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排序方式: 共有3821条查询结果,搜索用时 15 毫秒
1.
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.
3.
Alberto Rivero Luis Crovetto Lidia Lopez Ricardo Maselli Martín Nogus 《Muscle & nerve》1995,18(9):943-947
We performed single fiber electromyography (SFEMG) in the superior rectus and levator palpebralis (SR-LP) muscles of 17 patients with pure ocular myasthenia gravis (MG) and 9 controls. Thirteen patients were also assessed with SFEMG in the orbicularis oculi (OO) muscle. All the MG patients but none of the control subjects showed abnormal SFEMG jitter in the SR-LP muscles. On the other hand, only 62% of the MG patients had abnormal SFEMG jitter in the OO muscle. The procedure was well tolerated by the patients, and complications were minor. We conclude that SFEMG of the SR–LP muscles is a safe and highly sensitive technique for the diagnosis of ocular MG. © 1995 John Wiley & Sons, Inc. 相似文献
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M. A. Martín J. C. Rubio R. A. Wevers B. G. M. Van Engelen G. C. H. Steenbergen O. P. Van Diggelen M. De Visser C. De Die-Smulders A. Blázquez A. L. Andreu J. Arenas 《Annals of human genetics》2004,68(1):17-22
We report on 8 Dutch patients with McArdle's disease from 6 unrelated families. Molecular analysis revealed the presence of four previously described mutations: the common R49X mutation, the IVS14+1G>A mutation and the recently reported R269X and Y84X nonsense mutations; and two new molecular defects: a missense mutation R138W in the homozygous state in two siblings, and a frameshift mutation c.1797delT. This first genetic study of patients from The Netherlands with McArdle's disease confirms that the R49X mutation is also the most common in Dutch patients, and that there is genetic heterogeneity within this population. Moreover, our data support the hypothesis that the Y84X mutation is a relatively frequent mutation in McArdle's patients with a Central European background, and expand the already crowded map of mutations within the PYGM gene responsible for McArdle's disease. 相似文献
6.
Maria José GaldOn Estrella Durá Yolanda Andreu Maite Ferrando Rafael Poveda José Vicente Bagán 《Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics》2006,102(1):40-46
OBJECTIVE: This study analyzes the differences in psychological variables and symptomatology between temporomandibular disorder diagnosis subgroups. STUDY DESIGN: The sample included 114 temporomandibular disorder patients that were evaluated in coping, distress, and temporomandibular characteristics. Diagnostic muscular (n = 58) and articular (n = 56) subgroups were compared in these variables through a MANCOVA. RESULTS: Muscular patients show a higher level of general distress, specifically in the anxiety and somatization subscales and a more active coping style, with a tendency of a minor use of humor and a higher number of parafunctional habits, specifically, biting nails, hangnails, and lips. CONCLUSION: We discuss the differences found in order to design the targets of the psychological intervention of temporomandibular patients. 相似文献
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The physico-chemical methods for the study of the binding of ligands to tubulin are examined in-depth, emphasizing the assumptions on which they are based and their limitations. The criteria of specificity and linkage to protein self-association are presented. It is shown that, of the direct equilibrium binding techniques, Hummel-Dreyer gel permeation chromatography and rapid ultracentrifugation are applicable only when binding is not linked to protein self-association. Disc filtration is valid only when the reverse unbinding reaction is very low. Binding linked to protein self-association can be measured by batch gel permeation or by dialysis equilibrium. The indirect techniques, such as fluorescence perturbation or difference absorption spectroscopy are discussed in terms of the assumptions on which they are based. They are shown to be used best only after characterization of the binding by direct techniques. Equilibrium binding parameters can also be deduced from careful kinetic experiments. Comparison of calorimetrically measured enthalpies of binding to van't Hoff enthalpies derived from equilibrium measurements indicates that the method of choice is calorimetric, while comparison with van't Hoff analysis can reveal the existence of reaction steps not detected by equilibrium measurements. Use of other indirect approaches, such as titration of an enzymic activity, can also lead to the detection of additional steps. The criteria are set up for the proper data analysis of ligand binding linked to protein self-association and the selection of the proper mode of linkage. It is shown how the thermodynamic contributions of various moieties of a ligand can be established by a rational structural modification of the ligand and the proper analysis of the binding measurements, in which all non-specific entropic contributions are taken into account. It is demonstrated also how a similar analysis of binding data can lead to conclusions about the reaction pathway from a comparison of equilibrium thermodynamic measurements on judiciously modified ligand molecules. 相似文献
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10.
Sergi Sastre Guillem Bori Sebastian Garcia Andreu Combalia 《European journal of orthopaedic surgery & traumatology : orthopedie traumatologie》2005,15(1):63-65
A rare case of an infected chronic hematoma in a patient with immunodeficiency syndrome mimicking a soft tissue neoplasm is presented. There are few reported cases of hematogenous infection of chronic hematomas, which be difficult to differentiate from soft tissue neoplasms. 相似文献