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Marta López-Fauqued Laura Campora Frédérique Delannois Mohamed El Idrissi Lidia Oostvogels Ferdinandus J. De Looze Javier Diez-Domingo Thomas C. Heineman Himal Lal Janet E. McElhaney Shelly A. McNeil Wilfred Yeo Fernanda Tavares-Da-Silva 《Vaccine》2019,37(18):2482-2493
Background
The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.Methods
Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30?days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12?months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.Results
Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.Conclusions
No safety concerns arose, supporting the favorable benefit-risk profile of RZV. 相似文献2.
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Abrar M. Babateen Oliver M. Shannon Gerard M. OBrien Edward Okello Anmar A. Khan Sofia Rubele Emma Wightman Ellen Smith Nicholas McMahon Dilara Olgacer Christina Koehl William Fostier Inês Mendes David Kennedy John C. Mathers Mario Siervo 《Nutrients》2021,13(3)
Nitrate-rich food can increase nitric oxide production and improve vascular and brain functions. This study examines the feasibility of a randomised controlled trial (RCT) testing the effects of prolonged consumption of different doses of dietary nitrate (NO3−) in the form of beetroot juice (BJ) in overweight and obese older participants. A single-blind, four-arm parallel pilot RCT was conducted in 62 overweight and obese (30.4 ± 4 kg/m2) older participants (mean ± standard deviation (SD), 66 ± 4 years). Participants were randomized to: (1) high-NO3− (HN: 2 × 70 mL BJ/day) (2) medium-NO3− (MN: 70 mL BJ/day), (3) low-NO3− (LN: 70 mL BJ on alternate days) or (4) Placebo (PL: 70 mL of NO3−-depleted BJ on alternate days), for 13 weeks. Compliance was checked by a daily log of consumed BJ, NO3− intake, and by measuring NO3− and NO2− concentrations in plasma, saliva, and urine samples. Fifty participants completed the study. Self-reported compliance to the interventions was >90%. There were significant positive linear relationships between NO3− dose and the increase in plasma and urinary NO3− concentration (R2 = 0.71, p < 0.001 and R2 = 0.46 p < 0.001, respectively), but relationships between NO3− dose and changes in salivary NO3− and NO2− were non-linear (R2 = 0.35, p = 0.002 and R2 = 0.23, p = 0.007, respectively). The results confirm the feasibility of prolonged BJ supplementation in older overweight and obese adults. 相似文献
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Chakib Nejjari Abdelghafour Marfak Ahmed Rguig Abderrahmane Maaroufi Ihssane El Marouani Abderrafii El Haloui Bouchra El Johra Rachid Ouahabi Rachid Moulki Amina Idrissi Azami Youness El Achhab 《AIMS Public Health》2021,8(2):285
This study presents the relationships between ambient air pollutants and morbidity and emergency department visits among children and adults performed in Great Casablanca, the most populated and economic region in Morocco. This research was analyzed using conditional Poisson model for the period 2011–2013. In the period of study, the daily average concentrations of SO2, NO2, O3 and PM10 in Casablanca were 209.4 µg/m3, 61 µg/m3, 113.2 µg/m3 and 75.1 µg/m3, respectively. In children less than 5 years old, risk of asthma could be increased until 12% per 10 µg/m3 increase in NO2, PM10, SO2 and O3. In children over 5 years and adults, an increase of 10 µg/m3 air pollutant can cause an increase until 3% and 4% in respiratory consultations and acute respiratory infection, respectively. Similarly, impact on emergency department visits due to respiratory and cardiac illness was established. Our results suggest a not negligible impact on morbidity of outdoor air pollution by NO2, SO2, O3, and PM10. 相似文献
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Khang D. Nguyen Jiali Han Tricia Li Abrar A. Qureshi 《Archives of dermatological research》2014,306(6):555-560
Little data on cutaneous squamous cell carcinoma (SCC) epidemiology within the United States are currently available. Prior studies have focused on populations outside of the United States or been limited to regions within the US. In this study, prospective data were collected via biennial questionnaires from a total of 261,609 participants, which included women in the Nurses’ Health Study (NHS, 1976–2008) and Nurses’ Health Study II (NHS II, 1989–2009), and men in the Health Professionals Follow-Up Study (HPFS, 1986–2008). History of physician-diagnosed invasive SCC was confirmed by pathology record review. Over the entire follow-up period for each cohort, there were 1,265 invasive SCC cases per 100,000 persons in the NHS cohort, 389 cases per 100,000 persons in NHS II, and 2,154 cases per 100,000 persons in HPFS. An 18-year follow-up of participants in these cohorts revealed increasing invasive SCC incidence rates over time, with rates for men being consistently higher than those for women. In women, a larger proportion of invasive SCC lesions occurred on the lower extremities as compared to men (21 % in NHS vs. 6 % in HPFS, p < 0.0001; 14 % in NHS II vs. 6 % in HPFS, p < 0.0001), while in men, a larger proportion occurred on the head/neck (43 % in NHS vs. 60 % in HPFS, p < 0.0001; 48 % in NHS II vs. 60 % in HPFS, p < 0.0001). In summary, invasive SCC incidence rates among US men have been greater than those for women with distinct sites of common occurrence between men and women. 相似文献
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