Adaptive group sequential design for phase II clinical trials: A Bayesian decision theoretic approach

Bayesian decision theoretic approaches (BDTAs) have been widely studied in the literature as tools for designing and conducting phase II clinical trials. However, full Bayesian approaches that consider multiple endpoints are lacking. Since the monitoring of toxicity is a major goal of phase II trials, we propose an adaptive group sequential design using a BDTA, which characterizes efficacy and toxicity as correlated bivariate binary endpoints. We allow trade‐off between the two endpoints. Interim evaluations are conducted group sequentially, but the number of interim looks and the size of each group are chosen adaptively based on current observations. We utilize a loss function consisting of two components: the loss associated with accruing, treating, and monitoring patients, and the loss associated with making incorrect decisions. The performance of our Bayesian modeling, and the operating characteristics of decision rules under a wide range of loss function parameters are evaluated using seven scenarios in a simulation study. Our method is illustrated in the context of a single‐arm phase II trial of bevacizumab, gemcitabine, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma. Copyright © 2009 John Wiley & Sons, Ltd.     

胃胆宁汤治疗胆汁反流性胃炎54例

目的:观察自拟胃胆宁汤治疗胆汁反流性胃炎的临床疗效。方法:选符合标准的该病患者82例,随机分为两组,治疗组54例予自拟胃胆宁汤,对照组28例用吗丁啉片及雷尼替丁,两组治疗4周为1疗程。结果:治疗组痊愈20例,显效13例,有效16例,无效5例,总有效率为90.74%(95%CI=83.01%～98.48%);对照组痊愈5例,显效6例,有效9例,无效8例,总有效率为71.43%(95%CI=54.70%～88.16%);两组综合疗效比较,有显著性差异(u=2.3027,P=0.0215)。结论:自拟胃胆宁汤治疗胆汁反流性胃炎疗效优于吗丁啉及雷尼替丁,其收益为OR=0.25(95%CI=0.07～0.87),NNT=5(95%CI=2.78～37.88)。     

后现代心理学概观

后现代心理学家反对以往的心理学理论和流派把心理或行为看作是一个独立于研究者的“实体”。后现代心理学的典型特征是反对基础主义和本质主义。它认为心理现象并不是一种“精神实在” ,而是一种文化的社会建构。后现代心理学的理论基础是社会建构论 ,多元文化论、后现代女性心理学都是后现代心理学的重要形式。     

建立具有中国特色的临床医学工程体系势在必行

我们提出了一个建立具有中国特色的临床医学工程体系新理念，并且提出了一些具体建设性的意见。它涉及到政府行政管理、医学院校教育、医院科室人员配置以及传统观念的管理模式等，由于理念新、涉及面广，会有许多问题，仅供各界人士共同去探讨。     

Caring and cancer nursing: framing the reality using selected social science theory

Caring and cancer nursing: framing the reality using selected social science theory Despite the recent interest in caring for both academic and clinical nursing, the theoretical basis of this concept may appear somewhat elusive as the research and debate vary widely in their focus. As a result, the available literature may fail to consider the specific contextual issues which characterize caring as it is understood across different health care settings. Consideration of theory from disciplines close to nursing, it is suggested, may be useful in understanding the nature of such 'real world' caring. In this discussion the concept of caring within cancer nursing is explored by drawing on a number of social science and nursing sources. It is known that cancer provokes unique caring demands for nurses practising in this area. By examining the context of cancer, it is argued that effective caring deserves to be recognized as an important clinical variable which can influence a diverse range of issues such as patient satisfaction or therapeutic outcome. It is suggested that other nursing specialisms should also explore the psychosocial dimensions of caring in relation to their own role.     

劳动姿势对流量－容积曲线的影响─—波速学说的进一步验证

用“点值法”对健康工人４７３例［轻体力劳动工人（简称轻工）２４８例，重体力劳动工人（简称重工）２２５例］。作了流量一容积曲线和常规通气功能检查。结果表明：重工男女在４０岁以后其高肺容积流量下降，３０岁以后低肺容积流量上升，而且这些改变有随年龄增长而更加明显的倾向；轻工仅有个别年龄组的低肺容积流量上升。对７名健康坐位工作者模拟劳动的前倾姿势作多次通气功能检查，亦有明显高肺容积流量下降和低肺容积流量上升的现象，这一事实提示波速学说亦可应用于颈和躯干前倾进行重体力劳动工人的通气行为。     

An Electron Microscopic Study on the Process of Acid Demineralization of Cortical Bone

Demineralization has been shown to foster osteoinductive properties of cortical bone grafts, yet little is known about the process of demineralization and how to control it. The purpose of this study was to investigate the process of cortical bone demineralization by using scanning electron microscopy to evaluate how hydrochloric acid demineralizes cortical bone. Results showed that in the demineralization of diaphyseal cortical bone specimens using hydrochloric acid, a uniformly thick circumferential band of demineralized bone matrix surrounds an inner undecalcified bone core as the process of demineralization occurs. The interface between the demineralized and mineralized section of the bone specimens was extremely sharp. This interface between demineralized and undemineralized bone was noted to advance as a reaction front with increasing demineralization which resulted in continuous shrinkage of the inner cortical bone core. This study suggests that cortical bone demineralization can be best described using an advancing reaction front theory, and this explanation can be used for implementation of the concept of controlled demineralization. Received: 19 December 1996 / Accepted: 25 April 1997     

厄尔·迈纳的跨文化阐释

厄尔·迈纳的《比较诗学》从跨文化的角度对诗学作比较探讨 ,他以基础文类形成原创诗学为理论基础 ,以基础文类的分析作为跨文化阐释的切入点 ,以基础文类同异关系的把握作为诗学比较的可比性的基础 ,以一种宽容平等的对话精神作为跨文化阐释的态度 ,显示了比较诗学发展的一个必然的成熟过程。但科学的相对主义态度 ,注定了从事比较诗学面临着“诗学”“跨文化”“阐释”等因素的制约 ,这也同时为比较诗学的开拓提供了更多的空间。     

从脾论治磺脲类降糖药继发性失效

对 64例 2型糖尿病继发磺脲类降糖药失效患者 ,在继续口服磺脲类药的基础上加用健脾中药 ,结果显效 1 5例 ,有效 3 6例 ,无效 1 3例 ,总有效率 85 .2 4% ;治疗前后血糖明显下降 ,有显著性差异 ( P<0 .0 0 1 )     

晚期肺癌的中医证候研究

目的　探讨晚期肺癌的主要中医证候。方法　采用回顾性与前瞻性相结合的方法进行临床观察。结果　经 χ2 检验 ,不同中医证候的晚期肺癌组之间有显著性差异 (P <0 0 1) ,而血瘀证、气虚证、痰证、阴虚证最为多见 ;晚期非小细胞肺癌与晚期小细胞肺癌的中医证型没有显著性差异。结论　晚期肺癌的中医证候以血瘀证、气虚证、痰证、阴虚证为主 ;晚期非小细胞肺癌与小细胞肺癌的中医证候无明显差异。