在我国开展药物经济学研究的必要性、存在问题及政策建议

目的:促使药物经济学在我国得以开展并充分利用。方法:首先探讨了在我国开展药物经济学研究的必要性,然后指出哪些瓶颈性问题将会限制或者阻碍药物经济学在我国的最优化利用。结果:我国应加强药物经济学人才培养,在制定药物经济学评价指南的基础上逐步将药物经济学应用于国家基本药物政策。结论:卫生决策者对药物经济学的充分认识,有助于药物经济学在我国卫生决策领域得以充分利用并实现可持续发展。     

我国药物经济学研究中存在的问题与思考

目的促进我国药物经济学的研究和提高其运用水平。方法介绍了几种常用的药物经济学研究方法,分析了国内研究的现状和存在的问题。结果与结论广泛开展药物经济学研究是我国医药卫生事业发展的必然要求,但国内对药物经济学在运用中尚存在很多问题,建议从政策支持和准则规范上不断完善和发展药物经济学。     

国内外药物经济学的对比研究及在我国的发展前景

本文从药物经济学研究数量、研究氛围、研究准则和人才培养等方面分析了国内外药物经济学之间存在的差异 ,指出了我国药物经济学研究的不足 ,同时对药物经济学与不同群体之间的关系进行了分析 ,认为药物经济学将作为控制药品费用的一种策略在中国得到快速发展     

我国药物经济学研究现状分析和探讨

目的:探讨药物经济学在我国的应用.方法:采用文献计量学的方法和药物经济学评价标准,对我国已开展的药物经济学研究进行分析.结果:我国药物经济学的研究仍以理论探讨为主,在方案的研究中较多缺乏明确的观点,对成本计算方法、敏感度分析方面的正确运用不足.结论:仍需进行我国药物经济学研究的方法学讨论,并应建立适合国情的研究和方法学的标准.     

国外脑卒中药物经济学研究概况

目的：了解国外在脑卒中防治方面的药物经济学研究,为我国在相关领域开展药物经济学研究提供参考。方法：从脑卒中的预防、诊断、治疗、康复、护理及模型研究方法等方面,概述了国外药物经济学研究的进展。结果：国外注重对脑卒中二级预防的药物经济学研究,普遍采用模型研究方法,注重敏感性分析。结论：国外药物经济学研究方法和技术日益完善和成熟,为我国开展高质量的脑卒中药物经济学研究提供了借鉴。     

我国药物经济学研究现状分析和探讨

目的：探讨药物经济学在我国的应用。方法：采用文献计量学的方法和药物经济学评价标准。对我国已开展的药物经济学研究进展分析。结果：我国药物经济学的研究仍以理论探讨为主,在方案的研究中较多缺乏明确的观点。对成本计算方法、敏感度分析方面的正确运用不足。结论：仍需进行我国药物经济学研究的方法学讨论。并应建立适合国情的研究和方法学的标准。     

浅析药物经济学及其在我国医药领域的应用

本文简要介绍了药物经济学的基本概念、内涵、历史发展以及药物经济学研究的要素、评价方法与参数,并将药物经济学与我国医药领域相关应用相结合,阐述如何在我国医药领域新形势阶段应用药物经济学。     

对国内近5年药物经济学评价文献的系统分析与评估

目的 :分析我国近5年药物经济学评价的研究现状。方法 :对在2009-2013年国内学术期刊上发表的药物经济学评价文献进行系统分析与评估。结果 :经一定的入选标准筛选,获得有效文献411篇。分析发现,我国药物经济学评价在设计、方法和结果讨论中均存在不完善之处,提示我国药物经济学评价的质量有待提高。结论 :应通过加强学术交流、重视对药物经济学评价新技术的学习,以提高我国药物经济学评价的质量,进而使之能够有效指导今后我国医药资源的合理配置。     

药物经济学在国家基本药物目录管理中的应用

目的:探讨药物经济学在国家基本药物目录管理中的应用,为完善我国基本药物制度提供参考。方法:介绍《国家基本药物目录管理办法》中药物经济学的有关内容,分析我国药物经济学的研究现状和面临的困难,对药物经济学应用于国家基本药物目录管理今后的研究方向提出建议。结果与结论:基本药物目录遴选引入药物经济学理念和评价方法,符合我国的国情和基本药物制度发展趋势。但药物经济学目前面临的主要困难是专业人才缺乏、评价标准不统一、药物经济学认知度不高等。建议规范评价标准、提高数据科学性、增强药物经济学认知度。     

世界上6个国家药物经济学评价准则比较

药物经济学作为一门为医药及其相关决策提供经济学依据的应用性学科,从其诞生发展到现在,已近30年.如今,它已在控制药品费用、制定药品价格、评价治疗方案的优良等方面起到了不可低估的作用.然而,药物经济评价在缺乏统一的评价原则和标准的情况下是不具可比性和缺乏可信度的,因此,世界上越来越多的国家开始制订和颁布旨在规范药物经济学评价的评价准则.但是,我国目前还没有制定和颁布本国的药物经济学评价准则,因而直接影响着我国药物经济学评价的规范性及其应有作用的发挥.笔者在此对世界上率先或较早制定、颁布药物经济学评价准则的澳大利亚、加拿大等6个较有代表性的国家的药物经济学评价准则进行比较研究,以期对我国药物经济学评价准则的及早制定提供借鉴和参考.     

3种方案治疗急性上尿路感染的成本-效果分析

目的对3种方案治疗急性上尿路感染进行经济学分析。方法运用药物经济学成本-效果分析方法，对3种治疗方案进行评价，A组：头孢呋辛；B组：左氧氟沙星，C组：阿莫西林／克拉维酸，3组治疗方法均是静脉滴注3d后，改为口服10d。结果3组药物均可治疗急性上尿路感染，其中头孢呋辛组治疗有效率与细菌清除率最高，左氧氟沙星组最为经济，但是耐药菌株多见，治疗有效率与细菌清除率较低，阿莫西林／克拉维酸组价格最贵，治疗有效率与细菌清除率也较高。结论头孢呋辛治疗效果最佳，价格居中，是比较合适的选择，左氧氟沙星治疗最为经济，但是疗效最差，阿莫西林／克拉维酸价格最贵，疗效也较好，如细菌对头孢呋辛耐药时，也是较好的选择。     

关于医药产业中中、小企业发展的思考

目的：探讨中、小型医药企业的发展战略及发展方向。方法：通过对医药产业内中、小型医药企业的分类分析及竞争战略理论的探讨,提出中、小型医药企业的成功发展模式,结果与结论：技术先导型中、小型医药企业是未来中、小型医药企业的成功发展模式,为了促进这种类型的中、小型医药企业的发展,需要从企业和政府两个角度进行策略性探讨和调整。     

我国药妆店发展特征及改进策略

通过归纳药妆店在我国的发展历程,梳理出国内药妆店发展总体特征。针对药妆店经营过程中存在的问题,提出推动我国药妆店经营与发展的策略,为药妆店的高速健康发展提供参考。     

Evaluation of the microbial growth potential of pharmaceutical drug products and quality by design

The microbial growth potential of a pharmaceutical drug product refers to the ability of microorganisms to survive and proliferate in the product. Each drug formulation possesses a different potential for supporting or inhibiting microbial growth. Understanding this microbial growth potential can have a significant effect on the development and design of the drug manufacturing process. This article describes how this attribute can exert this effect on manufacturing process development and design through real examples and case studies obtained from the regulatory review of new drug and biologics license applications. In addition, this article describes how understanding the microbial growth potential of a pharmaceutical drug product is an element of the Quality by Design paradigm and how this understanding can simplify the drug development process and lead to better process design. LAY ABSTRACT: The microbial growth potential of a pharmaceutical drug product refers to the ability of microorganisms to survive and proliferate in the product formulation. Each drug product formulation possesses a different potential for supporting or inhibiting microbial growth depending on its components. Understanding this microbial growth potential can have a significant effect on the development and design of the drug manufacturing process. This article describes how this attribute can affect manufacturing process development and design through real examples and case studies obtained from the regulatory review of new drug and biologics license applications. In addition, this article describes how understanding the microbial growth potential of a pharmaceutical drug product is an element of the Quality by Design paradigm and how this understanding can simplify the drug development process and lead to better process design.     

EMA关于固定复方药物临床开发指导原则介绍

欧洲药品管理局（EMA）于2017年3月发布了关于固定复方药物临床开发的指导原则,该指导原则讨论了固定复方药物临床开发过程中的考虑要点和基本技术要求。我国目前尚无类似文件,通过对该指导原则的介绍,希望对我国固定复方药物的研发和审评工作提供参考。     

Lipid vesicles for skin delivery of drugs: reviewing three decades of research

Since liposomes were first shown to be of potential value for topical therapy by Mezei and Gulasekharam in 1980, studies continued towards further investigation and development of lipid vesicles as carriers for skin delivery of drugs. Despite this long history of intensive research, lipid vesicles are still considered as a controversial class of dermal and transdermal carriers. Accordingly, this article provides an overview of the development of lipid vesicles for skin delivery of drugs, with special emphasis on recent advances in this field, including the development of deformable liposomes and ethosomes.     

Therapeutic antibodies against CGRP or its receptor

CGRP is an extensively studied neuropeptide that has been implicated in the pathophysiology of migraine. While a number of small molecule antagonists against the CGRP receptor have demonstrated that targeting this pathway is a valid and effective way of treating migraine, off-target hepatoxicity and formulation issues have hampered the development for regulatory approval of any therapeutic in this class. The development of monoclonal antibodies to CGRP or its receptor as therapeutic agents has allowed this pathway to be re-investigated. Herein we review why CGRP is an ideal target for the prevention of migraine and describe four monoclonal antibodies against either CGRP or its receptor that are in clinical development for the treatment of both episodic and chronic migraine. We describe what has been publically disclosed about their clinical trials and future clinical development plans.     

美国药事管理学科发展及其启示

目的为我国药事管理学科发展提供参考。方法运用文献研究方法。结果与结论美国药事管理学科的发展历程可供我国借鉴。     

Disturbed development of the enteric nervous system after in utero exposure of selective serotonin re-uptake inhibitors and tricyclic antidepressants. Part 1: Literature review

The increase in selective serotonin re-uptake inhibitor (SSRI) use during pregnancy, questions concerning abnormal development of the enteric nervous system (ENS), increase in laxative use in children and the association of fluoxetine with infantile hypertrophic pyloric stenosis (IHPS) gave rise to this pharmacological literature review. The role of 5-HT and the NE uptake in ontogeny of the ENS and the effects SSRIs and TCAs might have on the development of the ENS were investigated. The literature study showed that SSRIs may influence the development of the ENS in two ways. Blockage of the serotonin re-uptake transporter (SERT) during foetal development could influence migration, differentiation and survival of cells. This could lead to abnormal development in the first trimester of pregnancy. The other way is that 5-HT seems to be a growth factor in the primitive ENS. This growth factor like action is mediated through the 5-HT(2B) receptor and stimulation of this receptor by SSRIs influences the fate of late-developing enteric neurons. This could lead to abnormal development in the second and third trimester. TCAs could influence the development of the ENS, besides through inhibition of the SERT, through inhibition of the norepinephrine transporter (NET). Expression of the NET seems to be essential for a full development of enteric neurons and especially for serotonergic neurons. In addition the NET was detected early in ontogeny and precedes neuronal differentiation, which suggests that TCAs might influence development of the ENS when exposed early in pregnancy. The insights of this study gave rise to hypotheses which will be tested in an epidemiological cohort study.     

台山县林业总体开发规划的决策分析

本文运用系统工程原理,借助环境辨识模型,对台山县的自然和社会环境进行了辨识,获得优势、制约和潜力环境因子;分析了该县林业发展的阶段性和林业资源特点;并进一步用系统诊断模型对该县森林生态经济系统进行诊断,把现实系统在时间、空间上层层展开,从而找出问题的根源、潜力、途径、优势和突破口;最后在前面研究的基础上,提出该县林业总体开发规划的总目标,并用层次分析模型进行总体开发规划的决策分析,提出总体开发规划的目标、规划区和措施。