RESUMEN
Background: Pneumothorax (PNX) represents a common clinical condition in emergency departments (EDs), requiring prompt recognition and treatment. The role of transthoracic ultrasounds (TUSs) in the diagnosis of PNX is still debated. We aimed to prospectively evaluate the accuracy of TUSs in the detection of spontaneous PNX in EDs. Methods: A total of 637 consecutive adult patients who presented to the EDs of four Italian hospitals complaining of acutely onset chest pain and dyspnoea were included in the study. Exclusion criteria were previous traumatic events, cardiogenic causes of pain/dyspnoea and suspected tension PNX. The absence of "lung sliding" (B-mode) and the "bar-code" sign (M-mode) were considered indicative of PNX in a TUS. Accuracy, sensitivity, specificity, and positive and negative predictive values (PPVs, NPVs) were calculated using a chest CT scan as reference. Results: Spontaneous PNX occurred in 93 patients: of those, 83 (89.2%) were correctly identified by TUSs. However, 306 patients with suspected PNX at TUS were not confirmed by chest CTs. The diagnostic accuracy of both the absence of "lung sliding" and "bar-code" sign during TUS was 50.4% (95% CI: 46.4-54.3), sensitivity was 89.2% (95% CI: 81.1-94.7), specificity was 43.8% (95% CI: 39.5-48.0), the PPV was 21.3% (95% CI: 19.7-23.1) and the NPV was 96.0% (95% CI: 92.9-97.7). Conclusions: TUS showed high sensitivity but low specificity in the identification of PNX in EDs. Relying exclusively on TUSs results for patients' management in ED settings is neither suitable nor recommendable. TUS examination can be useful to strengthen the clinical suspicion of PNX, but its results should be confirmed by a chest X-ray or CT scan.
RESUMEN
BACKGROUND: (Buccalin ®) is a Bacterial Lysates (BL) that belongs to a family of immune-stimulators, developed more than 30 years ago and it still has a role in the prophylaxis of Recurrent Respiratory Tract Infections (RRTI). However, original studies were conducted with an approach that does not seem to be aligned with the present methodologies. In addition, concomitant therapies substantially improved in the last decades. These two reasons strongly suggested to update our knowledge on the capacity of this bacterial lysate (Buccalin ®) to reduce the number of days with infectious episodes in patients with RRTI. METHODS: A double blind, placebo-controlled, randomized, multicentre study was programmed (EudraCT code: 2011-005187-25). The reduction of the number of days with infectious episodes (IE) was the primary endpoint. Secondary endpoints were the number of IE, the use of concomitant drugs, the efficacy on signs and symptoms of RRTI and the safety of the drug. Patients were treated according to the registered schedule and were followed up for a period of 6 months. RESULTS: From a cohort of 188 patients eligible for the study, 90 were included in the active group and 88 in the placebo group. The study was completed in 170 patients. A significant reduction of the number of days with IE was observed (6.57 days in the active group and 7.47 in the placebo group). Secondary endpoints were only partially achieved. No virtual adverse events related to the treatment were recorded. CONCLUSION: The administration of bacterial lysate (Buccalin ®) in patients with RRTI had the capacity to significantly reduce the number of days with IE in a multicentre, randomized, placebo controlled, clinical study. The treatment was safe. Of note, all patients were free to be treated with the best concomitant therapies. In these conditions, the positive results observed demonstrated that this bacterial lysate has maintained its capacity of reducing the days with infections in patients with RRTI, also in association to the concomitant therapies available nowadays.