RESUMO
PURPOSE: Computed tomography-guided transthoracic biopsy (CTTB) is a minimally invasive procedure with a high diagnostic yield for a variety of thoracic diseases. We comprehensively assessed a large CTTB cohort to predict procedural and patient factors associated with the risk of complications. MATERIALS AND METHODS: The medical record and computed tomography images of 1430 patients who underwent CTTB were reviewed individually to obtain clinical information and technical procedure factors. Statistical analyses included descriptive and summary statistics, univariate analysis with the Fisher test, and multivariate logistic regression. RESULTS: The most common type of complication was pneumothorax (17.4%), followed by bleeding (5.9%). Only 26 patients (1.8%) developed a major complication. Lung lesions carried a higher risk of complications than nonlung lesions. For lung lesions, the nondependent position of the lesion, vertical needle approach, trespassing aerated lung, and involvement of a trainee increased the risk of complication, whereas the use of the coaxial technique was a protective factor. The time with the needle in the lung, the number of biopsy samples, and the distance crossing the aerated lung were identified as additional risk factors in multivariate analysis. For nonlung lesions, trespassing the pleural space was the single best predictor of complications. A logistic regression-based model achieved an area under the receiver operating characteristic curve of 0.975, 0.699, and 0.722 for the prediction of major, minor, and no complications, respectively. CONCLUSIONS: Technical procedural factors that can be modified by the operator are highly predictive of the risk of complications in CTTB.
Assuntos
Pneumotórax , Radiografia Intervencionista , Humanos , Estudos Retrospectivos , Pulmão/patologia , Biópsia Guiada por Imagem/efeitos adversos , Fatores de Risco , Tomografia Computadorizada por Raios X , PrescriçõesRESUMO
The FDA-approved anthelmintic flubendazole has shown potential to be repositioned to treat cancer and dry macular degeneration; however, its poor water solubility limits its use. Amorphous solid dispersions may overcome this challenge, but the balance of excipients may impact the preparation method and drug release. The purpose of this study was to evaluate the influence of adjuvants and drug loading on the development of an amorphous solid dispersion of flubendazole-copovidone by hot-melt extrusion. The drug, copovidone, and adjuvants (magnesium stearate and hydroxypropyl cellulose) mixtures were statistically designed, and the process was performed in a twin-screw extruder. The study showed that flubendazole and copovidone mixtures were highly extrudable, except when drug loading was high (>40%). Furthermore, magnesium stearate positively impacted the extrusion and was more effective than hydroxypropyl cellulose. The extruded materials were evaluated by modulated differential scanning calorimetry and X-ray powder diffraction, obtaining positive amorphization and physical stability results. Pair distribution function analysis indicated the presence of drug-rich domains with medium-range order structure and no evidence of polymer-drug interaction. All extrudates presented faster dissolution (HCl, pH 1.2) than pure flubendazole, and both adjuvants had a notable influence on the dissolution rate. In conclusion, hot-melt extrusion may be a viable option to obtain stable flubendazole:copovidone amorphous dispersions.
Assuntos
Química Farmacêutica , Excipientes , Varredura Diferencial de Calorimetria , Portadores de Fármacos , Composição de Medicamentos , Temperatura Alta , Mebendazol/análogos & derivados , Pirrolidinas , Solubilidade , Compostos de VinilaRESUMO
The levitation of samples in an acoustic field has been of interest in the preparation and study of amorphous solid dispersions (ASD). Here, niclosamide-polymer solutions were levitated in a multi-emitter single-axis acoustic levitator and analyzed for 10 min at a High-resolution synchrotron X-ray powder diffraction beamline. This assembly enabled high-quality and fast time-resolved measurements with microliter sample size and measurement of solvent evaporation and recrystallization of niclosamide (NCL). Polymers HPMCP-55S, HPMCP-50, HPMCP-55, Klucel®, and poloxamers were not able to form amorphous dispersions with NCL. Plasdone® and Soluplus® demonstrated excellent properties to form NCL amorphous dispersions, with the last showing superior solubility enhancement. Furthermore, this fast levitation polymer screening showed good agreement with results obtained by conventional solvent evaporation screening evaluated for five days in a stability study, carried out at 40 °C/75% RH. The study showed that acoustic levitation and high-resolution synchrotron combination opens up a new horizon with great potential for accelerating ASD formulation screening and analysis.
Assuntos
Niclosamida , Síncrotrons , Acústica , Química Farmacêutica , Pós , Solubilidade , Difração de Raios X , Raios XRESUMO
PURPOSE: We have established an integrated thoracic radiology reading room within a multidisciplinary lung center clinic (LC). While our subjective experience has been positive, we sought to quantify how this model affects radiology workflow and whether the referring practitioners perceive value in having real-time access to a radiologist consultant. MATERIALS AND METHODS: Two diagnostic radiology workstations staffed by rotating thoracic radiologists and trainees were integrated within the LC. We assessed the impact on workflow by recording over 6 months the number, duration, and type of face-to-face radiology consultations to LC practitioners. We also conducted an anonymous survey to assess how LC practitioners felt with regard to the utility and value of our service. RESULTS: Face-to-face consultations account for an average of 10% of total time spent by radiologists in the LC, although on busy clinical days this can reach 25% to 30%. Our survey response rate was very high (86.4%, n=51), with overwhelming positive response by referring practitioners, who unanimously rate the usefulness of this service as high (9.8%) or extremely high (90.2%). Not a single respondent had a negative or even neutral view of this service. Moreover, 90.2% thought that radiology consultations directly add clinical value in >60% of episodes, whereas 86.2% responded that these alter management in >40% of episodes. CONCLUSIONS: Face-to-face radiology consultations in an integrated LC are numerous and comprise a sizable share of radiologist workload. More importantly, the radiologist is highly praised as a consultant, and this service is considered valuable and impactful for patient care.