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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55.
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Sleep disorders are prevalent in young children, the most frequent being disturbances in initiating and maintaining sleep. Behavioral and cognitive approaches are interesting techniques for their management. They can be used either for solving sleep problems at home, or in severe forms as part of a 'deconditioning' during a short hospitalization. 相似文献
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E M Ibrahim M B Satti H Y Al Idrissi M M Higazi G M Magbool A Al Quorain 《Cancer Detection and Prevention》1986,9(3-4):215-218
The purpose of this retrospective clinical study is to look into the etiological role of alshammah and alqat consumption in the causation of squamous cell carcinoma of the head and neck (SCHN) in Arabia. Alshammah and alqat are traditional forms of chewable tobacco very commonly used in southern Saudi Arabia and Yemem. In a 2 year period 64 patients with histologically proven SCHN were found. Most of them were originally from southern Saudi Arabia and Yemen. Of these 64 patients 52 (81%) admitted alshammah consumption. Of these 52 patients 22 admitted alqat consumption in addition. Thirty-eight (59%) had oral cancer, while the rest had pharyngeal and laryngeal cancer. All the 38 patients with oral cancer either used alshammah alone (16 patients) or used both alshammah and alqat (22 patients). The median duration of alshammah consumption was 15 years and that of alqat was 12 years. Alcohol was not consumed among the group and only few were cigarette smokers. Most patients presented in the late stage of the disease. The evidence implicating alshammah and alqat in the causation of SCHN is only clinically based. Further controlled prospective clinical and experimental studies are needed to confirm the theory. 相似文献
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Z. L. Sekkat M. Rouani S. Ghazi A. Il Idrissi M. Arahou R. Hassikou 《Phytothérapie》2017,15(5):253-262
The present work has a twofold purpose, the first is to valorize an endemic species of Morocco, which is widely used in traditional medicine and the second to suggest an alternative to synthetic anti-candida products, especially against Candida albicans. It’s about the blue wormwood (Artemisia mesatlantica M.) which is rarely discussed in the literature.In order to do this, the essential oil from a recent technical by microwave (MO) and another traditional by steam distillation (EVE), were analyzed by gas chromatography coupled with mass spectrometry. The anti-candida tests of three essential oils extracted by microwave (MO), hydrodistillation (H) and stream distillation (E.V.E), were performed on five reference strains. Five-fold dilutions were prepared ranging from 50% (v/v) to 3.12% (v/v). The minimum inhibitory concentrations were determined by microdilution.The chemical composition of oils shows that the main components are: β-thujone for both techniques EVE (62,05%) and MO (51,81%), followed by camphor (14.39%) for MO and α- thujone (4.68%) for EVE. The best potential is obtained in the case of the essential oil extracted by microwave. Reference synthetic products were also tested with approved doses and are generally ineffective 相似文献
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