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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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Esophageal foreign body causing direct aortic injury.   总被引:4,自引:0,他引:4  
Foreign bodies in the esophagus are uncommon causes of esophageal perforation. Many nonperforating cases are successfully managed by flexible gastroscopy. However, complicated foreign bodies such as those that result in esophageal perforation and vascular injury are best managed surgically. Gastroscopy remains the primary method of diagnosis. A case of a 59-year-old woman who developed retrosternal and intrascapular pain, odynophagia and hematemesis after eating fish is reported. Flexible gastroscopy showed arterial bleeding from the midthoracic esophagus. Computed tomography scan localized a 3 cm fish bone perforating the esophagus with surrounding hematoma. An aortogram did not reveal an actively bleeding aortoesophageal fistula. The fish bone was surgically removed and the patient recovered with no postoperative complications. This case illustrates the importance of early consideration for surgical intervention when confronted with a brisk arterial bleed from the esophagus with suggestive history of foreign body ingestion.  相似文献   
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The YAG (yttrium aluminum garnet) laser has been recommended for anterior capsulotomies. One major complication is elevated intraocular pressure. We report a study of the biochemical content of the aqueous humor after a YAG laser anterior capsulotomy. We analyzed 6-keto-prostaglandin F1 alpha, thromboxane B2 and protein concentrations in the aqueous humor of human eyes. The average values of protein, 6-keto-prostaglandin F1 alpha, and thromboxane B2 in the control eyes were 81.3 +/- 14.0 mg/dL, 17 +/- 30 pg/mL, and 10 +/- 10 pg/mL, respectively. These values were elevated to 182.4 +/- 81.3 mg/dL, 401 +/- 55 pg/mL, and 576 +/- 148 pg/mL, respectively, after YAG laser anterior capsulotomy. The samples with a moderate level of 6-keto-prostaglandin F1 alpha (less than 300 pg/mL) had negligible changes of thromboxane. The elevation of thromboxane was obvious only when prostaglandin levels rose above 300 pg/mL.  相似文献   
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