The diagnostic role of video-assisted thoracoscopic surgery in exudative pleural effusion and follow-up results in patients with nonspecific pleuritis.

OBJECTIVE: To assess the diagnostic value of video-assisted thoracoscopic surgery in exudative pleural effusions, and to evaluated the frequency of malignancy development with long term follow-up of patients defined as nonspecific pleuritis after surgery. . METHODS: The retrospective study was conducted at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey, and comprised data of patients with undiagnosed exudative pleural effusions seen between January 2008 and December 2013. Data related to clinical, radiological, thoracoscopical, histopathological and follow-up periods were obtained from the hospital records. SPSS 15 was used for data analysis. RESULTS: Of the 229 patients, 145(63.3%) were males and 84(36.7%) were females. The overall mean age was 54.5 }15.1 years. Malignancy was found in 84 (36.6%) patients, and tuberculosis in 26(11.4%). The remaining 119(52%) patients had nonspecific pleuritis and their mean follow-up period was 29.2}27.1 months (range: 1-103 months). Video-assisted thoracoscopic surgery was repeated in 3(2.52%) patients in the 1st, 4th and 16th months of followup period due to the recurrence of pleural effusion. Tuberculosis and mesothelioma were diagnosed in 1(0.8%) and 2(1.7%) cases, respectively. CONCLUSIONS: Video-assisted thoracoscopic surgery was found to be a valuable diagnostic procedure in patients with undiagnosed exudative pleural effusion.

Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair® in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial.

BACKGROUND AND OBJECTIVES: A patient-friendly and easy-to-use multi-dose dry powder inhaler, Discair®, has been recently developed. The objective of this study was to evaluate the bronchodilator efficacy of a single-dose 12/400-µg formoterol plus budesonide combination as a dry powder for inhalation delivered by Discair® in adult patients with moderate-to-severe, stable, chronic obstructive pulmonary disease. METHODS: A total of 33 male patients with moderate-to-severe, chronic obstructive pulmonary disease were included in this single-arm, open-label, phase IV trial. The primary efficacy parameters were the average maximum change in forced expiratory volume in 1 s (FEV1, in L) and time to maximum FEV1 response. Absolute and percent change from baseline in FEV1 and forced vital capacity, maximum change and time to peak forced vital capacity response were also evaluated. RESULTS: The mean post-bronchodilator FEV1 maximum value was significantly higher than the pre-bronchodilator baseline FEV1 value [1.66 (standard deviation 0.43) vs. 1.32 (standard deviation 0.35), p < 0.001], with an absolute change of 0.34 (standard deviation 0.18) and a percent change of 26.0 (standard deviation 0.14) from baseline to maximum response. The average time to peak FEV1 response was 3.94 h (standard deviation 2.75), while the standardized area under the response-time curve from 0 to 12 h for FEV1 was 2.72 (standard deviation 1.84). The FEV1 and forced vital capacity values recorded at each time point during the 12-h post-bronchodilator period were also significantly higher than the baseline values (p < 0.001 for each). CONCLUSIONS: Our findings revealed significant changes from baseline in post-bronchodilator peak and average FEV1 and forced vital capacity responses, indicating bronchodilator efficacy of a single-dose 12/400 µg formoterol plus budesonide dry powder formulation delivered by Discair® in patients with chronic obstructive pulmonary disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03028701.

Bronchodilator efficacy of 18 µg once-daily tiotropium inhalation via Discair® versus HandiHaler® in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial.

PURPOSE: To compare the bronchodilator efficacy of 18 µg once-daily tiotropium inhalation administered via Discair® versus HandiHaler® in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Fifty-eight patients with moderate-to-severe COPD were enrolled in this randomized, active-controlled, parallel-group, open-label, Phase IV non-inferiority trial. Patients were randomly assigned to a test group (n=29, inhalation with Discair) or a reference group (n=29, inhalation with HandiHaler). The primary efficacy parameter was the average maximum change in forced expiratory volume in 1 second (FEV1, in L). Change in forced vital capacity (FVC, in L), %FEV1 and %FVC, the standardized area under the response-time curve (AUC) for the absolute change in FEV1 and FVC, time to onset and peak of response, and safety data were also evaluated. RESULTS: The test inhaler was non-inferior to the reference inhaler in terms of maximum change in FEV1 at 24 h (unadjusted change: 0.0017 L [95% confidence interval [CI]: -0.0777, 0.0812]; change adjusted for time to reach maximum change in FEV1 and smoking in pack-years: 0.0116 L [95% CI: -0.0699, 0.0931]), based on a non-inferiority margin of 0.100 L. There were also no significant differences between the two groups in maximum change in FVC value from baseline (0.3417 L vs 0.4438 L, P=0.113), percent change from baseline (22.235 vs 20.783 for FEV1, P=0.662; 16.719 vs 20.337 for FVC, P=0.257), and AUC0-24 h (2.949 vs 2.833 L for FEV1, P=0.891; 2.897 vs 4.729 L for FVC, P=0.178). There were no adverse events, serious adverse events, or deaths. CONCLUSION: Our findings show that the Discair was non-inferior to the HandiHaler. More specifically, these devices had similar clinical efficacy in terms of time-dependent response over 24 h for patients with moderate-to-severe COPD.

Diagnostic and prognostic significance of survivin levels in malignant pleural effusion.

UNLABELLED: We aimed to evaluate the diagnostic and prognostic value of measuring survivin levels, which is an inhibitor of apoptosis in pleural effusions. METHODS: Group I, malignant (MPE) (n = 51); Group II, tuberculosis (TPE) (n = 18); Group III transudative (TE) (n = 9) effusions were enrolled prospectively. We used ELISA to analyze 78 effusions. The value for the differential diagnosis and the correlation between survivin and survival in MPE were analyzed. RESULTS: Survivin level was 41.75 ± 76.20 in MPE, 15.83 ± 10.92 in TPE and 8.33 ± 8.67 in TE. When the patients divided two groups as malignant and non-malignant pleural effusion (non-MPE), survivin level was significantly higher in MPE (41.75 ± 76.20) than in non-MPE (13.33±2.05) (p = 0.012). The cutoff value for survivin levels detected by ROC curve analysis was 7.5 pg/ml, with sensitivity and specificity values of 72%, 44%, respectively. Survivin had no discriminative power in differentiating exudative effusions of MPE from TPE (p = 0.405). There was no correlation between survivin level and age, sex, location, fluid pH, glucose, protein, albumine and ADA level while there was significant moderate correlation with fluid LDH (r = 0.49; p < 0.001). Survivin levels can distinguish patients who had poor prognosis (median survival 75 days, n = 24) and those who had good prognosis (median survival 219 days, n = 27, p = 0.03) in MPE. In conclusion, survivin expression levels detected with ELISA had no discriminative power in differentiating exudative effusions included MPE and TPE. Elevated survivin levels are associated with poor survival in MPE. Our results suggest that survivin may be a potential prognostic marker in MPE.

Predictive role of adenosine deaminase for differential diagnosis of tuberculosis and malignant pleural effusion in Turkey.

Tuberculous pleural effusion (TPE) is a common problem for differential diagnosis from malignant effusion (MPE) in epidemic areas of tuberculosis (TB). Prediction based on adenosine deaminase (ADA) is dependent on age as well as the tuberculosis incidence. The aim of the study was to evaluate cutoff values for ADA with sensitivity and specificity results for the differential diagnosis of MPE and TPE in a population with intermediate incidence of TB. We retrospectively analysed 196 patients with a definitive diagnosis of TPE (n = 114) and MPE (n = 82). The optimal cutoff value of ADA was determined using the receiver operating characteristic (ROC) curve. There was a statistically significant difference according to the levels of pleural fluid ADA between TPE and MPE groups (p < 0.0001). The cutoff value for diagnosing TPE was > 55 U/L, with a sensitivity = 86.8%, specificity = 86.6%, positive predictive value (PPV) = 90%, negative predictive value (NPV) = 82.6% and accuracy = 82.6%. We then combined ADA > 55 U/L and age < 50 and were able to discriminate the TPE group with increased specifity (95.7 %) and PPV (98.8%) results. The model could correctly classify 21 MPE out of 23 and 82 TPE out of 94 patients. A pleural fluid ADA value < 31 U/L suggests that TPE is highly unlikely with a sensitivity = 43.9 %, specificity = 100%, PPV = 100%, NPV = 71.3% and accuracy = 76.6%. It can be concluded that ADA is a very useful parameter for the differential diagnosis of TPE and MPE, specifically in youngers with a higher incidence of tuberculosis.