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Design flaws in randomized, placebo controlled, double blind clinical trials

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World Journal of Pharmacology 2012年第1期1卷 4-9页

作者： james David Adams jr Department of Pharmacology and Phar-maceutical Sciences University of Southern California School of Pharmacy Los Angeles CA 90089 United States

The hypothesis in drug clinical trials is that the drug is better than a placebo in patients suffering from a disease. The unstated assumption is that the drug cures the disease or is a powerful treatment for the disease. This is an incorrect assumption. Drugs do not cure or treat diseases. The body heals itself; drugs promote this ability of the body to heal itself. Placebos are assumed to be inactive; however, placebos can also promote the ability of the body to heal itself. Placebos are actually treatments that can stimulate endogenous healing mechanisms. The possible place of placebos in health management is controversial. Clinical trial design should be altered. The hypothesis of clinical trials should be that the drug speeds up or improves the healing of the patient, putting patient healing as the first objective. Placebos should not be used as controls but could be tested as drugs in their own right. The control in clinical trials should be no treatment. Alternatively, new drugs could be compared to existing drugs in clinical trials.

关键词：药物临床试验患者治疗方法临床分析

The "Regulative" Idea from k.nt to William james

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哲学门 2004年第S1期5卷 216-233页

作者： james Behuniak.jr. University of Hawaii USA

There are various routes that one might tak. in coming to understand American *** routes,however,are as direct as that which departs from k.nt and arrives at William james.

关键词： William however ism

Preventive medicine and the traditional concept of living in balance

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World Journal of Pharmacology 2013年第3期2卷 73-77页

作者： james David Adams jr Department of Pharmacology and Pharmaceutical Sciences University of Southern California

Chronic diseases such as arthritis, heart disease and type 2 diabetes are becoming much more common. The cost of maintaining patients inflicted with these diseases increases yearly. These diseases were less common prior to 1970. This paper will consider several questions. How do toxic lifestyles contribute to these chronic diseases? What is preventive medicine? How can traditional healing help educate people about disease prevention? What is the traditional concept of balance and how is it important in modern medicine? The dangers of obesity are discussed in terms of inflammatory adipok.ne and inflammatory fat production. Mechanisms of disease causation or promotion are reviewed for heart disease, type 2 diabetes, arthritis and cancer. A preventive medicine approach to preventing or perhaps curing these diseases is given which involves treating toxic lifestyles and encouraging people to live in balance. The traditional concept of balance is explained in traditional Chinese medicine terms and in scientific terms. Yin and yang are cold and hot but can also be seen as agonist and antagonist. In addition, yin and yang can be seen as rest and exercise. When yin and yang are in balance, chi flows in the body. Chi is the flow of extracellular and intracellular signaling compounds and processes in the body. When the body isin balance, it can heal itself. The traditional concept of balance should be taught as a central principle of preventive medicine.

关键词：慢性疾病糖尿病治疗方法临床分析

Effect of different intensities of physical activity on cardiometabolic mark.rs and vascular and cardiac function in adult rats fed with a high-fat high-carbohydrate diet

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Journal of Sport and Health Science 2018年第1期7卷 109-119页

作者： Romeo B.Batacan jr Mitch J.Duncan Vincent J.Dalbo Geraldine L.Buitrago Andrew S.Fenning School of Medical and Applied Sciences Central Queensland University Centre for Physical Activity Studies Central Queensland University School of Medicine & Public Health Priority Research Centre for Physical Activity and Nutrition Faculty of Health and MedicineThe University of Newcastle University Drive Clinical Biochemistry Laboratory Central Queensland University Centre for Biodiscovery and Molecular Development of Therapeutics Australian Institute of Tropical Health and MedicineJames Cook University

Back.round: Physical activity(PA) and diet are 2 lifestyle factors that affect cardiometabolic risk. However, data on how a high-fat highcarbohydrate(HFHC) diet influences the effect of different intensities of PA on cardiometabolic health and cardiovascular function in a controlled setting are yet to be fully established. This study investigated the effect of sedentary behavior, light-intensity training(LIT), and high-intensity interval training(HIIT) on cardiometabolic mark.rs and vascular and cardiac function in HFHC-fed adult ***: Twelve-week.old Wistar rats were randomly allocated to 4 groups(12 rats/group): control(CTL), sedentary(SED), LIT, and *** indices, glucose and lipid control, inflammatory and oxidative stress mark.rs, vascular reactivity, and cardiac electrophysiology of the experimental groups were examined after 12 week. of HFHC-diet feeding and PA ***: The SED group had slower cardiac conduction(p = 0.0426) and greater thoracic aortic contractile responses(p < 0.05) compared with the CTL group. The LIT group showed improved cardiac conduction compared with the SED group(p = 0.0003), and the HIIT group showed decreased mesenteric artery contractile responses compared with all other groups and improved endothelium-dependent mesenteric artery relaxation compared with the LIT group(both p < 0.05). The LIT and HIIT groups had lower visceral(p = 0.0057 for LIT, p = 0.0120 for HIIT)and epididymal fat(p < 0.0001 for LIT, p = 0.0002 for HIIT) compared with the CTL ***: LIT induced positive adaptations on fat accumulation and cardiac conduction, and HIIT induced a positive effect on fat accumulation,mesenteric artery contraction, and endothelium-dependent relaxation. No other differences were observed between groups. These findings suggest that few positive health effects can be achieved through LIT and HIIT when consuming a chronic and sustained HFHC diet.

关键词：高脂肪心脏老鼠食谱脉管标记成年物理

American government The Essentials james Q. Wilson, John J. Dilulio 8th ed.; postinaugural ed.

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American government The Essentials James Q. Wilson, John J. ...

2001年

作者： james Q. Wilson John J. Dilulio

来源：畅想之星图书光盘版（南... 评论

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赤道太平洋中的生物地球化学相互作用

人类环境杂志 1994年第1期23卷 62-66页

作者： Richard T.Barber jr. james W.Murray james J.McCarthy 张康生杜克大学环境学院海洋实验室华盛顿大学海洋学学院比较动物学陈列馆

在1992年,"全球海洋通量联合研究(JGOFS)"调查了赤道中部太平洋中的生物地球化学通量。赤道太平洋是赤道大气CO_2最大的天然来源,但通量的量级随厄尔·尼诺南方涛动而发生年际变化。赤道上涌水流低下的沉积物富含有机碳,这表明存在一股... 详细信息

在1992年,"全球海洋通量联合研究(JGOFS)"调查了赤道中部太平洋中的生物地球化学通量。赤道太平洋是赤道大气CO_2最大的天然来源,但通量的量级随厄尔·尼诺南方涛动而发生年际变化。赤道上涌水流低下的沉积物富含有机碳,这表明存在一股强大的输出通量,但同期新的初级生产力比根据新营养物的相对浓度所预测的值低。这项多学科的JGOFS研究计划的目的是,解决这一系统中明显的矛盾,并且评价赤道物理和生物过程在调控海洋-大气碳交换方面所起的作用。

关键词：赤道太平洋生物地球化学

创伤后深静脉血栓的预防机械预防和药物预防的前瞻性、随机性比较

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骨科动态 2006年第3期2卷 155-160页

作者： james P. STANNARD ROBERT R. LOPEZ-BEN DAVID A. VOLGAS EDWARD R. ANDERSON MATT BUSBEE DONNA k. k.RR GERALD R. McGWIN jr. JORGE E. ALONSO 罗从风（译）费起礼（校） Investigation performed at the University of Alabama at Birmingham Birmingham Alabama 上海第六人民医院骨科 200233 天津市天津医院 300211

背景：骨创伤后的深静脉血栓是十分重要的问题，但相关研究甚少。本研究的目的是评估两种不同方法对预防钝性创伤后深静脉血栓和肺栓塞的有效性。方法：共有224例住院患者参与此项预防创伤后静脉血栓形成的前瞻性随机性研究。200例患者... 详细信息

背景：骨创伤后的深静脉血栓是十分重要的问题，但相关研究甚少。本研究的目的是评估两种不同方法对预防钝性创伤后深静脉血栓和肺栓塞的有效性。方法：共有224例住院患者参与此项预防创伤后静脉血栓形成的前瞻性随机性研究。200例患者最终完成研究，比较两种不同的预防方案。A组患者在钝性创伤后24-48h内使用依诺肝素（30mg，皮下，每天两次）。B组患者在人院后使用脉冲式足泵并延迟使用依诺肝素。所有患者在出院前均行静脉核磁共振和超声检查。结果：A组共97例患者，B组共103例患者。22例患者（A组13人，B组9人）有深静脉血栓形成，其中A组2例还发生了肺栓塞。本组深静脉血栓的发生率为11％，A组13．4％，B组8．7％；A组和B组之间的差异无统计学意义。A组出现大的或闭塞性血栓共11例（发生率11．3％），B组仅3例（发生率2．9％）（p=0．025）。A组肺栓塞的发生率为2．1％，B组为0。A组有21例患者出现伤口并发症，B组为20例。住院期间发生深静脉血栓的患者人均用血7.4单位，无深静脉血栓的患者人均用血3．9单位（p〈0．05）。结论：结果显示严重的肌肉骨骼创伤后，早期使用机械预防（足泵）并延迟使用依诺肝素对预防深静脉血栓是相当有效的。比较两组患者，B组患者大的或闭塞性血栓的发生率明显低于A组患者。可信水平：治疗性研究，Ⅰ级。详细的可信水平描述参见作者须知。

关键词：深静脉血栓形成药物预防创伤后随机性机械依诺肝素住院期间肌肉骨骼

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药品设计是不同的

私法 2002年第2期3卷 163-199页

作者： [美]james A.Henderson,jr. Aaron D.Twersk. 宋工(译) 杜颖(校) 康奈尔法学院布鲁克林法学院北京大学法学院中共中央党校政法部

在一篇题为《〈侵权行为法重述(第三次):产品责任〉中有设计缺陷吗?》论文中,George Conk.评美国法律协会和新重述的报告人免除处方药制造者设计缺陷责任。本文是新重述的报告人对他和其他批评者的一个回应。本文第一部分概述Conk.论... 详细信息

在一篇题为《〈侵权行为法重述(第三次):产品责任〉中有设计缺陷吗?》论文中,George Conk.评美国法律协会和新重述的报告人免除处方药制造者设计缺陷责任。本文是新重述的报告人对他和其他批评者的一个回应。本文第一部分概述Conk.论文,包括他对新重述的解释。第二部分指出Conk.评中的重大错误:他误读了重述,而且他对血液案例的依靠是错位的。第三部分解释新重述对处方药品设计的处理和它对产品设计缺陷的一般处理之间的实质性的差别并使之正当化。这些差别包括新重述拒绝允许法院去考虑尚未得到FDA许可的可替代的更安全的处方产品(在一般设计条款下,法院通常是考虑尚未上市的替代性设计的)和拒绝牺牲一类患者的福利去增进另一类患者的福利(在一般设计条款下,这种消费者之间的相互利益牺牲通常是得到宽容的。第三部分也解释为什么药品设计诉讼不能通过减少其复杂性而合法地被变得更有利于原告,以及为什么新重述的规定不会明显地降低制造者发现新的、更加安全的处方产品的积极性。

关键词：产品责任设计缺陷药品设计

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利用直接推进技术测定渗透系数的最新进展

水文地质工程地质 2012年第1期39卷 8-12,18页

作者：王晓丽郑春苗刘改胜李文鹏 Steve k.obbe Edward Reboulet james J.Butler jr 北京大学水资源研究中心北京100871 阿拉巴马大学地质科学系阿拉巴马35487 美国堪萨斯大学堪萨斯州地质调查局堪萨斯66045 中国地质环境监测院北京100081

高精度测定渗透系数(k.的重要性不言自明,但是现阶段野外试验手段能够提供的关于k.信息不能满足高度非均质地层中污染物迁移预测模拟的需求。直接推进注入记录器(Direct-Push Injection Logger,DPIL)和直接推进渗透仪(Direct-Push Perm... 详细信息

高精度测定渗透系数(k.的重要性不言自明,但是现阶段野外试验手段能够提供的关于k.信息不能满足高度非均质地层中污染物迁移预测模拟的需求。直接推进注入记录器(Direct-Push Injection Logger,DPIL)和直接推进渗透仪(Direct-Push Permeameter,DPP)是新发展的水文地质参数测量仪器,能够使k.的测定达到前所未有的分辨率和成本效益水平。工具向地下推进过程中,通过对注水量、注水压力和其它的水文地球物理参数的同步监测,直接推进技术(Direct Push,DP)能快捷准确地获得地层渗透系数的垂向分布。DP技术几乎适用于所有野外松散地层,并且对场地的干扰很小。因此,它克服了许多基于既有井的传统含水层测试方法的局限性。最近在美国MADE试验场的一个案例研究表明,使用DPIL/DPP可以获得空间分辨率达1.5cm的k.垂向分布。未来,高精度直接推进技术还可以与新一代的地球物理技术,例如高精度探地雷达相结合,以实现不同位置DP测定k.的互联以及整个试验场k.三维分布的确定。

关键词：直接推进技术直接推进注入记录器直接推进渗透仪渗透系数