Tuberculous Pleural Disease (Pleuritis, Empyema): Clinical Perspective on First-Line Antituberculosis Medicines and Manufacturer-Based Content Analysis

Tuberculous pleural lesions (exudative pleurisy, tuberculous empyema) remain an urgent clinical and social problem, especially in conditions of high comorbidity, consequences of COVID-19, migration processes, hostilities, and disruption of the organisation of drug supplies. Despite the effectiveness of first-line antituberculosis medi­cines (isoniazid, rifampicin, pyrazinamide, ethambutol), the effectiveness of treatment of pleural forms is determined not only by the pharmacological properties of drugs, but also by their availability, the availability of appropriate dosages, fixed combinations, paediatric forms and confirmed production quality. Most clinical guide­lines are based on data on pulmonary forms of tuberculosis, which leads to a lack of direct evidence for pleural localisations and emphasises the importance of a structured analysis of the range of drugs by manufacturer. Objective — based on the modern evidence base, evaluate the clinical perspective and perform a manufacturer-oriented content analysis of the first-line antituberculosis medicines assortment (dosage forms, dosages, fixed combinations, registration status) for tuberculous pleural lesions (pleurisy, empyema), considering the effective­ness, safety, availability and continuity of treatment. Offer practical recommendations for clinicians (phthisiat­rician, pulmonologist, family doctor), clinical pharmacist, healthcare manager, administration of the institution, protocol and formulary commission. Materials and methods. A manufacturer-oriented content analysis of first-line antituberculosis medicines registered and approved for medical use in Ukraine in 2023—2025 was carried out. Data from international and national clinical guidelines (World Health Organization, American Thoracic Society, Centers for Disease Cont­rol and Prevention, European Respiratory Society, Infectious Diseases Society of America, standards of the Ministry of Health of Ukraine), registration dossiers, official instructions for medical use and the State Register of Medicines were used. Good Manufacturing Practice (GMP) compliance, inclusion in national evidentiary documents, compliance with international recommendations were assessed. The grouping of drugs by manufacturers was carried out according to the Sturges’ formula; dosage forms, dosages, fixed-dose combinations, pediatric suitability and the availability of bioequivalence data were evaluated separately. Results and discussion. A full range of dosage forms and dosages of first-line antituberculosis medicines necessary for the implementation of standard treatment regimens for pleural forms of tuberculosis has been identified. Differences between manufacturers in the presence of fixed combinations, low-dose and paediatric forms have been established, which determines the different level of their clinical suitability. The significance of penetration of drugs into the pleural space and the risks of subtherapeutic concentrations of rifampicin and pyrazinamide have been shown, which emphasise the importance of observing full-fledged regimens without interruption. Algorithms for the correction of adverse reactions, concomitant therapy and principles of intensive and continuation phases are analysed. Four groups of manufacturers were formed according to a comprehensive assessment of quality, availability, and stability of supply. An assortment of 41 drugs relevant for different patient categories, including children, has been identified. Gaps in fixed combinations and certain dosages have been identified, which require formulary and logistical solutions. Conclusions. Manufacturer-oriented content analysis is an effective tool for optimising the pharmacotherapy of tuberculous pleural lesions, providing a structured assessment of the range of first-line antituberculosis medicines in terms of effectiveness, safety, availability of dosages and quality of production. The results obtained make it possible to form reasonable recommendations for TB doctors, clinical pharmacists, formulary and procurement commissions, considering the need for continuity of treatment, minimisation of risks of resistance and increased patient adherence. The study highlights the need for further clinical work aimed at optimising treatment regimens specifically for pleural forms of tuberculosis and the introduction of Therapeutic Drug Monitoring in at-risk groups.