The impact of Vitreo-Macular interface abnormalities on the response to Anti-VEGF therapy for centre involving diabetic macular oedema.

BACKGROUND: The influence of Vitreomacular Interface Abnormalities (VMIA) such as Epiretinal Membrane (ERM) and/or vitreomacular traction (VMT) on the response of patients with Centre Involving Diabetic Macular Edema (CIDME) to standard of care Anti-VEGF medications is under-researched. The aims of this study were: 1) To determine the incidence of VMIA at baseline and 12 months amongst treatment naive patients commencing anti-VEGF treatment 2) To compare the response to Anti-VEGF medications at 3 monthly intervals for 12 months in a large cohort of patients with and without VMIA on their baseline OCT scan. Response was determined in terms of: number of injections, central macular thickness and visual acuity. METHODS: A retrospective case notes review of treatment naïve patients with newly diagnosed CIDME. Included patients had been commenced on intravitreal Anti-VEGF injections (ranibizumab or aflibercept) at a single centre. Inclusion criteria were: treatment naïve DME patients with a CMT of 400µ or more receiving anti-VEGF treatment with at least 12 months follow up and in whom macular OCT scans and visual acuity (VA) measurements were available within two weeks of baseline, 3, 6, 9 and 12 months. Exclusion criteria included: previous intravitreal therapy, previous vitrectomy, cataract surgery during the follow-up period, concurrent eye conditions affecting vision or CMT. RESULTS: 119 eyes met the inclusion criteria and underwent analysis. Groups were comparable in their baseline demographics. Baseline CMT measurements were comparable at baseline (417µ and 430µ in the No-VMIA and VMIA groups respectively) and improved to approximately 300µ in both groups. From 6 months CMT continued to improve in the no-VMIA while progressively deteriorating in the VMIA group. Change in CMT was statistically different at 12 months between the 2 groups (108µ and 79µ, p= 0.04). There was a mean of 7 injections after 12 months. CONCLUSION: Our study has shown a 46% incidence of VMIA amongst patients newly diagnosed with centre involving DME undergoing treatment with anti-VEGF injections. We have also demonstrated a significant difference in CMT and VA response to anti-VEGF treatment in patients with and without VMIA. Initial response was similar between the 2 groups up until 6 months. From 6 to 12 months significant differences in treatment response emerged. Differences in clinical response between patients with and without VMIA may help guide further prospective controlled studies and optimise treatment strategies.

Burden of Disease Study of Patients with Diabetic Macular Oedema in Spain.

INTRODUCTION: Diabetic macular oedema (DMO) is a complication of diabetic retinopathy that can result in vision loss. The disease can impact different spheres of a patient's life, including physical and psychological health, work, and activities of daily living, entailing an important use of healthcare and non-healthcare resources. This study aimed to estimate the socio-economic burden of DMO in Spain. METHODS: The burden of DMO was estimated from a societal perspective, per patient, year of treatment since diagnosis, and type of treatment. Four categories were considered: direct healthcare costs (DHC), direct non-healthcare costs (DNHC), labour productivity losses (LPL), and intangible costs (IC) associated with loss of quality of life. Average annual costs were calculated by multiplying the resources used per patient by their corresponding unit price (or financial proxy). For a more accurate estimation, differences in resource use between treatments (intravitreal anti-vascular endothelial growth factor injections of ranibizumab or aflibercept, and intravitreal dexamethasone implants) and year since diagnosis (first, second, and third year or beyond) were considered and presented separately. The reference year for costs was 2021. RESULTS: The average annual costs of DMO in the first year of treatment after diagnosis was estimated at €18,774, €17,512, and €16,188 per patient treated with ranibizumab, aflibercept, and dexamethasone, respectively. This burden would be reduced to €15,783, €15,701, and €12,233 in the second year, and to €15,119, €15,043, and €12,790 in the third year, respectively. Diagnosis of DMO entails an additional one-off cost of €485. DHC accounted for the greatest proportion of total annual costs per patient, independent of the year, with LPL also making an important contribution to total costs. CONCLUSIONS: The socio-economic impact of DMO on patients, the healthcare system, and society at large is substantial. The constant increase in its prevalence accentuates the need for planning and implementation of healthcare strategies to prevent vision loss and reduce the socio-economic burden of the disease.

Cognitive bias evaluation on the choice of treatment in common retinal disorders among retina specialists in 2023.

PURPOSE: The study aimed to discern the intent to treat with the therapeutic agents prescribed first or second line in the following eye conditions: neovascular age-related macular Degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and myopic maculopathy with choroidal neovascularization (MMNV). The study also aimed to distinguish the ophthalmologists' intended treatment for their patients from those that they would prescribe for themselves if they were affected by the above macular conditions. METHODS: The study utilized an online survey of 243 French ophthalmologists practicing medical retina, with males accounting for 54.3% of the participants. Data was obtained using a questionnaire that focused on the ophthalmologists' experience with various agents as well as their first and second line choices for nAMD, DME, RVO, and MMNV. RESULTS: The vast majority of French ophthalmologists (99%) had experience with the most widely used anti-vascular endothelial growth factors (anti-VEGFs); ranibizumab, bevacizumab, and aflibercept. Fewer than 8% reported experience with anti-VEGF drug reservoirs, biosimilars, or faricimab. The study findings also showed ranibizumab and aflibercept as the commonly prescribed first line choices for the above-mentioned ocular conditions. For the second line choice, the study showed that aflibercept and dexamethasone intravitreal implants were the most common across the four retinal conditions studied. The only difference in intent to treat for "patients" versus "yourself" was for biosimilars (0% to 0.8%, P=0.001). CONCLUSION: The findings regarding the first and second line choices for the mentioned ocular disorders were found to agree with the findings of published literature currently used in practice, with a tendency to prefer ranibizumab as first line therapy for neovascular disorders and aflibercept as first line therapy for macular edema. In addition, there were no differences between choices for first and second line therapy for patients vs. ophthalmologists.

Uveitis Following Intravitreal Injections of Faricimab: A Case Report.

PURPOSE: Faricimab, a novel pharmaceutical agent targeting both angiopoietin-2 and vascular endothelial growth factor-A pathways, has gained approval for treating neovascular age-related macular degeneration and diabetic macular oedema. While clinical trials have demonstrated its favorable safety profile, this research presents two cases of hypertensive uveitis following intravitreal Faricimab injections. METHODS: Medical history, clinical findings and multimodal images were retrospectively collected. RESULTS: The patients experienced elevated intraocular pressure, mutton-fat keratic precipitates, anterior and posterior segment inflammation shortly after faricimab administration. CONCLUSIONS: These cases prompt further investigation into the potential risk of uveitis associated with faricimab and underscore the importance of continued monitoring and research to elucidate its real-world safety profile.

Assessment of genetically modified maize MON 87419 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-140).

Genetically modified maize MON 87419 was developed to confer tolerance to dicamba- and glufosinate-based herbicides. These properties were achieved by introducing the dmo and pat expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 87419 and its conventional counterpart needed further assessment, except for the levels of arginine and protein in grains which did not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono-oxygenase (DMO) and phosphinothricin N-acetyltransferase (PAT) proteins as expressed in maize MON 87419. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 87419. In the context of this application, the consumption of food and feed from maize MON 87419 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 87419 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87419 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87419. The GMO Panel concludes that maize MON 87419 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT.

BACKGROUND: The National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm on optical coherence tomography. The DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial compared standard threshold macular laser with subthreshold micropulse laser to treat diabetic macular oedema suitable for macular laser. OBJECTIVES: Determining the clinical effectiveness, safety and cost-effectiveness of subthreshold micropulse laser compared with standard threshold macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm. DESIGN: A pragmatic, multicentre, allocation-concealed, double-masked, randomised, non-inferiority, clinical trial. SETTING: Hospital eye services in the UK. PARTICIPANTS: Adults with diabetes and centre-involving diabetic macular oedema with a central retinal subfield thickness of < 400 µm, and a visual acuity of > 24 Early Treatment Diabetic Retinopathy Study letters (Snellen equivalent > 20/320) in one/both eyes. INTERVENTIONS: Participants were randomised 1 : 1 to receive 577 nm subthreshold micropulse laser or standard threshold macular laser (e.g. argon laser, frequency-doubled neodymium-doped yttrium aluminium garnet 532 nm laser); laser treatments could be repeated as needed. Rescue therapy with intravitreal anti-vascular endothelial growth factor therapies or steroids was allowed if a loss of ≥ 10 Early Treatment Diabetic Retinopathy Study letters between visits occurred and/or central retinal subfield thickness increased to > 400 µm. MAIN OUTCOME MEASURES: The primary outcome was the mean change in best-corrected visual acuity in the study eye at 24 months (non-inferiority margin 5 Early Treatment Diabetic Retinopathy Study letters). Secondary outcomes included the mean change from baseline to 24 months in the following: binocular best-corrected visual acuity; central retinal subfield thickness; the mean deviation of the Humphrey 10-2 visual field in the study eye; the percentage of people meeting driving standards; and the EuroQol-5 Dimensions, five-level version, National Eye Institute Visual Function Questionnaire - 25 and Vision and Quality of Life Index scores. Other secondary outcomes were the cost per quality-adjusted life-years gained, adverse effects, number of laser treatments and additional rescue treatments. RESULTS: The DIAMONDS trial recruited fully (n = 266); 87% of participants in the subthreshold micropulse laser group and 86% of participants in the standard threshold macular laser group had primary outcome data. Groups were balanced regarding baseline characteristics. Mean best-corrected visual acuity change in the study eye from baseline to month 24 was -2.43 letters (standard deviation 8.20 letters) in the subthreshold micropulse laser group and -0.45 letters (standard deviation 6.72 letters) in the standard threshold macular laser group. Subthreshold micropulse laser was deemed to be not only non-inferior but also equivalent to standard threshold macular laser as the 95% confidence interval (-3.9 to -0.04 letters) lay wholly within both the upper and lower margins of the permitted maximum difference (5 Early Treatment Diabetic Retinopathy Study letters). There was no statistically significant difference between groups in any of the secondary outcomes investigated with the exception of the number of laser treatments performed, which was slightly higher in the subthreshold micropulse laser group (mean difference 0.48, 95% confidence interval 0.18 to 0.79; p = 0.002). Base-case analysis indicated no significant difference in the cost per quality-adjusted life-years between groups. FUTURE WORK: A trial in people with ≥ 400 µm diabetic macular oedema comparing anti-vascular endothelial growth factor therapy alone with anti-vascular endothelial growth factor therapy and macular laser applied at the time when central retinal subfield thickness has decreased to < 400 µm following anti-vascular endothelial growth factor injections would be of value because it could reduce the number of injections and, subsequently, costs and risks and inconvenience to patients. LIMITATIONS: The majority of participants enrolled had poorly controlled diabetes. CONCLUSIONS: Subthreshold micropulse laser was equivalent to standard threshold macular laser but required a slightly higher number of laser treatments. TRIAL REGISTRATION: This trial is registered as EudraCT 2015-001940-12, ISRCTN17742985 and NCT03690050. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 50. See the NIHR Journals Library website for further project information.

The retina is a layer at the back of the eye. Its centre is called the macula and is responsible for central vision. Some people with diabetes develop diabetic macular oedema. In diabetic macular oedema fluid leaks from retinal blood vessels and builds up at the macula, resulting in sight loss. Diabetic macular oedema can be mild or severe; this can be determined measuring the thickness of the macula, which is measured in micrometres (µm). One micrometre is one thousandth of a millimetre. In mild diabetic macular oedema, the thickness of the macula increases, but is less than 400 µm. Patients with mild diabetic macular oedema can be treated with a laser and there are two laser types. The standard threshold macular laser has been available for many years. It clears the diabetic macular oedema but produces a 'burn' in the retina. The subthreshold micropulse laser is newer. It does not produce a burn but also clears the diabetic macular oedema. The lack of a burn, however, has led to doubts about whether or not this laser works as well as the standard threshold macular laser because 'no burn' was taken to mean 'less benefit'. These doubts led to our establishing the DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial, which compared these two lasers for people with mild diabetic macular oedema. A total of 266 people suitable for either laser joined the study at 16 NHS hospitals across the UK; 133 received standard threshold macular laser and 133 received subthreshold micropulse laser. The choice of laser was determined by chance. The DIAMONDS trial found that the subthreshold micropulse laser was as good as the standard threshold macular laser (i.e. 'clinically equivalent') in terms of improving people's vision, reducing macula thickness, allowing people to meet driving standards and maintaining their quality of life, both in general terms and for vision in particular. There was a small increase (less than one session on average per person) in the number of laser treatment sessions needed with subthreshold micropulse laser. The costs of both laser treatments were about the same.

Assessment of genetically modified Maize MON 87429 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-161).

Maize MON 87429 was developed to confer tolerance to dicamba, glufosinate, quizalofop and 2,4-D herbicides. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 87429 and its conventional counterpart needs further assessment, except for the levels of phytic acid in grains, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the DMO, PAT, FT_T and CP4 EPSPS proteins as expressed in maize MON 87429. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 87429. In the context of this application, the consumption of food and feed from maize MON 87429 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 87429 is as safe as the conventional counterpart and non-GM maize reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87429 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87429. The GMO Panel concludes that maize MON 87429, as described in this application, is as safe as its conventional counterpart and the tested non-GM maize reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified oilseed rape MON 94100 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-169).

Oilseed rape MON 94100 was developed to confer tolerance to dicamba herbicide. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between oilseed rape MON 94100 and its conventional counterpart needs further assessment, except for the levels of carbohydrates, calcium and ADF in seeds, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono-oxygenase (DMO) protein as expressed in oilseed rape MON 94100. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of oilseed rape MON 94100. In the context of this application, the consumption of food and feed from oilseed rape MON 94100 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that oilseed rape MON 94100 is as safe as the conventional counterpart and non-GM oilseed rape reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable oilseed rape MON 94100 seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape MON 94100. The GMO Panel concludes that oilseed rape MON 94100 is as safe as its conventional counterpart and the tested non-GM oilseed rape reference varieties with respect to potential effects on human and animal health and the environment.

NMDA Receptor Antagonists Increase the Release of GLP-1 From Gut Endocrine Cells.

Type 2 diabetes mellitus (T2DM) remains one of the most pressing health issues facing modern society. Several antidiabetic drugs are currently in clinical use to treat hyperglycaemia, but there is a need for new treatments that effectively restore pancreatic islet function in patients. Recent studies reported that both murine and human pancreatic islets exhibit enhanced insulin release and ß-cell viability in response to N-methyl-D-aspartate (NMDA) receptor antagonists. Furthermore, oral administration of dextromethorphan, an over-the-counter NMDA receptor antagonist, to diabetic patients in a small clinical trial showed improved glucose tolerance and increased insulin release. However, the effects of NMDA receptor antagonists on the secretion of the incretin hormone GLP-1 was not tested, and nothing is known regarding how NMDA receptor antagonists may alter the secretion of gut hormones. This study demonstrates for the first time that, similar to ß-cells, the NMDA receptor antagonist MK-801 increases the release of GLP-1 from a murine L-cell enteroendocrine model cell line, GLUTag cells. Furthermore, we report the 3' mRNA expression profiling of GLUTag cells, with a specific focus on glutamate-activated receptors. We conclude that if NMDA receptor antagonists are to be pursued as an alternative, orally administered treatment for T2DM, it is essential that the effects of these drugs on the release of gut hormones, and specifically the incretin hormones, are fully investigated.

Genetic Modification as a New Approach to Ameliorate the Therapeutic Efficacy of Stem Cells in Diabetic Retinopathy.

Over the last decades, the strategy of using stem cells has gained a lot of attention in treating many diseases. Recently, DR was identified as one of the common complications experienced by diabetic patients around the world. The current treatment strategy needs to be addressed since the active progression of DR may lead to permanent blindness. Interestingly, varieties of stem cells have emerged to optimize the therapeutic effects. It is also known that stem cells possess multilineage properties and are capable of differentiating, expanding in vitro and undergoing genetic modification. Moreover, modified stem cells have shown to be an ideal resource to prevent the degenerative disease and exhibit promising effects in conferring the migratory, anti-apoptotic, anti-inflammatory and provide better homing for cells into the damaged tissue or organ as well promoting healing properties. Therefore, the understanding of the functional properties of the stem cells may provide the comprehensive guidance to understand the manipulation of stem cells making them useful for long-term therapeutic applications. Hence in this review the potential use and current challenges of genetically modified stem cells to treat DR will be discussed along with its future perspectives.

Development of a high-throughput differential mobility separation-tandem mass spectrometry (DMS-MS/MS) method for clinical urine drug testing.

INTRODUCTION: Differential mobility separation (DMS) is an analytical technique used for rapid separation of ions and isomers based on gas phase mobility prior to entering a mass spectrometer for analysis. The entire DMS process is accomplished in fewer than 20 ms and can be used as a rapid alternative to chromatographic separation. OBJECTIVE: The primary objective was to evaluate the utility of DMS-tandem mass spectrometry (DMS-MS/MS) as a replacement for immunoassay-based clinical toxicology testing. METHODS: A sensitive DMS-MS/MS method was developed and validated for simultaneous identification of 33 drugs and metabolites in human urine samples. After DMS optimization, the method was validated and used to screen 56 clinical urine samples. These results were compared to results obtained by immunoassay. RESULTS: The DMS-MS/MS method achieved limits of detection ranging from 5 to 100 ng/mL. Moreover, the total analysis time was 2 min per sample. For the method performance evaluation, DMS-MS/MS results were compared with previously obtained urine toxicology immunoassay results. DMS-MS/MS showed higher sensitivity and identified 20% more drugs in urine, which were confirmed by LC-MS/MS. CONCLUSION: The DMS-MS/MS as applied in our lab demonstrated the capability for rapid drug screening and provided better analytical performance than immunoassay.

Impacto del tratamiento de adultos mayores con ISRS y su relación con los tratamientos odontológicos / The impact of treating older adults with SSRI and its relationship with dental treatments

La población mayor de 60 años es el grupo etario de mayor crecimiento en el mundo. Debido a que la depresión es una patología frecuente en la persona adulta mayor y anciana, los inhibidores de la recap- tación de la serotonina (ISRS) son el tratamiento de primera línea de elección. Este trabajo referencia la asociación del consumo de estos fármacos con la disminución de la densidad ósea mineral (DMO), el riesgo de fracturas y su repercusión en la atención odontológica. Además, incluye una breve descripción de la homeostasis ósea y la relación depresión-carga alostática. El trabajo interdisciplinario y una correcta anamnesis pueden detectar posibles complicaciones y riesgos vinculados con este tipo de medicamen- tos. Ello facilitaría un mejor manejo, más aún en el adulto mayor, donde una pequeña variable puede repercutir en su integridad (AU)

The population over 60 is the fastest growing age group in the world. Depression is a frequent pathology in the elderly and the elderly, with serotonin reuptake inhibitors (SSRI) being the 1st line treatment of choice. The association of the consumption of this drug with a decrease in bone mineral density (BMD), risk of fractures and its impact on dental care are referenced in this work. In addition, it includes a brief description of bone homeostasis and the depression-allostatic load relationship. Interdisciplinary work and a correct anamnesis can detect possible complications and risks linked to this type of medication, facilitating better management and even more so in the elderly, where a small variable can affect their integrity (AU)

Peripheral Determinants of Oxygen Utilization in Heart Failure With Preserved Ejection Fraction: Central Role of Adiposity.

The aim of this study was to determine the arteriovenous oxygen content difference (ΔAVo2) in adult subjects with and without heart failure with preserved ejection fraction (HFpEF) during systemic and forearm exercise. Subjects with HFpEF had reduced ΔAVo2. Forearm diffusional conductance for oxygen, a lumped conductance parameter that incorporates all impediments to the movement of oxygen from red blood cells in skeletal muscle capillaries into the mitochondria within myocytes, was estimated. Forearm diffusional conductance for oxygen was not different among adults with HFpEF, those with hypertension, and healthy control subjects; therefore, diffusional conductance cannot explain the reduced forearm ΔAVo2. Instead, adiposity was strongly associated with ΔAVo2, suggesting an active role for adipose tissue in reducing exercise capacity in patients with HFpEF.

Efectos de las plataformas vibratorias en la salud ósea en mujeres posmenopáusicas / Effects of Vibratory Platforms on Bone Health in Postmenopausal Women

Estudios recientes han sugerido que los estímulos mecánicos (vibraciones) de alta frecuencia y baja magnitud pueden ejercer un efecto positivo sobre la morfología ósea y beneficiar su cantidad y calidad. La plataforma vibratoria es una máquina popular que se introdujo en la última década como una nueva promesa contra el tratamiento de la osteoporosis. Actualmente, en el mundo hay más de 200 millones de mujeres posmenopáusicas que sufren osteoporosis. Esta enfermedad es una de las más comunes y costosas de la salud pública. El ejercicio físico complementado con el tratamiento vibratorio puede que sea considerado como una estrategia efectiva para la prevención y tratamiento de la osteoporosis posmenopáusica. Esta revisión ofrece una visión general de cuestiones significativas relacionadas con la terapia con la plataforma vibratoria para la prevención y tratamiento de la osteoporosis en mujeres postmenopáusicas. El objetivo de esta revisión ha sido conocer los últimos avances de entrenamiento con plataformas vibratorias para la mejoría de la masa ósea en mujeres posmenopáusicas. Existe una gran discrepancia respecto al uso de estas como tratamiento osteoporósico, uso de diferentes tipos de plataformas, distintas frecuencias, amplitud, aceleración o duración del tratamiento. La escasa literatura estableció que la plataforma vibratoria Galileo es la que más se utiliza en dicha población, pero se necesitan más intervenciones para concretar los beneficios y daños de este tratamiento en mujeres postmenopáusicas(AU)

Recent studies have suggested that mechanical stimuli (vibrations) of high frequency and low magnitude can exert a positive effect on bone morphology and benefit quantity and quality. The vibrating platform is a popular machine introduced in the last decade as a new promise against the treatment of osteoporosis. Currently, there are more than 200 million postmenopausal women in the world suffering from osteoporosis. This disease is one of the most common and expensive in public health. Physical exercise supplemented with vibrational treatment may be considered an effective strategy for the prevention and treatment of postmenopausal osteoporosis. This review offers an overview of significant issues related to therapy with the vibration platform for the prevention and treatment of osteoporosis in postmenopausal women. The objective of this review is to know the latest advances in vibratory platforms training for the improvement of bone mass in postmenopausal women. There is a great discrepancy regarding the use of vibratory platforms as osteoporosis treatment, the use of different types of platforms, different frequencies, amplitude, acceleration or duration of treatment. The limited literature established that Galileo vibration platform is the most used in this population, but more interventions are needed to grasp the benefits and harms of this treatment in postmenopausal women(AU)

Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial.

BACKGROUND: In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) < 400 µm, as per National Institute for Health and Care Excellence guidelines. It remains unclear whether subthreshold micropulse laser is superior and should replace standard threshold laser for the treatment of eligible patients. METHODS: DIAMONDS is a pragmatic, multicentre, allocation-concealed, randomised, equivalence, double-masked clinical trial that aims to determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser compared with standard threshold laser, for the treatment of diabetic macular oedema with CST < 400 µm. The primary outcome is the mean change in best-corrected visual acuity in the study eye from baseline to month 24 post treatment. Secondary outcomes (at 24 months) include change in binocular best corrected visual acuity; CST; mean deviation of the Humphrey 10-2 visual field; change in percentage of people meeting driving standards; European Quality of Life-5 Dimensions, National Eye Institute Visual Functioning Questionnaire-25 and VisQoL scores; incremental cost per quality-adjusted life year gained; side effects; number of laser treatments and use of additional therapies. The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials. The difference between lasers for change in best-corrected visual acuity (using 95% CI) will be compared to the permitted maximum difference of five Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Linear and logistic regression models will be used to compare outcomes between treatment groups. A Markov-model-based cost-utility analysis will extend beyond the trial period to estimate longer-term cost-effectiveness. DISCUSSION: This trial will determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser, when compared with standard threshold laser, for the treatment of diabetic macular oedema, the main cause of sight loss in people with diabetes mellitus. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN17742985 . Registered on 19 May 2017 (retrospectively registered).

Assessment of genetically modified soybean MON 87708 × MON 89788 × A5547-127, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2016-135).

Soybean MON 87708 × MON 89788 × A5547-127 (three-event stack soybean) was produced by conventional crossing to combine three single events: MON 87708, MON 89788 and A5547-127. The GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the three-event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the three-event stack soybean, as described in this application, is as safe as and nutritionally equivalent to its conventional counterpart and the non-GM reference varieties tested. The nutritional impact of food/feed derived from the three-event stack soybean is expected to be the same as that of food/feed derived from the conventional counterpart and non-GM reference varieties. In the case of accidental release of viable seeds of the three-event stack soybean into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the three-event stack soybean. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the three-event stack soybean is as safe as its conventional counterpart and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

Real Life Experience of Dexamethasone Implant in Refractory Diabetic Macular Oedema.

PURPOSE: The purpose of this retrospective study was to examine the efficacy of dexamethasone implant in refractory diabetic macular oedema (DMO) in real life settings. METHODS: In all, 24 eyes of 22 patients that required treatment with single or multiple intravitreal dexamethasone implants for refractory DMO were included in the study. Patients having macular oedema for another retinal disease were excluded from the study. The patient data were collected and analyzed retrospectively. As a demographic data age, gender, the type of diabetes and the duration of DMO were collected. Changes in central foveal thickness and the number of hyper reflective spots (HRS) were analyzed with Heidelberg SD-OCT. Furthermore, the best-corrected visual acuity (BCVA) and changes in the intraocular pressure (IOP) were measured. RESULTS: In all, 50.0% of the eyes with baseline BCVA 0.45 (±2.4) lines in ETDRS LogMAR scale received only one implant during the follow-up of 332 (±79) days. At the end of the follow-up, BCVA was 0.26 (±2.0) lines. The other 50.0% of the eyes with baseline BCVA 0.64 (±3.0) lines received the second implant in 156 (±38) days. Central retinal thickness (CRT) at baseline was 333 (±44) µm in the eyes with only one implant and 497 (±125) µm in the eyes with 2 or more implants. IOP lowering medication was needed for 8.3% of the eyes. The decrease in the number of HRS was significant (8±17, p=0.048) in response to dexamethasone implantation. CONCLUSION: The dexamethasone implant is a useful treatment in refractory DMO and HRS seen in the OCT might indicate inflammation in the retina.

Effectiveness of Intravitreal Dexamethasone Implant Treatment for Diabetic Macular Edema in Vitrectomized Eyes

Objectives: To report the effectiveness and long-term outcomes of intravitreal dexamethasone implantation for diabetic macular edema (DME) in vitrectomized eyes. Materials and Methods: Medical records of patients were retrospectively reviewed. Time of pars plana vitrectomy (PPV), PPV indications, interval between DEX injection and PPV, other intravitreal treatment prior to DEX application, best corrected visual acuity (BCVA), intraocular pressure (IOP), and central retinal thickness (CRT) measured by optical coherence tomography were recorded. Results: Seventeen eyes of 17 patients were included in the study. The mean follow-up after DEX injection was 21±2.4 months (12-43 months). The female/male ratio was 11/6. Mean age was 60.7 years (46-70 years). Sixteen eyes (94.1%) were pseudophakic at the time of DEX treatment. The most common indication for PPV was tractional retinal detachment (8 eyes, 47.1%). Ten eyes (58.8%) received a single injection and a total of 30 DEX implantations were performed. Mean BCVA was 0.77 logarithm of the minimum angle of resolution (logMAR) units before the first injection and improved to 0.64, 0.68 and 0.66 logMAR after 1, 3 and 6 months, respectively (p<0.01). CRT decreased significantly from 452 µm at baseline to 310, 368±34 and 375 µm after 1, 3 and 6 months, respectively (p<0.04). Mean IOP was 16±1.2 mmHg at baseline and 18.2, 18.8 and 18.5 mmHg after 1, 3, and 6 months (p>0.05). Two eyes (%8) received topical anti-glaucoma medication (IOP≥25 mmHg). Similar results were observed in eyes receiving repeated DEX injections. Conclusion: Intravitreal DEX injection treatment seems to be effective for improving BCVA and decreasing CRT in vitrectomized eyes with DME. This effect seemed to last for 6 months in most eyes, but maximized at 3 months. Patients with repeated injections often require injection before 6 months.

Effect of common processing of soybeans on the enzymatic activity and detectability of the protein, Dicamba Mono-Oxygenase (DMO), introduced into dicamba-tolerant MON 87708.

Assessing the safety of genetically engineered crops includes evaluating the risk (hazard and exposure) of consuming their newly expressed proteins. The dicamba monooxygenase (DMO) protein, introduced into soybeans to confer tolerance (DT) to dicamba herbicide, was previously characterized and identified to pose no food or feed safety hazards. Most agricultural commodities (e.g., soybeans, maize) enter the food supply after processing methods that can include exposure to high temperatures, harsh solvents or pH extremes that can adversely impact the structure and function of proteins. To understand the likelihood of exposure to DMO in foods from DT soy, enzymatically active and/or immunodetectable forms of DMO were measured in pilot-scale productions of two soy foods (soymilk and tofu), and eight processed fractions (full fat flour, inactivated full fat flour, defatted flour, toasted meal, protein isolate, protein concentrate, crude lecithin, and refined, bleached and deodorized oil). Western blot analysis detected DMO in tofu and in five of the eight processed fractions. DMO activity was not detected in either soymilk or tofu, nor in six of the eight processed fractions. Therefore, many commercial soy processing methods can denature and/or degrade introduced proteins, like DMO. Although the DMO protein has shown no evidence of hazard, this study demonstrates that processing further reduces any food or feed risk by limiting dietary exposure to intact DMO protein.

[Document management systems to support quality management systems at university hospitals - an interview-based study]. / Dokumenten-Management-Systeme zur Unterstützung des Qualitätsmanagements an Universitätskliniken ­ Eine interviewbasierte Studie.

In order to save and control the processes and quality of medical services, a suitable steering system of all relevant documents is essential from the point of view of clinical quality management. Systems supporting an automated steering system of documents are called document management systems (DMS), and they also enter the healthcare sector. The use of DMS in the German healthcare sector has hardly been investigated so far. To close this knowledge gap, interviews were carried out with German university hospitals over a six-month period and subjected to a qualitative content analysis according to Mayring. In total, 25 university hospitals agreed to participate in this study, 19 of which have been working with a digital DMS for about six years on average. There was a great variety among the IT systems used. Document management and usability of the DMS as well as its integration into existing IT structures were key decision-making criteria for the selection of a digital DMS. In general, the long-term usability of the DMS is supported by regular evaluation of one's own requirements for the system, administration and training programs. In addition, DMS have a positive effect on patient safety and the quality of medical care.