resistant TB mortality.
    UNASSIGNED: of the 7,692 eligible patients, 1,234 (16.0%) died. Males predominated (707, 57.3%) and the median age was 36 years (Interquartlile Range: 29-45 years). The majority (978, 79.2%) were HIV-TB co-infected with 911 (93%) on antiretroviral treatment (ART). The predictors included HIV-TB co-infection without ART (aIRR 3.4; 95% CI: 2.3-5.1), unknown ART status (aIRR: 1.8; 95% CI: 1.4-2.3), aged ≥60 years (aIRR: 2.1; 95% CI: 1.6-2.7), previous drug-resistant TB (aIRR: 1.5; 95% CI: 1.2-1.8) and exposure to second-line drugs (aIRR: 1.7; 95% CI: 1.4-2.0). Other predictors were hospitalization during treatment initiation (aIRR 2.5; 95% CI 2.0-3.1), initiation in other treatment facilities (aIRR: 2.2; 95% CI: 1.6-2.9) and rifampicin-resistant (aIRR: 1.2; 95% CI: 1.1-1.4). Bedaquiline fumarate was a significant protective factor against death (aIRR: 0.5; 95% CI: 0.4-0.5).
    UNASSIGNED: older age, HIV co-infection without ART, hospitalization for treatment initiation, exposure to second-line drugs and a previous episode of drug-resistant TB were predictors for DR-TB mortality. Early treatment initiation and provision of antiretroviral treatment for all co-infected patients may reduce DR-TB mortality in the Province.
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  • 文章类型: Journal Article
    耐多药气管支气管结核的治疗提出了挑战,和研究bedaquiline或delamanid作为治疗这种情况的疗效是有限的。这项回顾性队列研究于2017年至2021年进行。该研究从病历中提取了耐多药气管支气管结核患者的数据,并对预后进行了随访。参与者分为三组:bedaquiline,Delamanid,和对照组。分析临床结局及早期培养转化的危险因素。这项研究包括101名患者,有32、25和44名患者,Delamanid,分别为对照组和对照组。三组间治疗成功率差异无统计学意义。治疗2个月或6个月后,与对照组相比,bedaquiline和delamanid组均具有明显更高的培养物转化率,培养转化的中位时间显著缩短(bedaquiline组:2周,delamanid组:2周,对照组:12周,P<0.001)。在2个月时,使用贝达奎林或德拉曼尼德治疗被确定为培养物转化的独立预测因子(贝达奎林组:aOR=13.417,95%CI4.067-44.260,德拉曼尼德组:aOR=9.333,95%CI2.498-34.878)或6个月(贝达奎林治疗组:aOR=13.333,95%CI3.379-52.与bedaquiline相比,delamanid组在管腔狭窄方面表现出更好的改善。在耐多药气管支气管结核的早期治疗阶段,含有bedaquiline或delamanid的方案可能会加速培养物的转化,和delamanid似乎有可能有效改善气道狭窄。
    The treatment of multidrug-resistant tracheobronchial tuberculosis poses challenges, and research investigating the efficacy of bedaquiline or delamanid as treatment for this condition is limited. This retrospective cohort study was conducted from 2017 to 2021. The study extracted data of patients with multidrug-resistant tracheobronchial tuberculosis from medical records and followed up on prognoses. Participants were divided into three groups: the bedaquiline, delamanid, and control group. Clinical outcomes and the risk factors associated with early culture conversion were analyzed. This study included 101 patients, with 32, 25, and 44 patients in the bedaquiline, delamanid, and control groups respectively. The differences in the treatment success rates among the three groups did not show statistical significance. Both the bedaquiline and delamanid groups had significantly higher culture conversion rates compared to the control after 2 or 6 months of treatment, with significantly shorter median times to culture conversion (bedaquiline group: 2 weeks, delamanid group: 2 weeks, control group: 12 weeks, P < 0.001). Treatment with bedaquiline or delamanid were identified as independent predictors of culture conversion at 2 months (bedaquiline group: aOR = 13.417, 95% CI 4.067-44.260, delamanid group: aOR = 9.333, 95% CI 2.498-34.878) or 6 months (bedaquiline group: aOR = 13.333, 95% CI 3.379-52.610, delamanid group: aOR = 5.000, 95% CI 1.357-18.426) of treatment through multivariable logistic regression analyses. The delamanid group showed better improvement in lumen stenosis compared to bedaquiline. Regimens containing bedaquiline or delamanid may accelerate the culture conversion during the early treatment phase in multidrug-resistant tracheobronchial tuberculosis, and delamanid appears to have the potential to effectively improve airway stenosis.
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  • 文章类型: Journal Article
    BACKGROUND: In 2022, the WHO recommended the 6-month regimens BPaL (bedaquiline + pretomanid + linezolid) and BPaLM (BPaL + moxifloxacin) as treatment options for most forms of drug-resistant TB. SLASH-TB estimates the cost-saving and cost-effectiveness for the healthcare system and patients when a country switches from current standard-of-care treatment regimens to BPaL/BPaLM.
    METHODS: Country data from national TB programmes (NTP) are used to calculate the costs for all regimens and treatment outcomes. Where BPaL/BPaLM is not currently used, clinical trial outcomes data are used to estimate cost-effectiveness. DALYs are calculated using the Global Burden of Disease (GBD) database.
    RESULTS: We present the results of four countries that have used the tool and shared their data. When shorter and longer regimens are replaced with BPaL/BPaLM, the savings per patient treated in Pakistan, the Philippines, South Africa, and Ukraine are $746, $478, $757, and $2,636, respectively. An increased number of patients would be successfully treated with BPaL/BPaLM regimens, with 411, 1,025, 1,371 and 829 lives saved and 20,179, 27,443, 33,384 and 21,924 DALYs averted annually in the four countries, respectively.
    CONCLUSIONS: Through BPaL/BPaLM regimens, drug-resistant TB treatment has become more effective, shorter, less burdensome for patients, cheaper for both health systems and patients, and saves more lives.
    BACKGROUND: En 2022, l\'OMS a préconisé l\'utilisation des schémas thérapeutiques (bedaquiline + pretomanid + linezolid) et BPaLM (BPaL + moxifloxacin), d\'une durée de 6 mois, comme alternatives pour traiter la plupart des formes de TB résistante aux médicaments. SLASH-TB a réalisé une estimation des économies et de la rentabilité pour le système de santé et les patients lorsqu\'un pays décide de passer des schémas thérapeutiques standards actuels au BPaL/BPaLM.
    UNASSIGNED: Les programmes nationaux de lutte contre la TB (NTP) utilisent les données nationales pour évaluer les coûts des différents schémas thérapeutiques et des résultats des traitements. Si le BPaL/BPaLM n\'est pas utilisé actuellement, les données des essais cliniques sont utilisées pour estimer le rapport coût-efficacité. Les années de vie ajustées sur l\'incapacité (DALYs, pour l’anglais « disability-adjusted life-years ») sont calculées à l\'aide de la base de données Global Burden of Disease (GBD).
    UNASSIGNED: Nous présentons les résultats de quatre pays qui ont utilisé l\'outil et partagé leurs données. Lorsque les schémas plus courts et plus longs sont remplacés par BPaL/BPaLM, les économies par patient traité au Pakistan, aux Philippines, en Afrique du Sud et en Ukraine sont respectivement de 746, 478, 757 et 2 636 dollars. L\'utilisation des schémas BPaL/BPaLM permettrait de traiter un plus grand nombre de patients avec succès, ce qui sauverait respectivement 411, 1 025, 1 371 et 829 vies et éviterait 20 179, 27 443, 33 384 et 21 924 DALYs par an dans les quatre pays.
    CONCLUSIONS: Les schémas BPaL/BPaLM ont révolutionné le traitement de la tuberculose pharmacorésistante en le rendant plus efficace, plus rapide, moins contraignant pour les patients, plus économique pour les systèmes de santé et les patients, et en sauvant un plus grand nombre de vies.
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  • 文章类型: Journal Article
    BACKGROUND: In 2022, the WHO announced that the 6-month BPaL/M regimen should be used for drug-resistant TB (DR-TB). We estimate the patient and provider costs of BPaL compared to current standard-of-care treatment in the Philippines.
    METHODS: Patients on BPaL under operational research, or 9-11-month standard short oral regimen (SSOR) and 18-21-month standard long oral regimen (SLOR) under programmatic conditions were interviewed using the WHO cross-sectional TB patient cost tool. Provider costs were assessed through a bottom-up and top-down costing analysis.
    RESULTS: Total patient costs per treatment episode were lowest with BPaL (USD518.0) and increased with use of SSOR (USD825.8) and SLOR (USD1,023.0). Total provider costs per successful treatment were lowest with BPaL (USD1,994.5) and increased with SSOR (USD3,121.5) and SLOR (USD10,032.4). Compared to SSOR, BPaL treatment was cost-effective at even the lowest willingness to pay threshold. As expected, SLOR was the costliest and least effective regimen.
    CONCLUSIONS: Costs incurred by patients on BPaL were 37% (95% CI 22-56) less than SSOR and 50% (95% CI 32-68) less than SLOR, while providers could save 36% (95% CI 21-56) to 80% (95% CI 64-93) per successful treatment, respectively. The study shows that treatment of DR-TB with BPaL was cost-saving for patients and cost-effective for the health system.
    BACKGROUND: En 2022, l\'OMS a annoncé que le traitement BPaL/M de 6 mois devrait être utilisé pour la TB pharmacorésistante (DR-TB). Nous estimons les coûts du BPaL pour les patients et les prestataires par rapport au traitement standard actuel aux Philippines.
    UNASSIGNED: Des patients sous BPaL dans le cadre d\'une recherche opérationnelle, ou un régime oral court standard de 9 à 11 mois (SSOR, pour l’anglais « standard short oral regimen ») et un régime oral long standard de 18 à 21 mois (SLOR, pour l’anglais « standard long oral regimen ») dans des conditions programmatiques ont été interrogés à l\'aide de l\'outil transversal de l\'OMS sur le coût pour les patients atteints de TB. Les coûts des fournisseurs ont été évalués par une analyse ascendante et descendante des coûts.
    UNASSIGNED: Les coûts totaux pour les patients par épisode de traitement étaient les plus bas avec BPaL (518,0 USD) et augmentaient avec l\'utilisation de SSOR (825,8 USD) et SLOR (1 023,0 USD). Les coûts totaux des prestataires par traitement réussi étaient les plus bas avec BPaL (1 994,5 USD) et ont augmenté avec SSOR (3 121,5 USD) et SLOR (10 032,4 USD). Comparé à SSOR, le traitement BPaL était rentable même au seuil de volonté de payer le plus bas. Comme prévu, le SLOR était le régime le plus coûteux et le moins efficace.
    CONCLUSIONS: Les coûts encourus par les patients sous BPaL étaient inférieurs de 37% (IC à 95% 22–56) à ceux du SSOR et de 50% (IC à 95% 32–68) à ceux du SLOR, tandis que les prestataires pouvaient économiser respectivement 36 % (IC à 95% 21–56) à 80% (IC à 95% 64–93) par traitement réussi. L\'étude montre que le traitement de la DR-TB par BPaL a permis de réaliser des économies pour les patients et pour le système de santé.
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  • 文章类型: Journal Article
    Bedaquiline(BDQ),一种创新的抗结核药,因其对耐药结核病的潜在有效性而受到关注。这项研究调查了含BDQ的方案对埃及耐多药结核病(MDR-TB)患者治疗成功率的影响。我们进行了一项前瞻性队列研究,纳入了2020年4月1日至2021年6月30日在埃及耐多药结核病中心接受治疗的所有成年非妊娠患者,随访时间延长至2022年12月31日。该研究比较了根据国家方案开具BDQ的患者与接受MDR-TB常规治疗的患者。治疗成功率,死亡率,和不良事件使用描述性统计分析,卡方检验,逻辑回归,和Kaplan-Meier存活曲线。使用倾向评分匹配和Cox风险回归对潜在混杂因素进行校正。本研究共纳入84例患者。研究参与者的平均年龄为39岁;22.6%为女性,57.1%是失业者或家庭主妇,1.2%患有人类免疫缺陷病毒(HIV)。关于治疗方案,67.8%暴露于基于BDQ的治疗。在55例(65.5%)治疗成功的患者中,BDQ组(73.7%)的成功率明显高于常规组(48.1%),P=0.042。此外,BDQ组的皮肤变色发生率明显高于常规组(38.6%对0.0%,P<0.001)。尽管BDQ组的死亡率较低(14.0%比常规组的22.2%),Kaplan-Meier生存分析显示没有与BDQ组相关的额外死亡率,风险比(HR)为0.62(95%CI0.21-1.78,P=0.372)。倾向得分匹配,同时考虑病变部位等因素,糖尿病,丙型肝炎病毒,吸烟,显示与BDQ纳入相关的成功率显着提高,HR为6.79(95%CI1.8-25.8)。总之,BDQ是治疗耐多药结核病的有效和可耐受的药物,与常规治疗相比,死亡率较低。
    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.
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  • 文章类型: Journal Article
    耐多药结核病(MDR-TB)是指抵抗至少两种主要药物的结核病,即异烟肼和利福平。评估耐多药结核病的管理,进行痰培养转化。这项研究旨在确定接受全口服延长方案的MDR-TB患者的培养转化状态。
    这项研究构成了在医院环境中进行的观察性和前瞻性研究。这项研究是在微生物学系进行的,IGIMS,巴特那,从2020年10月到2022年3月。在完成两个月的全口服较长方案并使用分枝杆菌生长指示管(MGIT)960系统在液体肉汤中培养后,按照标准方案,在全口服较长方案的多药耐药性肺结核中进行了一次痰液样本和一个早晨样本。四个月然后六个月,直到我们得到否定的结果。
    最大病例数,77(74.8%),属于19-35岁年龄组。男性68人(66.1%),女性35人(33.9%),分别,男女比例为1.9:1。经过2个月的口服较长方案治疗,在103个案例中,我们发现98例(95.1%)患者痰培养阳性,只有5例(4.2%)患者痰培养阴性.经过6个月的口服较长方案治疗,在101个案例中,我们发现16例(15.8%)患者痰培养阳性,85例(85.2%)患者痰培养阴性.
    耐多药肺结核(MDR-TB)患者接受全口服延长治疗方案,bedaquiline的引入导致积极的结果,如更多的痰培养阴性证明,文化逆转的减少,并降低了开发耐多药结核病耐药形式的风险。
    UNASSIGNED: Multidrug-resistant tuberculosis (MDR-TB) refers to tuberculosis that resists at least two primary drugs, namely isoniazid and rifampicin. To assess the management of MDR-TB, sputum culture conversion is performed. This study aimed to determine the culture conversion status of MDR-TB patients undergoing an all-oral longer regimen.
    UNASSIGNED: This research constitutes an observational and prospective study conducted within a hospital setting. The study was done at the Department of Microbiology, IGIMS, Patna, from October 2020 to March 2022. Culture conversion in multidrug resistance pulmonary tuberculosis on all-oral longer regimens took one spot and one morning sample of sputum as per standard protocol after completing two months of all-oral longer regimens and culturing it in liquid broth using Mycobacterium Growth Indicator Tube (MGIT) 960 System at two, four then six months till we got a negative result.
    UNASSIGNED: Maximum number of the cases, 77 (74.8%), belonged to 19-35 years of age group. Males were 68 (66.1%) and females were 35 (33.9%), respectively, with male to female ratio of 1.9:1. After 2 months of oral longer regimen treatment, out of 103 cases, we found 98 (95.1%) patients had sputum for culture positive and only five (4.2%) patients had sputum for culture negative. After 6 months of oral longer regimen treatment, out of 101 cases, we found 16 (15.8%) patients had sputum for culture positive and 85 (85.2%) patients had sputum for culture negative.
    UNASSIGNED: In patients with multidrug-resistant pulmonary tuberculosis (MDR-TB) who received an all-oral longer regimen, the introduction of bedaquiline led to positive outcomes as evidenced by a greater number of negative sputum cultures, a decrease in culture reversions, and a reduced risk of developing a more resistant form of MDR-TB.
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