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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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Effect of leptin on the regulation of placental hormone secretion in cultured human placental cells.
Raquel Coya Pedro Martul Jaime Algorta Ma Angeles Aniel-Quiroga Ma Angeles Busturia Rosa Se?arís 《Gynecological endocrinology》2006,22(11):620-626
Placenta is an important source of leptin during pregnancy that contributes to the high plasma leptin levels in pregnant women. Leptin and its functional receptors are synthesized in trophoblast cells that, in turn, secrete gestational hormones supporting a paracrine or autocrine role for leptin in the endocrine activity of the placenta. In the present study we examined the effect of leptin on in vitro release of gestational hormones (human chorionic gonadotropin (hCG), human placental lactogen (hPL), progesterone, estrogens and testosterone) by human term placental cells in culture. Placentas at term were obtained immediately after delivery from mothers with uncomplicated pregnancies. Progesterone, hCG, hPL, estradiol, estrone, estriol and testosterone levels were measured by different assays in culture media of cells maintained in monolayer culture after incubation for 12, 24, 48 or 72 h with leptin or placebo. Incubation with leptin did not modify hCG, hPL, progesterone, estriol and estrone secretion for any of the doses and times assayed. However, leptin led to a dose-dependent decrease in estradiol release. This effect was observed when treatment with recombinant human leptin spanned from 12 to 72 h. At this time an increase in testosterone levels was observed in leptin-treated cells versus placebo. These results indicate that leptin can be considered a gestational hormone implied in the endocrine function of the placenta, with an important role in control of the production of steroid reproductive hormones in placental cells in vitro. 相似文献
8.
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
9.
Ronald Martin Jaime Williams Thomas Hadjistavropoulos Heather D Hadjistavropoulos Michael MacLean 《Revue canadienne de recherche en sciences infirmières》2005,37(2):142-164
The literature suggests that pain in the elderly, especially among seniors with dementia, is under-assessed and under-treated.This qualitative study solicited the perspectives of seniors, front-line nursing staff, nursing-home administrators, and informal caregivers of seniors with dementia on the current status of pain assessment and management. The views of these participants complement the research findings reported in the literature. While some of their explanations and potential solutions concerning under-treatment of pain in seniors echo views that have been presented in the literature, the participants also pointed to factors and avenues that have been given less formal consideration (e.g., systemic barriers to effective assessment and treatment of pain).They also highlighted the need for pain-control strategies beyond medication. The implications of these findings are discussed. 相似文献
10.
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