■乌克兰仍然是世界卫生组织对耐药结核病(TB)的高度优先国家。利福平耐药结核病(RR-TB)的发病率更长,更复杂,和更昂贵的治疗。2021年,乌克兰报告了4025例RR-TB病例,比所有30个欧盟/欧洲经济区国家加起来多5.4倍(751例)。
■该研究的目的是确定线探针测定(LPA)的诊断准确性,AIDAutoimmunDiagnostikaGmbH,用于检测抗结核药物的耐药性及其临床应用以选择治疗方案。
■一项前瞻性观察性队列研究。
■从2019年5月至2020年6月,我们连续招募了在地区生理疾病中心住院的活动性结核病患者(Vinnytsia,乌克兰),年龄在18至82岁之间。LPA在国立皮罗戈夫纪念医科大学的遗传研究实验室进行,Vinnytsia,乌克兰。
■在研究期间对来自126例TB患者的84个临床标本和97个培养分离株进行了检测。与异烟肼(H)的表型药敏试验(DST)相比,临床样品的LPA准确性(95%置信区间)为80.1(68.5-89.0),利福平(R)74.7(62.4-84.6),74.4(62.5-84.1)乙胺丁醇,71.4(41.9-91.6)用于链霉素,84.6(62.4-96.5)用于硫脲/乙硫酰胺,左氧氟沙星(Lfx)为84.6(73.6-92.3),分别。我们发现LPA对H的敏感性明显更高,R,与临床标本相比,培养分离株和Lfx(p<0.05)。LPA在Xpert对R易感的17名患者中的6名(35.5%)中检测到不同的突变。在一组来自乌克兰的RR-TB患者中,使用可注射药物的较短治疗方案显示了5%(8/156)的低适合率。
■初始LPA检测可准确识别抗结核药物的耐药性,并有助于选择适当的治疗方案。尽量减少经验疗法的暴露。
由医疗保健和生物医学专业人员撰写的关于快速耐药性检测对乌克兰结核病患者治疗影响的研究,以更好地了解我们如何改善治疗结果并防止耐药细菌的传播。乌克兰有超过4000名结核病患者对至少一种药物(利福平)耐药,是所有30个欧盟/欧洲经济区国家总和的五倍。不幸的是,2019年,只有约60%的此类患者得到了成功治疗。当时,乌克兰大多数患有结核病的人,在检查了对利福平的抗性后,最初接受一线或二线抗结核药物的标准组合,然后传统使用的测试结果(通常在几周后)才可用于个性化治疗.或者,痰液可以运送到距离治疗地点数百公里的一些超载参考实验室。研究人员做了什么?INNOVA4TB团队在常规实践中实施了耐药性的快速诊断,指导结核病患者的关键抗生素使用。在2019-2020年期间,共测试了来自126名个体的181个样本。研究人员发现了什么?这项新的诊断技术准确地检测了痰液样本中对9种抗结核药物的耐药性。选择合适的结核病治疗方案可能会有所帮助,将决策时间从1个月缩短到2天。在研究时间推荐9个月较短的注射剂标准化治疗方案仅适用于乌克兰Vinnytsia地区5%的患者。该研究表明,在一个资源有限且结核病实验室能力有限的国家,从零开始成功实施了新的分子诊断技术。该测试可以促进可用病房在具有不同耐药性的患者中的最佳分布以及治疗方案之间的正确选择。
UNASSIGNED: Ukraine remains a high World Health Organization priority country for drug-resistant tuberculosis (TB). Rifampicin-resistant TB (RR-TB) has a more protracted, more complicated, and more expensive treatment. In 2021, Ukraine reported 4025 RR-TB cases - 5.4 times more (751) than all 30 European Union/ European Economic Area countries together.
UNASSIGNED: The objective of the
study was to determine the diagnostic accuracy of line probe assay (LPA), AID Autoimmun Diagnostika GmbH, for detecting resistance to anti-TB drugs and its clinical application for selecting treatment regimens.
UNASSIGNED: A prospective observational cohort
study.
UNASSIGNED: From May 2019 to June 2020, we consecutively enrolled patients with active TB hospitalized at the Regional Phthisiopulmonology Center (Vinnytsia, Ukraine), aged between 18 and 82 years. The LPA was performed in the Genetic Research Laboratory at National Pirogov Memorial Medical University, Vinnytsia, Ukraine.
UNASSIGNED: A total of 84 clinical specimens and 97 culture isolates from 126 TB patients were tested during the
study. Accuracy (95% confidence interval) of LPA for clinical samples in comparison with phenotypic drug susceptibility test (DST) was 80.1 (68.5-89.0) for isoniazid (H), 74.7 (62.4-84.6) for rifampicin (R), 74.4 (62.5-84.1) for ethambutol, 71.4 (41.9-91.6) for streptomycin, 84.6 (62.4-96.5) for prothionamide/ethionamide, and 84.6 (73.6-92.3) for levofloxacin (Lfx), respectively. We found a significantly higher sensitivity of LPA for H, R, and Lfx for the culture isolates compared to clinical specimens (p < 0.05). LPA detected different mutations in 6 out of 17 (35.5%) patients susceptible to R by Xpert. A shorter treatment regimen with an injectable agent demonstrated a low suitability rate of 5% (8/156) in a cohort of RR-TB patients from Ukraine.
UNASSIGNED: Initial LPA testing accurately identifies resistance to anti-TB drugs and facilitates the selection of an appropriate treatment regimen, minimizing exposure to empirical therapy.
Study about the impact of rapid resistance detection on the treatment of patients with tuberculosis in Ukraine written by healthcare and biomedical professionals to better understand how we can improve the results of treatment and to prevent spreading of resistant bacteriaWhy was the study done? Ukraine has over 4000 patients with tuberculosis (TB) resistant to at least one drug (rifampicin) - five times that of all 30 European Union/European Economic Area countries combined. Unfortunately, only about 60% of such patients have been successfully treated in 2019. At that time, the majority of people suffering from tuberculosis in Ukraine, after checking resistance to rifampicin, initially received standard combinations of the first-line or second-line anti-TB medicines before the result of traditionally used tests (usually few weeks later) became available to individualize the treatment. Alternatively, the sputum could be transported to some overloaded reference laboratories located hundreds of km away from the treatment places.What did the researchers do? The INNOVA4TB team implemented rapid diagnostics of drug resistance in routine practice, guiding key antibiotics use in TB patients. A total of 181 samples from 126 individuals were tested during 2019-2020.What did the researchers find? This new diagnostic technology accurately detected resistance to 9 anti-TB drugs in sputum samples. It could be helpful to select appropriate TB treatment regimens, reducing time for decision from 1 month up to 2 days. Recommended at the study time 9-month shorter standardized treatment regimen with injectable agent was suitable only for 5% of patients for whom it was indicated in Vinnytsia region of Ukraine.What do the findings mean? The
study has demonstrated successful implementation of the new molecular diagnostic technology from scratch in a country with restricted resources and limited TB laboratory capacity. This test can facilitate optimal distribution of available wards among patients with different profiles of resistance and correct choice between treatment options.