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1.
Artigo em Inglês | MEDLINE | ID: mdl-38492905

RESUMO

BACKGROUND & AIMS: Vedolizumab and ustekinumab pharmacokinetics in pregnancy and the infant after in utero exposure remain incompletely defined. We aim to define the antenatal stability of ustekinumab and vedolizumab levels and the time at which infant drug levels become undetectable. METHODS: This multicenter prospective observational cohort study recruited pregnant or preconception women with inflammatory bowel disease receiving vedolizumab or ustekinumab. Trough drug levels, clinical data, and biochemical data were documented preconception, during each trimester of pregnancy, and postpartum. Maternal and cord blood drug levels were measured at delivery and in infants until undetectable. Infant outcomes were assessed until 2 years of age. RESULTS: A total of 102 participants (vedolizumab, n = 58) were included. The majority of mothers were, and remained, in clinical and biochemical remission. Maternal vedolizumab levels decreased over the course of pregnancy in association with increasing weight, rather than increasing gestation. Maternal ustekinumab levels remained stable. The median time to drug becoming undetectable in the infant was shorter for vedolizumab (11 wk; range, 5-19 wk; n = 32) than ustekinumab (14 wk; range, 9-36 wk; n = 17) and correlated positively with infant delivery level. Thirty-two of 41 (88%) and 17 of 30 (67%) vedolizumab- and ustekinumab-exposed infants had undetectable drug levels by 15 weeks of age, respectively. Pregnancy and infant outcomes were favorable. Twenty infants with undetectable drug levels received the rotavirus vaccine, with no adverse reactions reported. CONCLUSIONS: Maternal vedolizumab levels decreased, whereas ustekinumab levels remained stable over the course of pregnancy. Most vedolizumab- and approximately half of ustekinumab-exposed infants had undetectable drug levels by 15 weeks of age. No concerning maternal or infant safety signals were identified.

2.
Br J Neurosurg ; : 1-6, 2024 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-38197314

RESUMO

BACKGROUND: A temporo-sphenoidal encephalocoele occurs when temporal lobe herniates through a defect in the greater wing of the sphenoid bone into the sphenoid air sinus. The natural history is not well-understood, though presentation in adulthood with CSF rhinorrhoea and/or meningitis is typical. Lateral pneumatisation of the sphenoid sinus and elevated BMI may be contributory. AIMS: We explored the feasibility of a transorbital approach (TOA) for repair, using a combination of 3D modelling and simulation. We then successfully deployed this technique in vivo. METHODS: CT imaging for three patients who had previously undergone transcranial repair of lateral temporo-sphenoidal encephalocoele was used to generate data allowing 3D printed models of the skull base to be produced. The transorbital approach was simulated by performing a lateral orbitotomy followed by drilling of the sphenoid wing to expose the antero-basal middle fossa. 3D object scanning was used to create virtual models of the skull base post-surgery, from which surgical access was quantified in two ways: the area (mm2) of the middle fossa exposed by the TOA and the vertical attack angle. RESULTS: The mean surface area of the cranial access window achieved by simulated TOA was 325mm2. The mean vertical attack angle was 25°. One patient was subsequently treated successfully via TOA with no recurrence of their CSF leak, no orbital morbidity, excellent cosmesis, but resolving V2 numbness (follow-up 7 months). CONCLUSIONS: We have shown that the transorbital approach provides adequate surgical access. In our single case, surgical repair of a lateral temporo-sphenoidal encephalocoele via TOA was feasible, safe, and effective. This approach may offer some advantages compared with transcranial or endonasal approaches.

3.
J Oral Rehabil ; 47(11): 1411-1421, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32841377

RESUMO

OBJECTIVES: Dental rehabilitation post-radiotherapy often requires the consideration of dental implants. However, these are tentatively prescribed due to the concern of hypovascularisation and possible osteoradionecrosis. Hence, the current study assessed the microvasculature of the dento-alveolar bone at implant sites taking into consideration the exact radiotherapy dose received to the region. MATERIALS AND METHODS: Bone cores were taken from nine patients during implant treatment and compared to nine control patients. Specimens were stained using CD31 and digitalised using a high-resolution scanner for qualitative and quantitative assessment of the microvasculature. Monaco® treatment planning system was used to volume the implant site providing mean dose (Dmean ) and maximum dose (Dmax ). RESULTS: A total of 23 bone cores were retrieved for analysis. The cohort had a Dmean of 38.4 Gy (59.6-24.3 Gy). Qualitative analysis identified a clear reduction in the miniscule terminal capillaries and high incidence of obliterated lumens with increasing radiotherapy. Microvasculature density of irradiated patients was markedly reduced (P = .0034) compared to the control group with an inverse correlation to RT doses (P < .0001). Specifically, doses up to 30 Gy appear to preserve sufficient vascularisation (~77% in comparison with control) and tissue architecture. By contrast, exposure to higher doses 40%-61% of the micro-vessels were lost. CONCLUSION: Intensity-modulated radiotherapy doses above 30 Gy identified reduction in microvasculature which is a lower threshold than previously accepted. In pharyngeal cancer patients' doses to the jaw bones often exceed this threshold. Coupled with favourable survival in certain oropharyngeal and nasopharyngeal cancer, dental rehabilitation via implants provides a significant clinical challenge.


Assuntos
Neoplasias Nasofaríngeas , Radioterapia de Intensidade Modulada , Humanos , Microvasos , Neoplasias Nasofaríngeas/radioterapia , Dosagem Radioterapêutica
4.
Healthc Financ Manage ; 69(7): 40-7, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26376508

RESUMO

Provider organizations that have experience in implementing value-based physician compensation can recommend the following best practices, among others: Clearly link changes in physician compensation to the broader strategic and financial objectives of the organization. Focus financial incentives on evidence-based measures that physicians find credible and achievable. Make sure everyone understands the incentive measures and compensation formulas before implementing changes. Provide complete data transparency for all aspects of performance.


Assuntos
Médicos/economia , Desenvolvimento de Programas/métodos , Salários e Benefícios , Instalações de Saúde/economia , Indicadores de Qualidade em Assistência à Saúde , Reembolso de Incentivo
5.
Eur J Gastroenterol Hepatol ; 36(1): 52-61, 2024 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-37942750

RESUMO

OBJECTIVES: Low skeletal muscle index (SMI) is common in inflammatory bowel disease (IBD) but has an uncertain relationship with active intestinal inflammation. This study evaluated body composition by whole-body dual-energy X-ray absorptiometry (DXA) in patients with IBD and healthy controls to enable the value of formal body composition analysis to be judged. METHODS: Patients with IBD and sex/age-matched controls prospectively underwent full body composition assessment by DXA, assessment by BMI, eating questionnaires and handgrip strength. Disease activity was assessed by faecal calprotectin (active ≥150 µg/g). A cohort undergoing biologic induction therapy were assessed at baseline and after ≥13 weeks. RESULTS: Total fat mass was higher in 54 patients with IBD (56% Crohn's disease, 61% male) than in 30 controls (median 25.1 vs. 18.7 kg, P  = 0.042). DXA offered little more than BMI. Low SMI was more common than in controls (15% vs. 0%, P  = 0.027). A normal BMI was seen in many patients with low SMI and handgrip strength was a poor marker of change in SMI. Body composition was similar in 28 patients with active vs. 22 with inactive disease. However, SMI increased specifically by 9.7% ( P  = 0.004) and BMI by 6.4% ( P  = 0.012) in 9 responders to therapy. CONCLUSION: DXA identifies many patients with reduced SMI who are not detected by standard methodologies. While disease activity is not associated with low SMI, resolution of inflammation leads to improved SMI. The potential for recognition of such patients to influence therapeutic decisions underlines the need for DXA assessment in clinical practice.


Assuntos
Força da Mão , Doenças Inflamatórias Intestinais , Humanos , Masculino , Feminino , Absorciometria de Fóton , Estudos Prospectivos , Índice de Massa Corporal , Composição Corporal , Doenças Inflamatórias Intestinais/diagnóstico por imagem , Músculo Esquelético , Inflamação
6.
Inflamm Bowel Dis ; 2024 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-38330216

RESUMO

BACKGROUND: Despite reassuring clinical safety data, thrombocytosis, anemia, lymphopenia, and liver function derangements have been observed in infants born to women with inflammatory bowel disease (IBD) treated with thiopurines and biologics. We aimed to define the prevalence, course, associations, and clinical impact of hematological and biochemical abnormalities in such infants. METHODS: This multicenter prospective cohort study assessed clinical, hematologic, and biochemical outcomes of infants exposed to thiopurines or biologics in utero for management of maternal IBD. Liver transaminases, full blood examination, and infant thiopurine metabolites (where exposed) were taken at delivery and 6 weeks of age. Abnormal results were repeated until normalization. Infants were followed clinically by a pediatric gastroenterologist up to 2 years of age. RESULTS: A total of 130 infants were included. Thrombocytosis and elevated alanine transaminase (ALT) were seen in over half of infants up to 6 months of age with no significant clinical impact. Elevated ALT was associated with increasing maternal C-reactive protein in second trimester, while thrombocytosis was associated with increasing maternal C-reactive protein and fecal calprotectin in third trimester. Preceding infection and vaccination were associated with an increased risk of elevated alkaline phosphatase at 3 months. In those exposed to thiopurines, increasing maternal 6-methylmercaptopurine at delivery was associated with increased ALT to 6 months. CONCLUSIONS: Infants born to women with IBD commonly developed thrombocytosis, elevated alkaline phosphatase, and elevated ALT. These findings were associated with exposure to maternal inflammation, elevated 6-methylmercaptopurine at delivery, and infant vaccinations and infections, and had minimal clinical consequence.


Hematological and biochemical abnormalities have been observed in infants born to women with inflammatory bowel disease. This prospective study shows that thrombocytosis and elevated alanine transaminase are common in infants to 6 months of age and are associated with maternal inflammation, rather than with in utero medication exposures.

7.
J Crohns Colitis ; 2024 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-38366352

RESUMO

BACKGROUND AND AIMS: The risk of intrahepatic cholestasis of pregnancy (ICP) is increased in thiopurine exposed pregnancies. Thiopurine 'shunting', with a 6-methylmecrcaptopurine (MMP) to 6-thioguanine (TGN) ratio of >11, progresses over pregnancy, and may promote ICP development. We aimed to explore the association between thiopurine exposure and ICP, including the hypothesized impact of thiopurine shunting, and identify risk minimization strategies. METHODS: This prospective multi-centre cohort study compared thiopurine and biologic monotherapy exposed pregnant participants. Disease activity and obstetric outcome data, thiopurine metabolites, bile acids and transaminases were obtained preconception, in each trimester, at delivery, and post-partum. Thiopurine dose management was at the discretion of the treating physician. RESULTS: 131 thiopurine and 147 biologic monotherapy exposed pregnancies were included. MMP/TGN ratio increased from preconception to third trimester (p<0.01), with approximately 25% of participants shunting in pregnancy. Second trimester split-dosing led to a decrease in the median MMP/TGN ratio from 18 (IQR 6-57) to 3 (IQR 2-3.5) at delivery (p=0.04). The risk of ICP was increased in thiopurine exposed pregnancies (6.7% (7/105) vs 0% (0/112), p<0.001), with all ICP cases occurring in the setting of antenatal thiopurine shunting. Thiopurine dose increases (RR 8.10 [95% CI 1.88-34.85] p=0.005) and shunting in third trimester (6.20 [1.21-30.73] p=0.028) and at delivery (14.18 [1.62-123.9] p=0.016) were associated with an increased risk of ICP. CONCLUSIONS: Thiopurine exposure is associated with an increased risk of ICP, particularly following dose increases antenatally and with shunting in late pregnancy. The latter may be effectively managed with split dosing, although further studies are warranted.

8.
Br Dent J ; 235(10): 783-788, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-38001199

RESUMO

Medication-related osteonecrosis of the jaw (MRONJ) is a severe adverse event, most commonly associated with dental extractions as a predisposing event. However, it is possible that established MRONJ may be existent before dental extractions and is mistaken for odontogenic disease. The provision of a dental extraction will lead to clinically obvious MRONJ with the cause being attributed to tooth removal. We present a case series of ten patients with pre-existing necrosis of the jaw before dental extraction.Retrospective data were collected on ten patients who presented to the oral surgery department between 2017-2021, diagnosed with pre-existing necrosis. A diagnosis of pre-existing MRONJ was made based on the identification of necrotic bone clinically, either with plain film or cone beam computed tomography (CBCT). Patients with pre-existing necrosis presented with a range of symptoms, including pain, swelling and tooth mobility. Plain film imaging revealed a variety of findings, including periapical radiolucency, periodontal ligament widening and bone loss. CBCT imaging confirmed a necrotic pattern of bone destruction confirming a diagnosis of pre-existing MRONJ.There is increasing evidence to suggest that local inflammation can be a predisposing factor for MRONJ development as opposed to surgical intervention. This case series provides early insight into the presentation of pre-existing MRONJ.


Assuntos
Osteonecrose da Arcada Osseodentária Associada a Difosfonatos , Conservadores da Densidade Óssea , Humanos , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/diagnóstico por imagem , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/etiologia , Conservadores da Densidade Óssea/efeitos adversos , Tomografia Computadorizada de Feixe Cônico , Difosfonatos/efeitos adversos , Estudos Retrospectivos , Extração Dentária
9.
Aliment Pharmacol Ther ; 58(3): 309-321, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37305984

RESUMO

BACKGROUND: Disturbance of skeletal muscle mass has clinically important implications in patients with inflammatory bowel disease (IBD), but accurate quantification requires radiation-intense techniques. AIMS: We aimed to compare point-of-care muscle assessments and their change with therapy with those using reference-standard whole-body dual energy X-ray absorptiometry (DXA). METHODS: Adult patients with IBD and healthy controls underwent prospective assessment of muscularity by ultrasound of the dominant arm and both thighs, bioelectrical impedance analysis (BIA), anthropometric measurements, and DXA. Patients with active IBD were assessed again ≥13 weeks after initiating biologic induction therapy. RESULTS: In 54 patients with IBD and 30 controls, all muscle assessments correlated significantly with DXA-derived skeletal muscle index (SMI). In IBD, ultrasound of the arm and legs had the best agreement with DXA-derived SMI (mean difference 0 kg/m2 , 95% limits of agreement -1.3 to 1.3), while BIA overestimated DXA-derived SMI by 1.07 (-0.16 to +2.30) kg/m2 . In 17 patients who underwent biologic therapy, the percentage change in DXA-derived SMI correlated significantly with the percentage change in all other muscle assessment techniques. Responders (n = 9) increased SMI from baseline to follow-up when derived from DXA (mean 7.8-8.5 kg/m2 , p = 0.004), ultrasound of the arm and legs (300-343 cm2 , p = 0.021) and BIA (9.2-9.6 kg/m2 , p = 0.011). CONCLUSIONS: Ultrasound of the arm and legs out-performed other point-of-care methods in its accuracy of measuring muscle mass. All methods, except mid-arm circumference, were responsive to therapy-induced change. Ultrasound is the preferred non-invasive test for measuring muscle mass in patients with IBD.


Assuntos
Composição Corporal , Sistemas Automatizados de Assistência Junto ao Leito , Adulto , Humanos , Composição Corporal/fisiologia , Índice de Massa Corporal , Impedância Elétrica , Estudos Prospectivos , Antropometria , Absorciometria de Fóton/métodos , Músculo Esquelético/diagnóstico por imagem , Músculo Esquelético/fisiologia
10.
Eur J Gastroenterol Hepatol ; 35(5): 609-612, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-36966753

RESUMO

Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) remains the preferred surgical option for medically refractory ulcerative colitis. Management of individuals with an IPAA prior to and during pregnancy presents challenges that can have serious consequences. Infertility, mechanical obstructive and inflammatory pouch complications are frequently encountered in pregnant women with an IPAA. Mechanical obstructions occur due to a variety of underlying aetiologies, including stricturing disease, adhesions and pouch twists. Conservative management of such obstructions often results in resolution of symptoms without a need for endoscopic or surgical intervention, although endoscopic decompression may be attempted in isolation or as a bridge to definitive surgical intervention. Parenteral nutrition, and early delivery, may also be necessary. Faecal calprotectin and intestinal ultrasound, both of which are accurate in pregnancy, are useful in the setting of suspected inflammatory pouch complications, in some circumstances allowing for avoidance of pouchoscopy. Penicillin-based antimicrobials can be considered first line in pregnancy for the management of pouchitis and pre-pouch ileitis, and biologics can be safely instituted in the setting of refractory disease or suspected Crohn's disease-like inflammation of the pouch or pre-pouch ileum. Pragmatism, clear patient communication and multidisciplinary discussion are essential in approaching pregnant women with complications of an IPAA, particularly given the lack of definitive evidence to guide therapeutic decisions.


Assuntos
Colite Ulcerativa , Bolsas Cólicas , Pouchite , Proctocolectomia Restauradora , Gravidez , Humanos , Feminino , Proctocolectomia Restauradora/efeitos adversos , Descompressão Cirúrgica/efeitos adversos , Vértebras Lombares , Pouchite/diagnóstico , Pouchite/etiologia , Pouchite/terapia , Colite Ulcerativa/diagnóstico , Anastomose Cirúrgica/efeitos adversos , Fertilidade , Bolsas Cólicas/efeitos adversos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/terapia
11.
Prim Dent J ; 11(3): 108-116, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36073051

RESUMO

Osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ) are uncommon conditions, however when present they have a significant impact on a patient's quality of life and are notoriously difficult to treat. With medical advances resulting in improved survival rates and increased life expectancy, it is likely that general dental practitioners (GDPs) will more frequently be involved in the oral health management of patients at risk of both ORN and MRONJ. Though management of both diseases is beyond the scope of primary care dentistry, the GDP still has a key role in the patient's overall care. It is therefore important to have a good understanding of these conditions and their consequences for dental treatment in order to provide adequate patient support. Management requires a multidisciplinary approach to treatment and as part of this GDPs are integral in prevention, early recognition and maintenance of oral health following diagnosis. This article aims to refresh the reader's knowledge regarding MRONJ and ORN and support the GDP in managing this patient group.


Assuntos
Osteonecrose da Arcada Osseodentária Associada a Difosfonatos , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/diagnóstico , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/etiologia , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/terapia , Assistência Odontológica , Odontólogos , Humanos , Papel Profissional , Qualidade de Vida , Encaminhamento e Consulta
12.
Br Dent J ; 232(4): 213-218, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-35217738

RESUMO

This article discusses relevant information for the dental sector regarding metastatic cancers beyond breast and prostate cancer. Typically, tumour sites such as lung, renal, colorectal, gastrointestinal, thyroid, hepatic and pancreatic cancers are increasingly being referred for bone-targeting agents upon evidence of bone metastases.The current article explores the presenting dental status of these tumour groups on the background of survival outcomes. In addition, the article provides insight towards the complexity in achieving 'dental fitness' and whether 'dental stability' could be an alternative to consider via palliative dentistry in certain cases.


Assuntos
Neoplasias Ósseas , Neoplasias da Mama , Neoplasias da Próstata , Neoplasias Ósseas/tratamento farmacológico , Neoplasias Ósseas/secundário , Neoplasias da Mama/tratamento farmacológico , Humanos , Masculino , Cuidados Paliativos , Neoplasias da Próstata/patologia
13.
Br Dent J ; 2022 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-35145242

RESUMO

Introduction Metastatic prostate cancer (MPC) patients due to receive bone-targeting agents (BTAs) are expected to undertake a dental assessment before commencing. The aim of this study was to determine the dental status of this tumour group and understand the challenges the dental practitioner faces in attempting to achieve 'dental fitness'.Materials and methods Data were retrospectively collected from a dedicated pre-BTA dental assessment clinic and analysed for MPC. Statistical analysis and observational data were used to compare patient and tumour demographics.Results A total of 111 patients were included in this cohort, with the majority of patients presenting with only bone metastases (BM) and no additional metastatic sites. On average, MPC patients presented with 19.3 teeth and were below the threshold for functional dentition. The 75-84-year-old age group had the worst horizontal bone loss score and subsequently lose six teeth over a decade (p = 0.001). In addition, all MPC tumour sub-categories showed favourable survival rates.Conclusion MPC patients have a high dental burden on presentation, likely associated with their age. Favourable survival prospects and the cumulation of BTAs and dental disease would suggest a heightened risk of medication-related osteonecrosis of the jaw in this group compared to many other tumour sites.

14.
Br Dent J ; 2022 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-35027687

RESUMO

Introduction Dental pre-assessment before bone-targeting agents (BTA) in oncology patients is a well-recognised practice; yet, guidance on this has typically been unable to differentiate between the intricacies of varying oncology groups. This study assesses the presenting dental status of oncology patients with bone metastases (BM) due to commence BTA, to determine whether differences exist with varying tumour groups.Materials and methods Data were retrospectively collected from a dedicated pre-BTA dental assessment clinic. Statistical analysis and observational data were used to compare patient and tumour demographics as well as to their peers via the Adult Dental Health Survey.Results A total of 492 patients with a solid tumour diagnosis and BM requiring BTA were included in this retrospective study. Demographics such as sex, age, smoking status and tumour site were all significant for the number of teeth present (p = 0.000). Furthermore, survival data post-BTA identified prostate, breast and thyroid groups surviving over 12 months following dental assessment (p <0.000). In contrast, the remaining groups such as lung, colorectal and gastrointestinal had poorer outcomes (p <0.000).Conclusion Pre-BTA dental assessment should consider and incorporate additional patient and tumour demographics to allow for a tailored and personalised dental treatment plan. Application of this principle would look to optimise oral function while considering tumour prognosis to avoid over- or under-prescribing pre-BTA dental treatment.

15.
Br Dent J ; 232(2): 95-100, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-35091612

RESUMO

Introduction Patients with bony metastatic breast cancer (MBC) due to receive bone-targeting agents (BTA) are expected to undertake a dental assessment before commencing. The aim of this study was to determine the dental status of this tumour group and understand the challenges the dental practitioner faces in attempting to achieve 'dental fitness'.Materials and methods Data were retrospectively collected from a dedicated pre-BTA dental assessment clinic and analysed for MBC. Statistical analysis and observational data were used to compare patient and tumour demographics.Results A total of 229 patients were included in this cohort. On average, this cohort loses one tooth per decade (p = 0.003). Classifying the tumour sub-types provided observational differences in dental status with patients with triple negative MBC having the best dentition at presentation. These observations were more clinically profound when overlaid with survival following post-BTA dental assessment as patients with triple negative MBC had the lowest median survival (eight months, p = 0.002). In contrast, patients with luminal A breast cancer had a very complex presenting dentition with a median survival of 20 months.Conclusion A clear difference exists in the outcomes of MBC patients and therefore a pre-BTA dental assessment should consider and integrate both patient and tumour demographics into dental treatment planning.


Assuntos
Neoplasias Ósseas , Neoplasias da Mama , Neoplasias Ósseas/tratamento farmacológico , Neoplasias Ósseas/secundário , Neoplasias da Mama/tratamento farmacológico , Odontólogos , Feminino , Humanos , Papel Profissional , Estudos Retrospectivos
16.
Aliment Pharmacol Ther ; 55(6): 700-704, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34907546

RESUMO

BACKGROUND: Ustekinumab is increasingly used in pregnant women with inflammatory bowel disease (IBD). Existing safety data are reassuring, but the stability of ustekinumab levels in pregnancy, degree of transfer to the infant and time to infant clearance are unknown. METHODS: In this prospective observational study, ustekinumab-exposed women with IBD had trough levels measured in each trimester of pregnancy and at delivery. Infant ustekinumab levels were measured at delivery and ongoing until clearance was achieved. Trough ustekinumab level stability in individuals across pregnancy was compared by Skillings-Mack test. Spearman coefficients were used to correlate maternal and infant delivery levels, and median time to infant ustekinumab clearance was defined. RESULTS: 19 pregnant women receiving ustekinumab were included. There was no difference in ustekinumab levels across pregnancy in those with two or more representative trough levels (P = 0.83, n = 11). Infant delivery ustekinumab levels were higher than maternal levels, with a median infant:maternal ratio of 1.79 (IQR 1.26-3.1). There was a positive correlation between maternal and infant delivery ustekinumab levels (r = 0.75, P = 0.001) and an inverse correlation between the number of days from final antenatal dose and delivery infant ustekinumab level (r = -0.65, P = 0.006). Median time of infant ustekinumab clearance was 9 (range 6-19) weeks (n = 9). CONCLUSION: Ustekinumab drug levels appear stable in pregnancy, with a delivery infant:maternal ratio similar to that of anti-TNFs. Infant ustekinumab clearance was complete by 20 weeks post-partum, however, infants exposed in utero should avoid live vaccination before 12 months of age until further clearance data are obtained.


Assuntos
Doenças Inflamatórias Intestinais , Complicações na Gravidez , Feminino , Humanos , Lactente , Doenças Inflamatórias Intestinais/tratamento farmacológico , Gravidez , Complicações na Gravidez/tratamento farmacológico , Gestantes , Estudos Prospectivos , Ustekinumab/efeitos adversos
17.
Clinicoecon Outcomes Res ; 13: 873-881, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34675567

RESUMO

BACKGROUND: Foot temperature monitoring for the prevention and early detection of diabetic foot ulcers (DFU) is evidence-based and recommended in clinical practice. However, easy-to-use remote monitoring tools have been lacking, thereby preventing widespread adoption. OBJECTIVE: To evaluate the cost-effectiveness of remote foot temperature monitoring (RFTM) (Siren's Neurofabric™ Diabetic socks) in addition to standard of care (SoC) versus SoC alone for early detection of DFU with diabetic neuropathy and a moderate to high risk of DFU. METHODS: A payer perspective decision-tree analysis was conducted to compare expected DFU occurrence and subsequent amputation rates and costs between treatment strategies over one year. Inputs in the model were sourced from publicly available literature and relevant health technology assessments. One-way sensitivity analyses were performed for each model variable. RESULTS: In the base-case scenario, RFTM plus SoC was a dominant strategy compared to SoC alone. RFTM plus SoC was associated with cost savings of $38,593 per additional ulcer avoided versus SoC alone, and $8027 per patient per year on average compared to SoC alone. These results were highly robust to one-way sensitivity analysis; all scenarios remained dominant if compliance was ≥13%. CONCLUSION: RFTM is a cost-effective addition to SoC in patients with diabetic neuropathy at a moderate-to-high risk of DFU and subsequent amputation. Further, reduction in DFU and associated complications may result in improvements in the patient's quality of life and mental health. Future studies are needed to evaluate the compliance and reduction of DFU occurrence in patients on RFTM.

18.
J Obstet Gynaecol India ; 69(Suppl 2): 182-187, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31686754

RESUMO

OBJECTIVE: To assess the impact of hysteroscopic tissue removal systems (TRS) on histopathology tissue diagnosis. MEASUREMENTS AND METHODS: This is a paired-comparison ex vivo study in which 23 endometrial sections from hysterectomized uteri (13 benign and 10 hyperplasia/cancer) were analyzed in a simulation laboratory center at a university teaching hospital. After routine tissue processing, a section of endometrium was provided for ex vivo TRS with suture mounting to a uterine model (Polly, Remedy). Morcellated specimens using the Hologic® MyoSure hysteroscopic device were processed for histopathologic analysis by two blinded pathologists (Pa and Pb) and compared to the original specimens' tissue diagnoses. RESULTS: Sufficient tissue for evaluation was found in 100% (23/23) of TRS specimens by Pa and 91.3% by Pb. TRS specimen diagnoses were concordant with routine histologic diagnosis 86.9% (20/23, k = 0.76) for Pa and 80.9% (17/21, k = 0.68) for Pb. Sensitivity and specificity were 70%/100% for Pa and 80%/91% for Pb, respectively. The false-positive (overdiagnosed) and false-negative rates (underdiagnosed) were 0%/30% and 9%/20% for Pa and Pb. Both Pa and Pb underdiagnosed most specimens confirmed by routine tissue diagnosis. TRS specimen diagnoses between Pa and Pb were concordant in 76.2% (16/21, k = 0.60). CONCLUSION: TRS may adversely impact the ability to provide a histologic tissue analysis. Up to 30% of samples were overdiagnosed and 20% underdiagnosed. If confirmed, pathologists may need to reassess workflows to better offset potential underdiagnosis of malignant specimens as findings may be obscured through TRS. Additionally, surgeons may need to reconsider specimen handling, so highest yield specimens are provided to pathology.

19.
Obstet Gynecol ; 132(4): 972-985, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30204700

RESUMO

Vaginal cuff dehiscence is an infrequent complication of hysterectomy, with the potential for evisceration and additional morbidity. This review aims to describe the incidence, risk factors, preventative measures, and management. Identification of specific risk factors is problematic because many studies either lack comparison groups or are underpowered as a result of the rarity of this complication. Good surgical technique to optimize vaginal cuff healing and minimize the risk of postoperative cuff infection are important as is avoidance of early intercourse, traumatic vaginal penetration, or excess strain on the vaginal cuff during the postoperative period. Judicious use of electrocautery or other thermal energy, use of delayed absorbable sutures, and adequate tissue bites can further decrease the risk of dehiscence. Prompt recognition and management are critical to achieve best outcomes.


Assuntos
Histerectomia/efeitos adversos , Hérnia Incisional/etiologia , Deiscência da Ferida Operatória/etiologia , Feminino , Humanos , Incidência , Hérnia Incisional/cirurgia , Fatores de Risco , Deiscência da Ferida Operatória/epidemiologia , Deiscência da Ferida Operatória/prevenção & controle , Cicatrização
20.
Obstet Gynecol Surv ; 73(11): 641-649, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30468239

RESUMO

IMPORTANCE: Cervical stenosis is a challenging clinical entity that requires prompt identification and management in order to avoid iatrogenic injury at the time of endocervical canal cannulation. OBJECTIVE: The aim of this study was to identify cervical stenosis and discuss associated etiologies, risk factors, and review medical and surgical approaches for overcoming cervical stenosis. EVIDENCE ACQUISITION: Computerized searches of MEDLINE and PubMed were conducted using the key words "cervix", "cervical stenosis," "embryo transfer," "hysteroscopy complications," "misoprostol," and "ultrasound." References from identified sources were manually searched to allow for a thorough review. Data from relevant sources were compiled to create this review. RESULTS: Transcervical access to the uterine cavity is frequently required for procedures such as hysteroscopy, dilation and curettage, endometrial biopsy, sonohysterogram, hysterosalpingogram, intrauterine insemination, embryo transfer in those undergoing in vitro fertilization, and insertion of intrauterine devices. These procedures can become complicated when difficult cannulation of the endocervical canal is encountered. Management strategies include preprocedural use of cervical-ripening agents or osmotic dilators, ultrasound guidance, no-touch vaginoscopy, manual dilatation, and hysteroscopic resection of the obstructed endocervical canal. CONCLUSIONS AND RELEVANCE: Cervical stenosis is associated with iatrogenic complications that can result in significant patient morbidity. In patients undergoing in vitro fertilization, difficult embryo transfer is associated with lower pregnancy rates. The clinician should carefully consider the patient's menopausal status, risk factors, and symptoms in order to anticipate difficult navigation of the endocervical canal. Various medical and surgical management strategies, including hysteroscopic resection, can be used to overcome the stenotic cervix.


Assuntos
Colo do Útero/patologia , Dilatação/métodos , Doenças do Colo do Útero/patologia , Doenças do Colo do Útero/cirurgia , Colo do Útero/cirurgia , Constrição Patológica/complicações , Constrição Patológica/diagnóstico , Feminino , Fertilização in vitro/métodos , Humanos , Histeroscopia/métodos , Infertilidade Feminina/etiologia , Doenças do Colo do Útero/diagnóstico
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