Abstract
The objective of the study:to run a multicenter non-interventional observational study to assess treatment outcomes in tuberculosis patients receiving combination drugs with fixed doses, and to evaluate tolerability and safety of these drugs.Subjects and methods.13 TB units participated in this study which lasted from 2016 to 2018. The primary population (PP) included of 489 patients, after applying the exclusion criteria – the subpopulation (subPP) included 267 patients with newly detected pulmonary tuberculosis and relapses who received treatment as per chemotherapy regimen I or III. Descriptive statistics methods were used for statistical data processing.Results.Of all PP, 267 (54.6%) completed the main course of chemotherapy. (subPP). Out of 489 patients, treatment was discontinued in 118 (24.1%) of them. Primary drug resistance was detected in 30 (6.1%) patients out of 489 patients, secondary drug resistance – in 74 (15.1%) of 489. In subPP, by the end of the intensive phase the sputum conversion was achieved in 78 (96.3%) of 81 patients. Clinical and X-ray changes had been observed in this subgroup for 106.2 to 63.3 days (median 90). The duration of the intensive phase in the subPP made 107.9 ± 50.5 days. In safety assessment, 191 adverse events (AE) were registered in 149 (30.5%) of 489 patients. By severity, most AEs were minor (164 out of 191), moderate AEs were less frequent (20 out of 191), and there were 7 cases of serious AEs. 61 AEs in 57 (38.2%) out of 149 patients were confidently associated with in-take of the studied drugs. The structure of those AEs, transient transaminase level elevation prevailed (45 (73.8%) of 61 AEs, but there was a single case (1.6%) drug-induced hepatitis). Among the serious AEs, two cases were safely resolved by the end of the protocol, two of them were fatal in TB/HIV co-infection, and three cases were diagnosed with cancer.
Highlights
Цель исследования: оценка в многоцентровом неинтервенционном наблюдательном исследовании результатов лечения больных туберкулезом с использованием комбинированных препаратов с фиксированными дозами, переносимости и безопасности этих препаратов
The multicenter observational non-interventional study of combination anti-tuberculosis drugs used in treatment of pulmonary tuberculosis patients
Most adverse events (AE) were minor (164 out of 191), moderate AEs were less frequent (20 out of 191), and there were 7 cases of serious AEs. 61 AEs in 57 (38.2%) out of 149 patients were confidently associated with in-take of the studied drugs
Summary
В период с мая 2016 г. по январь 2019 г. проведено наблюдательное ретро- и проспективное когортное многоцентровое исследование (ННИ) в 13 центрах, открытых во всех федеральных округах (кроме Сибирского) на базе научных и лечебных учреждений, оказывающих противотуберкулезную помощь. Согласно протоколу FFI-TBC-01/15 (v:1.0 от 28.05.2015 г.) в ННИ включены пациенты с впервые выявленным или рецидивом туберкулеза органов дыхания без бактериовыделения или с таковым при сохраненной чувствительности МБТ к изониазиду и рифампицину с указанием на прием в интенсивной фазе I и III режимов химиотерапии одного из КПФД: фтизопирама (изониазид 150 мг + пиразинамид 500 мг), или фтизоэтама (изониазид 150 мг + этамбутол 400 мг), или фтизопирама В6 (пиразинамид 500 мг + изониазид 150 мг + пиридоксина гидрохлорид 15 мг), или фтизоэтама В6 (этамбутол 400 мг + изониазид 150 мг + пиридоксина гидрохлорид 15 мг), или изокомба (изониазид 60 мг + рифампицин 120 мг + пиразинамид 300 мг + этамбутола гидрохлорид 225 мг + пиридоксина гидрохлорид 20 мг). Согласно протоколу наблюдательного исследования FFI-TBC-01/15 (v:1.0 от 28.05.2015 г.) НЯ считали любое неблагоприятное проявление (включая отклонение лабораторных показателей), симптом или заболевание, возникновение которых по времени совпадало с приемом исследуемого лекарственного препарата. Согласно указанному протоколу термин НЯ также включал клинически значимые изменения лабораторных показателей и любых других диагностических процедур (например, если они потребовали проведения ранее незапланированных диагностических процедур, лечения или послужили причиной выведения пациента из исследования), на основании чего вы-
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