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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4.
Cough and paradoxical vocal fold motion 总被引:8,自引:0,他引:8
Kenneth W. Altman MD PhD C. Blake Simpson MD Milan R. Amin MD Mona Abaza MD Ron Balkissoon MD Roy R. Casiano MD 《Otolaryngology--head and neck surgery》2002,127(6):501-511
OBJECTIVES: The differential diagnosis and treatment of patients with chronic cough, paradoxical vocal fold motion, and disordered breathing can be a challenge to most practicing otolaryngologists. Tracheobronchial (ie, asthma, bronchitis, and tracheal stenosis), laryngeal (ie, vocal fold paralysis and neoplasms), and rhinologic (ie, allergies and rhinosinusitis) etiologies are commonly diagnosed and treated effectively. However, occasionally one is faced with patients who are refractory to medical treatment and have no obvious rhinologic, laryngeal or pulmonary cause. STUDY DESIGN AND SETTING: We conducted a review of the literature. METHODS: We present a thorough review of the current medical literature exploring the complex neurologic mechanisms involved in the production of cough and the relationship between gastroesophageal reflux disease, vagal neurapathy, and paradoxical vocal fold motion. RESULTS: The diagnosis and successful treatment of chronic cough can be complex. It requires a thorough understanding of the neurologic mechanisms behind cough excitation and suppression. Successful treatment strategies include aggressive management of the patient's reactive airway disease, gastroesophageal reflux disease, and, in select cases, paradoxical vocal fold motion. This may involve a well-coordinated effort among pulmonologists, otolaryngologists, gastroenterologists, and speech pathologists. CONCLUSION: Gastroesophageal reflux disease, vagal neuropathy, and paradoxical vocal fold motion are additional causes of chronic cough and disordered breathing that need to be considered, in the absence of obvious laryngotracheal and/or rhinologic pathology. A high index of suspicion is essential in making the diagnosis and formulating an effective multidisciplinary treatment plan for these patients. 相似文献
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Enyioma N OBINECHE Michael PT GILLETT Abdishakur ABDULLE Mustapha SULAIMAN Mona AL-ROKHAIMI 《Nephrology (Carlton, Vic.)》2002,7(3):115-120
SUMMARY: In patients with chronic renal failure (CRF), hyperleptinaemia has been widely reported, but the exact mechanisms leading to elevated leptin levels are unclear. Impaired renal clearance of leptin and the influence of other hormones may be important. In this study, we measured serum leptin levels in 150 patients on haemodialysis, peritoneal dialysis or in the predialysis phase of CRF. Furthermore, we measured plasma levels of insulin, growth hormone (GH) and insulin-like growth factor 1 (IGF-1), as well as plasma levels of triacylglycerols and total low density lipoprotein (LDL)- and high density lipoprotein (HDL)-cholesterol. We observed significantly elevated levels of leptin, particularly in female patients, and leptin was shown to correlate significantly with insulin, total and LDL-cholesterol and log triacylglycerols. Leptin was inversely correlated with GH concentrations, but was not correlated with IGF-1 levels. Despite the multiple correlations established between leptin levels and other variables, only hyperinsulinaemia in CRF seems to be important as a determinator of leptin levels. 相似文献
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Selective homing of phenotypically lytic cells within nasopharyngeal carcinoma biopsies: numerous CD8- and CD16-positive cells in the tumor. 总被引:1,自引:0,他引:1
M Lakhdar M H Ben Aribia M Maalej A Ladgham 《International journal of cancer. Journal international du cancer》1991,48(1):57-61
We present a comparative analysis of cell-mediated immunity between circulating lymphocytes and tumor-infiltrating lymphocytes (TIL) from patients with nasopharyngeal carcinoma (NPC). Phenotypic analysis using a panel of monoclonal antibodies (MAbs) to define lymphocytic subsets has revealed a selective homing of phenotypically lytic cells such as CD8- and CD16-positive cells, but a low percentage of macrophages when compared to PBL of NPC patients. Also, PBL and TIL contain an equivalent percentage of activated T-lymphocytes expressing HLA-DR molecules and IL-2 receptors. Functionally, TIL exhibit an abolished NK-cell activity and concomitant decrease of proliferative response to phytohemagglutinin (PHA) and concanavalin A (ConA) stimulation when compared with PBL. 相似文献
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Kiran Chang Mona Sarkiss Kyoung Sook Won Joseph Swafford Lyle Broemeling Isis Gayed 《Journal of nuclear medicine》2007,48(3):344-348
Cancer patients frequently have anemia or an altered coagulation state that may affect their risk stratification for perioperative cardiac events. We performed this study to investigate the incidence of perioperative cardiac events in cancer patients who had abnormal stress myocardial perfusion imaging (MPI) results versus cancer patients with normal MPI results. METHODS: We included 394 consecutive cancer patients with normal (n = 201) or abnormal (n = 193) results on MPI studies performed for preoperative risk stratification. MPI was performed within 6 mo before each patient's scheduled operation. All the patients had surgical procedures requiring general anesthesia, except for 18 who had endoscopic or colonoscopic procedures. We retrospectively reviewed their data for the incidence of major cardiac events intraoperatively and for 1 mo postoperatively. We collected data on their cancer type, risk factors for coronary artery disease, MPI findings, risk of operation, and intraoperative or postoperative major cardiac events, which included death, myocardial infarction (MI), and congestive heart failure (CHF). RESULTS: The patients with abnormal MPI results included 97 with ischemia, 80 with scarring, and 16 with mixed scarring and ischemia. The mean left ventricular ejection fraction and end-diastolic volume were 63.8% +/- 9.8% and 82.0 +/- 53.5 mL in the normal MPI group versus 52.1% +/- 13.1% and 118.1 +/- 53.4 mL in the abnormal-MPI group (P < 0.001). There were 9 major intraoperative or postoperative cardiac events (4.7%) in the patients with abnormal MPI results and none in the patients with normal MPI results (P = 0.001). These major events consisted of 3 deaths, 2 acute MIs, 1 non-Q-wave MI, and 3 cases of CHF. Four of these patients had only scarring on their MPI studies, 3 had ischemia, and 2 had scarring and ischemia. CONCLUSION: Normal MPI results have a high negative predictive value for perioperative cardiac events in cancer patients. Abnormal MPI results, whether demonstrating scarring or ischemia, should prompt appropriate perioperative management in patients with cancer to minimize major cardiac events. 相似文献