Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

BackgroundGSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.MethodsVoluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated.ResultsFrom May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry.ConclusionsData currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs.     

The impact of the COVID-19 pandemic on hepatitis B virus vaccination and transmission among men who have sex with men: A mathematical modelling study

BackgroundDuring the COVID-19 pandemic, the number of hepatitis B virus (HBV) vaccinations among men who have sex with men (MSM) has been considerably lower than before the pandemic. Moreover, less frequent HBV testing and a reduction in numbers of sex partners have been reported. We assessed the impact of these COVID-19-related changes on HBV transmission among MSM in the Netherlands.MethodsWe estimated the changes in sexual activity, HBV testing, and HBV vaccination among MSM during the pandemic from Dutch data. We used a deterministic compartmental model and investigated scenarios with small or large declines in sexual activity, testing, and vaccination for the current phase of the pandemic (without available data). We examined the increase in HBV vaccinations needed to prevent further increase in HBV incidence.ResultsWith a decrease in numbers of sex partners of 15–25% during the first lockdown and 5% during the second lockdown, we found a decline of 6.6% in HBV incidence in 2020, despite a >70% reduction in HBV testing and vaccination during the first lockdown. With numbers of sex partners rebounding close to pre-pandemic level in 2021, and a reduction of 15% in testing and 30% in vaccination in 2021, we found an increase of 1.4% in incidence in 2021 and 3.1% in 2026. With these changes, an increase of ≥60% in HBV vaccinations in 2022 would be needed to bring the HBV incidence in 2023 back to the level that it would have had if the COVID-19-related changes had not occurred.ConclusionsDespite reductions in sexual activity during the COVID-19 pandemic, the decrease in HBV vaccinations may result in a small increase in HBV incidence after 2021, which may persist for years. It is important to restore the vaccination level and limit further increase in HBV transmission among MSM.     

The measurement of neck strength: A guide for sports medicine clinicians

This masterclass aims to provide an overview of the measurement of neck strength and the factors which can increase the ecological validity of the testing protocol within an athletic population. Adopting a ‘gold standard’ method for measuring neck strength is of vital importance when determining strength differences across sports, ages and sexes. Without a ‘gold standard’ method current variations in testing procedure and equipment have created challenges in establishing normative neck strength data. With encouraging evidence that higher neck strength can have a protective effect against sports-related head and neck injuries, including concussion, new injury prevention knowledge may be impeded by a lack of consensus on how to accurately measure neck strength, with a number of different methods available. This masterclass will outline the factors clinicians should consider when selecting a device and measurement protocol when measuring maximal neck strength as well as how to interpret the results.     

Assessment of dental implant surface stability at the nanoscale level

ObjectivesTo study the oxide layer stability of certified dental implants of system "P", made based on TiO₂ alloy with carbon coating. To perform a comparative statistical analysis of the obtained data with the available data for the dental implants of systems "A" and "B".MethodsX-ray microtomography and X-ray fluorescence analysis were used to study soft tissue biopsy specimens. Supernatants were studied by dynamic light scattering and transmission electron microscopy when simulating free emission of nanoscale metal oxide particles from the surface of dental implants as well as when simulating physical loading. A comparative analysis of three parameters of nanoscale particles was performed by statistical data analysis. The surface of the "P" system dental implant with surface treatment was analyzed by scanning electron microscopy.ResultsBoth free emission of nanoscale oxide layer particles and yield of nano- and microscale particles during simulation of physical load were confirmed. Statistically significant differences were noted in a comparative analysis of the size and frequency of occurrence of these particles in the supernatants obtained from the surfaces of three dental implant systems. The elemental composition of the particles and the composition and structure of the "P" system dental implants themselves were analyzed.SignificanceThe developed method of dynamic light scattering can be used to compare the stability of the oxide layer of standardized medical products manufactured on the basis of the TiO₂ alloy.     

Cytokine and LL-37 gene expression levels in Bartonella spp. seropositive and seronegative patients of a rheumatology clinic

PurposeThe variation in the immune response to Bartonella spp. infection in humans remains unclear. The present study compares the expression of selected interleukins, cytokines and cathelicidin (LL-37) in rheumatology clinic patients suffering from musculoskeletal symptoms with healthy blood donors. The patients had previously been tested for the presence of Bartonella henselae antibodies.MethodsGene expression of LL-37, interleukin (IL)-2, IL-4, IL-6, IL-12, interferon-(IFN)-γ, and tumor necrosis factor (TNF-α)-α was determined in blood samples using quantitative Polymerase Chain Reaction (qPCR). Statistical analysis was prepared with STATISTICA.ResultsStatistically significant differences in the mRNA levels of the tested cytokines (IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-12; p<0.0001) were observed between the healthy controls and patients; however, no difference was observed for LL37 mRNA (p ?= ?0.1974). No significant differences in mRNA expression were observed between IgG in anti-Bartonella seropositive and seronegative individuals (p>0.05). The only significant differences between the Bartonella spp. DNA positive and negative patients, indicated by PCR, were observed for TNF-α and IL-12 mRNA (p ?= ?0.0045 and p ?= ?0.0255, respectively).ConclusionA broadly similar immune response to the tested cytokines was observed among the participants irrespective of anti-Bartonella spp. IgG seropositivity. However, the Bartonella DNA-positive participants demonstrated significantly lower expression of IL-12 and TNF-α mRNA; this may indicate that these bacteria have a suppressive influence on the immune system.     

持续性特发性耳鸣严重程度的相关因素分析

目的 探讨导致持续性特发性耳鸣严重程度的相关因素。 方法 分析870例持续性特发性主观性耳鸣患者的一般资料、病史、听力学结果、耳鸣匹配实验、耳鸣残疾量表、匹兹堡睡眠质量指数量表和焦虑自评量表,应用多因素Logistic回归分析研究与患者耳鸣严重程度相关的因素。 结果 (1)性别(P<0.001)、年龄(P=0.010)、耳鸣主调声频率(P=0.005)、听力损失(P=0.037)、焦虑程度(P<0.001)、睡眠状况(P<0.001)在THI分级上差异有统计学意义(P<0.05);(2)病程(P=0.053)、侧别(P=0.437)、主调声响度(P=0.120)在THI分级上差异均无统计学意义(P>0.05)。 结论 女性患者特发性耳鸣的程度较男性更为严重;低频较高频更扰人;焦虑程度和睡眠状况是影响耳鸣严重程度的因素,而病程、侧别、耳鸣主调声响度不是影响患者特发性耳鸣严重程度的因素。