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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5.
Walid K. Abu Saleh Phillip Mason Odeaa Al Jabbari Hany Samir Brian A. Bruckner 《Texas Heart Institute journal / from the Texas Heart Institute of St. Luke's Episcopal Hospital, Texas Children's Hospital》2015,42(6):569-571
The Impella 5.0, a percutaneously inserted left ventricular assist device, has been used to support patients who have severe heart failure or who are undergoing high-risk percutaneous coronary intervention. We report our surgical placement of the Impella 5.0, through a graft sewn to the aorta, to unload the left ventricle of a 59-year-old man who was undergoing venoarterial extracorporeal membrane oxygenation for postcardiotomy shock. The patient underwent successful placement of a long-term left ventricular assist device before his discharge from the hospital. The versatility of the Impella 5.0 is exemplified in this patient who was successfully bridged to long-term support. 相似文献
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Mohammed Al Essa Abdulrahman Alissa Abdalrhman Alanizi Rami Bustami Feras Almogbel Omar Alzuwayed Meshari Abo Moti Nouf Alsadoun Wasmiyah Alshammari Abdulkareem Albekairy Shmeylan Al Harbi Mohammed Alhokail Jawaher Gramish 《Saudi Pharmaceutical Journal》2019,27(1):138-144
Background
Herbal medicine has been widely utilized by pregnant women despite the limited available evidence regarding the safety and efficacy of that practice. The current available studies, from different countries, estimated that the use of herbal medicine during pregnancy range from 7% up to 96%. The aim of this study is to determine the prevalence, attitude, source of information, and reasoning behind the use of herbal medicine among pregnant women in Saudia Arabia.Methods
A cross-sectional study conducted using a convenience sample including pregnant women who visited the obstetric clinics at King Abdulaziz Medical City in Riyadh, Saudi Arabia. A survey was administered in order to evaluate the prevalence and perception toward herbal medicine use among pregnant women in Saudi Arabia.Results
A total of 297 pregnant women completed the survey. The results showed that 56% of the respondents have used some type of herbal medicine during their pregnancy. Olive oil was utilized in 26% of the respondents followed by cumin 20% and garlic 15%. In addition, 37% of the respondents used herbal medicine by their own initiative, while 33% and 12% used herbal medicine based on recommendations from their families and friends, respectively. Furthermore, 19% of the respondents reported a positive attitude toward herbal medicine use during pregnancy. In addition, the percentage of women with positive attitude was marginally higher among respondents with lower educational level.Conclusion
The prevalence of using herbal medicine is considerably high among pregnant women in Saudi Arabia. Unfortunately, the majority of the users relied on informal sources to use herbal medicine during pregnancy. 相似文献8.
Introduction: Cutaneous T-cell lymphomas (CTCL) are rare non-Hodgkin lymphomas of skin-homing T-cells that initially or mainly manifest cutaneously. Treatment of CTCL is challenging given the disease states’ varying presentation and prognosis. Systemic treatment options often lack comparative evidence and have relatively low response rates and short duration of response. The recent Food and Drug Administration (FDA) approval of mogamulizumab in adult patients with relapsed or refractory (R/R) CTCL after at least one prior line of therapy provided a new treatment option to patients with advanced disease.
Areas covered: The authors discuss basic information about CTCL and mogamulizumab’s mechanism of action. Then, the authors discuss the agent’s efficacy. Finally, the authors evaluate the safety of mogamulizumab in comparison to other agents available in CTCL.
Expert opinion: Mogamulizumab has been shown to be an effective and well tolerated therapy for patients with relapsed and refractory MF/SS with excellent activity in the circulating component of the disease. 相似文献
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Characterization of Left Atrial Mechanics in Hypertrophic Cardiomyopathy and Essential Hypertension Using Vector Velocity Imaging 下载免费PDF全文
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