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A new direction for Alzheimer's research

Neural Regeneration Research 2018年第2期13卷 190-193页

作者： James D.Weinstein Marshall University School of Medicine Medical Center

Despite decades of research, at present there is no curative therapy for Alzheimer＇s disease. Changes in the way new drugs are tested appear to be necessary. Three changes are presented here and will be discussed. The first change is that Alzheimer＇s disease must be considered a disease of four major pathological processes, not one. The four processes are： 1） vascular hy- poperfusion of the brain with associated mitochondrial dysfunction, 2） destructive protein inclusions, 3） uncontrolled oxidative stress, and 4） proinflammatory immune processes second- ary to microglial and astrocytic dysfunction in the brain. The second change recommended is to alter the standard cognitive measurement tools used to quantify mental decline in test patients. Specifically the Dementia Severity Rating Scale （DSRS） should supersede Mini-Mental State Examination （MMSE） and other popular tests, and a measurement scale developed in research should be used to produce a linear and non-irregular baseline. Finally, accepting the concept that four etiologies cause Alzheimer＇s disease leads to the last necessary change, that new thera- pies must be employed directed against all four causes, likely as a combination. There are drugs ready to be employed in such a combinations which are available and used clinically for other purposes so can be used ＂offlabel＂ and one such combination is suggested.

关键词： Alzheimer's disease etiologies combination therapy cognitive testing failed research off-label use Dementia Severity Rating Scale

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Efficacy,Safety and Characteristics of the Amplatzer Vascular Plug II and IV Utilization for Various Percutaneous Occlusions in Children under 10 Years

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Congenital Heart Disease 2022年第4期17卷 421-436页

作者： Hugues Lucron Alban-Elouen Baruteau Caroline Ovaert Ali Houeijeh Mélanie Brard Patrice Guerin François Bourlon Claire Dauphin Saskia Tuttle Maha Tagorti Rishika Banydeen François Godart Antilles-Guyane M3C Paediatric Cardiology Center University Hospital of MartiniqueFort-de-FranceFrance L’institut du Thorax INSERMCNRSUNIV NantesCHU NantesNantesFrance Department of Paediatric Cardiology and Pediatric Cardiac Surgery University Hospital of NantesNantesFrance Department of Paediatric and Congenital Heart Disease University Hospital of MarseilleMarseilleFrance Department of Paediatric and Congenital Heart Disease University Hospital of Lille-Nord de FranceLilleFrance Department of Paediatric and Congenital Heart Disease Cardiothoracic Center of MonacoMonaco Department of Paediatric and Congenital Heart Disease University Hospital of Clermont-FerrandClermont-FerrandFrance Clinical Research Department CHU Martinique(University Hospital of Martinique)Fort-de-FranceFrance

Objectives:We aim to describe the efficacy,safety,and characteristics of the Amplatzer Vascular Plug(AVP)II and IV“off-label”use for multiple cardiovascular occlusions in children under 10 ***:Observational retrospective multicenter(2007–2020,6 centers)review of paediatric procedures using AVP II or ***:A total of 125 children(49.6%aged≤1 year,147 lesions)underwent 136 successive procedures(success rate:98.5%)using 169 devices(109 AVP IV,60 AVP II).The mean device diameter was 7.7±3.2 mm(4–20 mm).The median AVP size to vessel diameter ratio was 1.3(0–2).The median age and weight at implantation were 1.0 year(0.01–9.98)and 8.4 kg(1–69).Procedures were heterogeneous(55 patent ductus arteriosus(PDA),28 collaterals,18 sequestrations,22 arteriovenous/veinovenous/coronary fistulas,6 vertical veins,6 conduits,5 ventricular septal defects,7 miscellaneous).Day 1 and 6-month occlusion rates were respectively 94.8%and 98.5%.Major adverse events(MAE)occurred in 5.2%of cases(no procedure-related deaths),and more frequently in weight≤5 kg(p=0.01),younger patients(p=0.03)during PDA closure(p=0.02)of tubular types(p=0.02)using larger devices(p=0.03)and AVP II(p=0.003).Independent predictor of MAE risk was a higher AVP diameter to patient weight ratio(Odds-ratio:2.33,95%confidence interval 1.31–4.13,p=0.004,optimal cut off:1.45).Conclusions:Both AVPs are safe and effective for percutaneous occlusions in children under *** devices represent an alternative“off label”use for well selected paediatric patients.

关键词： Amplatzer vascular plug(AVP)II and IV cardiovascular occlusions off-label use children under 10 years efficacy safety

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住院患者抗肿瘤药物超说明书使用回顾性研究

住院患者抗肿瘤药物超说明书使用回顾性研究

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第七届中国药学会医院肿瘤药学大会

作者：田云尤海生曹舫陕西省肿瘤医院药剂科西安交通大学第一附属医院

目的:对陕西省抗肿瘤药物超说明书用药情况进行了定性和定量研究,对于强化超说明书用药的监管,减少不合理的超说明书用药提供依据。方法:使用回顾性调研的方法对陕西省2所医院2017年度11-12月肿瘤住院患者病历的抗肿瘤药物应用情况进行... 详细信息

目的:对陕西省抗肿瘤药物超说明书用药情况进行了定性和定量研究,对于强化超说明书用药的监管,减少不合理的超说明书用药提供依据。方法:使用回顾性调研的方法对陕西省2所医院2017年度11-12月肿瘤住院患者病历的抗肿瘤药物应用情况进行评价。收集有关患者特征,肿瘤疾病和全身治疗的数据,并将每个个体的抗肿瘤药物治疗方案与相应的药品说明书、国际治疗指南进行比较。结果:1178名患者中,355名（30.1%）接受了超说明书用药。所有药物应用的超说明书用药评价显示,主要的30种抗肿瘤药物中,超说明书最常见的为奈达铂（25.1%）、其次为紫杉醇（21.1%）,多西他赛（15.8%）,顺铂（13.8%）。其中,NCCN支持的占50.98%。结论:建立了以超说明书用药为主要评价内容的抗肿瘤药物医嘱点评方法,能够使临床药师全面深入判断抗肿瘤药物在超说明书用药环节存在的问题,为进一步开展相关研究提供思路。

关键词： off-label use prospective anticancer therapy

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