利巴韦林的安全性与利益-风险分析

目的:评价利巴韦林在丙型肝炎和呼吸道合胞病毒感染治疗中的利益-风险。方法:通过对文献的系统综述,并结合国内和世界卫生组织ADR监测数据对药品利益-风险进行半定量分析。结果:共获得581篇可用的相关文献。文献综述和病例分析的结果表明利巴韦林常见不良反应是过敏性反应和血液系统障碍,且有5例致死的不良反应病例报告。利益-风险分析表明利巴韦林对丙型肝炎的治疗效果较好,但其不良反应不容忽视,尤其是出现致畸、致死胎的严重不良反应的病例报告,提示在应用该药时应明确相关禁忌证;在治疗合胞病毒呼吸道感染方面,利巴韦林疗效远低于不良反应的得分,提示应尽量规范该类用途。结论:利巴韦林的常见不良反应为过敏性反应和血液系统障碍。利巴韦林联合干扰素对治疗丙型肝炎利益优于风险,对其他疾病的疗效尚待进一步证实。

胺碘酮的安全性与利益-风险分析

目的回顾性分析我国近20年胺碘酮在临床的使用情况,探讨其不良反应(ADR)发生的临床特点、产生原因及预防措施,并评价胺碘酮在治疗心律失常疾病中的利益与风险。方法利用《中文科技期刊数据库》收集临床资料,按照设定的标准,用SPSS 11.5软件进行统计分析,并对药品利益-风险进行半定量分析。结果共获得113篇可用的相关文献,共计有5806个临床病例参加安全性评价,发生ADR计1384例次。ADR涉及心血管系统、消化系统、甲状腺系统、皮肤、神经系统、呼吸系统、眼部等多个系统和器官,且有4例致死、4例晕厥的严重ADR病例报告。结论利益-风险分析表明胺碘酮对心律失常的治疗效果较好,但其ADR不容忽视,窦性心动过缓,低血压、甲状腺异常、肺纤维化是常见的ADR。其中,肺损害是胺碘酮的主要ADR之一。

药品利益-风险分析的基本方法

众所周知,任何一种药品给人们带来的预期利益和潜在风险总是相伴而生的.一种药品被批准上市,是根据现有研究资料对其利益与风险进行权衡和比较的结果[1].

利益-风险分配模型:公司治理的理论前提

本文综述了新古典理论、委托代理理论和不完全合同理论及Zinglas的“准租金”概念分析公司治理的理论前提;在此基础上指出,公司治理的理论前提不仅要解决已经创造出来的准租金的分配,还要解决如何才能尽可能地通过约束条件让合约双方尽力创遣准租金/企业价值。本文认为,公司治理的本质和理论前提是:指导(相应利益方)企业准租金(或利益/公司价值)分配和企业风险分配进行事后谈判的一系列约束条件。本文还分析了利益—风险分配模型与现有理论模型之间的关系。

Performance-based seismic financial risk assessment of reinforced concrete frame structures

Engineering facilities subjected to natural hazards(such as winds and earthquakes) will result in risk when any designed system(i.e.capacity) will not be able to meet the performance required(i.e.demand).Risk might be expressed either as a likelihood of damage or potential financial loss.Engineers tend to make use of the former(i.e.damage).Nevertheless,other non-technical stakeholders cannot get useful information from damage.However,if financial risk is expressed on the basis of probable monetary loss,it will be easily understood by all.Therefore,it is necessary to develop methodologies which communicate the system capacity and demand to financial risk,Incremental dynamic analysis(IDA) was applied in a performance-based earthquake engineering context to do hazard analysis,structural analysis,damage analysis and loss analysis of a reinforced concrete(RC) frame structure.And the financial implications of risk were expressed by expected annual loss(EAL).The quantitative risk analysis proposed is applicable to any engineering facilities and any natural hazards.It is shown that the results from the IDA can be used to assess the overall financial risk exposure to earthquake hazard for a given constructed facility.The computational IDA-EAL method will enable engineers to take into account the long-term financial implications in addition to the construction cost.Consequently,it will help stakeholders make decisions.

Controlling the Risk of Construction Delay in the Middle East： State-of-the-Art Review

The financial crisis in late 2008 arrested economic development in the construction sector in the Middle East, with the result that investors＇ confidence in the sector is severely depressed. Delays constitute one of the highest impediments to project success. In this respect, the traditional management is no longer sufficient for construction project success. The objective of this study is to conduct a literature review to identify additional effective measures for controlling the potential delays risks in construction projects in order to maximize the opportunities for success in those projects. Thirty-six scholarly articles published between 2000 and 2011 are reviewed to identify related MDRC （measures for delays risks control）. This survey reveals that 60% of the studies are related to decision-making, performance, risk management variations and poor management knowledge of stakeholders and that 20% of these studies are undertaken in the Middle East. A further 25% of the studies are related to the lack of financial risk by stakeholders, and of these 14% are in the Middle East. A knowledge gap is identified in terms of project performance, stakeholder management and risk management, which are seen as significant measures of success in controlling project delay.

Prospective Consensus Building-Ethical Consideration on History of Reason and List of Risks＊

In consensus building process in medicine, it is said that it is crucial for its participants to understand why each stakeholder, patient, his/her family, physician, nurse, etc., in decision-making has his/her own opinion. In order to understand this condition more deeply, I develop the notion of ＂reason of opinion＂ to characterize the process as ＂prospective consensus building.＂ This prospective consensus building should satisfy the requirements of having ＂history of reason＂ and ＂list of risks.＂ The former requirement, history of reason, can be characterized by making clear when one started to form the reason of an opinion, how one formed the reason, what kind of relationship is supposed to be between the present opinion and its reason, and what kind of result is expected to come out after a decision making. The latter requirement, the list of risks, should display what kind of outcomes are supposed to come out in each alternative of the decision making. Prospective consensus building makes it possible, firstly, for the stakeholders to understand the patient＇s needs more deeply. For the patient, secondly, the each stakeholder would be able to become aware of his/her own sense of value and to confirm what he/she expects from the result of his/her decision-making. For all the stakeholders, thirdly, it would make it possible to decrease the amount of risks of misunderstanding and to share their expectations for their well-being. Finally, the stakeholders can reach a satisfactory consensus and find a way to the better solution.

分散型决策结构下供应链协同实现机制的理论探讨

供应链协同从系统和全局的高度看待企业关系,在追求整体绩效目标的同时实现成员企业更为持久的利益。分散型决策结构更符合供应链管理的一般特征,多参与主体、多目标冲突环境等复杂因素共同影响协同的实现。利益-风险机制和关系机制在分散型决策结构下共同推动企业参与协同,两种机制相互影响。利益-风险机制具有基础性作用,可以分为直接机制和间接机制;关系机制通过资产专用性投资来建立,是供应链协同实现的必要条件。

Predicting Corporate Failure and Global Financial Crisis： Theory and Implications

The purpose of this paper is to discuss corporate failure issues in the context of the global financial crisis. After considering some key issues, the paper shows how relevant these issues are relevant in the present financial fiasco. It is clear that corporate failure brings untold hardships to all stakeholders. Again the problem of predicting corporate failure in the midst of the financial contagion could be overcome with sound risk management structure in place. The discussion mainly focuses on corporate failure within the context of the global financial distress. To the best of our knowledge this study is the first of its kind, which provides conceptual insights on predicting corporate failure and the global financial distress.

An Empirical Analysis of the Determinants of the Performance of the Global Private Equity Funds Markets

Over the last decade, the private equity （PE） industry, primarily venture capital and leveraged buyout investments, has matured massively. Consequently, public interest towards that particular asset class has increased rapidly. This study seeks to empirically assess the determinants of private equity funds＇ （PEFs） performance around the world. The study comprises a panel data of 103 publicly traded PEFs globally for the period of 2007-2013. Generalized least squares （GLS） technique is employed to regress the explanatory variables. The objective is accentuated on the major contributing factors that make a PEF successful. The analysis, in this paper, examines the effect of fund size, investment size, geographical focus, and industrial specialization on return. The empirical results provide evidence that： （1） Fund size and industrial specialization were observed to have an insignificant influence on the funds＇ returns in our panels; （2） Investment size is positively related to fund performance, indicating that larger deal sizes exhibited superior performance level; and （3） Geographical focus exhibited a negative association with fund performance, leading to the conclusion that limited geographical deployment of funds or absence of market diversification resulted in a fall in funds＇ returns. Consequently, to proxy for return of funds, stock prices of listed PEFs under LPEQ listings were employed.

Corporate Sustainability and Ethical Codes Effectiveness

In the last years, the issues regarding both sustainable development and business global responsibility have qualified the corporate governance effectiveness. Many international institutions have intervened and the companies, at least formally, have increased their attention to the interaction between stakeholder relationship management and economic, social, and environmental responsibility. The numerous and frequent scandals underline the discrepancy between the firms＇ formal statements and the substantial behaviors. Most of the companies, in the industrialized country, publish well-structured code of ethics and conduct, explicating the strategic values assigned to the global responsibility. The research considers the capability of the code of conduct to influence effectively the behaviors, in relation with the needs of transparency, sharing, coherent individual behavior, and control. In relation to the importance conferred to the sustainable development by the European Union （EU）, the analysis examines listed companies with the greatest market capitalization operating in the Great Britain, Germany, and Italy, in order to verify the firms＇ behavioral uniformity and the effectiveness of sustainability policies. The analysis shows that the codes of ethics seem to remain only formal declarations. Conscious and rational governance not only transfers values and principles of sustainability to the firm＇s behaviors and its result system, but also goes beyond a mere diffusion and formalization of codes of ethics and conducts. To achieve that, it is necessary to develop productive behaviors focused on the risk control and on managing behaviors of all the organization＇s members, in particular in reference to the stakeholder relationship management. The codes of ethics, in fact, seem to assume a poor relevance for the corporate sustainability promotion if a correct formal structure does not occur integrated with strategies and processes which assure a constant workability. It requests especially： the ethic culture diffusion and sharing of related values and principles; definition and integration of critical success dimensions in relation to economic, environmental, and ecological responsibility; and identification of relevant ethical parameters and control of their observance.

Children＇s Problem Behaviors During Free Time as an Incentive for the Increase in Social Risks and Health Risks

Since children, as a rule, have more free time than adults, it is adults＇ responsibility to provide children with a chance to spend the time of relaxation, play, and fun in a beneficial way. Unfortunately, children＇s spare time is nowadays very frequently organized for the sake of brushing up children＇s knowledge, skills, and competences, which is accomplished by means of escalating extra-curriculum activities. When expressed by teacher and parents, these ambition-related attitudes pave the way for the disappearance of children＇s personal interests and motivations to perform complicated tasks which are perceived as unwanted or obscure by the affected children themselves. This form of adults＇ behavior may lead to the feelings of frustration, stress, demotivation, or rebellion on behalf of their children. The said emotional states, especially in relation to the lack of spontaneous play, give rise to serious psychic dysfunctions, and the instability of children＇s psychic balance. It may also pave the way for various forms of destructive behavior that mostly characterize children of younger school age who are about to start schooling.

Risk and Intellectual Property in Technical Standard Competition： A Game Theory Perspective

Technical standard is typically characterized by network effect.The key point for a technical standard is the consumers' choice,which is based on consumers' maximum benefits.When a technical standard becomes a national standard,its interests have been integrated into the national interests.National interests are divided into economic profits and security factors.From the perspective of consumers' choice,this paper deals with the main factors which affect the result of technical standard competition- the risk and profits of intellectual property based on the assumption of bounded rationality and dynamic game theory.

Time-consistent investment-reinsurance strategies towards joint interests of the insurer and the reinsurer under CEV models

The present paper studies time-consistent solutions to an investment-reinsurance problem under a mean-variance framework.The paper is distinguished from other literature by taking into account the interests of both an insurer and a reinsurer jointly.The claim process of the insurer is governed by a Brownian motion with a drift.A proportional reinsurance treaty is considered and the premium is calculated according to the expected value principle.Both the insurer and the reinsurer are assumed to invest in a risky asset,which is distinct for each other and driven by a constant elasticity of variance model.The optimal decision is formulated on a weighted sum of the insurer’s and the reinsurer’s surplus processes.Upon a verification theorem,which is established with a formal proof for a more general problem,explicit solutions are obtained for the proposed investment-reinsurance model.Moreover,numerous mathematical analysis and numerical examples are provided to demonstrate those derived results as well as the economic implications behind.

欧盟药物临床试验质量管理规范检查启动因素及结果研判的概述

如何有效地利用有限的监管资源,提高药物临床试验质量管理规范(GCP)检查的质量和效率,保证药物临床试验的质量和合规性,成为我国及其他各国药监机构所面临的挑战。本文以欧洲药物管理局(EMA)负责的集中审批程序的药品注册申请为例,对启动GCP检查的风险因素以及结果研判进行总结分析,以期为国内启动临床试验现场核查工作以及审评过程中如何根据核查结果进行最终的药物风险-利益比的评估提供参考,同时促进我国临床研究各参与方不断提高临床试验的质量。