Tuberculosis preventive treatment

结核病预防性治疗
  • 文章类型: Journal Article
    结核病预防性治疗(TPT)是结核病(TB)控制的重要策略。风湿病(RD)患者处于活动性结核病发展的高风险中。在临床实践中需要更多关于患者依从性的研究。本研究旨在探讨RD患者潜伏性结核感染(LTBI)筛查和TPT的潜在困难和障碍。
    方便抽样用于招募有LTBI筛查和TPT适应症的RD门诊患者。对所有参与者进行了有关LTBI筛查和预防性治疗的知识和态度的问卷调查。
    在200名RD患者中,大多数人意识到他们因风湿性疾病而增加了ATB的风险,并且知道结核病是可以治愈的。与LTBI筛查意愿的主要关联是高等教育(P=0.013)。与愿意接受LTBI治疗的主要关联是个人风险感和认为治疗可以降低ATB的风险(P<0.001)。超过一半的受访者不能接受每天服用6片或更多的药丸,而超过一半的患者可以耐受9个月或更长时间的治疗过程。大多数(65.4%)更喜欢自己的风湿病学家开始治疗。
    对RD患者进行有关结核病个体风险和治疗副作用的教育,并教育/授权风湿病学家与患者讨论这些方面,并提供LTBI筛查和治疗,可能有助于提高患者对LTBI筛查和TPT的依从性。
    UNASSIGNED: Tuberculosis preventive treatment (TPT) is an important strategy for tuberculosis (TB) control. Rheumatic diseases (RD) patients are at high risk for active TB development. More researches are needed in terms of patient compliance in clinical practice. This study aims to explore the potential difficulties and obstacles in latent tuberculosis infection (LTBI) screening and TPT in RD patients.
    UNASSIGNED: Convenience sampling was used to recruit RD outpatients who had indications for LTBI screening and TPT. All participants were given questionnaires on knowledge and attitudes regarding screening and preventive treatment of LTBI.
    UNASSIGNED: Of the 200 RD patients, most people were aware that they were at increased risk of ATB due to their rheumatic disease and knew that TB was curable. The main association with willingness to have screening for LTBI was tertiary education (P = 0.013). The main association with willingness to take treatment for LTBI was a sense of personal risk and belief that the treatment would reduce risk of ATB (P < 0.001). More than half of the people surveyed could not accept taking 6 or more pills per day, while more than half of the patients could tolerate a treatment course of 9 months or longer. Most (65.4%) preferred their own rheumatologists to initiate treatment.
    UNASSIGNED: Educating RD patients about their individual risks of TB and the side effects of treatment, and educating/empowering rheumatologists to discuss these aspects with their patients and to offer LTBI screening and treatment, may help improve patients\' compliance with LTBI screening and TPT.
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  • 文章类型: Journal Article
    目的:本研究调查了肺结核(PTB)密切接触者对结核病预防性治疗(TPT)的依从率,并确定了与中国TPT依从性相关的因素。
    方法:多中心,集群随机化,开放标签对照试验在3个地点进行,涉及中国34个县.确定了细菌学证实的利福平和异烟肼易感PTB病例的密切接触者,并筛查了潜伏性结核感染(LTBI)。符合条件的参与者被随机分配到3H2P2组,包括三个月,利福喷丁和异烟肼每周两次的方案,或者6H组,这需要每天服用6个月的异烟肼。为了评估影响依从性的因素,采用两水平逻辑回归模型.
    结果:在发起TPT的2,434名密切接触者中,2,121(87.1%)完成了该方案。在没有完成TPT的313个人中,60.1%的人拒绝继续,27.8%因不良影响而停药。两水平逻辑回归模型揭示了与TPT依从性增强相关的几个因素:3H2P2组的登记(比值比(OR)=2.09),由负责TPT的结核病药房管理(OR=2.55),医护人员的监督(OR=6.40),和临床医生的激励(OR=2.49)。相反,任何不良反应的发生(OR=0.08)被确定为非依从性的危险因素.
    结论:在密切接触者中,对患有LTBI的个体实施TPT是可行的。对TPT的坚持可以通过更短的时间来增强,更安全的治疗方案和支持性干预措施,例如对TPT接受者的直接监督治疗和对管理TPT的医疗保健提供者的激励措施。
    OBJECTIVE: This study examined adherence rates to tuberculosis preventive treatment (TPT) among close contacts of individuals with pulmonary tuberculosis (PTB) and identified factors associated with TPT adherence in China.
    METHODS: A multicenter, cluster-randomized, open-label control trial was carried out across three sites involving 34 counties in China. Close contacts of bacteriologically confirmed rifampin and isoniazid-susceptible PTB cases were identified and screened for latent tuberculosis infection (LTBI). Eligible participants were randomly assigned to either the 3H2P2 group, which consisted of a 3-month, twice-weekly regimen of rifapentine and isoniazid, or the 6H group, which entailed a 6-month daily regimen of isoniazid. To assess the factors influencing adherence, a two-level logistic regression model was utilized.
    RESULTS: Out of the 2434 close contacts who initiated TPT, 2121 (87.1%) completed the regimen. Of the 313 individuals who did not complete TPT, 60.1% refused to continue, and 27.8% discontinued due to adverse effects. The two-level logistic regression model revealed several factors associated with enhanced TPT adherence: enrollment in the 3H2P2 group (odds ratio [OR] = 2.09), management by a TB dispensary responsible for TPT (OR = 2.55), supervision by healthcare workers (OR = 6.40), and clinician incentives (OR = 2.49). Conversely, the occurrence of any adverse effects (OR = 0.08) was identified as a risk factor for nonadherence.
    CONCLUSIONS: Administering TPT to individuals with LTBI is feasible among close contacts. Adherence to TPT can be enhanced through shorter, safer treatment regimens and supportive interventions, such as directly supervised therapy for TPT recipients and incentives for healthcare providers managing TPT.
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  • 文章类型: Journal Article
    结核病(TB)仍然是艾滋病毒感染者(PLHIV)的主要死亡原因。结核病预防性治疗(TPT)可以在完成后的几年内预防PLHIV中的活动性结核病感染。在2019-2021年期间,TPT(使用异烟肼)的六个月课程是乌干达最容易获得的;然而,程序数据表明,在此期间,TPT程序丢失率(LTFU)为12%。我们评估了2019年至2021年乌干达四家地区转诊医院(RRH)的PLHIV中与TPTLTFU相关的因素。
    我们从Masaka的患者LTFU上的TPT寄存器中提取了程序数据,Mbale,穆本德,和JinjaRRH。收集的其他数据包括客户人口统计,HIV抗逆转录病毒治疗(ART)的持续时间,TPT启动年份,坚持,和入口点。LTFU被定义为未能完成连续六个月的异烟肼而一次停止超过两个月。我们使用卡方检验对独立性进行了双变量分析。将双变量分析中p<0.05的变量纳入logistic回归模型以建立与LTFU相关的独立因素。
    总的来说,在四个RRH中的TPT上启动了24,206个客户端。他们的平均年龄为40岁(范围,1-90岁),15962人(66%)为女性。总共22,260(92%)的TPT依从性>95%。与LTFU相关的独立因素包括接受ART<3个月(AOR:3.1,95%CI:2.1-4.5)和20-24年(AOR:4.7,95%CI:1.9-12)或25-29年(AOR:3.3,95%CI:1.3-8.2),而15-19年。
    PLHIV刚刚开始ART,在四个RRH中,年轻人在2019-2021年期间从TPT成为LTFU的可能性更高。对20-29岁的PLHIV和新开始接受ART的人群进行密切随访可以改善TPT的完成情况。
    UNASSIGNED: Tuberculosis (TB) remains the leading cause of death among people living with HIV (PLHIV). TB preventive treatment (TPT) can prevent active TB infection in PLHIV for several years after it is completed. During 2019-2021, the six-month course of TPT (using isoniazid) was the most readily available in Uganda; however, program data indicated a TPT program loss to follow-up (LTFU) rate of 12 % during this period. We evaluated factors associated with TPT LTFU among PLHIV in four regional referral hospitals (RRHs) in Uganda from 2019 to 2021.
    UNASSIGNED: We abstracted program data from TPT registers on patient LTFU at Masaka, Mbale, Mubende, and Jinja RRHs. Additional data collected included client demographics, duration on HIV antiretroviral therapy (ART), year of TPT initiation, adherence, and point of entry. LTFU was defined as the failure to finish six consecutive months of isoniazid without stopping for more than two months at a time. We conducted bivariate analysis using the chi-square test for independence. Variables with p < 0.05 in bivariate analysis were included in a logistic regression model to establish independent factors associated with LTFU.
    UNASSIGNED: Overall, 24,206 clients were started on TPT in the four RRHs. Their median age was 40 years (range, 1-90 years), and 15,962 (66 %) were female. A total of 22,260 (92 %) had TPT adherence >95 %. Independent factors associated with LTFU included being on ART for <3 months (AOR: 3.1, 95 % CI: 2.1-4.5) and 20-24 years (AOR: 4.7, 95 % CI: 1.9-12) or 25-29 years (AOR: 3.3, 95 % CI: 1.3-8.2) compared to 15-19 years.
    UNASSIGNED: PLHIV just starting ART and young adults had higher odds of being LTFU from TPT during 2019-2021 in the four RRHs. Close follow-up of PLHIV aged 20-29 years and those newly initiated on ART could improve TPT completion.
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  • 文章类型: Journal Article
    BACKGROUND: Both 1 month of daily (1HP) and 3 months of weekly (3HP) isoniazid-rifapentine are recommended as short-course regimens for TB prevention among people living with HIV (PLHIV). We aimed to assess acceptability and preferences for 1HP vs. 3HP among PLHIV.
    METHODS: In a cross-sectional survey among PLHIV at an HIV clinic in Kampala, Uganda, participants were randomly assigned to a hypothetical scenario of receiving 1HP or 3HP. Participants rated their level of perceived intention and confidence to complete treatment using a 0-10 Likert scale, and chose between 1HP and 3HP.
    RESULTS: Among 429 respondents (median age: 43 years, 71% female, median time on ART: 10 years), intention and confidence were rated high for both regimens. Intention to complete treatment was rated at least 7/10 by 92% (189/206 randomized to 1HP) and 93% (207/223 randomized to 3HP). Respectively 86% (178/206) and 93% (208/223) expressed high confidence to complete treatment. Overall, 81% (348/429) preferred 3HP over 1HP.
    CONCLUSIONS: Both 1HP and 3HP were highly acceptable regimens, with 3HP preferred by most PLHIV. Weekly, rather than daily, dosing appears preferable to shorter duration of treatment, which should inform scale-up and further development of short-course regimens for TB prevention.
    BACKGROUND: L\'association isoniazide-rifapentine est recommandée comme traitement de courte durée pour la prévention de la TB chez les personnes vivant avec le VIH (PVVIH), à raison d\'un mois de traitement quotidien (1HP) et de 3 mois de traitement hebdomadaire (3HP). Nous avons cherché à évaluer l\'acceptabilité et les préférences des PVVIH pour le traitement 1HP par rapport au traitement 3HP.
    UNASSIGNED: Dans le cadre d\'une enquête transversale menée auprès de PVVIH dans une clinique VIH de Kampala, en Ouganda, les participants ont été assignés de manière aléatoire à un scénario hypothétique de réception de 1HP ou de 3HP. Les participants ont évalué leur niveau d\'intention perçue et de confiance pour terminer le traitement en utilisant une échelle de Likert de 0 à 10 et ont choisi entre 1HP et 3HP.
    UNASSIGNED: Parmi les 429 répondants (âge médian : 43 ans, 71% de femmes, durée médiane de la thérapie antirétrovirale : 10 ans), l\'intention et la confiance ont été jugées élevées pour les deux schémas. L\'intention de terminer le traitement a été évaluée à au moins 7/10 par 92% (189/206 randomisés pour 1HP) et 93% (207/223 randomisés pour 3HP). Respectivement 86% (178/206) et 93% (208/223) ont exprimé une grande confiance dans le fait de terminer le traitement. Dans l\'ensemble, 81% (348/429) ont préféré la 3HP à la 1HP.
    CONCLUSIONS: Les schémas 1HP et 3HP étaient tous deux très acceptables, le schéma 3HP étant préféré par la plupart des PVVIH. L\'administration hebdomadaire, plutôt que quotidienne, semble préférable à une durée de traitement plus courte, ce qui devrait inspirer l\'extension et le développement de schémas thérapeutiques de courte durée pour la prévention de la TB.
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  • 文章类型: Journal Article
    印度的2021年结核病(TB)预防性治疗指南将矽肺作为筛查组,然而,对暴露于二氧化硅粉尘的个体的潜伏性结核感染(LTBI)检测没有得到充分重视.关注估计有5200万接触二氧化硅粉尘的工人,尤其是Khambhat的玛瑙石工人,古吉拉特邦,我们的研究旨在估计LTBI的患病率,确定预测因子,并收集结核病和矽肺病专家的见解。采用顺序解释性混合方法方法,一项横断面研究涉及Khambhat的463名年龄≥20岁的玛瑙石工人,使用IGRA试剂盒进行LTBI测试。与专家的深入访谈补充了定量发现。在玛瑙石工人中,58%的LTBI检测呈阳性,预测因素包括更长的暴露,工作类型,和BCG疫苗接种。我们的研究结果表明,与普通人群相比,LTBI的负担几乎是两倍,特别是在接触二氧化硅粉尘较高的职业中。专家主张将暴露于二氧化硅粉尘的个人纳入高危人群进行LTBI测试,探索具有成本效益的替代方案,如改善皮肤敏感性测试,和更短的结核病预防治疗方案,以提高依从性。未来的研究应该探索对LTBI高患病率和最佳暴露持续时间的二氧化硅粉尘暴露个体的预先结核病预防性治疗。这项研究强调了在暴露于二氧化硅粉尘的人群中,迫切需要政策变化和创新方法来预防结核病。影响全球职业卫生战略。
    The 2021 tuberculosis (TB) preventive treatment guidelines in India included silicosis as a screening group, yet latent TB infection (LTBI) testing for silica-dust-exposed individuals is underemphasized. Focusing on an estimated 52 million silica-dust-exposed workers, particularly agate-stone workers in Khambhat, Gujarat, our study aims to estimate LTBI prevalence, identify predictors, and gather insights from TB and silicosis experts. Employing a sequential explanatory mixed-methods approach, a cross-sectional study involved 463 agate-stone workers aged ≥ 20 years in Khambhat, using IGRA kits for LTBI testing. In-depth interviews with experts complemented quantitative findings. Among agate-stone workers, 58% tested positive for LTBI, with predictors including longer exposure, type of work, and BCG vaccination. Our findings reveal a nearly double burden of LTBI compared to the general population, particularly in occupations with higher silica dust exposure. Experts advocate for including silica-dust-exposed individuals in high-risk groups for LTBI testing, exploring cost-effective alternatives like improved skin sensitivity tests, and shorter TB preventive treatment regimens to enhance compliance. Future research should explore upfront TB preventive treatment for silica-dust-exposed individuals with high LTBI prevalence and optimal exposure duration. This study underscores the urgent need for policy changes and innovative approaches to TB prevention among silica-dust-exposed populations, impacting global occupational health strategies.
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  • 文章类型: Journal Article
    结核病事件病例与通报病例之间存在全球差距。积极的家庭接触调查是缩小这一差距的策略之一。它具有对弱势和符合条件的群体进行早期诊断和预防性治疗的优势。这项研究评估了埃塞俄比亚中部接触调查和结核病预防性治疗依从性的实践。
    从2022年1月1日至2022年12月30日在埃塞俄比亚中部进行了一项涵盖所有注册的细菌学确认的肺结核患者及其密切接触者的横断面研究。
    索引案例共宣布了1372名家庭联系人。从这79.44%(1090)的接触者中接受了一次性结核病筛查,总共有4例(0.36%)活动性结核病病例。在484名耐药结核病指数病例的家庭接触者中,5.53%(14)患有推定性结核病,0.79%(2)患有活动性结核病。而在837例药物敏感结核病指数病例的家庭接触者中,推定结核病病例为1.91%(16),活动性结核病病例为0.23%(2)。在142名合格的15岁以下儿童中,81.69%(116)开始了结核病预防治疗,84.48%(98)完成了治疗。在多变量逻辑回归中,结核病预防性治疗不依从性的相关因素是2-5岁(aOR,0.02,95%CI(0.002-0.20)和年龄5-15岁(aOR,0.04,95%CI(0.002-0-0.95))P=<0.05)。
    与国家和全球目标相比,DR-TB指数病例的接触筛查实践较低。常规接触调查的产率较低,表明筛选的质量。与许多其他国家相比,结核病预防性治疗的开始和完成率也很低,全球成就需要进一步改善,尤其是完成。应计划替代机制,以提高结核病筛查的产量和结核病预防性治疗的依从性。
    UNASSIGNED: There is a global gap between tuberculosis incident cases and the notified cases. Active household contact investigation is one of the strategies to narrow this gap. It has the advantage of giving early diagnosis and preventive treatment to vulnerable and eligible groups. This study assessed the practice of contact investigation and tuberculosis preventive treatment adherence in central Ethiopia.
    UNASSIGNED: A cross-sectional study covering all registered bacteriologically confirmed pulmonary tuberculosis patients and their close contacts was conducted in central Ethiopia from January 1, 2022, to December 30, 2022.
    UNASSIGNED: A total of 1372 household contacts were declared by the index cases. From these 79.44 % (1090) contacts received a one-time tuberculosis screening giving a total of four (0.36 %) active TB cases. Among 484 household contacts of drug-resistant tuberculosis index cases, 5.53 % (14) had presumptive tuberculosis and 0.79 % (2) had active tuberculosis. While among 837 household contacts of drug-susceptible tuberculosis index cases presumptive TB cases were 1.91 % (16) and active TB cases were 0.23 % (2). Of the 142 eligible under 15 children 81.69 % (116) had started tuberculosis preventive treatment and 84.48 % (98) completed the treatment. On multivariable logistic regression, the associated factor for tuberculosis preventive treatment non-adherence was age 2-5 years (aOR, 0.02, 95 % CI (0.002-0.20) and age 5-15 years (aOR, 0.04,95 % CI (0.002-0 0.95)) P=<0.05).
    UNASSIGNED: There was low contact screening practice in the DR-TB index cases as compared to national and global targets. The yield of routine contact investigation was low and it indicates the quality of screening. Tuberculosis preventive treatment initiation and completion rates were also low as compared to those of many other countries and global achievements which need further improvement, especially for completion. Alternative mechanisms should be planned to increase the yield of tuberculosis screening and tuberculosis preventive treatment adherence.
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  • 文章类型: Journal Article
    背景:结核病(TB)筛查和提供结核病预防性治疗(TPT)以及抗逆转录病毒治疗是人类免疫缺陷病毒(HIV)护理的关键组成部分。亚的斯亚贝巴城市管理局尚未充分评估2019年冠状病毒病(COVID-19)期间TPT的摄取情况。这项研究旨在评估亚的斯亚贝巴城市管理局所有公立医院在COVID-19期间新开始接受抗逆转录病毒治疗的HIV感染者(PLHIV)的TPT摄取状况,埃塞俄比亚。
    方法:从2022年4月至7月进行了回顾性数据回顾。常规区健康信息系统2数据库在2020年4月至2022年3月期间进行了审查。计算比例和平均值以及标准偏差。进行Logistic回归分析以评估与TPT完成相关的因素。P值<0.05被认为是统计学上显著的。
    结果:总共1,069例艾滋病毒感染者,18岁及以上的新开始接受抗逆转录病毒治疗,其中1,059人(99.1%)接受了结核病症状筛查。112(86.1%)的结核病症状阴性。总的来说,78.8%(719)结核症状阴性的病例开始TPT,其中70.5%和22.8%已完成和终止TPT,分别。在接受TPT的719例病例中,334(46.5%)和385(53.5%)开始每周服用异烟肼加利福喷丁三个月,每天服用异烟肼预防性治疗六个月,分别。每周服用异烟肼加利福喷丁三个月的PLHIV更有可能完成TPT(调整后的优势比[AOR],1.68;95%置信区间[CI],1.01,2.79)与每天接受异烟肼预防治疗六个月的人相比。
    结论:虽然筛查结核病的PLHIV比例很高,TPT的摄入量很低,远低于实现90%TPT覆盖率的国家目标。总的来说,在这项研究中,相当比例的病例停止了TPT。需要进一步加强PLHIV中潜伏性结核病感染的计划管理。因此,亚的斯亚贝巴市卫生局当局和计划管理人员应努力加强在公立医院PLHIV中启动和完成TPT。
    BACKGROUND: Screening for tuberculosis (TB) and providing TB preventive treatment (TPT) along with antiretroviral therapy is key components of human immune deficiency virus (HIV) care. The uptake of TPT during the coronavirus disease 2019 (COVID-19) period has not been adequately assessed in Addis Ababa City Administration. This study aimed at assessing TPT uptake status among People living with HIV (PLHIV) newly initiated on antiretroviral therapy during the COVID-19 period at all public hospitals of Addis Ababa City Administration, Ethiopia.
    METHODS: A retrospective data review was conducted from April-July 2022. Routine District Health Information System 2 database was reviewed for the period from April 2020-March 2022. Proportion and mean with standard deviation were computed. Logistic regression analysis was conducted to assess factors associated with TPT completion. A p-value of < 0.05 was considered statistically significant.
    RESULTS: A total of 1,069 PLHIV, aged 18 years and above were newly initiated on antiretroviral therapy, and of these 1,059 (99.1%) underwent screening for TB symptoms. Nine hundred twelve (86.1%) were negative for TB symptoms. Overall, 78.8% (719) of cases who were negative for TB symptoms were initiated on TPT, and of these 70.5% and 22.8% were completed and discontinued TPT, respectively. Of 719 cases who were initiated on TPT, 334 (46.5%) and 385 (53.5%) were initiated on isoniazid plus rifapentine weekly for three months and Isoniazid preventive therapy daily for six months, respectively. PLHIV who were initiated on isoniazid plus rifapentine weekly for three months were more likely to complete TPT (adjusted odds ratio [AOR],1.68; 95% confidence interval [CI], 1.01, 2.79) compared to those who were initiated on Isoniazid preventive therapy daily for six months.
    CONCLUSIONS: While the proportion of PLHIV screened for TB was high, TPT uptake was low and far below the national target of achieving 90% TPT coverage. Overall a considerable proportion of cases discontinued TPT in this study. Further strengthening of the programmatic management of latent TB infection among PLHIV is needed. Therefore, efforts should be made by the Addis Ababa City Administration Health Bureau authorities and program managers to strengthen the initiation and completion of TPT among PLHIV in public hospitals.
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  • 文章类型: Journal Article
    背景:利福平的药代动力学数据,用于结核病预防治疗(TPT)时不可用。我们旨在描述利福平用于TPT的药代动力学,在标准和更高剂量下,并评估利福平暴露的预测因子。
    方法:在万隆进行了药代动力学子研究,印度尼西亚在2R2随机试验的参与者中,比较了20mg/kg/天(2R20)和30mg/kg/天(2R30)的高剂量利福平两个月的TPT方案,在青少年和成人中使用4个月的标准剂量利福平,剂量为10mg/kg/天(4R10)。在治疗2-8周后进行强化药代动力学取样。非隔室地评估药代动力学参数。使用单向ANOVA和Tukey的事后检验比较两组之间的总暴露量(AUC0-24)和峰值浓度(Cmax)。多变量线性回归分析用于评估AUC0-24和Cmax的预测因子。
    结果:我们在这项研究中招募了51名参与者。在4R10、2R20和2R30臂中,几何平均值AUC0-24分别为68.0、186.8和289.9h·mg/L,Cmax分别为18.4、36.7和54.4mg/L,分别观察到较高的个体差异。与4R10臂相比,AUC0-24和Cmax在2R20和2R30臂中显著较高(p<0.001)。药物剂量,体重,女性和女性是利福平AUC0-24和Cmax升高的预测因子(p<0.05)。AUC0-24和Cmax值远高于结核病患者的报告值。
    结论:与标准剂量相比,将利福平剂量加倍和三倍导致暴露量增加3倍和4倍。药代动力学/药效学建模和模拟是必要的,以支持缩短使用高剂量利福平的TPT方案。
    BACKGROUND: Pharmacokinetic data of rifampin, when used for tuberculosis preventive treatment (TPT) are not available. We aimed to describe the pharmacokinetics of rifampin used for TPT, at standard and higher doses, and to assess predictors of rifampin exposure.
    METHODS: A pharmacokinetic sub-study was performed in Bandung, Indonesia among participants in the 2R2 randomized trial, which compared TPT regimens of 2 months of high-dose rifampin at 20 mg/kg/day (2R20) and 30 mg/kg/day (2R30), with 4 months of standard-dose rifampin at 10 mg/kg/day (4R10) in adolescents and adults. Intensive pharmacokinetic sampling was performed after 2-8 weeks of treatment. Pharmacokinetic parameters were assessed non-compartmentally. Total exposure (AUC0-24) and peak concentration (Cmax) between arms were compared using one-way ANOVA and Tukey\'s post-hoc tests. Multivariable linear regression analyses were used to assess predictors of AUC0-24 and Cmax.
    RESULTS: We enrolled 51 participants in this study. In the 4R10, 2R20, and 2R30 arms, the geometric mean AUC0-24 was 68.0, 186.8, and 289.9 h⋅mg/L, and Cmax was 18.4, 36.7, and 54.4 mg/L, respectively; high interindividual variabilities were observed. Compared with the 4R10 arm, AUC0-24 and Cmax were significantly higher in the 2R20 and 2R30 arms (P < 0.001). Drug doses, body weight, and female sex were predictors of higher rifampin AUC0-24 and Cmax (P < 0.05). AUC0-24 and Cmax values were much higher than those previously reported in persons with TB disease.
    CONCLUSIONS: Doubling and tripling the rifampin dose led to three- and four-fold higher exposure compared to standard dose. Pharmacokinetic/pharmacodynamic modelling and simulations are warranted to support trials of shortening the duration of TPT regimens with high-dose rifampin.
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  • 文章类型: Journal Article
    背景:结核病仍然是HIV(PLHIV)感染者中传染病死亡的主要原因。结核病预防治疗(TPT)是一种具有成本效益的干预措施,可降低发病率和死亡率。我们使用了ZIMPHIA2020的数据来评估TPT摄取和与其使用相关的因素。
    方法:ZIMPHIA横断面家庭调查,估计年龄≥15岁的PLHIV患者的HIV治疗结局。随机选择的参与者提供了人口统计和临床信息。我们使用调查权重应用多变量逻辑回归模型。通过Jackknife系列估计差异以确定与TPT摄取相关的因素。
    结果:2419例PLHIV≥15岁的样本中有65%是女性,44%的人没有初等教育,29%的人居住在城市中心。总的来说,38%的人曾服用过TPT,包括目前服用TPT的15%。控制其他变量,在最后一次与艾滋病毒相关的访问中筛查结核病的人,那些在过去12个月内去过结核病诊所的人,那些HIV病毒载量抑制的人更有可能服用TPT。
    结论:研究结果表明PLHIV中TPT覆盖率不理想。需要有针对性的干预措施和政策来解决TPT吸收的障碍,以降低PLHIV中的结核病发病率和死亡率。
    BACKGROUND: Tuberculosis remains the leading cause of death by an infectious disease among people living with HIV (PLHIV). TB Preventive Treatment (TPT) is a cost-effective intervention known to reduce morbidity and mortality. We used data from ZIMPHIA 2020 to assess TPT uptake and factors associated with its use.
    METHODS: ZIMPHIA a cross-sectional household survey, estimated HIV treatment outcomes among PLHIV aged ≥15 years. Randomly selected participants provided demographic and clinical information. We applied multivariable logistic regression models using survey weights. Variances were estimated via the Jackknife series to determine factors associated with TPT uptake.
    RESULTS: The sample of 2419 PLHIV ≥15 years had 65% females, 44% had no primary education, and 29% lived in urban centers. Overall, 38% had ever taken TPT, including 15% currently taking TPT. Controlling for other variables, those screened for TB at last HIV-related visit, those who visited a TB clinic in the previous 12 months, and those who had HIV viral load suppression were more likely to take TPT.
    CONCLUSIONS: The findings show suboptimal TPT coverage among PLHIV. There is a need for targeted interventions and policies to address the barriers to TPT uptake, to reduce TB morbidity and mortality among PLHIV.
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  • 文章类型: Journal Article
    与糖尿病(DM)相关的结核病(TB)是一个日益严重的问题,特别是在中低资源国家。我们进行了一个开放标签,平行组,随机化,在墨西哥城的三级护理中心进行对照试验,以评估异烟肼(INH)或利福平(RIF)在2型DM患者中的结核病预防治疗(TPT)。参与者被分配给6个月INH300mg/天加吡哆醇75mg或3个月RIF600mg/天。主要结果是导致永久停止治疗的不良事件,并被认为可能或可能与研究药物有关。我们纳入了130个科目,68例随机分配至INH,62例随机分配至RIF。根据不良事件安全小组的建议,我们过早停止了这项研究。两组之间的不良事件总体频率没有差异。然而,由于2级复发或3级或4级肝毒性,INH组出现明显更多的永久性治疗中断.相比之下,由于3级或4级胃肠道不耐受,RIF组出现更多的治疗中断.使用INH或RIF的TPT不够安全,不足以被认为是2型DM和TB感染患者的通用适应症。这些结果强调需要为2型DM患者寻找具有更好安全性的替代结核病预防措施。
    Tuberculosis (TB) associated with diabetes mellitus (DM) is a growing problem, particularly in low- and medium-resource countries. We conducted an open-label, parallel-group, randomized, and controlled trial in a tertiary care center in Mexico City to assess TB preventive treatment (TPT) with isoniazid (INH) or rifampicin (RIF) in people with type 2 DM. Participants were assigned six months of INH 300 mg/day plus pyridoxine 75 mg or three months of RIF 600 mg/day. The primary outcomes were adverse events resulting in permanent treatment cessation and considered possibly or probably related to study drugs. We included 130 subjects, 68 randomized to INH and 62 to RIF. We prematurely halted the study based on recommendations of the Adverse Event Safety Panel. There was no difference between arms in the overall frequency of adverse events. However, the INH group had significantly more permanent treatment interruptions due to grade 2 recurrent or grade 3 or 4 hepatoxicity. In comparison, the RIF arm had more treatment interruptions due to grade 3 or 4 gastrointestinal intolerance. TPT using INH or RIF is not safe enough to be considered a universal indication to patients with type 2 DM and TB infection. These results underline the need to search for alternative TB preventions with better safety profiles for type 2 DM patients.
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