RESUMEN
BACKGROUND: To investigate the safety (adverse events [AEs] and post-vaccination multiple sclerosis [MS] activity within 6 weeks), clinical efficacy (protection against coronavirus disease 2019 [COVID-19]), and vaccine-induced humoral immunogenicity (SARS-CoV-2 neutralizing antibody, anti-nucleocapsid IgG, and anti-spike IgG) of the Sinopharm (BBIBP-CorV) vaccine among people with MS (PwMS) receiving different disease-modifying therapies (DMTs). METHODS: This prospective cohort study was conducted between November 2021 and May 2022. PwMS were followed for six months after the 2nd dose of vaccination. Antibody responses were measured 2-16 weeks after the 2nd dose injection. Multivariate logistic regression was employed to assess the impact of each DMT on dichotomous antibody responses, adjusting for age, sex, MS phenotype, expanded disability status scale, disease duration, and vaccination-antibody titration interval. RESULTS: Among the 261 screened PwMS, 209 (aged 38.23 ± 9.73 years, female: 70.8%; relapsing-remitting MS: 80.4%) were included. The frequencies of experiencing non-serious AEs and post-vaccination MS activity were 66.0% and 4.8%, respectively. Breakthrough COVID-19 infection was observed in 14.8% of the PwMS. A subcohort of 125 PwMS was assessed for antibody responses. Positive neutralizing antibodies, anti-nucleocapsid IgG, and anti-spike IgG were detected in 36.8%, 35.2%, and 52.0% of the PwMS, respectively. Multivariate regression indicated a 96% (OR: 0.04 [95% CI: 0.00, 0.51], P = 0.013), 93% (OR: 0.07 [0.01, 0.64], P = 0.019), and 89% (OR: 0.11 [0.01, 0.96], P = 0.045) reduced odds of positive neutralizing antibody, anti-nucleocapsid IgG, and anti-spike IgG, respectively, among fingolimod-receivers. Additionally, anti-CD20s-receivers had 88% (OR: 0.12 [0.02, 0.85], P = 0.034) lower odds of being positive for anti-nucleocapsid IgG. CONCLUSIONS: BBIBP-CorV appeared to be well tolerated in PwMS, with promising clinical efficacy. However, a suboptimal humoral response was observed in PwMS receiving fingolimod and anti-CD20s. Future research should investigate the relationship between humoral responses and the frequency and severity of COVID-19 infection across various DMTs.
Asunto(s)
Anticuerpos Neutralizantes , Vacunas contra la COVID-19 , COVID-19 , Esclerosis Múltiple , Humanos , Femenino , Masculino , COVID-19/prevención & control , COVID-19/inmunología , COVID-19/epidemiología , Adulto , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/administración & dosificación , Estudios Prospectivos , Persona de Mediana Edad , Esclerosis Múltiple/inmunología , Esclerosis Múltiple/tratamiento farmacológico , Anticuerpos Neutralizantes/sangre , Anticuerpos Neutralizantes/inmunología , Anticuerpos Antivirales/sangre , Anticuerpos Antivirales/inmunología , SARS-CoV-2/inmunología , Inmunogenicidad Vacunal/inmunología , Estudios de Cohortes , Resultado del Tratamiento , Inmunoglobulina G/sangre , Inmunoglobulina G/inmunología , Vacunas de Productos InactivadosRESUMEN
BACKGROUND: Door-to-needle (DTN) is the duration between patient's arrival at the hospital and receiving intravenous thrombolysis in ischemic stroke settings, for which studies have reported delays in women. The "D's of stroke care" describes 8 steps (D1 to D8) in patients' time tracker. We implemented simple modifications to the "D's of stroke care" by splitting D4 and D6 steps into these substeps: patients' arrival to the emergency room (D4-A), early assessment by a neurologist (D4-B), neurologist decision on patient's eligibility to receive recombinant tissue plasminogen activator (D6-A), and patient's transfer to the stroke unit (D6-B). We evaluated the effect of these changes on reducing DTN time disparity between men and women. METHODS: This study was conducted from September 2019 to August 2021, at a comprehensive stroke center. Patients were analyzed in 2 groups: group 1, before, and group 2, after using the modifications. Sex as the main variable of interest along with other covariates was regressed toward the DTN time. RESULTS: In groups 1 and 2, 47 and 56 patients received intravenous thrombolysis, respectively. Although there was a significant difference in DTN≤1 hour between women and men in group 1 (36% vs. 52%, P =0.019), it was not significantly different in group 2 ( P =0.97). Regression analysis showed being female was a significant predictor of DTN>1 hour in group 1 (adjusted odds ratio=6.65, P =0.02), whereas after using the modifications, sex was not a significant predictor for delayed DTN. CONCLUSIONS: Implementing these substeps reduced sex disparity in DTN time in our center.
Asunto(s)
Accidente Cerebrovascular , Activador de Tejido Plasminógeno , Masculino , Humanos , Femenino , Activador de Tejido Plasminógeno/uso terapéutico , Fibrinolíticos/uso terapéutico , Terapia Trombolítica , Accidente Cerebrovascular/tratamiento farmacológico , Servicio de Urgencia en Hospital , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
Background: Myasthenia gravis (MG) is a chronic neuromuscular disease, which physically and mentally affects the patient's life, with depression being one of the most important psychological complications in these patients. This study aims to investigate the prevalence of depression and its associated factors in a group of Iranian patients with MG. Methods: This was a cross-sectional study in which consecutive patients diagnosed with MG who referred to two referral neuromuscular clinics affiliated to the Tehran University of Medical Sciences, Tehran, Iran, were evaluated for eligibility. Patients with a previously known psychiatric disorder and those with a family history of mental disorders were excluded. Eligible patients were interviewed and screened for depression through the administration of the Hamilton Depression Rating Scale (HDRS) and the Iranian version of Beck Depression Inventory-II (BDI-II). Results: A total of 62 patients participated in this study. The total prevalence of depression according to the HDRS and BDI-II scores was 64.5% and 53.2%, respectively. The mild depression was the most frequent level of depression based on the HDRS (33.9%) and BDI-II (22.6%) scores. None of the variables, including age, sex, duration of the disease, and dosages of prednisolone, pyridostigmine, and azathioprine, were correlated with the severity of depression. The number of academic years was the only variable associated with the lower HDRS score (P = 0.037). Conclusion: Based on the current findings, depression was common among Iranian patients with MG. The severity of depressive symptoms was unrelated to age, sex, marital status, duration of the disease, the daily dosage of medications, and thymectomy status. Further investigations are needed to reveal the exact burden of depression in patients with MG and address the importance of preventive interventions for improving the quality of life (QOL) in these patients.