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1.
Eplasty ; 24: e31, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38846503

RESUMO

Background: Postsurgical pyoderma gangrenosum (PSPG) is a highly uncommon and unpredictable wound healing complication. Rapid progression of ulcers at incisions can cause unfettered dehiscence. Most commonly, PSPG involves breast procedures; however, in this work, we detail a case of a patient who developed PSPG 10 days postoperatively after penile inversion vaginoplasty. Methods: The patient in this case underwent a penile inversion vaginoplasty with orchiectomy in the standard fashion. She had no risk factors for PSPG. Following an uncomplicated hospital stay, the patient developed difficulty with pain control and increasing serous drainage on the 10th postoperative day. On readmission, the patient was found to have developed large, mildly purulent ulcers throughout the perineal wound edges. On exam under anesthesia, the neovaginal canal was found to be patent and intact. The dehisced portions of the incisions were left open and redressed with occlusive bismuth-petrolatum dressing. Dermatology was promptly consulted with suspicion for PSPG. The patient was started on an 18-day prednisone taper with cyclosporine, along with doxycycline and ciprofloxacin. Results: After 5 days of immunosuppressive treatment, the ulcers visibly converted to healthy granulation tissue and were no longer actively purulent. Following another washout, the dehisced wound edges were reapproximated. At follow-up, the patient had no evidence of PSPG recurrence and continued dilating on schedule. Our patient recovered from PSPG without further complications and a satisfactory aesthetic result. Conclusions: This unique case highlights the importance of prompt dermatological consultation, immunosuppression, and avoidance of further pathergy in the setting of suspicion for PSPG.

3.
Clin Genet ; 2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38658784

RESUMO

Acute promyelocytic leukemia (APL) represents 5%-10% of childhood acute myeloid leukemia (AML) and is the most curable subtype of AML. Fanconi anemia (FA) is one of the most common inherited bone marrow failure syndromes caused by biallelic pathogenic variants (PV) in specific DNA-repair genes. Biallelic PVs in FANCD1/BRCA2 (FA-D1) account for 3% of FA and are associated with early-onset leukemia and a high risk of solid tumors. We report a 4 year-old boy from non-consanguineous parents diagnosed with standard risk APL. This child had café-au-lait spots and an extra thumb remnant. Genomic sequencing revealed two PV in FANCD1/BRCA2 confirming a diagnosis of FA-D1. Chromosomal breakage studies were compatible with FA. Each parent carried one variant and had no personal history of cancer. Morphological then molecular remissions were achieved with all-trans retinoic acid and Arsenic trioxide. This patient underwent haploidentical stem cell transplant. In addition to our patient, a literature search revealed four additional patients with APL/FA, with a total of three patients with FA-D1. This raises the possibility of an association between such rare disorders. Practical management of APL in the setting of FA-D1 is discussed with an overview of current evidence and knowledge gaps.

4.
Ann Plast Surg ; 92(5): 491-498, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38563555

RESUMO

BACKGROUND: YouTube is a platform for many topics, including plastic surgery. Previous studies have shown poor educational value in YouTube videos of plastic surgery procedures. The purpose of this study was to evaluate the quality and accuracy of YouTube videos concerning gynecomastia surgery (GS). METHODS: The phrases "gynecomastia surgery" (GS) and "man boobs surgery" (MB) were queried on YouTube. The first 50 videos for each search term were examined. The videos were rated using our novel Gynecomastia Surgery Specific Score to measure gynecomastia-specific information, the Patient Education Materials Assessment Tool (PEMAT) to measure understandability and actionability, and the Global Quality Scale to measure general quality. RESULTS: The most common upload source was a board-certified plastic surgeon (35%), and content category was surgery techniques and consultations (51%). Average scores for the Global Quality Scale (x̄ = 2.25), Gynecomastia Surgery Specific Score (x̄ = 3.50), and PEMAT Actionability (x̄ = 44.8%) were low, whereas PEMAT Understandability (x̄ = 77.4%) was moderate to high. There was no difference in all scoring modalities between the GS and MB groups. Internationally uploaded MB videos tended to originate from Asian countries, whereas GS videos tended to originate from non-US Western countries. Patient uploaders had higher PEMAT Actionability scores than plastic surgeon uploaders. CONCLUSIONS: The quality and amount of gynecomastia-specific information in GS videos on YouTube are low and contain few practical, take-home points for patients. However, understandability is adequate. Plastic surgeons and professional societies should strive to create high-quality medical media on platforms such as YouTube.


Assuntos
Ginecomastia , Educação de Pacientes como Assunto , Mídias Sociais , Gravação em Vídeo , Humanos , Ginecomastia/cirurgia , Educação de Pacientes como Assunto/normas , Educação de Pacientes como Assunto/métodos , Mídias Sociais/normas , Masculino
5.
Australas Psychiatry ; : 10398562241245292, 2024 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-38605531

RESUMO

OBJECTIVE: Australia has inadequate publicly available data regarding the use of involuntary psychiatric care. This study examined the association between patient clinical/demographic factors and involuntary psychiatric admission following initial psychiatric assessment in Royal Darwin Hospital. METHOD: Retrospective review of 638 psychiatric assessments followed by covariate analysis of patient variables associated with involuntary psychiatric admission. RESULTS: Most of the 225 psychiatric admissions were involuntary (92%). Male patients and those with a preferred language other than English had the highest risk of being admitted involuntarily (RR 1.09, χ2 [1] = 3.9, p = .048, and RR 1.11, p = .036, respectively). CONCLUSIONS: Further research regarding the influence of patient demographics and clinical factors on rates of involuntary admissions, particularly for Aboriginal patients, is recommended. The findings prompt discussion on strategies to improve monitoring of involuntary care and barriers to voluntary treatment.

6.
iScience ; 27(3): 109198, 2024 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-38439970

RESUMO

Numerous multi-omic investigations of cancer tissue have documented varying and poor pairwise transcript:protein quantitative correlations, and most deconvolution tools aiming to predict cell type proportions (cell admixture) have been developed and credentialed using transcript-level data alone. To estimate cell admixture using protein abundance data, we analyzed proteome and transcriptome data generated from contrived admixtures of tumor, stroma, and immune cell models or those selectively harvested from the tissue microenvironment by laser microdissection from high grade serous ovarian cancer (HGSOC) tumors. Co-quantified transcripts and proteins performed similarly to estimate stroma and immune cell admixture (r ≥ 0.63) in two commonly used deconvolution algorithms, ESTIMATE or ConsensusTME. We further developed and optimized protein-based signatures estimating cell admixture proportions and benchmarked these using bulk tumor proteomic data from over 150 patients with HGSOC. The optimized protein signatures supporting cell type proportion estimates from bulk tissue proteomic data are available at https://lmdomics.org/ProteoMixture/.

7.
Chempluschem ; : e202400083, 2024 Mar 24.
Artigo em Inglês | MEDLINE | ID: mdl-38523404

RESUMO

We report the synthesis of core-shell Ni-Pt nanoparticles (NPs) with varying degrees of crystallographic facets and surface layers rich in Pt via a seed-mediated thermolytic approach. Mixtures of different surfactants used during synthesis resulted in preferential surface passivation, which in turn dictated the size, chemical composition, and geometric evolution of these PtNi NPs. Electrochemical investigations of these pristine core-shell Ni-Pt structures in the oxygen reduction reaction (ORR) show that their catalytic functionalities outperform the commercial Pt/C reference catalyst. The enhanced electrocatalytic ORR performances of these Pt-based PtNi NPs are correlated with the weakened oxygen binding strength or surface-adsorbed hydroxyl (OH) species on active Pt surface sites induced by the downshift of the d-band center as a result of compressive strain effects. Our studies offer a robust synthetic approach for the development of core-shell nanostructures for enhanced ORR catalysis.

8.
Aust N Z J Psychiatry ; 58(5): 416-424, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38332613

RESUMO

BACKGROUND: ICD-11 complex post-traumatic stress disorder is a more severe condition than post-traumatic stress disorder, and recent studies indicate it is more prevalent among military samples. In this study, we tested the psychometric properties of the International Trauma Questionnaire, assessed the relative prevalence rates of post-traumatic stress disorder and complex post-traumatic stress disorder in the sample population and explored relationships between complex post-traumatic stress disorder and post-traumatic stress disorder and a range of risk factors. METHODS: Survey participants (N = 189) were mental health support-seeking former-serving veterans of the Australian Defence Force (ADF) recruited from primary care. Confirmatory factor analysis was used to test the factorial validity of the International Trauma Questionnaire. RESULTS: The latent structure of the International Trauma Questionnaire was best represented by a two-factor second-order model consistent with the ICD-11 model of complex post-traumatic stress disorder. The International Trauma Questionnaire scale scores demonstrated excellent internal reliability. Overall, 9.1% (95% confidence interval = [4.8%, 13.5%]) met diagnostic requirements for post-traumatic stress disorder and an additional 51.4% (95% confidence interval = [44.0%, 58.9%]) met requirements for complex post-traumatic stress disorder. Those meeting diagnostic requirements for complex post-traumatic stress disorder were more likely to have served in the military for 15 years or longer, had a history of more traumatic life events and had the highest levels of depression, anxiety and stress symptoms. CONCLUSION: The International Trauma Questionnaire can effectively distinguish between post-traumatic stress disorder and complex post-traumatic stress disorder within primary care samples of Australian Defence Force veterans. A significantly greater proportion of Australian Defence Force veterans met criteria for complex post-traumatic stress disorder than post-traumatic stress disorder. Australian military mental health services should adopt the International Trauma Questionnaire to routinely screen for complex post-traumatic stress disorder and develop complex post-traumatic stress disorder specific interventions to promote recovery in Australian Defence Force veterans with complex post-traumatic stress disorder.


Assuntos
Classificação Internacional de Doenças , Transtornos de Estresse Pós-Traumáticos , Veteranos , Humanos , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/diagnóstico , Veteranos/estatística & dados numéricos , Masculino , Austrália/epidemiologia , Adulto , Pessoa de Meia-Idade , Feminino , Psicometria/instrumentação , Psicometria/normas , Inquéritos e Questionários , Reprodutibilidade dos Testes , Prevalência
9.
Am Nat ; 203(3): 347-361, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38358809

RESUMO

AbstractClassic evolutionary theory predicts that predation will shift trait means and erode variance within prey species; however, several studies indicate higher behavioral trait variance and trait integration in high-predation populations. These results come predominately from field-sampled animals comparing low- and high-predation sites and thus cannot isolate the role of predation from other ecological factors, including density effects arising from higher predation. Here, we study the role of predation on behavioral trait (co)variation in experimental populations of guppies (Poecilia reticulata) living with and without a benthic ambush predator (Jaguar cichlid) to better evaluate the role of predation and where density was equalized among replicates twice per year. At 2.5 years after introduction of the predators (∼10 overlapping generations), 40 males were sampled from each of the six replicate populations and extensively assayed for activity rates, water column use, and latency to feed following disturbance. Individual variation was pronounced in both treatments, with substantial individual variation in means, temporal plasticity, and predictability (inverse residual variance). Predators had little effect on mean behavior, although there was some evidence for greater use of the upper water column in predator-exposed fish. There was greater variance among individuals in water column use in predator-exposed fish, and they habituated more quickly over time; individuals higher in the water column fed slower and had a reduced positive correlation with activity, although again this effect was time specific. Predators also affected the integration of personality and plasticity-among-individual variances in water column use increased, and those in activity decreased, through time-which was absent in controls. Our results contrast with the extensive guppy literature showing rapid evolution in trait means, demonstrating either increases or maintenance of behavioral variance under predation.


Assuntos
Ciclídeos , Poecilia , Animais , Masculino , Comportamento Predatório , Personalidade , Água
10.
Artigo em Inglês | MEDLINE | ID: mdl-38418208

RESUMO

OBJECTIVE: To determine the factors associated with second attempt success and the risk of adverse events following a failed first attempt at neonatal tracheal intubation. DESIGN: Retrospective analysis of prospectively collected data on intubations performed in the neonatal intensive care unit (NICU) and delivery room from the National Emergency Airway Registry for Neonates (NEAR4NEOS). SETTING: Eighteen academic NICUs in NEAR4NEOS. PATIENTS: Neonates requiring two or more attempts at intubation between October 2014 and December 2021. MAIN OUTCOME MEASURES: The primary outcome was successful intubation on the second attempt, with severe tracheal intubation-associated events (TIAEs) or severe desaturation (≥20% decline in oxygen saturation) being secondary outcomes. Multivariate regression examined the associations between these outcomes and patient characteristics and changes in intubation practice. RESULTS: 5805 of 13 126 (44%) encounters required two or more intubation attempts, with 3156 (54%) successful on the second attempt. Second attempt success was more likely with changes in any of the following: intubator (OR 1.80, 95% CI 1.56 to 2.07), stylet use (OR 1.65, 95% CI 1.36 to 2.01) or endotracheal tube (ETT) size (OR 2.11, 95% CI 1.74 to 2.56). Changes in stylet use were associated with a reduced chance of severe desaturation (OR 0.74, 95% CI 0.61 to 0.90), but changes in intubator, laryngoscope type or ETT size were not; no changes in intubator or equipment were associated with severe TIAEs. CONCLUSIONS: Successful neonatal intubation on a second attempt was more likely with a change in intubator, stylet use or ETT size.

11.
Proc Biol Sci ; 291(2016): 20232666, 2024 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-38351808

RESUMO

Wildlife is increasingly exposed to sublethal transient cancer risk factors, including mutagenic substances, which activates their anti-cancer defences, promotes tumourigenesis, and may negatively impact populations. Little is known about how exposure to cancer risk factors impacts the behaviour of wildlife. Here, we investigated the effects of a sublethal, short-term exposure to a carcinogen at environmentally relevant concentrations on the activity patterns of wild Girardia tigrina planaria during a two-phase experiment, consisting of a 7-day exposure to cadmium period followed by a 7-day recovery period. To comprehensively explore the effects of the exposure on activity patterns, we employed the double hierarchical generalized linear model framework which explicitly models residual intraindividual variability in addition to the mean and variance of the population. We found that exposed planaria were less active compared to unexposed individuals and were able to recover to pre-exposure activity levels albeit with a reduced variance in activity at the start of the recovery phase. Planaria showing high activity levels were less predictable with larger daily activity variations and higher residual variance. Thus, the shift in behavioural variability induced by an exposure to a cancer risk factor can be quantified using advanced tools from the field of behavioural ecology. This is required to understand how tumourous processes affect the ecology of species.


Assuntos
Ecologia , Neoplasias , Humanos , Animais , Comportamento Animal , Animais Selvagens , Fatores de Risco
12.
Plast Reconstr Surg ; 2023 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-38051145

RESUMO

BACKGROUND: The vertical rectus abdominis myocutaneous (VRAM) flap has emerged as the workhorse flap for perineal and pelvic reconstruction. We aimed to evaluate outcomes of VRAM flap over a 20-year period and the role of mesh abdominal wall reinforcement following VRAM flap-based reconstruction. METHODS: We conducted a retrospective review of all consecutive patients who underwent pelvic reconstruction with a VRAM flap between January 2001 and March 2021. Our primary outcome measure included recipient and donor surgical site occurrences (SSOs). RESULTS: We identified a total of 546 patients (55% females) with a mean age was 58 years and mean BMI was 27 kg/m 2. Mesh was used at the time of VRAM reconstruction to reinforce the abdominal donor site in 36% of patients. Recipient-site SSOs occurred in 38% of patients while donor-site SSOs occurred in 17% of patients. Hernia was identified in 9.9% of patients while bulge developed in 6.4% of patients. Cox proportional hazards regression model for hernia occurrence identified age, BMI, tobacco use (HR 2.03, 95% CI [1.02 - 4.04]) and use as an extended VRAM (HR 2.13, 95% CI [1.04 - 4.36]). The use of mesh or component separation were not independent protective factors for hernia occurrence. CONCLUSION: The pedicled VRAM flap is versatile and is our preferred flap for reconstruction of pelvic and perineal defects. The use of mesh/component separation to allow for fascial closure was not shown to reduce donor site hernia occurrence.

13.
Can J Kidney Health Dis ; 10: 20543581231215849, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38107158

RESUMO

Rationale: Imatinib is used in the treatment of Philadelphia chromosome positive (Ph+) leukemias and has been reported to have a direct effect on bone physiology. Presentation: To report on a child with Ph+ acute lymphoblastic leukemia who presented with bilateral flank pain and gross hematuria. Diagnosis: She was diagnosed with obstructive kidney stones 101 days after commencing daily oral imatinib. Stone analysis revealed the presence of calcium phosphate. Interventions and outcome: The patient passed the stones spontaneously with medical therapy that included the use of thiazide, allopurinol, and potassium citrate, but she required temporary insertion of a double-J stent to relieve an obstruction. Novel findings: Imatinib inhibits receptor tyrosine kinases and stimulates the flux of calcium from the extracellular fluid into bone, resulting in hypocalcemia with a compensatory rise in parathyroid hormone that may result in phosphaturia and the formation of calcium phosphate stones. Given that kidney stones are rare events in children, we believe that monitoring for kidney stone formation needs to be performed in children receiving imatinib.


Justification: L'imatinib est utilisé dans le traitement des leucémies à chromosome Philadelphie (Ph+) et a été décrit comme ayant un effet direct sur la physiologie osseuse. Présentation du cas: Une enfant atteinte d'une leucémie lymphoblastique aiguë à Ph+ présentant des douleurs lombaires bilatérales et une hématurie macroscopique. Diagnostic: La patiente a reçu un diagnostic de calculs rénaux obstructifs 101 jours après avoir commencé la prise quotidienne d'imatinib par voie orale. L'analyse des calculs a révélé la présence de phosphate de calcium. Interventions et résultats: La patiente a éliminé spontanément ses calculs grâce à un traitement médical qui comprenait un diurétique thiazidique, de l'allopurinol et du citrate de potassium, mais on a dû lui insérer temporairement une endoprothèse double J pour traiter une obstruction. Nouveaux enseignements: L'imatinib inhibe les récepteurs de la tyrosine kinase et favorise le flux du calcium du liquide extracellulaire vers les os, ce qui entraîne une hypocalcémie avec élévation secondaire de l'hormone parathyroïdienne pouvant provoquer une phosphaturie et la formation de calculs de phosphate de calcium. Puisque la formation de calculs rénaux est rare chez les enfants, nous pensons qu'elle devrait faire l'objet d'une surveillance chez les enfants qui reçoivent de l'imatinib.

14.
J Clin Med ; 12(24)2023 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-38137622

RESUMO

(1) Background: Bone healing is influenced by various mechanical factors, such as stability, interfragmentary motion, strain rate, and direction of loading. Far cortical locking (FCL) is a novel screw design that promotes bone healing through controlled fracture motion. (2) Methods: This study compared the outcome of distal femur fractures treated with FCL or SL (standard locking) screws and an NCB plate in a randomised controlled prospective multicentre trial. The radiographic union scale (RUST) and healing time was used to quantify bone healing on follow-up imaging. (3) Results: The study included 21 patients with distal femur fractures, 7 treated with SL and 14 treated with FCL screws. The mean working length for patients with SL screws was 6.1, whereas for FCL screws, it was 3.9. The mean RUST score at 6 months post fracture was 8.0 for patients with SL plates and 7.3 for patients with FCL plates (p value > 0.05). The mean healing time was 6.5 months for patients with SL plates and 9.9 months for patients with FCL plates (p value < 0.05). (4) Conclusions: Fractures fixed with SL plates had longer working lengths and faster healing times when compared to FCL constructs, suggesting that an adequate working length is important for fracture healing regardless of screw choice.

16.
World J Surg ; 47(12): 3270-3280, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37851066

RESUMO

BACKGROUND: Within our ageing population, there is an increasing number of elderly patients presenting with oesophagogastric cancer. Resection remains the mainstay of curative treatment however it has substantial morbidity. The aim of this study was to assess whether age was an independent predictor of resection related complications in our unit. METHODS: A retrospective cohort study of prospectively collated data from 2002 to 2020 of patients undergoing resection for oesophageal and gastric cancers was analysed. Patients aged over 75 and 75 and under were compared for peri-operative morbidity (via the Clavien-Dindo classification), length of stay (LOS), unplanned readmission, 30- and 90-day mortality, and use of neoadjuvant therapy. RESULTS: Data for 466 consecutive patients undergoing oesophagogastric resection (277 oesophagectomy and 189 gastrectomy) were available for analysis. 22% of patients were aged over 75 (14% (39/277) of the oesophagectomy cohort, 34% (65/189) of the gastrectomy cohort). Oesophagectomy patients over 75 were more likely to develop post-operative complications, particularly cardiac or thromboembolic, (69.2%) than those in the younger cohort (50.4%, p = 0.029). There was no difference in complication rates between the younger and older patients undergoing gastrectomy (29.0% vs. 33.9% p = 0.495). The 30- and 90-day mortality rates were 1.4% (n = 4) and 2.5% (n = 7), respectively, for the oesophagectomy cohort and 1.1% (n = 2) and 1.6% (n = 3) for the gastrectomy cohort, with no difference between age groups. CONCLUSION: In this series, we found that patients over the age of 75 were able to undergo oesophageal and gastric resection with curative intent with acceptable post-operative morbidity and mortality.


Assuntos
Neoplasias Esofágicas , Neoplasias Gástricas , Idoso , Humanos , Estudos Retrospectivos , Neoplasias Gástricas/complicações , Esofagectomia/efeitos adversos , Complicações Pós-Operatórias/etiologia , Gastrectomia/efeitos adversos
17.
ANZ J Surg ; 93(12): 2857-2863, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37658592

RESUMO

BACKGROUND: Laparoscopic gastric bypass (LGB) is an increasingly utilized approach to bariatric surgery in Australia. A high proportion of those procedures are revisional due to Australia's legacy of laparoscopic adjustable gastric banding (LAGB), which is not the case internationally. The aim of this study was to compare post-operative outcomes in an Australian general foregut surgery unit against benchmarks published in the literature. METHODS: This is retrospective cohort study of morbidly obese patients undergoing primary or revisional laparoscopic Roux-en-Y gastric bypass (RYGB) or laparoscopic one anastomosis gastric bypass (OAGB) with the two senior authors between 5 May 2015 and 27 June 2019. Perioperative data for the unit's first 100 cases were collected prospectively, stored on a unit database and analysed. Post-operative complications at 30 days, 90 days, mortality, length of hospital stay, and Defined Adverse Events were chosen as indicators of the perioperative outcome (as defined in the Monash Bariatric Surgery Registry). RESULTS: In this cohort, 35% of procedures were RYGB and 65% were OAGB. The majority (58%) were revisional procedures. Most patients (74%) were female. The median age was 50. The comorbidity profile of the population was similar to those published internationally. The median hospital stay was 4 days. There was no mortality. Early complications occurred in 9% of patients, with 3% occurring late. CONCLUSION: Outcomes of our first 100 cases are comparable with those recorded in the literature, notwithstanding a much higher proportion of revisional cases. LGB can be safely introduced in Australian general foregut surgery units by experienced laparoscopic surgeons.


Assuntos
Derivação Gástrica , Gastroplastia , Laparoscopia , Obesidade Mórbida , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Derivação Gástrica/efeitos adversos , Obesidade Mórbida/cirurgia , Obesidade Mórbida/epidemiologia , Gastroplastia/efeitos adversos , Estudos Retrospectivos , Austrália/epidemiologia , Laparoscopia/métodos , Reoperação/métodos , Resultado do Tratamento
18.
J Cancer Policy ; 38: 100446, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37777010

RESUMO

Lenalidomide (Revlimid®) was originally approved by the Food and Drug Administration (FDA) in 2005, however, a generic version was not available until 2022. In that time, the price of lenalidomide has increased more than 20 times, and in 2021 alone, it accounted for >$5.8 billion dollars in Medicare Part D spending. This was a direct consequence of legal tactics employed by the manufacturer to thwart development of generic formulations of lenalidomide. In this report, we review the clinical development of lenalidomide, provide background on generic drug manufacturing in the United States (US), describe the steps that the manufacturer took to prevent entry of generic lenalidomide into the US market, and advocate for legislative reform of the FDA approval process and patent law protections in the US.


Assuntos
Medicamentos Genéricos , Medicare Part D , Estados Unidos , Lenalidomida , Indústria Farmacêutica , Comércio
20.
J Craniofac Surg ; 34(7): 2191-2194, 2023 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-37646360

RESUMO

INTRODUCTION: Secondary alveolar bone grafting (ABG) is a common procedure performed at cleft care centers used to fill the alveolar cleft. The advent of techniques such as minimally invasive trephine drill harvest and placement of continuous-infusion pain pumps at the donor site has made outpatient ABG an increasingly feasible and cost-effective procedure. However, enhanced recovery after surgery protocols to maximize pain control and recovery times for this patient population have not been well established. METHODS: A retrospective single-institution review was conducted of pediatric patients with cleft palate who underwent iliac crest bone graft ABG at a large urban academic children's hospital from 2017 to 2022. Patient age, alveolar cleft repair laterality, pain scores, surgery duration, hospital LOS, readmissions, and re-operations within 30 days were examined. RESULTS: Fifty-four patients met our inclusion criteria. Fifty patients (92.6%) received a pain pump during the operation. The median duration of surgery and LOS in the post-anesthesia care unit were 1.28 and 1.75 hours, respectively. Fifty-two patients (96.3%) were discharged on the same day as their surgery whereas 2 patients (3.7%) stayed in the hospital overnight. The median pain score at the time of discharge was 0 (interquartile range 0, 0). There were 6 (11.1%) minor complications including 5 pain pump malfunctions and 1 recipient site wound breakdown. There was 1 readmission (1.9%) for development of a surgical site infection at the hip and no re-operations within 30 days of surgery. CONCLUSION: The described outpatient ABG protocol demonstrates effective postoperative pain control, short hospital LOS, and few complications requiring hospital readmission or reoperation.

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