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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3.
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Moshe Yaniv Tali Becker Michal Goldwirt Sam Khamis David M Steinberg Shlomo Weintroub 《Clinical journal of sport medicine》2006,16(5):392-396
OBJECTIVE: Little is known about the interactions of sports-related demands and human body, in particular on musculoskeletal features, during growth. Focusing on the relationship between soccer and lower limb alignment, we examined the hypothesis that varus knee deviation is more prevalent among high-performance pediatric and adolescent soccer players. DESIGN: Cross-sectional study with focused sampling. SETTING: First league sports clubs. PARTICIPANTS: 106 male child/adolescent soccer players aged 10 to 21 years and 68 age-matched tennis players. INTERVENTIONS: All athletes completed a demographic questionnaire and underwent physical examinations, which included height, weight, generalized laxity, knee, ankle, foot and spine axis, hip range of motion, tibial torsion, Q angle, foot navicular height, and progression angle. MAIN OUTCOME MEASUREMENT: Varus/valgus axis was determined by the intercondylar intermalleolar distance while standing. Soccer and tennis players were compared on knee axis and other outcome variables by analysis of covariance, adjusting for age and by t-tests within age groups. RESULTS: A significantly higher prevalence of knee varus was found among the soccer players compared to that among the tennis players. The difference in intracondylar distance was statistically significant after the age of 13 years (P < 0.001). In addition, compared to tennis players, soccer players had higher foot arches, decreased hip external rotation and increased external tibial torsion. CONCLUSIONS: Varus knee axis deviation was more common among children and adolescent soccer players than among tennis players. The prevalence was more pronounced among players aged 13 years or older. Further research is needed to explore the rationale of this phenomenon. 相似文献
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T. M. Skerry M.D. M.R.C.V.S. R. Suswillo A. J. El Haj N. N. Ali R. A. Dodds L. E. Lanyon 《Calcified tissue international》1990,46(5):318-326
Summary Previous studies of Alcian blue-induced birefringence in adult avian cortical bone showed that a short period of intermittent
loading rapidly produces an increased level of orientation of proteoglycans within the bone tissue. In the absence of further
loading, this persists for over 24 hours. We have proposed that this phenomenon could provide a means for “capturing” the
effects of transient strains, and so provide a persistent, constantly updated strain-related influence on osteocyte populations
related to the bones' averaged recent strain history, in effect, a “strain memory” in bone tissue. In our present study, we
use the Alcian blue-induced birefringence technique to demonstrate that proteoglycan orientation also occurs after intermittent
loading of both cortical and cancellous mammalian bonein vivo andin vitro. We also show that the change in birefringence is proportional to the magnitude of the applied strain, and that the reorientation
occurs rapidly, reaching a maximal value after only 50 loading cycles. Examination of electron micrographs of bone tissue
after staining with cupromeronic blue allows direct visualization and quantification of the change in proteoglycan orientation
produced by loading. This shows that intermittent loading is associated with a realignment of the proteoglycan protein cores,
bringing them some 5 degrees closer to the direction of collagen fibrils in the bone matrix. 相似文献
8.
Cyclodextrin formulation of dorzolamide and its distribution in the eye after topical administration. 总被引:2,自引:0,他引:2
Hakon H Sigurdsson Einar Stefánsson Elínborg Gudmundsdóttir Thór Eysteinsson Margrét Thorsteinsdóttir Thorsteinn Loftsson 《Journal of controlled release》2005,102(1):255-262
Due to limited aqueous solubility of dorzolamide at physiologic pH, the pH of Trusopt eye drops (cont. 2% dorzolamide) has to be kept at about 5.65, and to increase the topical bioavailability of the drug from Trusopt the contact time of the drug with the eye surface is increased by increasing the viscosity of the eye drops to 100 cps. This low pH and high viscosity can lead to local irritation. In this study, dorzolamide hydrochloride was formulated as 2% and 4% low viscosity solutions (viscosity 3 to 5 cps) containing randomly methylated beta-cyclodextrin at pH 7.45. These formulations were evaluated in rabbits. The animals were sacrificed at various time points after topical administration of the drug and the dorzolamide concentration determined in the different parts of the eye. Trusopt was used as a reference standard. The topical availability of dorzolamide from the cyclodextrin-containing eye drops appeared to be comparable to that from Trusopt and the drug reached retina and optic nerve to give measurable concentrations for at least 8 h after administration of the eye drops. 相似文献
9.
Youness El harrech Hassan Jira Jaouad Chafiki Mohamed Ghadouane Ahmed Ameur Mohamed Abbar 《Actas urologicas espa?olas》2009,33(1):93-96
Nutcracker syndrome is caused by compression of the left renal vein between the aorta and the superior mesenteric artery where it passes in the fork formed at the bifurcation of these arteries. The phenomenon results in left renal venous hypertension. The syndrome is manifested by left flank and abdominal pain, with or without unilateral haematuria. The nutcracker syndrome has been treated in various ways. We report one case of the syndrome and discuss the place of surveillance in its management. 相似文献
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