RESUMEN
BackgroundPregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed. MethodsWe conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185). We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period. Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus. ResultsWe identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included. Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant in the context of A/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03) - corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.
RESUMEN
RESUMEN Antecedentes: el carcinoma de células de Hürtlhe (CCH) de la glándula tiroides representa el 0,4-10% de los tumores diferenciados de tiroides. Se trataría de un carcinoma diferenciado de entidad propia. El tratamiento resulta controvertido dado que no existen estudios controlados prospectivos aleatorizados que validen la extensión de la tiroidectomía y la eficacia del tratamiento adyuvante con yodo radiactivo o radioterapia. Objetivo: analizar los factores pronósticos y de tratamiento que afectan la supervivencia del CCH. Material y métodos: se llevó a cabo una revisión sistemática de las bases MEDLINE, EMBASE COCHRANE y LILACS-BIREME con el objetivo de encontrar literatura relevante con respecto a los factores de riesgo y pronóstico que influyen en la supervivencia. Resultados: se identificaron el género masculino, tamaño tumoral > 4 cm, la invasión ganglionar y extratiroidea y las metástasis a distancia como factores de mal pronóstico. La tiroidectomía total muestra una tendencia favorable a la mayor supervivencia. Conclusión: el manejo de los pacientes con CCH continúa presentando aspectos controvertidos. Se requieren investigaciones a gran escala sobre tratamientos multimodales. El Registro Nacional abierto a todos los cirujanos por la AACCyC, cuyos resultados se conocerán en 2023, podrían aportar evidencias de mayor calidad. Los autores son conscientes de que esta presentación contiene fortalezas y debilidades. Entre las primeras, es el primer metanálisis que se realiza sobre factores pronóstico y de supervivencia del CCH; sin embargo, el grado de heterogeneidad de los trabajos resulta muy alto para algunas variables y no ha sido posible incluir otros factores de riesgo que puedan afectar el pronóstico.
ABSTRACT Background: Hürthle cell carcinoma (HCC) of the thyroid gland, which accounts for about 0.4-10% of all differentiated thyroid cancer, is considered differentiated carcinoma with a distinct entity. The treatment of this disease is controversial since there are no prospective randomized controlled trials validating the extent of thyroidectomy and the efficacy of adjuvant treatment with radioactive iodine or radiation therapy. Objective: The aim of this study is to analyze the prognostic factors affecting survival of patients with HCC. Material and methods: We performed an electronic search in MEDLINE, EMBASE, COCHRANE, and LILACS-BIREME databases to find relevant literature regarding risk and prognostic factors affecting survival. Results: Male sex, tumor size > 4 cm, lymph node involvement, extrathyroid extension and distant metastases were associated with adverse outcome. Total thyroidectomy showed a trend toward higher survival. Conclusions: The management of patients with HCC is still controversial. Large-scale research on multimodal treatments is required. The AACCyC national registry which is opened to all surgeons will provide high quality evidence on the matter. The authors are aware of the strengths and weaknesses of this presentation. This is the first meta-analysis on risk factors and survival of HCC; however, the degree of heterogeneity of the studies was very high for some variables and it was not possible to include in this analysis other risk factors that could affect the prognosis.
