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1.
Harefuah ; 163(5): 278-285, 2024 May.
Artículo en Hebreo | MEDLINE | ID: mdl-38734939

RESUMEN

INTRODUCTION: The importance of myopia management lies in the desire to minimize the potential ocular risks that increase with high myopia. AIMS: To assess the decrease in myopia progression using topical low dose atropine combined with peripheral blur contact lenses (CL). METHODS: This retrospective review study included 25 children between the ages of 8.5 years to 14 years. The children all had a minimal increase in myopia of 0.75D during the year prior to treatment. The children were divided into two groups. The control group included 14 children who wore single-vision spectacles )SV) averaging 3.20±0.9D ranging from 1.5-5.3D. The study group included 11 children who wore dual-focus CL, with an average prescription of 3.4±0.7D ranging from 2.5 to 4.3D, for one year. At that point, when an additional myopia increase was observed, the children were additionally treated with topical 0.01% atropine for two years (CL+A0.01). RESULTS: There was an increase in myopia in the SV group of 1.12±0.52D, 1.08±0.56D and 0.96±0.53D in the first, second, and third years, respectively. The myopia increase in the CL+A0.01 group was 0.57±0.48D, 0.14±0.34D, and 0.17±0.29D in the first, second, and third years, respectively. CONCLUSIONS: Low-dose atropine combined with peripheral blur contact lenses was effective in decreasing myopia progression in this study. Additional, larger-scale studies are required in the future. DISCUSSION: This study found a significant decrease in myopia progression in the second and third years of treatment. The CL group showed less effectivity than the CL+A0.01 group.


Asunto(s)
Atropina , Lentes de Contacto , Progresión de la Enfermedad , Miopía , Humanos , Atropina/administración & dosificación , Niño , Miopía/terapia , Miopía/fisiopatología , Estudios Retrospectivos , Adolescente , Masculino , Femenino , Resultado del Tratamiento , Midriáticos/administración & dosificación , Soluciones Oftálmicas/administración & dosificación , Anteojos
2.
Am J Ophthalmol ; 2024 Apr 25.
Artículo en Inglés | MEDLINE | ID: mdl-38677637

RESUMEN

PURPOSE: To measure and compare the inter- examiner reproducibility of manifest refraction in patients with keratoconus. DESIGN: Prospective, inter-examiner reliability analysis comparing "cases and controls" METHODS: Patients with Keratoconus (KC) and healthy subjects had undergone manifest refraction by the same two skilled optometrists, each was masked to the refraction of the other, on the same day. The KC group was comprised of patients with KC, who were recruited from the cornea clinic. The control group consisted of healthy individuals who wore spectacles and did not have KC. Participants for the control group were recruited from the clinic's staff, including doctors, technicians, nurses, and medical students. The study took place in one tertiary medical center in Israel from April 2021 to May 2022. The results of the manifest refraction and achieved corrected distance visual acuity (CDVA) were compared between groups. RESULTS: A total of 120 eyes of 60 patients were enrolled in the study; Thirty in the keratoconus group and 30 in the control group. A difference of 0.67±0.83 D and 0.19±0.21 D in the absolute manifest cylinder was observed between the optometrists in the keratoconus (95% LoA, -0.96, 2.30) and control group (95% LoA, -0.22, 0.61), respectively (p<0.001). Multivariate analysis revealed a 22-fold higher likelihood of an error exceeding 0.75 D in cylinder measurements (OR, 22.24; 95% CI, 2.39-206.95) and a tenfold likelihood of a difference of at least one row on the Snellen chart for CDVA (OR,10.32; 95% CI,2.39-44.44) in the KC group. CONCLUSION: when compared to healthy subjects, patients with KC exhibit greater variability in manifest refraction. This discrepancy has the potential to influence the decision-making process when managing patients with KC.

3.
Can J Ophthalmol ; 2024 Jan 11.
Artículo en Inglés | MEDLINE | ID: mdl-38219792

RESUMEN

OBJECTIVE: It is accepted that ocular parameters are more correlated with the fellow eye. This poses a challenge in ophthalmic research. There is a relative scarcity of data concerning the extent of correlation. The aim of this study was to analyze and quantify the correlation of different ocular parameters. DESIGN: Historical registry analysis. PARTICIPANTS: All patients examined in a 10-year period (2011-2021) in one academic tertiary medical centre in central Israel. METHODS: Data from optical coherence tomography examinations and biometry of a single examination of both eyes taken at the same time from each patient was included. Pearson's r values were calculated to estimate the extent of correlation. RESULTS: A total of 17,212 patients were included. Mean age was 73 ± 12.7 years, and 54.5% were female. All examined parameters were highly statistically significantly correlated between eyes (all with p < 0.1 × 10-36), whereas the strength of correlation differed. Very weak correlation was seen in central macular thickness (r = 0.189), and a weak correlation was seen in anterior-chamber depth (r = 0.379) and retinal nerve fibre layer thickness (r = 0.479). A strong correlation was seen in central corneal thickness (r = 0.754), and a very strong correlation was seen in axial length (r = 0.900). CONCLUSIONS: In a retrospective analysis of optical coherence tomography and biometry measurements of >10,000 patients, all examined parameters were highly statistically significantly correlated. Correlation magnitude varied, with structural characteristics more correlated than functional ones. Including both eyes in an outcome analysis likely will introduce bias. We recommend adjusting for inter-eye correlation in all studies assessing ocular outcome measures.

4.
Artículo en Inglés | MEDLINE | ID: mdl-38183467

RESUMEN

PURPOSE: The purpose of this study is to assess the diagnostic accuracy of ChatGPT in the field of ophthalmology. METHODS: This is a retrospective cohort study conducted in one academic tertiary medical center. We reviewed data of patients admitted to the ophthalmology department from 06/2022 to 01/2023. We then created two clinical cases for each patient. The first case is according to the medical history alone (Hx). The second case includes an addition of the clinical examination (Hx and Ex). For each case, we asked for the three most likely diagnoses from ChatGPT, residents, and attendings. Then, we compared the accuracy rates (at least one correct diagnosis) of all groups. Additionally, we evaluated the total duration for completing the assignment between the groups. RESULTS: ChatGPT, residents, and attendings evaluated 126 cases from 63 patients (history only or history and exam findings for each patient). ChatGPT achieved a significantly lower accurate diagnosis rate (54%) in the Hx, as compared to the residents (75%; p < 0.01) and attendings (71%; p < 0.01). After adding the clinical examination findings, the diagnosis rate of ChatGPT was 68%, whereas for the residents and the attendings, it increased to 94% (p < 0.01) and 86% (p < 0.01), respectively. ChatGPT was 4 to 5 times faster than the attendings and residents. CONCLUSIONS AND RELEVANCE: ChatGPT showed low diagnostic rates in ophthalmology cases compared to residents and attendings based on patient history alone or with additional clinical examination findings. However, ChatGPT completed the task faster than the physicians.

5.
Retina ; 44(1): 78-82, 2024 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-37607406

RESUMEN

PURPOSE: To evaluate the risk of a retinal redetachment in women after vaginal delivery versus cesarean delivery. METHODS: Retrospective cohort analysis of patients diagnosed with retinal detachment (RD) who had later delivered in one tertiary medical center. Recurrence rates of RD were obtained from medical charts. RESULTS: A total of 967 women with RDs were evaluated, and 66 patients met the inclusion criteria. The mean age at the time of RD was 22.64 ± 5.81 SD years and 21.75 ± 5.47 SD years in the vaginal delivery group and the cesarean section group, respectively. None of the patients had a history of eye surgery or traumatic eye injury before the event of RD. In all patients, the detached retina was surgically reattached. Retinal detachment was not recorded in the fellow eye during follow-up. We report four cases of redetachment after birth in four women. In our study, there was a 5% rate (n = 2) of RD after a vaginal delivery as compared with a 7.5% (n = 2) redetachment rate for patients after a cesarean delivery ( P = 0.654). CONCLUSION: The risk of a redetachment of the retina in women is not increased after a vaginal delivery as compared with a cesarean delivery. Therefore, in our opinion, there is no ophthalmic benefit in a cesarean section for a woman with prior RD.


Asunto(s)
Cesárea , Desprendimiento de Retina , Humanos , Femenino , Embarazo , Cesárea/efectos adversos , Estudios Retrospectivos , Desprendimiento de Retina/diagnóstico , Desprendimiento de Retina/epidemiología , Desprendimiento de Retina/etiología , Parto Obstétrico/efectos adversos , Estudios de Cohortes
6.
J Neuroophthalmol ; 43(1): 29-33, 2023 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-36790061

RESUMEN

BACKGROUND: To describe recent cases of optic neuritis in patients who received a vaccine for COVID-19. METHODS: Retrospective case series of patients diagnosed with optic neuritis after a recent COVID-19 vaccination with BNT162b2 (Pfizer-BioNTech), in one university-affiliated tertiary hospital, from January 2021 to June 2021. Data were obtained from medical charts. RESULTS: We describe 7 patients who developed optic neuritis after immunization with the BNT162b2 vaccine. CONCLUSIONS: A causal relationship cannot be deduced, and the importance of COVID-19 vaccination is not challenged. However, the authors encourage a prospective monitoring and reporting system for all patients receiving COVID-19 vaccines, to further assess the spectrum of adverse events in large databases.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Neuritis Óptica , Humanos , Vacuna BNT162 , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Neuritis Óptica/diagnóstico , Neuritis Óptica/etiología , Estudios Prospectivos , Estudios Retrospectivos , SARS-CoV-2 , Vacunación/efectos adversos
8.
Ophthalmic Epidemiol ; 30(5): 515-522, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-36598174

RESUMEN

PURPOSE: The application of myopia definition varies considerably within the literature. The purpose of this study was to examine the relationship between different myopia and high myopia definitions and resultant prevalence estimates. METHODS: A population-based cross-sectional study of 1,588,508 Israeli adolescents assessed for medical fitness before mandatory military service at the age of 17 years between 1993 through 2015. Participants underwent non-cycloplegic autorefraction. Nine definitions of myopia and seven definitions of high myopia were examined. Prevalence estimates for each definition were calculated and compared with the reference definition (right eye spherical equivalent (SE)≤-0.50D and ≤-6.00D for myopia and high myopia, respectively), to yield a rate ratio (RR) across definitions. RESULTS: Applying the right eye SE≤-0.50D reference definition yielded 31.0% myopia prevalence. While some definitions resulted in similar prevalence estimates, using the right eye SE of ≤-0.75D; ≤-1.00D or least minus meridian of ≤-0.75D definitions yielded 28.8%, 26.3%, and 26.9% myopia prevalence, respectively, which corresponded to a 7.1%, 15.1% and 13.4% reduction in myopia RR, respectively. The prevalence of high myopia demonstrated considerable alternations, with a 1.7-fold increase in prevalence for the narrower threshold of SE≤-5.00D compared with SE≤-6.00D reference definition (4.2% and 2.4%, respectively). CONCLUSIONS: The prevalence of myopia and especially high myopia varies between frequently applied definitions, considering diverse thresholds, eye lateralization, and spherical vs. astigmatic refractive components. This variability highlights the pressing need for standardization of myopia definition in ophthalmic research. The results of this study provide crude estimates of a "conversion rate" across data, allowing comparisons between studies that utilize different myopia definitions.


Asunto(s)
Miopía , Humanos , Adolescente , Estudios Transversales , Miopía/epidemiología , Refracción Ocular , Pruebas de Visión , Ojo , Prevalencia
9.
Eye (Lond) ; 37(9): 1834-1839, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36127423

RESUMEN

OBJECTIVE: To evaluate the accuracy of the ABCD Progression Display and the ABCD grading system in a population of adult patients with keratoconus. METHODS: A retrospective cohort analysis of all adult patients with keratoconus followed at the Shamir Medical Center between 2012 and 2017. A recommendation by the cornea specialist to undergo corneal crosslinking (CXL) was used as a surrogate of ectasia progression. The ABCD grading was not available to the treating physician and was computed post-hoc. Sensitivity and specificity of the ABCD Progression Display was calculated, and multivariate regression was used to estimate the risk to undergo CXL when the ABCD Progression Display indicated progression. The ABCD grading was compared between patients who required CXL to those who did not. A single eye of each patient was included. Sensitivity and specificity of the ABCD Progression Display were 82% and 73%, respectively. A multivariable model adjusted for possible confounders, found that ABCD Progression was associated with a 7-fold risk of undergoing CXL compared to a patient in whom progression was not recorded in the ABCD Progression Display (OR = 7.55; 95% CI = 3.82-14.93, p < 0.001). RESULTS: 293 eyes of 293 patients were analysed. Mean age at presentation was 26.92 ± 6.12 years. In 68 eyes, progression of keratoconus was recorded and CXL was performed (CXL-group). CONCLUSION: The ABCD Progression Display demonstrated adequate sensitivity and specificity and high predictive capabilities of keratoconus progression. It can be effectively utilized as an initial screening test in adults with keratoconus.


Asunto(s)
Queratocono , Fotoquimioterapia , Adulto , Humanos , Adulto Joven , Queratocono/diagnóstico , Queratocono/tratamiento farmacológico , Fármacos Fotosensibilizantes/uso terapéutico , Estudios Retrospectivos , Riboflavina/uso terapéutico , Colágeno/uso terapéutico , Reactivos de Enlaces Cruzados/uso terapéutico , Rayos Ultravioleta , Topografía de la Córnea
10.
Cornea ; 2023 Dec 28.
Artículo en Inglés | MEDLINE | ID: mdl-38166187

RESUMEN

PURPOSE: The aim of the study was to evaluate the efficacy and safety of quantum molecular resonance in the treatment of dry eye disease. METHODS: This study was a double-blind randomized control trial in 1 academic medical center, for 2 years. Participants received treatment or a placebo with the Rexon-Eye device, once per week for 4 weeks. The primary outcome was the change in dry eye symptoms assessed by the Ocular Surface Disease Index (OSDI). Secondary outcomes were clinical findings associated with the dry eye such as meibomian gland dysfunction (MGD) score, tear break-up time (TBUT), corneal fluorescein staining, Schirmer test, and best-corrected visual acuity (BCVA). RESULTS: Forty patients were recruited, 20 in each arm. The mean age was 63.5 ± 15.1 years and 27 (67.5%) were female. The mean OSDI score significantly improved in the intervention group from 19.15 ± 10.3 to 10.5 ± 7.0 (P < 0.001), whereas the control group showed no significant change (14.4 ± 8.4 to 15.5 ± 8.6, P = 0.830). MGD scores significantly improved in the intervention group (1.57 ± 1.2 to 0.8 ± 0.9, P = 0.006), whereas showing no significant change in the control group (1.60 ± 0.9 to 1.99 ± 1.0, P = 0.244). The corneal staining score also showed significant improvement in the intervention group (P = 0.045) and a nonsignificant decline in the placebo group (P = 0.50). No significant difference was seen in TBUT, visual acuity, and Schirmer scores between groups. No harm resulting from treatment was reported during the duration of the trial. CONCLUSIONS: High-frequency electrotherapy may have a positive effect on symptoms and signs of dry eye. This emerging technology may become part of the arsenal of therapeutic modalities for this condition.

11.
Harefuah ; 161(11): 664-667, 2022 Nov.
Artículo en Hebreo | MEDLINE | ID: mdl-36578235

RESUMEN

INTRODUCTION: Microsporidia is a phylum of intracellular parasites that secrete spores and stay in water sources. These parasites can cause infection in humans by invading the digestive system, the urinary system, the muscular system and the eye. Recently, the Israeli Ministry of Health announced that dozens of people in Israel were suspected of being infected with microsporidial keratitis after bathing in the waters of the Kinneret (Sea of Galilee). Here we present a brief overview of this microsporidial keratitis as well as three case presentations.


Asunto(s)
Infecciones Fúngicas del Ojo , Queratitis , Microsporidios , Humanos , Infecciones Fúngicas del Ojo/diagnóstico , Infecciones Fúngicas del Ojo/microbiología , Queratitis/diagnóstico , Queratitis/microbiología , Microsporidios/aislamiento & purificación
12.
J Refract Surg ; 38(10): 668-673, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36214349

RESUMEN

PURPOSE: To assess the refractive prediction error of four intraocular lens (IOL) calculation formulas in eyes that have undergone scleral fixation using the four-flanged technique. METHODS: This was a retrospective cohort analysis of patients who underwent scleral fixation using the four-flanged technique at the Shamir Medical Center between 2020 and 2021. Refractive prediction errors for four IOL prediction formulas (Barrett Universal II, Holladay 1, SRK/T, and Kane) were obtained by subtracting the predicted spherical equivalent from the postoperative spherical equivalent. Mean arithmetic refractive prediction error and mean absolute error were calculated and compared. RESULTS: Twenty-three eyes of 23 patients were included in the analysis. The Akreos AO60 IOL (Bausch & Lomb, Inc) was implanted in 9 eyes and the BunnyLens HP IOL (Hanita Lenses) in 14 eyes. Mean age was 72.84 ± 13.2 years. All formulas produced myopic mean arithmetic refractive prediction error. Mean arithmetic refractive error and mean absolute error were equal in absolute number. Mean arithmetic refractive prediction errors were -0.72 diopters (D) for Barrett Universal II, -0.61 D for Holladay 1, -0.77 D for SRK/T, and -0.94 D for Kane formulas. The refractive outcome differed significantly from the predicted refraction in all formulas. There were no statistically significant differences in prediction errors between the formulas. CONCLUSIONS: Refractive outcomes of the four-flanged fixation technique produced myopic results compared to the predicted refraction for all formulas tested. This suggests that the effective lens position is more anterior than in-the-bag IOL implantation. [J Refract Surg. 2022;36(10):668-673.].


Asunto(s)
Lentes Intraoculares , Miopía , Facoemulsificación , Errores de Refracción , Anciano , Anciano de 80 o más Años , Biometría/métodos , Humanos , Implantación de Lentes Intraoculares/métodos , Persona de Mediana Edad , Miopía/cirugía , Óptica y Fotónica , Refracción Ocular , Estudios Retrospectivos
13.
Sci Rep ; 12(1): 15206, 2022 09 08.
Artículo en Inglés | MEDLINE | ID: mdl-36076017

RESUMEN

A growing number of familial Mediterranean fever (FMF) patients in Israel do not have a single country of origin for all four grandparents. We aimed to predict the Mediterranean fever gene (MEFV) variant most likely to be found for an individual FMF patient, by a machine learning approach. This study was conducted at the Sheba Medical Center, a referral center for FMF in Israel. All Jewish referrals included in this study carried an FMF associated variant in MEFV as shown by genetic testing performed between 2001 and 2017. We introduced the term 'origin score' to capture the dose and different combinations of the grandparents' origin. A machine learning approach was used to analyze the data. In a total of 1781 referrals included in this study, the p.Met694Val variant was the most common, and the variants p.Glu148Gln and p.Val726Ala second and third most common, respectively. Of 26 countries of origin analyzed, those that increased the likelihood of a referral to carry specific variants were identified in North Africa for p.Met694Val, Europe for p.Val726Ala, and west Asia for p.Glu148Gln. Fourteen of the studied countries did not show a highly probable variant. Based on our results, it is possible to describe an association between modern day origins of the three most common MEFV variant types and a geographical region. A strong geographic association could arise from positive selection of a specific MEFV variant conferring resistance to endemic infectious agents.


Asunto(s)
Fiebre Mediterránea Familiar , Fiebre Mediterránea Familiar/complicaciones , Fiebre Mediterránea Familiar/genética , Humanos , Israel , Judíos , Aprendizaje Automático , Mutación , Pirina/genética
15.
J Matern Fetal Neonatal Med ; 35(25): 7911-7916, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34107848

RESUMEN

OBJECTIVE: We aimed to assess the role of lactate and hemoglobin levels as predictors for the need for blood transfusion in post-partum hemorrhage (PPH). METHODS: A retrospective cohort study of women with PPH in a single university-affiliated tertiary medical center between August 2018 and June 2020. PPH was defined as an estimated excessive blood loss (of more than 500 ml following vaginal delivery and 1000 ml following a cesarean delivery) requiring at least one uterotonic drug and fluid resuscitation. Women were stratified by the need of requiring blood transfusion due to hemorrhage. The criteria for blood transfusion were: (1) clinically severe uncontrollable ongoing hemorrhage; (2) symptomatic anemia (maternal tachycardia >110 beats per minute, dizziness, syncope or presyncope) in the presence of Hb 7-8 g/dL; or (3) postpartum Hb level < 7 g/dL regardless of maternal symptoms or signs of anemia. Demographic, labor characteristics as well as laboratory data were collected. For all women the Shock Index (SI: heart rate divided by systolic blood pressure) was calculated. Women without available data on immediate (more than 15 min from the bleeding initiation) hemoglobin (Hb) level and lactate concentrations were excluded. RESULTS: Overall, out of 22,241 deliveries during the study, 94 women were included, of them 26 (23.4%) required blood transfusion. The antepartum Hb level was lower in the transfused group (11.7 ± vs 12.4 ± 1.0 re/dL, p = .01). No significant differences were found in demographic and labor characteristics. In multivariate logistic regression analysis, a lower immediate postpartum Hb and a higher SI higher were associated with blood transfusion requirement (adjusted odds ratio (aOR) 3.45 [CI] 1.82-7.69, p < .001] and aOR 1.25 [CI 1.03-1.55, p = .03], respectively). The combination of SI, immediate postpartum Hb and lactate concentration provided the best integration, with an area under the curve of 0.86, sensitivity 92.65%, specificity 61.54%, positive and negative predictive values of 86.3% and 76.2%, respectively. CONCLUSION: The combination of SI, immediate postpartum Hb and lactate levels is a good predictor for the need of blood requirement in PPH.


Asunto(s)
Anemia , Hemorragia Posparto , Embarazo , Femenino , Humanos , Hemorragia Posparto/diagnóstico , Estudios Retrospectivos , Transfusión Sanguínea , Hemoglobinas , Lactatos
16.
J Matern Fetal Neonatal Med ; 35(25): 9093-9097, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34882060

RESUMEN

OBJECTIVES: Intrapartum transperineal ultrasound (ITU) is an accepted tool for assessing fetal head position and station prior to operative vaginal delivery attempt. However, the validity of intrapartum ultrasound in real-life obstetrics with operators at different proficiency level is yet to be established. We aimed to investigate the association between operator level of training and reliability of angle of progression (AOP) measurements in real-life obstetrics. METHODS: This was a retrospective study in one university medical center. We included women who underwent ITU for the measurement of AOP, before vacuum assisted delivery from November 2017 to September 2020. AOP measurements performed by residents and their correlation to head station were compared to those performed by specialists. RESULTS: A total of 320 cases met the inclusion criteria. In 234 of them, AOP measurements were performed by specialists and in 86 by residents. Average AOP for each station was similar between the specialists and the residents groups, indicating similar accuracy. However, measurements in the residents group were more scattered (median deviation 11.4° vs. 8.9°, respectively, p = .021), indicating poorer precision. CONCLUSIONS: AOP measurements performed by obstetrics and gynecology (OBGYN) specialists are more precise than those performed by residents. Efforts should be taken to improve ITU training and to implement assessment of performance programs.


Asunto(s)
Feto , Presentación en Trabajo de Parto , Embarazo , Femenino , Humanos , Reproducibilidad de los Resultados , Estudios Retrospectivos , Ultrasonografía Prenatal , Estudios Prospectivos
18.
Rheumatology (Oxford) ; 60(6): 2878-2883, 2021 06 18.
Artículo en Inglés | MEDLINE | ID: mdl-34144604

RESUMEN

OBJECTIVE: FMF is an autoinflammatory disease of genetic origin. Colchicine is the mainstay of treatment for the prevention of attacks and long-term complications but 5-10% of FMF patients are resistant to colchicine therapy. The aim of our study was to investigate the real-life safety and efficacy of anakinra in a cohort of patients with colchicine-resistant FMF. METHODS: In this retrospective study, patients treated with anakinra for colchicine-resistant FMF between 2010 and 2018 were identified using the computerized database of Sheba Medical Center and enrolled in the study. Data from structured clinical files were analysed to evaluate the efficacy and safety outcomes. To assess efficacy, we used the Global Assessment Score (GAS), a measure comprised of three different domains: number of attacks per month, duration of attacks and number of sites involved in the attacks. Reported adverse events were compiled. RESULTS: A total of 44 patients (24 female) were treated with anakinra. Of these patients, 75% were homozygous for the M649V mutation. The mean duration of treatment was 18 months. The GAS decreased significantly from 6.6 (IQR 5.3-7.8) before treatment to 2 (IQR 0-4.2) while on treatment (P < 0.001). During anakinra treatment, six hospitalizations were reported (three due to related adverse effects). In addition, 11 patients suffered from injection site reactions (5 ceased treatment). Twelve patients reported mild side effects. CONCLUSION: Treatment with anakinra is beneficial for the majority of colchicine-resistant FMF patients and is relatively safe.


Asunto(s)
Fiebre Mediterránea Familiar/tratamiento farmacológico , Proteína Antagonista del Receptor de Interleucina 1/uso terapéutico , Adulto , Antirreumáticos/uso terapéutico , Estudios de Cohortes , Colchicina , Resistencia a Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
19.
JAMA Otolaryngol Head Neck Surg ; 147(8): 739-743, 2021 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-34165512

RESUMEN

Importance: Peripheral facial nerve (Bell) palsy has been reported and widely suggested as a possible adverse effect of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. Israel is currently the leading country in vaccination rates per capita, exclusively using the BNT162b2 vaccine, and all residents of Israel are obligatory members of a national digital health registry system. These factors enable early analysis of adverse events. Objective: To examine whether the BNT162b2 vaccine is associated with an increased risk of acute-onset peripheral facial nerve palsy. Design, Setting, and Participants: This case-control study was performed from January 1 to February 28, 2021, at the emergency department of a tertiary referral center in central Israel. Patients admitted for facial nerve palsy were matched by age, sex, and date of admission with control patients admitted for other reasons. Exposures: Recent vaccination with the BNT162b2 vaccine. Main Outcomes and Measures: Adjusted odds ratio for recent exposure to the BNT162b2 vaccine among patients with acute-onset peripheral facial nerve palsy. The proportion of patients with Bell palsy exposed to the BNT162b2 vaccine was compared between groups, and raw and adjusted odds ratios for exposure to the vaccine were calculated. A secondary comparison with the overall number of patients with facial nerve palsy in preceding years was performed. Results: Thirty-seven patients were admitted for facial nerve palsy during the study period, 22 (59.5%) of whom were male, and their mean (SD) age was 50.9 (20.2) years. Among recently vaccinated patients (21 [56.7%]), the mean (SD) time from vaccination to occurrence of palsy was 9.3 (4.2 [range, 3-14]) days from the first dose and 14.0 (12.6 [range, 1-23]) days from the second dose. Among 74 matched controls (2:1 ratio) with identical age, sex, and admittance date, a similar proportion were vaccinated recently (44 [59.5%]). The adjusted odds ratio for exposure was 0.84 (95% CI, 0.37-1.90; P = .67). Furthermore, analysis of the number of admissions for facial nerve palsy during the same period in preceding years (2015-2020) revealed a relatively stable trend (mean [SD], 26.8 [5.8]; median, 27.5 [range, 17-35]). Conclusions and Relevance: In this case-control analysis, no association was found between recent vaccination with the BNT162b2 vaccine and risk of facial nerve palsy.


Asunto(s)
Parálisis de Bell/etiología , Vacunas contra la COVID-19 , Vacunas contra la COVID-19/efectos adversos , Estudios de Casos y Controles , Femenino , Humanos , Israel , Masculino , Persona de Mediana Edad , Centros de Atención Terciaria
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