This retrospective cohort study evaluates the efficacy and safety of intrapleural fibrinolytic therapy (tPA/DNase) in patients with tuberculous pleural effusion compared with non-tuberculous pleural infection at Hospital Canselor Tuanku Muhriz (HCTM), Malaysia. The study aims to compare radiological improvement, clinical outcomes, and treatment-related adverse events to provide evidence supporting the use of IPFT in tuberculous pleural effusion.
Adults aged ≥18 years.
Patients with tuberculous pleural effusion or non-tuberculous pleural effusion diagnosed based on clinical, radiological, laboratory, microbiological, histopathological, and/or pleuroscopic findings.
Patients who received intrapleural fibrinolytic therapy with tissue plasminogen activator and deoxyribonuclease during the study period.
Malignant and transudative pleural effusion
Patients who received intrapleural fibrinolytic therapy as monotherapy with either tissue plasminogen activator or deoxyribonuclease alone.
Incomplete medical records
All adult patients diagnosed with tuberculous pleural effusion and non-tuberculous pleural effusion who received IPFT using tissue plasminogen activator and deoxyribonuclease, during the study period. Relevant data will be extracted from patients' case notes or electronic medical records.
Other
Retrospective
Intrapleural Fibrinolytic Therapy (IPFT)
Procedure/SurgeryPatients received intrapleural fibrinolytic therapy with alteplase and DNase through an intercostal chest tube for management of complicated pleural infection. Clinical outcomes following IPFT were compared between patients with tuberculous pleural effusion and non-tuberculous pleural effusion.
Percentage reduction in pleural opacity area on chest radiograph following IPFT
Radiological response to IPFT will be assessed by measuring the percentage reduction in pleural opacity area on chest radiographs from baseline (Day 0, prior to IPFT initiation) to the follow-up radiograph performed between Day 7-10 after IPFT initiation or the earliest available follow-up radiograph, whichever occurs earlier. Pleural opacity area will be measured using Horos software version 3.3.2.
Clinical characteristics of participants with TPE and non-TPE
The number of participants with each prespecified categorical clinical characteristic-including presenting symptoms, comorbidities, positive microbiological findings, radiological findings and treatment-related characteristics-will be reported separately for the TPE and non-TPE groups, unit of measurement: Number of participants.
Clinical treatment success following IPFT
Clinical treatment success will be defined as successful management of the pleural effusion without the need for video-assisted thoracoscopic surgery or surgical decortication within 30 days after the first IPFT dose. The proportion of participants achieving treatment success will be compared between the TPE and non-TPE groups. Unit of measurement : Percentage of participants
Treatment-related adverse events following IPFT in patients with TPE
Treatment-related adverse events associated with IPFT in patients with TPE will be assessed, including chest pain requiring analgesic treatment, pleural bleeding or haemothorax, and secondary pleural infection or empyema attributable to IPFT. Adverse events will be identified from clinical documentation, laboratory results, imaging findings, and treatment records following IPFT administration.
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