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11.
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12.
合理使用抗菌药物不仅能有力保护人类珍贵的药物资源,而且可促进感染病患者的规范诊治与健康。患者之间、病原菌之间、感染病之间及抗菌药物之间均存在明显差异,抗菌药物个体化治疗是合理用药的必由之路,关注感染病诊治中的人体、病原体、疾病与药物是个体化治疗的关键,值得临床高度重视。 相似文献
13.
14.
Abdelhadi Lahoum Nasserdine Sabaou Christian Bijani Noureddine Bouras Frédéric Pont Selma P. Snini Florence Mathieu 《Saudi Pharmaceutical Journal》2019,27(1):56-65
The actinobacterium strain ABH26 closely related to Saccharothrix xinjiangensis, isolated from an Algerian Saharan soil sample, exhibited highly antagonist activity against Gram-positive bacteria, yeasts and filamentous fungi. Its ability to produce antimicrobial compounds was investigated using several solid culture media. The highest antimicrobial activity was obtained on Bennett medium. The antibiotics secreted by strain ABH26 on Bennett medium were extracted by methanol and purified by reverse-phase HPLC using a C18 column. The chemical structures of the compounds were determined after spectroscopic (1H NMR, 13C NMR, 1H-1H COSY and 1H-13C HMBC spectra), and spectrometric (mass spectrum) analyses. Two new cyanogriside antibiotics named cyanogriside I (1) and cyanogriside J (2), were characterized along with three known caerulomycins, caerulomycin A (3), caerulomycin F (4) and caerulomycinonitrile (5). This is the first report of cyanogrisides and caerulomycins production by a member of the Saccharothrix genus. The minimum inhibitory concentrations (MIC) of these antibiotics were determined against pathogenic microorganisms. 相似文献
15.
目的改构α-防御素-1(HNP-1)使其成为一端带J链的改构体J-HNP-1分子,并探索建立能有效表达和分泌J-HNP-1,其表达产物又易于被检测和分离纯化的哺乳动物细胞表达系统。方法利用重组PCR技术,使HNP-1一端带上J链;将J-HNP-1 DNA片段插入哺乳动物细胞表达载体pcDNA3.1(-)/Myc-HisC中,构建出C端带Myc和6×His的rpcDNA3.1(-)/Myc-HisC/J-HNP-1;将此重组真核表达载体导入COS-7细胞,分别从mRNA和蛋白质水平分析J-HNP-1的表达情况,并同步检测细胞可溶性蛋白及培养上清的抗菌活性。结果采用RT-PCR法从被转染的细胞中扩增出1条约786bp的片段,其大小与预测相符;采用Western印迹法,用抗His抗体检测到细胞可溶性蛋白及培养上清在相对分子质量约24×103处有强反应条带显示;细胞可溶性蛋白及培养上清的抗菌活性检测显示,经rpcDNA3.1(-)/Myc-HisC/J-HNP-1转染的COS-7细胞的可溶性蛋白和培养上清均有明显的抗菌活性。结论α-防御素-1(HNP-1)被成功改构成杀菌肽J-HNP-1;所建立的J-HNP-1哺乳动物细胞表达载体系统能有效表达和分泌活性J-HNP-1。 相似文献
16.
G. Kahlmeter D. F. J. Brown F. W. Goldstein A. P. MacGowan J. W. Mouton I. Odenholt A. Rodloff C-J. Soussy M. Steinbakk F. Soriano O. Stetsiouk 《Clinical microbiology and infection》2006,12(6):501-503
The main objectives of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are to harmonise breakpoints for antimicrobial agents in Europe, and to act as the breakpoint committee for the European Medicines Agency (EMEA) during the registration of new antimicrobial agents. Detailed EUCAST procedures for harmonising and setting breakpoints for antimicrobial agents are available on the EUCAST website. Beginning with the current issue, a series of EUCAST Technical Notes will be published in CMI, based on the rationale documents produced by EUCAST for each of the antimicrobial agents studied, with the aim of highlighting important background information underlying decisions on breakpoints made by EUCAST. 相似文献
17.
A. Trovato S. Kirjavainen E. M. Galati A. M. Forestieri L. Iauk 《Phytotherapy research : PTR》1995,9(8):591-593
The decoction of Sclerocarya birroea Hochst. shows hypoglycaemic effects, an increase in plasma IRI in normal rats and an incremented oral-glucose tolerance. The decoction is also active against diet-induced hypercholesterolaemia. 相似文献
18.
Janet Fricke Carolyn Unsworth Diane Worrell 《Australian Occupational Therapy Journal》1993,40(1):7-15
This paper reports an inter-rater reliability study on the Functional Independence Measure (FIM). The FIM measures inpatient burden of care, as reflected in 18 self care items, rated on a seven point scale from dependent to independent. The subjects were 40 occupational therapists, divided according to experience with the FIM and randomly assigned to a FIM training or non-training group. Subjects rated video tapes of four stroke patients on transfers, bathing, dressing, grooming, toileting and eating items from the FIM. Rater consensus was calculated using the intraclass correlation coefficient (ICC), percentage agreement and a measure of disagreement. Rating accuracy was measured by comparisons with an expert rater. Ratings were most reliable when done by clinicians with no prior FIM experience, from the FIM training group. It is strongly recommended that all clinicians undergo FIM training before using this tool to ensure acceptable reliability. 相似文献
19.
We investigated the clinical background of patients at Shin-Kokura Hospital who showed a positive culture of pleural effusion
during the period from January 1998 through December 2002. Microorganism cultures of the pleural effusions of 127 patients
were performed in this 5-year period. Seventeen patients showed a positive microorganism culture from a pleural effusion,
and 12 of these patients (70.6%) were 60 years old or more. Ten patients were diagnosed with thoracic empyema. Thirteen patients
had an underlying disease such as malignancy (5 cases), diabetes mellitus (4 cases), etc. A purulent effusion and a high concentration
of lactic dehydrogenase (LDH) in the pleural fluid were more frequently recognized in the positive-culture group. A total
of 21 strains of microorganism were isolated from the 17 patients, including 10 strains of Gram-positive cocci, 6 strains
of Gram-negative bacilli, 3 strains of anaerobes, 1 strain of mycobacterium (Mycobacterium tuberculosis), and 1 strain of fungus. Susceptibility to antimicrobial agents was generally good for most of the microorganisms isolated.
Of the 17 patients, chest-tube drainage was performed in 13, and 6 needed a surgical operation. Twelve patients improved,
but 5 died. In this study, thoracic empyema accounted for 58.8% of the 17 cases with a positive culture of pleural effusion.
Of the 10 thoracic empyema patients, 5 patients needed surgical treatment in spite of adequate antimicrobial treatment and
chest-tube drainage. Our data indicate that thoracic empyema is still difficult to treat, and thus adequate and rapid treatment
is needed for any pleural infection. 相似文献
20.
加强行业管理规范人体器官移植技术 总被引:5,自引:0,他引:5
人体器官移植技术历经近半个世纪的发展历程.在上个世纪70年代我国逐步开展对肝脏、心脏和肾脏等器官移植技术的研究工作。近5年来,随着国际医学研究交流频繁,国内一些大型医疗机构加大了对器官移植技术上的投入.使人体器官移植技术发展迅猛。但同时也伴随着一些医疗费用过高、买卖供体等问题的出现。因此,如何规范人体器官移植技术.是当前的一个重要研究课题。 相似文献