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31.
32.
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33.
34.
35.
目的探讨经皮冠状动脉介入(PCI)和静脉溶栓在急性心肌梗死患者中的应用价值。方法选择我院2013年1月至2014年9月收治的60例急性心肌梗死患者作为研究对象,随机分为实验组和对照组各30例。实验组患者采用PCI治疗,对照组患者采用静脉溶栓治疗,比较两组患者血管再通率、死亡发生率、ST段回落情况、住院时间、近远期不良事件发生率、左室舒张末径和左室射血分数变化情况。结果实验组血管再通率显著高于对照组,差异有统计学意义(P<0.05),而近期和远期不良事件发生率均低于对照组,近期不良事件发生率组间比较差异有统计学意义(P<0.05),而远期不良事件发生率比较差异无统计学意义(P>0.05)。实验组患者死亡发生率、ST段回落和住院时间均低于对照组,差异均有统计学意义(P<0.05)。实验组左室射血分数在术后1个月、3个月和6个月时均显著高于对照组,差异均有统计学意义(P<0.05)。结论急性心肌梗死患者应用PCI治疗可显著提高血管再通率、降低死亡和不良事件发生率,有效改善心功能。 相似文献
36.
王鹏远 《中国继续医学教育》2021,(5)
目的评价血液科白血病疾病护理中应用健康教育的临床效果,为白血病护理工作提供参考。方法选择医院收治的白血病患者,总计60例。进行白血病患者随机分组护理,对照组与试验组各30例白血病患者,分别采取常规护理和常规护理+健康教育,比较2组白血病患者的负性情绪、自我效能状况评分以及护理满意度、护理依从率。结果试验组白血病患者干预后SAS、SDS、GSES评分均明显优于对照组,护理满意度与护理依从率均明显高于对照组,指标差异具有统计学意义,P>0.05。结论血液科白血病治疗期间配合落实常规护理、健康教育可以在提高患者自我效能的同时提高患者的依从性,符合患者身心护理需求,整体护理效果显著。 相似文献
37.
C. Banella M. Ginevrino G. Catalano E. Fabiani G. Falconi M. Divona P. Curzi P. Panetta M.T. Voso N.I. Noguera 《Hematology/oncology and stem cell therapy》2021,14(2):163-168
FGFR–TACC, found in different tumor types, is characterized by the fusion of a member of fibroblast grown factor receptor (FGFR) tyrosine kinase (TK) family to a member of the transforming acidic coiled-coil (TACC) proteins. Because chromosome numerical alterations, hallmarks of FGFR–TACC fusions are present in many hematological disorders and there are no data on the prevalence, we studied a series of patients with acute myeloid leukemia and myelodysplastic syndrome who presented numerical alterations using cytogenetic traditional analysis. None of the analyzed samples showed FGFR3–TACC3 gene fusion, so screening for this mutation at diagnosis is not recommended. 相似文献
38.
39.
You-Wen Tan 《World Journal of Meta-Analysis》2021,9(6):488-495
Nilotinib is a specific breakpoint cluster region-Abelson leukemia virus-tyrosine kinase inhibitor that is used as an effective first- or second-line treatment in imatinib-resistant chronic myelogenous leukemia (CML) patients. Hepatotoxicity due to nilotinib is a commonly reported side effect; however, abnormal liver function test (LFT) results have been reported in asymptomatic cases. When alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels are more than five-fold the upper limit of the normal (ULN) or when the serum total bilirubin level is more than three-fold the ULN, dose modification or discontinuation of nilotinib is recommended, resulting in decreased levels of hematological indicators in certain patients with CML. Nilotinib-induced hyperbilirubinemia typically manifests as indirect bilirubinemia without elevated ALT or AST levels. Such abnormal liver functioning is thus not attributed to the presence of a true histologic lesion of the liver. The underlying mechanism may be related to the inhibition of uridine diphosphate glucuronosyltransferase activity. Therefore, nilotinib dose adjustment is not recommended for this type of hyperbilirubinemia, and in the absence of elevated liver enzyme levels or presence of abnormal LFT findings, physicians should consider maintaining nilotinib dose intensity without modifications. 相似文献
40.
Yu Fan Xiaoling Liao Yuesong Pan Kehui Dong Yilong Wang Yongjun Wang 《Journal of stroke and cerebrovascular diseases》2019,28(1):220-226