Efficacy and Safety of Intrapleural Fibrinolytic Therapy in Tuberculous Pleural Effusion Versus Non-Tuberculous Pleural Infection: A Ten-Year Retrospective Study at Hospital Canselor Tuanku Muhriz (FIB-TB Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Percentage reduction in pleural opacity area on chest radiograph following IPFT
研究概览
简要总结
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.
详细描述
- This is a single-centre retrospective cohort study conducted at HCTM, Malaysia.
- Medical records of adult patients (≥18 years) who received intrapleural fibrinolytic therapy (IPFT) between 1 January 2016 and 31 December 2025 will be reviewed.
- Eligible patients who received combined intrapleural tissue plasminogen activator and deoxyribonuclease therapy will be identified according to the predefined inclusion and exclusion criteria.
- Patients will be categorized into two cohorts based on the underlying diagnosis:
- Tuberculous pleural effusion (TPE)
- Non-tuberculous pleural effusion (Non-TPE)
- Demographic data, comorbidities, clinical presentation, laboratory and pleural fluid findings, microbiological results, imaging findings, IPFT regimen, and treatment outcomes will be extracted from electronic medical records using a standardized data collection form.
- The primary outcome will be radiological improvement, assessed by the percentage reduction in pleural opacity on chest radiographs before and after IPFT.
- Secondary outcomes will include clinical symptom improvement, pleural fluid drainage volume, changes in inflammatory markers, requirement for additional pleural interventions or surgery, and treatment-related adverse events, including bleeding, chest pain requiring analgesia, and secondary pleural infection.
- Baseline characteristics and clinical outcomes will be compared between the TPE and NTPI cohorts using appropriate descriptive and inferential statistical analyses. Multivariable regression analysis will be performed to identify factors associated with treatment outcomes and to adjust for potential confounding variables where appropriate.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Malignant and transudative pleural effusion
- •Patients who received intrapleural fibrinolytic therapy as monotherapy with either tissue plasminogen activator or deoxyribonuclease alone.
- •Incomplete medical records
研究组 & 干预措施
Non- Tuberculous Pleural Effusion
Non-TPE: Patients with pleural infection who had no microbiological or histological evidence of MTB and/or for whom an alternative diagnosis was established.
干预措施: Intrapleural Fibrinolytic Therapy (IPFT) (Procedure)
Tuberculous Pleural effusion
Definite TPE - Patients with microbiologically confirmed TB from pleural fluid or pleural biopsy specimens (positive MTB culture, AFB smear, or Xpert MTB), and/or histopathological evidence of caseating granulomatous inflammation consistent with TB on pleural biopsy.
OR
Clinical TPE - Patients without microbiological or histopathological confirmation but diagnosed by a respiratory physician based on clinical, radiological, biochemical, and/or pleuroscopic findings. Diagnosis requires at least two supportive criteria: compatible TB symptoms, radiological features suggestive of pleural TB, pleural fluid ADA >40 U/L, pleuroscopy findings suggestive of tuberculous pleuritis (e.g., pleural nodularity, inflammation, thickening, adhesions, or granulomatous changes), and/or clinical or radiological improvement following empirical anti-tuberculosis therapy.
干预措施: Intrapleural Fibrinolytic Therapy (IPFT) (Procedure)
结局指标
主要结局
Percentage reduction in pleural opacity area on chest radiograph following IPFT
时间窗: Day 0 (before initiation of IPFT) to Day 7-10 after initiation of 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.
次要结局
- Clinical characteristics of participants with TPE and non-TPE(From diagnosis until completion of the index hospital admission)
- Clinical treatment success following IPFT(Day 0 (before IPFT initiation) to Day 7-10 after IPFT initiation or until hospital discharge, with surgical intervention assessed within 30 days after IPFT initiation)
- Treatment-related adverse events following IPFT in patients with TPE(From initiation of IPFT until hospital discharge or within 30 days after IPFT initiation)