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1.
Anat Sci Educ ; 2021 Feb 02.
Artículo en Inglés | MEDLINE | ID: mdl-33527687

RESUMEN

Three-dimensional (3D) digital anatomical models show potential to demonstrate complex anatomical relationships; however, the literature is inconsistent as to whether they are effective in improving anatomy performance, particularly for students with low spatial visualization ability (Vz). This study investigated the educational effectiveness of a 3D stereoscopic model of the pelvis, and the relationship between learning with 3D models and Vz. It was hypothesized that participants learning with a 3D pelvis model would outperform participants learning with a two-dimensional (2D) visualization or cadaveric specimen on a spatial anatomy test, particularly when comparing those with low Vz. Participants (n = 64) were stratified into three experimental groups, who each attended a learning session with either a 3D stereoscopic model (n = 21), 2D visualization (n = 21), or cadaveric specimen (n = 22) of the pelvis. Medical and pre-medical student participants completed a multiple choice pre- and post-test during their respective learning session, and a long-term retention (LTR) test two months later. Results showed no difference in anatomy test improvement or LTR performance between experimental groups. A simple linear regression analysis showed that within the 3D group, participants with high Vz tended to retain more than those with low Vz on the LTR test (R2 = 0.31, p = 0.01). The low Vz participants may be cognitively overloaded by the complex spatial cues from the 3D stereoscopic model. Results of this study should inform resource selection and curriculum design for health professional students, with attention to the impact of Vz on learning.

2.
Immunogenetics ; 2021 Feb 22.
Artículo en Inglés | MEDLINE | ID: mdl-33616677

RESUMEN

Signaling lymphocyte activation molecule family member 9 (SLAMF9) is a cell surface protein of the CD2/SLAM family of leukocyte surface receptors. It is conserved throughout mammals and has roles in the initiation of inflammatory responses and regulation of plasmacytoid dendritic cell function. Through comparison of reference sequences encoding SLAMF9 in human, mouse, and primate sequences, we have determined that the SLAMF9 gene underwent successive mutation events, resulting in the loss of the protein and subsequent recovery of a less stable version. The mutations included a single base pair deletion in the second exon and a change in the splice acceptor site of that same exon. These changes would have had the effect of creating and later repairing a frameshift in the coding sequence. These events took place since the divergence of the human lineage from the chimpanzee-human last common ancestor and represent the first known case of the functional loss and recovery of a gene within the human lineage.

3.
Int J Food Microbiol ; 340: 109042, 2021 Feb 16.
Artículo en Inglés | MEDLINE | ID: mdl-33461002

RESUMEN

The development of antimicrobial resistance in foodborne pathogens is a growing public health concern. This study was undertaken to determine the antimicrobial susceptibility of Salmonella enterica subspecies enterica isolated from the Australian commercial egg layer industry. S. enterica subspecies enterica (n=307) isolated from Australian commercial layer flock environments (2015-2018) were obtained from reference, research and State Government laboratories from six Australian states. All Salmonella isolates were serotyped. Antimicrobial susceptibility testing (AST) for 16 antimicrobial agents was performed by broth microdilution. Antimicrobial resistance genes and sequence types (STs) were identified in significant isolates by whole genome sequencing (WGS). Three main serotypes were detected, S. Typhimurium (n=61, 19.9%), S. Senftenburg (n=45, 14.7%) and S. Agona (n=37, 12.1%). AST showed 293/307 (95.4%) isolates were susceptible to all tested antimicrobial agents and all isolates were susceptible to amoxicillin-clavulanate, azithromycin, ceftiofur, ceftriaxone, ciprofloxacin, colistin, florfenicol, gentamicin, kanamycin and trimethoprim-sulfamethoxazole. Low levels of non-susceptibility were observed to streptomycin (2.3%, n=7), sulfisoxazole (2.0%, n=6), chloramphenicol (1.3%, n=4) and tetracycline (1.0%, n=3). Very low levels of non-susceptibility were observed to ampicillin (2/307; 0.7%) and cefoxitin (2/307; 0.7%). Two isolates (S. Havana and S. Montevideo), exhibited multidrug-resistant phenotypes to streptomycin, sulfisoxazole and tetracycline and possessed corresponding antimicrobial resistance genes (aadA4, aac(6')-Iaa, sul1, tetB). One S. Typhimurium isolate was resistant to ampicillin and tetracycline, and possessed both tetA and blaTEM-1B. WGS also identified these isolates as belonging to ST4 (S. Montevideo), ST578 (S. Havana) and ST19 (S. Typhimurium). The absence of resistance to highest priority critically important antimicrobials as well as the extremely low level of AMR generally among Australian commercial egg layer Salmonella isolates likely reflect Australia's conservative antimicrobial registration policy in food-producing animals and low rates of antimicrobial use within the industry.

5.
J Robot Surg ; 2021 Jan 11.
Artículo en Inglés | MEDLINE | ID: mdl-33426577

RESUMEN

Intra-operatively placed cryopreserved placental tissue allograft (CPTA) has shown promise in expediting the recovery urinary continence (UC) following robot-assisted radical prostatectomy (RARP). In this retrospective review of a prospectively maintained single-surgeon, single-institution RARP database, we compare three groups of patients: historical controls (C; N = 183 men) that received no allograft versus two different CPTA products (total CPTA N = 162 [A1 N = 81; A2 N = 81]). The CPTA product was intra-operatively placed as an onlay over the area of the neurovascular bundles during RARP. CPTA cases had significantly faster median time to UC (A1 = 1.4 months; A2 = 1.45 months) versus controls (1.64 months), p = 0.01. On multivariable analysis, use of A1 (HR 1.55, 95% CI [1.14-2.09], p = 0.005) and use of A2 (HR 1.53, CI [1.11-2.11], p = 0.01) were significantly associated with quicker return of UC. Older age (HR 0.97, CI [0.96-0.99], p = 0.001) and non-organ-confined clinical stage (HR 0.51, CI [0.26-1.0] p = 0.05), were significantly associated with slower return of UC. In a propensity score-matched analysis of 77 CPTA patients with sufficient follow-up versus controls, there was significantly less biochemical recurrence (BCR; p = 0.01). Our study indicates that CPTA use appears to accelerate time to UC in age- and performance status-matched men undergoing RARP without increased risk of BCR.

6.
Clin Cancer Res ; 2020 Nov 04.
Artículo en Inglés | MEDLINE | ID: mdl-33148674

RESUMEN

PURPOSE: Somatic mutations in phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), which encodes the p110α catalytic subunit of PI3K, are found in multiple human cancers. While recurrent mutations in PIK3CA helical, regulatory, and kinase domains lead to constitutive PI3K pathway activation, other mutations remain uncharacterized. To further evaluate their clinical actionability, we designed a basket study for patients with PIK3CA-mutant cancers with the isoform-specific PI3K inhibitor taselisib. PATIENTS AND METHODS: Patients were enrolled on the basis of local PIK3CA mutation testing into one of 11 histology-specific cohorts and treated with taselisib at 6 or 4 mg daily until progression. Tumor DNA from baseline and progression (when available) was sequenced using a next-generation sequencing panel. Exploratory analyses correlating genomic alterations with treatment outcomes were performed. RESULTS: A total of 166 patients with PIK3CA-mutant cancers were enrolled. The confirmed response rate was 9%. Activity varied by tumor type and mutant allele, with confirmed responses observed in head and neck squamous (15.4%), cervical (10%), and other cancers, plus in tumors containing helical domain mutations. Genomic analyses identified mutations potentially associated with resistance to PI3K inhibition upfront (TP53 and PTEN) and postprogression through reactivation of the PI3K pathway (PTEN, STK11, and PIK3R1). Higher rates of dose modification occurred at higher doses of taselisib, indicating a narrow therapeutic index. CONCLUSIONS: Taselisib had limited activity in the tumor types tested and is no longer in development. This genome-driven study improves understanding of the activity, limitations, and resistance mechanisms of using PI3K inhibitors as monotherapy to target PIK3CA-mutant tumors.

7.
Curr Rheumatol Rep ; 22(11): 83, 2020 Oct 06.
Artículo en Inglés | MEDLINE | ID: mdl-33025188

RESUMEN

PURPOSE OF REVIEW: This review will summarize recent data defining the relationship between rheumatoid arthritis (RA) and the microbiome at mucosal sites throughout the body. It will highlight what is known, what is speculated, and current knowledge gaps regarding the microbiome in RA. RECENT FINDINGS: An extensive relationship between the microbiome and immune cell function can influence RA-related inflammation and T cell and B cell biology. Studies are beginning to characterize microbial changes in individuals who are at risk for RA, which is a critical element needed to understand the influence of the microbiome on RA pathogenesis. Expanding our understanding of the microbiome in RA beyond the bacteria at the gut and oral mucosae into the lung and urogenital surfaces, including viral and fungal components, and establishing the relationship across mucosal sites will be critical in future work. Importantly, approaches to manipulate the microbiome could lead to novel therapeutic and preventive strategies.

8.
mSphere ; 5(5)2020 09 09.
Artículo en Inglés | MEDLINE | ID: mdl-32907950

RESUMEN

The major surface lipophosphoglycan (LPG) of Leishmania parasites is critical to vector competence in restrictive sand fly vectors in mediating Leishmania attachment to the midgut epithelium, considered essential to parasite survival and development. However, the relevance of LPG for sand flies that harbor multiple species of Leishmania remains elusive. We tested binding of Leishmania infantum wild-type (WT), LPG-defective (Δlpg1 mutants), and add-back (Δlpg1 + LPG1) lines to sand fly midguts in vitro and their survival in Lutzomyia longipalpis sand flies in vivo Le. infantum WT parasites attached to the Lu. longipalpis midgut in vitro, with late-stage parasites binding to midguts in significantly higher numbers than were seen with early-stage promastigotes. Δlpg1 mutants did not bind to Lu. longipalpis midguts, and this was rescued in the Δlpg1 + LPG1 lines, indicating that midgut binding is mediated by LPG. When Lu. longipalpis sand flies were infected with the Le. infantum WT or Le. infantum Δlpg1 or Le. infantum Δlpg1 + LPG1 line of the BH46 or BA262 strains, the BH46 Δlpg1 mutant, but not the BA262 Δlpg1 mutant, survived and grew to numbers similar to those seen with the WT and Δlpg1 + LPG1 lines. Exposure of BH46 and BA262 Δlpg1 mutants to blood-engorged midgut extracts led to mortality of the BA262 Δlpg1 but not the BH46 Δlpg1 parasites. These findings suggest that Le. infantum LPG protects parasites on a strain-specific basis early in infection, likely against toxic components of blood digestion, but that it is not necessary to prevent Le. infantum evacuation along with the feces in the permissive vector Lu. longipalpis IMPORTANCE It is well established that the presence of LPG is sufficient to define the vector competence of restrictive sand fly vectors with respect to Leishmania parasites. However, the permissiveness of other sand flies with respect to multiple Leishmania species suggests that other factors might define vector competence for these vectors. In this study, we investigated the underpinnings of Leishmania infantum survival and development in its natural vector, Lutzomyia longipalpis We found that LPG-mediated midgut binding persists in late-stage parasites. This observation is of relevance for the understanding of vector-parasite molecular interactions and suggests that only a subset of infective metacyclic-stage parasites (metacyclics) lose their ability to attach to the midgut, with implications for parasite transmission dynamics. However, our data also demonstrate that LPG is not a determining factor in Leishmania infantum retention in the midgut of Lutzomyia longipalpis, a permissive vector. Rather, LPG appears to be more important in protecting some parasite strains from the toxic environment generated during blood meal digestion in the insect gut. Thus, the relevance of LPG in parasite development in permissive vectors appears to be a complex issue and should be investigated on a strain-specific basis.

9.
Eur Urol ; 78(4): 489-491, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32736929

RESUMEN

The EAU guidelines panel on muscle-invasive and metastatic bladder cancer (MIBC) recently recommended open radical cystectomy (ORC) as the best surgical approach for MIBC patients. We critically re-examine the indications for considering ORC as the first choice over robot-assisted radical cystectomy. To the best of our knowledge, this is not supported by trials or meta-analyses.

10.
Avian Pathol ; 49(6): 658-665, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32835491

RESUMEN

Spotty Liver Disease (SLD) is an emerging disease of serious concern in the egg production industry, as it causes significant egg loss and mortality in layer hens. The causative agent is a newly identified Gram-negative bacterium, Campylobacter hepaticus, and knowledge about C. hepaticus pathogenesis and the potential for vaccine development is still in its infancy. Current detection methods for SLD, such as PCR and culturing, only detect an active infection and will not give any indication of a past infection from which the bacteria have been cleared. An immunological assay, on the other hand, can provide information on previous infections and therefore is crucial in vaccine development against SLD. In the present study, we have developed the first immunoassay capable of detecting C. hepaticus-specific antibodies present in the sera of infected birds. The assay uses C. hepaticus total protein extract (TPE) as the antigen coating on enzyme-linked immunosorbent assay (ELISA) plates. The cross reactivity of C. hepaticus antibodies with closely related C. jejuni and C. coli antigens was successfully overcome by pre-absorbing the sera using C. jejuni cell extracts. The assay was validated using sera samples from both naturally- and experimentally-infected birds, birds vaccinated with formalin-killed bacteria, and serum samples from SLD-negative birds (control group). The optimized ELISA assay had 95.5% specificity and 97.6% sensitivity. The immunoassay provides a useful tool for monitoring the exposure of poultry flocks to C. hepaticus infection and can be used to direct and support vaccine development. HIGHLIGHTS The first immunoassay developed for Spotty Liver Disease (SLD). A useful method for detecting C. hepaticus-specific antibodies in birds. Highly specific (95.5%) and sensitive (97.6%) assay. A key tool for use in epidemiological studies and vaccine development.

11.
Appetite ; 155: 104842, 2020 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-32810574

RESUMEN

Food production--especially raising animals for meat--has a massive negative impact on the environment and contributes to global warming. To address this, we investigated whether information about food sustainability would increase purchases of sustainable foods by patrons of university cafés. In Study 1, patrons were randomly assigned either to see a menu that had sustainability labels indicating the degree of environmental impact of each item, or to see a menu without labels. Women who saw the labels were significantly more likely to purchase sustainable foods, whereas men were not influenced by the labels. In Study 2 we targeted one sustainable menu item (a veggie burger) and, in a 2 (sustainability) x 2 (taste) design, varied whether patrons learned that the veggie burger was especially sustainable or especially tasty. Women were significantly more likely to purchase the veggie burger if they learned it was sustainable or tasty, but again, the manipulations had no effect on men. We discuss why women are more likely to change their food choices to eat more sustainably than are men.

12.
BMC Public Health ; 20(1): 1257, 2020 Aug 18.
Artículo en Inglés | MEDLINE | ID: mdl-32811459

RESUMEN

BACKGROUND: The Household Health Survey (HHS) was developed to understand the socioeconomic determinants of mental and physical health, and health inequalities in health and social care. This paper aims to provide a detailed rationale of the development and implementation of the survey and explore socio-economic variations in physical and mental health and health care. METHODS: This comprehensive longitudinal public health survey was designed and piloted in a disadvantaged area of England, comprising questions on housing, physical health, mental health, lifestyle, social issues, environment, work, and finances. After piloting, the HHS was implemented across 28 neighbourhoods - 10 disadvantaged neighbourhoods for learning (NfLs), 10 disadvantaged comparator sites, and eight relatively advantaged areas, in 2015 and 2018. Participants were recruited via random sampling of households in pre-selected neighbourhoods based on their areas of deprivation. RESULTS: 7731 residents participated in Wave 1 (N = 4319) and 2 (n = 3412) of the survey, with 871 residents having participated in both. Mental health, physical health, employment, and housing quality were poorer in disadvantaged neighbourhoods than in relatively advantaged areas. CONCLUSIONS: This survey provides important insights into socio-economic variations in physical and mental health, with findings having implications for improved care provision to enable residents from any geographical or socio-economic background to access suitable care.

13.
Anat Sci Educ ; 2020 Jul 28.
Artículo en Inglés | MEDLINE | ID: mdl-32722854

RESUMEN

Reduction in faculty positions in higher education and increased graduate matriculation rates represent a higher education conundrum. Planned happenstance theory (PHT) is a career development model focusing on positive outcomes resulting from unpredictable precareer events. This mixed methods study explores how PHT applies to the career paths of a clinical anatomy (CA) postgraduate cohort. It provides insight into educational practices designed to equip students for labor markets inside and outside academia. Alumni of CA (n = 12; 2014-2018) were interviewed about career-related events transpiring from graduate studies to present, allowing exploration on how PHT contextualizes their shared experiences. Planned happenstance career inventory (PHCI) enumerated planned happenstance skill (PHS) scores. Total PHS was referenced 527 times across 12 interviews. Of the PHS references, curiosity established highest incidence (154 references, 29%), optimism (132 references, 25%), flexibility (101 references, 19%), risk-taking (85 references, 16%), and persistence (55 references, 10%) and 43 distinct happenstance events were documented. In addition, social networking (52 references) arose as an emergent code and was divided into internal networking (28 references, 54%) and external networking (24 references, 46%). Application of the five-point PHCI scale revealed: curiosity (4.4 ± 0.3; mean ± SD), flexibility (3.6 ± 0.7), persistence (4.4 ± 0.3), optimism (4.3 ± 0.4), and risk-taking (4.1 ± 0.5). Curiosity had the strongest association with happenstance event incidence. Social networking was a key substituent of PHT not yet described in the literature. Educational practices incorporating PHT concepts, with emphasis on curiosity, may provide graduates novel metacognitive skills needed to develop novel career paths.

14.
Mol Cancer Ther ; 19(7): 1486-1496, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32371589

RESUMEN

Treatment response assessment for patients with advanced solid tumors is complex and existing methods require greater precision. Current guidelines rely on imaging, which has known limitations, including the time required to show a deterministic change in target lesions. Serial changes in whole-genome (WG) circulating tumor DNA (ctDNA) were used to assess response or resistance to treatment early in the treatment course. Ninety-six patients with advanced cancer were prospectively enrolled (91 analyzed and 5 excluded), and blood was collected before and after initiation of a new, systemic treatment. Plasma cell-free DNA libraries were prepared for either WG or WG bisulfite sequencing. Longitudinal changes in the fraction of ctDNA were quantified to retrospectively identify molecular progression (MP) or major molecular response (MMR). Study endpoints were concordance with first follow-up imaging (FFUI) and stratification of progression-free survival (PFS) and overall survival (OS). Patients with MP (n = 13) had significantly shorter PFS (median 62 days vs. 310 days) and OS (255 days vs. not reached). Sensitivity for MP to identify clinical progression was 54% and specificity was 100%. MP calls were from samples taken a median of 28 days into treatment and 39 days before FFUI. Patients with MMR (n = 27) had significantly longer PFS and OS compared with those with neither call (n = 51). These results demonstrated that ctDNA changes early after treatment initiation inform response to treatment and correlate with long-term clinical outcomes. Once validated, molecular response assessment can enable early treatment change minimizing side effects and costs associated with additional cycles of ineffective treatment.

15.
Environ Toxicol Chem ; 2020 Apr 09.
Artículo en Inglés | MEDLINE | ID: mdl-32274818

RESUMEN

Per- and polyfluoroalkyl substances (PFAS) have been used in aqueous film-forming foams used in firefighting, resulting in soil and groundwater contamination and leading to human exposure via animal products grown in contaminated areas. The present study reports the relationship between PFAS intake by hens and the PFAS concentrations in the edible parts of eggs. Laying hens were exposed via drinking water to different concentrations of 4 PFAS compounds (perfluorooctane sulfonate [PFOS], perfluorohexane sulfonate [PFHxS], perfluorooctanoic acid [PFOA], and perfluorohexanoic acid) over 61 d. Egg PFAS residues were assessed for a further 30 d after exposure ceased. The target concentrations of PFAS were 0, 0.3, 3, 30, and 300 µg/L for the treatment groups T1-T5, respectively; and PFAS residues were determined from the eggs collected every second day. There was a linear correlation between the PFAS concentrations in the drinking water of hens and those detected in the egg, which could be useful in estimating PFAS concentrations in the egg by measuring water concentrations. Exposure of hens to drinking water with PFAS concentrations below the Australian Government Department of Health limits (PFOS and PFHxS, 0.07 µg/L; PFOA, 0.56 µg/L), and with no other sources of PFAS exposure, is unlikely to result in egg PFAS concentrations that would exceed the 10% limit set by Food Standards Australia New Zealand for human consumption. Environ Toxicol Chem 2020;00:1-9. © 2020 SETAC.

17.
J Neurol ; 267(7): 1970-1979, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32172379

RESUMEN

OBJECTIVE: We investigated the long-term cognitive effects of concussion in 19,261 members of the general population and a cohort of varsity American football players with a history of frequent head impacts, using tests that are known to be sensitive to small changes in performance. METHODS: We asked 19,261 participants to complete a demographic questionnaire and 12 cognitive tests measuring aspects of executive function, including inhibitory control. We compared the performance of those reporting a history of concussion (post-concussion) to those reporting no history of concussion (non-concussed) on the cognitive battery and four non-cognitive variables. We used the results of this population-level study to predict the profile of cognitive performance in varsity American football players, who completed the same cognitive tasks. RESULTS: Post-concussion and non-concussed participants did not differ on 11 of the 12 cognitive tasks employed. However, on a test of inhibitory control based on the classic Stroop paradigm, post-concussion participants showed accuracy-related impairments specific to the incongruent conditions of the task. Post-concussion participants reported higher levels of anxiety, depression, and trouble concentrating. An entirely independent sample of 74 varsity American football players demonstrated the same pattern of impairment: compared to healthy controls, they scored significantly lower on the test of inhibitory control but were indistinguishable from controls on the 11 other tasks. INTERPRETATION: Self-reported concussion is not associated with long-term general effects on cognitive function. Nevertheless, those who report at least one concussion and those who expose themselves to long-term frequent sport-related head impacts do have a modest, but statistically robust, deficit of inhibitory control.

18.
Br J Clin Pharmacol ; 86(8): 1585-1599, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32144791

RESUMEN

AIMS: International Prostate Symptom Score (IPSS) is a marker of lower urinary tract symptoms (LUTS) deterioration or improvement in benign prostate hyperplasia (BPH). Whereas changes in IPSS relative to baseline have been used as endpoints in clinical trials, little attention has been given to the time course of symptoms. The current investigation aimed to develop a drug-disease model to describe individual IPSS trajectories in moderate and severe BPH patients. METHODS: A model-based meta-analytical approach was used including data from 10 238 patients enrolled into Phase III and IV studies receiving placebo, tamsulosin, dutasteride or combination therapy over a period of up to 4 years. Model predictive performance was assessed using statistical and graphical criteria. Subsequently, simulations were performed to illustrate the implications of treatment with drugs showing symptomatic and disease-modifying properties in patients with varying disease progression rates. RESULTS: Improvement and worsening of IPSS could be characterized by a model including a sigmoid function which disentangles drug effects from placebo and varying disease progression rates on IPSS. Mean estimate (95% confidence intervals) for the disease progression rate was 0.319 (0.271-0.411) month-1 . Treatment effect on IPSS (DELTA) was found to be 0.0605, 0.0139 and 0.0310 month-1 for placebo, tamsulosin and combination therapy, respectively. In addition, it appears that individual trajectories can be clustered together into different phenotypes describing the underlying disease progression rate (i.e. slow, moderate and fast progressors). CONCLUSIONS: The availability of a drug-disease model enables the evaluation of interindividual differences in disease progression rate, deterioration of symptoms and treatment effects on LUTS/BPH.

19.
Immunol Rev ; 294(1): 124-132, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32030763

RESUMEN

The primary manifestation of rheumatoid arthritis (RA) is articular disease; however, extra-articular disease can also occur. In particular, pulmonary disease is a leading cause of morbidity and mortality in individuals with RA. Herein, we will review the types, prevalence, risk factors, and potential pathophysiology of lung disease in individuals with established RA. We will also discuss the emerging understanding of potential role of the lung in the generation of RA-related autoantibodies during a period of disease development termed "pre-RA." Finally, we will discuss a research agenda outlining the next steps to improve our understanding and management of lung inflammation and lung disease throughout the natural history of RA.

20.
Int J Clin Pract ; 74(5): e13480, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-31927774

RESUMEN

AIM: To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia. METHODS: This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed-dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT-TAM FDC), or placebo. End-points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs. RESULTS: The intent-to-treat population comprised 489 patients (DUT-TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT-TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT-TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT-TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6-10 points in the total MSHQ score were more likely to report SexAEs. CONCLUSION: Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT-TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.


Asunto(s)
Dutasterida/efectos adversos , Síntomas del Sistema Urinario Inferior/tratamiento farmacológico , Hiperplasia Prostática/tratamiento farmacológico , Salud Sexual , Tamsulosina/efectos adversos , Anciano , Método Doble Ciego , Dutasterida/uso terapéutico , Eyaculación/efectos de los fármacos , Humanos , Libido/efectos de los fármacos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Salud del Hombre , Persona de Mediana Edad , Erección Peniana , Estudios Prospectivos , Hiperplasia Prostática/complicaciones , Conducta Sexual , Encuestas y Cuestionarios , Tamsulosina/uso terapéutico
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