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1.

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   
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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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Atrophy of salivary glands may occur by ductal obstruction caused by calculus, infection or neoplastic processes, or as consequence of systemic diseases and aging. In the present work, we have used histochemical methods to study the expression of elastic and collagen fibers during experimental atrophy of the submandibular gland of mice. Glandular atrophy was accompanied by a rapid increase in collagen deposition in both septal and intralobular regions. The expression of elastic fibers was not significantly altered during atrophy; a discrete increase of elastic fibers was noted only around ductal structures. The results showed that experimental ductal obstruction is a useful in vivo model to study molecular events that take part in the remodeling of the extracellular matrix during atrophy of salivary glands.  相似文献   
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To assess the magnitude and nature of interpersonal violence resulting in hospitalisation of children and to identify subgroups at risk of repeat hospital admissions, a population-based, retrospective study of all violence hospitalisations in Western Australia for children aged 9 years or less was undertaken, using the 1990–2004 linked data retrieved from the Western Australian Mortality Database and the Hospital Morbidity Data System.
Of the 747 patients aged <10 years incurring 834 hospitalisations for the consequences of violence during the study period, 570 (76%) were less than 4 years of age. A total of 43 deaths from violence were recorded and 74 (9%) patients were admitted for more than one episode of violence. Victims aged 0–4 years from rural (hazard ratio [HR] = 2.72; 95% confidence interval [CI] 1.35, 5.43) and remote parts (HR = 2.79; 95% CI 1.25, 6.25) of the state were at increased risk of a subsequent admission for violence compared with those residing within the metropolitan area. Indigenous children aged 5–9 years were significantly more likely (HR = 3.57; 95% CI 1.14, 11.13) to incur a second hospitalisation for violence than their non-Indigenous counterparts. The identification of young victim subgroups at high risk of repeat hospitalisations is important for developing intervention strategies to reduce the burden of interpersonal violence. Young children aged 0–4 years living in rural and remote locations and Indigenous children aged 5–9 years should be specifically targeted for attention.  相似文献   
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A child had the characteristic clinical and EEG pattern of migrating partial seizures in infancy with left temporal lobe atrophy, hippocampal sclerosis and cortical-subcortical blurring.Seizures were drug-resistant, with recurring episodes of status epilepticus. The child developed microcephaly with arrest of psychomotor development. Focal brain lesions, in the context of migrating partial seizures, have not been previously reported.[Published with video sequences].  相似文献   
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Distributional Issues in the Analysis of Preventable Hospitalizations   总被引:1,自引:0,他引:1  
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Eating disorders have generally been considered uncommon among ethnic minorities. However, there are data that suggest bulimia nervosa may not be all that rare in some minority groups. Furthermore, emerging data on binge eating disorder (BED) have indicated high rates in some ethnic groups, and these data prompt reconsideration of the view that minority populations are protected from eating disorders. The current report reviews data on bulimia nervosa and BED in ethnic minority groups. Ramifications of a broader diversity of affected individuals on our understanding of eating disorders will be addressed, and directions for further research will be discussed.  相似文献   
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