Background and Objectives. The ideal type of sedation for endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is not known. Two previous studies comparing the diagnostic yield between moderate sedation (MS) and deep sedation/general anesthesia (DS/GA) had provided conflicting results with one study clearly favoring the latter. No study had addressed cost. This is concerning for pulmonologists without routine access to anesthesia services. Our objective was to assess the impact of MS and Monitored Anesthesia Care (sedation administered and monitored by an anesthesiologist) on the outcomes and cost of EBUS-TBNA. Materials and Methods. We performed a retrospective review of prospectively collected data on consecutive EBUS-TBNA performed under two different types of sedation in a single academic center. A diagnostic TBNA was defined as an aspirate yielding any specific diagnosis or if subsequent surgery or follow-up of nondiagnostic/normal aspirates showed no pathology. Current Medicare time-based allowances were used for professional charges calculation. Results. There was no difference observed between MS and MAC in regards of the diagnostic yield (92.9% versus 91.9%), procedure duration, number, location, and size of lymph node (LN) sampled, but there were more passes per LN with MAC. The average charges were 74.30 USD for MS and 319.91 for MAC. There were more hypotensive and desaturations episodes with MAC but none required escalation of care. Conclusions. When performed under MS, EBUS-TBNA has similar diagnostic yield as under MAC but may be associated with less side effects. The difference in sedation cost is modest; however, an additional 245$ for each EBUS done under MAC would have significant cost implications on the health system. These findings are of critical importance for bronchoscopists without routine access to anesthesia services and for optimization of healthcare cost and resource utilization.
Stability studies of pharmaceutical products ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as prerequisite for the acceptance and approval of any pharmaceutical product. Stability of a pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications. Stability studies are required to be conducted in a planned way following the guidelines issued by ICH, who and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been included in the present review
Goodpasture syndrome is a rare autoimmune disease comprising antiglomerular basement membrane (anti-GBM) crescentic glomerulonephritis and pulmonary capillaritis with circulating anti-GBM antibodies. Rarely, antibody-negative cases have been described. We report a young, African American adult woman admitted with flank pain and hematuria with laboratory testing and kidney biopsy demonstrating anti-GBM crescentic glomerulonephritis with elevated anti-GBM antibody levels. She received treatment but remained dialysis-dependent. She was seronegative and clinically stable until she presented 8 months later with dyspnea and hemoptysis requiring mechanical ventilation. Bronchoscopy revealed diffuse alveolar hemorrhage. She was treated for relapse of Goodpasture syndrome. However, anti-GBM antibodies were undetectable. This case emphasizes prompt diagnosis and treatment of Goodpasture syndrome to preserve renal function. Additionally, clinical manifestations of Goodpasture syndrome and its degree of activity do not necessarily correlate with the actual antibody titer on relapse. Clinicians should have enhanced awareness of this atypical presentation of a rare disease.
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