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51.
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52.
目的探讨新诊断2型糖尿病(T2DM)常见中医证型与非酒精性脂肪肝(NAFLD)及其相关危险因素的相关性,为中西医结合治疗提供临床指导。方法选择沧州中西医结合医院门诊和病房收治的300例新诊断T2DM患者作为研究对象,根据其是否合并NAFLD分为合并NAFLD组,单纯T2DM组。记录2组一般资料,依照《糖尿病中医防治指南》对所有患者进行辨证分型,记录2组腰围、身高、体质量、体质量指数(BMI)、肝功指标[丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、γ-谷氨酰转肽酶(GGT)、碱性磷酸酶(ALP)]、血脂指标(TG、TC、HDL-C、LDL-C)及血尿酸(SUA)、空腹血糖(FPG)、空腹胰岛素(FINS)、空腹C-肽(FC-P)、胰岛素抵抗指数(HOMA-IR),分析各中医证型与客观化指标的关系。结果合并NAFLD组124例,单纯T2DM组176例,2组性别、年龄比较差异无统计学意义(P均>0.05);合并NAFLD组的痰湿郁阻证占比明显高于T2DM组(P<0.05),其余分型占比组间比较差异无统计学意义(P均>0.05);合并NAFLD组的腰围、BMI、TG、TC、FC-P、HOMA-IR均显著高于T2DM组(P均<0.05),其余指标2组比较差异无统计学意义(P均>0.05);非条件Logistic回归分析显示,NAFLD的独立危险因素为BMI、TG、HOMA-IR。结论痰湿郁阻证是T2DM合并NAFLD患者的最常见证型,肥胖、胰岛素抵抗、脂质代谢紊乱是T2DM合并NAFLD患者的独立危险因素。 相似文献
53.
Nicola Flaum Emma J. Crosbie Richard J. Edmondson Miriam J. Smith Dafydd G. Evans 《Clinical genetics》2020,97(1):54-63
Ovarian cancer is the fourth most common cause of cancer-related death in women in the developed world, and one of the most heritable cancers. One of the most significant risk factors for epithelial ovarian cancer (EOC) is a family history of breast and/or ovarian cancer. Combined risk factors can be used in models to stratify risk of EOC, and aid in decisions regarding risk-reduction strategies. Germline pathogenic variants in EOC susceptibility genes including those involved in homologous recombination and mismatch repair pathways are present in approximately 22% to 25% of EOC. These genes are associated with an estimated lifetime risk of EOC of 13% to 60% for BRCA1 variants and 10% to 25% for BRCA2 variants, with lower risks associated with remaining genes. Genome-wide association studies have identified single nucleotide polymorphisms (SNPs) thought to explain an additional 6.4% of the familial risk of ovarian cancer, with 34 susceptibility loci identified to date. However, an unknown proportion of the genetic component of EOC risk remains unexplained. This review comprises an overview of individual genes and SNPs suspected to contribute to risk of EOC, and discusses use of a polygenic risk score to predict individual cancer risk more accurately. 相似文献
54.
目的本研究以护理结局分类(NOC)为基础,筛选符合慢性心力衰竭患者的相关护理结局,由此构建具有专科专病特点的慢性心力衰竭患者护理结局评价表。方法成立研究核心小组,应用文献回顾法、专家函询法确定护理结局分类指标,并进行统计学分析,最终建立慢性心力衰竭护理结局分类评价表。结果通过研究,确定慢性心力衰竭护理结局中包含4个领域、8个一级指标、68个二级指标。4个领域分别是生理健康、功能健康、健康知识和行为、心理社会健康。一级指标中包含心脏泵血功能、活动耐力、社会支持、抑郁水平等。二级指标中包含心脏指数、血压、呼吸困难、情绪波动大、步行距离、步行速度等68个指标。统计学分析中:第一、二轮函询专家的积极系数分别为90%、100%,专家权威系数为0.895,专家意见协调程度(P<0.05)。结论本研究成功建立慢性心力衰竭护理结局分类评价表,有助于临床护士用于评价护理措施的有效性,也使其成为一种标准化语言,便于应用到护理电子信息系统中进行绩效测算等。但是本研究不足之处是未能将该研究进行临床实证,未能进一步确认其有效性。 相似文献
55.
Kun Ma Jiayun Liu Youjin Wang Yubin Zhong Zhenfeng Wu Ruiying Fan Shanfeng Guo 《Journal of gastrointestinal oncology.》2020,11(6):1350
BackgroundOur study aims to investigate changes in cell-free DNA (cfDNA) concentration and integrity in primary hepatocellular carcinoma (PHC) patients before and after transcatheter arterial chemoembolization (TACE) treatment and their influence on the evaluation of prognosis of the disease.MethodsA total of 84 PHC patients admitted to the Affiliated Hospital of Nanjing University of Chinese Medicine from December 2016 to December 2017 were included as the study group, while 55 healthy people served as the control group. Plasma cfDNA concentration and integrity were determined using qRT-PCR. The correlation between cfDNA concentration/integrity and clinical characteristics of PHC patients were analyzed. A ROC curve was used to investigate the sensitivity and specificity of cfDNA as detection indices. Univariate and multivariate analyses were used to analyze factors affecting recurrence in PHC patients and compare recurrence-free survival (RFS) of PHC patients with high cfDNA expression and low cfDNA expression.ResultsPlasma cfDNA concentration and integrity were significantly higher in PHC patients before TACE treatment than in healthy people and significantly lower after treatment than before (P<0.05). The cfDNA concentration was significantly correlated with tumor size, lymph node metastasis, TNM stage, and BCLC stage, while cfDNA integrity was significantly correlated with tumor size, TNM stage, and BCLC stage (P<0.05). ROC results showed that the area under the curve (AUC) value of cfDNA concentration was the largest, with an optimal cut-off of 10.51 ng/mL. Multivariate regression analysis for COX showed that the TNM stage, cfDNA concentration, and AFP were independent risk factors that affected PHC patients’ survival.ConclusionsPlasma cfDNA concentration in PHC patients is more sensitive and specific than any other tumor marker. It is an independent risk factor for PHC patients treated with TACE. Therefore, it is hypothesized cfDNA is a potential biomarker for prognostic evaluation of PHC patients treated with TACE. 相似文献
56.
《Burns : journal of the International Society for Burn Injuries》2022,48(1):201-214
BackgroundThere is an urgent need to empower practitioners to undertake quality improvement (QI) projects in burn services in low-middle income countries (LMICs). We piloted a course aimed to equip nurses working in these environments with the knowledge and skills to undertake such projects.MethodsEight nurses from five burns services across Malawi and Ethiopia took part in this pilot course, which was evaluated using a range of methods, including interviews and focus group discussions.ResultsCourse evaluations reported that interactive activities were successful in supporting participants to devise QI projects. Appropriate online platforms were integral to creating a community of practice and maintaining engagement. Facilitators to a successful QI project were active individuals, supportive leadership, collaboration, effective knowledge sharing and demonstrable advantages of any proposed change. Barriers included: staff attitudes, poor leadership, negative culture towards training, resource limitations, staff rotation and poor access to information to guide practice.ConclusionsThe course demonstrated that by bringing nurses together, through interactive teaching and online forums, a supportive community of practice can be created. Future work will include investigating ways to scale up access to the course so staff can be supported to initiate and lead quality improvement in LMIC burn services. 相似文献
57.
彭梅琼 《中国继续医学教育》2020,(7):179-181
目的了解护理专案改善在降低住院患者跌倒发生率中的应用效果。方法将医院2016年1月—2018年12月的80例住院患者随机分组,传统护理组对于住院患者给予传统护理,护理专案模式组对于住院患者采取护理专案模式。比较两组满意评分;护理人员工作积极性评分;护理前后住院患者对跌倒危险因素的掌握水平、住院患者遵医行为;跌倒的发生率。结果护理专案模式组满意评分、住院患者对跌倒危险因素的掌握水平、住院患者遵医行为、护理人员工作积极性评分、跌倒的发生率对比传统护理组有优势,P<0.05。结论住院患者实施护理专案模式效果确切,可提高护理服务质量和住院患者自我防护能力,降低跌倒的发生率。 相似文献
58.
Jessica K. Perrotte Michael R. Baumann Raymond T. Garza Willie J. Hale 《Ethnicity & health》2020,25(1):47-64
ABSTRACTObjectives: The present study investigated the relationships of enculturation and depressive symptoms with health risk behavior engagement in Mexican-American college students and examined how these relationships differed by gender. Previous research has noted consistent gender differences in health risk behavior (e.g. alcohol use, substance use, and risky sexual behavior) among Latina/os, and emphasized the role of U.S. acculturation in this difference. Research examining the role of heritage cultural retention (i.e. enculturation), and including the added influence of mental health variables, such as depressive symptoms, is currently lacking. This study sought to address this gap.Design: A large sample (N?=?677) of Mexican-American college students from four universities (located in New York, California, Florida, and Texas) completed an online questionnaire assessing health risk behaviors and corresponding variables.Results: We found that males who endorsed more behavioral enculturation and depressive symptoms were more likely to engage in health risk behavior than all others in the sample. Contrary to previous literature, no relationship was found between behavioral enculturation and health risk behavior in females.Conclusion: The current study found behavioral enculturation to be associated with depressive symptoms, and in turn with health risk behaviors among the males in our sample. Additional research will be needed to identify the mechanism underlying the relationship between enculturation and depressive symptoms as well as between depressive symptoms and risky behavior. 相似文献
59.
60.