6000张抗菌药物处方专项点评分析及监管措施的探讨

目的:对我院门诊不合理使用抗菌药物处方进行分析,提高我院合理使用抗菌药物水平,探讨不合理使用抗菌药的原因及合理使用抗菌药的监管措施。方法:利用本院抗菌药处方信息系统,抽取2016年1月~12月抗菌药物处方,每月抽查抗菌药处方500张,包括16个科室共6000张进行处方点评,将药物选择不适宜;药物选择起点高,用法用量不适宜;溶液的浓度不适宜;溶媒量不适宜;联合用药是不适宜,诊断不规范,无适应症用药,重复用药,疗程偏长汇总分析。结果:不合理处方涉及16个科室,1160张不合理抗菌药处方,占抽取处方的19.33%,不合理处方包括十方面的内容,共1340处,占总抽查处方的22.33%。结论:我院门诊抗菌药物使用存在不合理性,不合理抗菌药处方占总抽查处方的百分率偏高,抗菌药物专项点评有利于发现科室存在的普遍问题,提出干预措施为持续改进提供参考。     

血清降钙素原在神经外科ICU抗菌药物管理中的应用

目的 分析PCT(PCT)在神经外科ICU中抗菌药物管理中的作用.方法 回顾分析2011年5月至2012年5月沈阳军区总医院神经外科ICU中67例常规经验性判断无法明确是否存在细菌感染而应用PCT指导抗菌药物管理的病例.PCT截断点为0.25 ng/mL.结果 47例PCT检测应用在抗菌药初始应用阶段,男27例,女20例.高血压脑出血20例,闭合性颅脑损伤10例,自发蛛网膜下腔出血17例.40例PCT检测低于判断标准病例未使用抗菌药.20例PCT检测应用在抗菌药停用阶段,男12例,女8例.高血压脑出血10例,颅脑损伤5例,颅内动脉瘤5例.15例PCT检测低于标准停用抗菌药.55例PCT指导未使用抗菌药及停用抗菌药病例观察1周,均无感染相关并发症发生.结论 PCT在神经外科ICU中可以有效指导部分病例的抗菌药物管理,较经验性用药可更为有效地减少抗菌药的用量.     

浅谈抗菌药物的合理使用

在目前的形势下,抗菌药物的应用最为广泛。随着医药科学和制药工业的迅猛发展,新的抗菌药物的种类、品种、剂型已不断用于临床,抗菌谱也越来越广,使得细菌性疾病可以比较容易得到控制,但是,医生在使用和选用抗菌药时遇到的问题随之增多,抗菌药物的长期大量应用,特别是不注意合理应用、误用、滥用、等现象,不仅造成大量的浪费,以及达不到良好的治疗效果,更重要的是导致细菌耐药的产生及不良反应,而细菌耐药性又直接导致了用药剂量的增大,甚至更新换代。因此必须合理使用抗菌药物,防止滥用抗菌药物,或用昂贵的抗菌药,以杜绝、减少药源性疾病,做到有的放矢合理用药。     

以树代粮,肥了牛羊

正畜牧业的快速发展为人类提供了各种各样的肉、蛋、奶等畜产品,但人们也感觉到了畜产品的原有风味不再有,并且还担心畜产品的安全问题。尤其是近年来用药和饲料引起畜产品的安全问题此起彼伏,为了促进畜禽生长和预防疾病,大量使用抗生素,随之产生的耐药性、药物残留等问题严重危害了人体健康。特别是"瘦肉精"和"三聚氰胺"等事件加剧了人们对现代畜禽产品的担忧。那么向消费者提供无污染、无药物残留的畜产品已成为我们义不容辞的责     

生态制剂对雏鸡早期污染鸡白痢沙门氏菌的预防效果

本文阐述了应用双乳生(双歧杆菌和乳杆菌复合制剂)、促菌生、抗菌药和先用抗菌药后用双乳生对预防雏鸡白痢病的效果。试验结果表明,用生态制剂的各组,其日增重、存活率及饲料利用率均高于不用药物的对照组。同时揭示了在早期污染白痢沙门氏菌严重的雏鸡群,预防时以先用抗菌药后用生态制剂效果最佳。     

结核分枝杆菌耐药性的分子生物学研究进展

结核病一直是世界性问题,我国其发病情况尤为严重,是亚洲的第二大结核病发病国家。结核病治疗方面常使用抗生素作为首选药物,随着抗菌药的滥用,结核杆菌对多种抗菌药产生耐药性,结核病耐药患者增多,治疗难度增加。因此,结核杆菌耐药分子机制的研究更加重要,新型抗结核药物研制更加迫切。结核分枝杆菌的基因突变是引起耐药的主要分子学依据,因此基于结核分枝杆菌耐药性相关基因的深入探索,对于预防结核病的传播及治疗皆具有深远影响。本文从分子生物学角度分析了近年来结核分枝杆菌耐药性产生的原因及相关研究进展。     

芽胞杆菌的作用机制及对畜禽生产性能的影响

近年来人们对畜产品已从数量转为对质量的需求,对食品、饲料生产加工过程中毒害物质超标及其残留问题越发引起社会的关注和重视,开发无公害、安全的绿色饲料添加剂、食品已成为趋势。众所周知,抗生素的应用在畜牧业产生了巨大的经济效益。但由于抗生素的大量使用,随之出现的负面效应也日益突出,表现为病原微生物产生耐药性和药物在     

我院专项治理前后抗菌药物使用情况分析

目的:通过分析抗菌药物临床应用专项治理前后住院患者抗菌药的使用情况,以促进合理用药。方法:随机抽取我院2010年1至2011年12月病例1680份,抽取甲状腺/乳腺/疝气/闭合性骨折I类切口手术病历100份,分析治理前后抗菌药物使用率、使用强度、病原送检率、DDDs、DUI及I类切口抗菌药物应用情况。结果:治理前住院患者抗菌药物使用率、使用强度分别为68.50%、49.8DDD;治理后分别为56.2%、37.8DDD,显著降低(P<0.05)。治理前有四种抗菌药物DUI>1,依次为头孢哌酮/舒巴坦钠>头孢噻吩钠=头孢唑啉>头孢呋辛;治理后有两种抗菌药物DUI>1,依次为磺苄西林>头孢哌酮/舒巴坦钠;治理后I类切口手术患者预防使用抗菌药物比例略为下降,疗程符合率、用药合理率明显上升(P<0.05)。结论:我院住院患者抗菌药使用情况基本达到《抗菌药物临床应用专项工作方案》要求。但在某些方面,如I类切口使用率、疗程、用药选择上需要持续改进,应加强对I类切口的监管力度,以确保用药的经济、有效、合理。     

抗真菌药物的新作用靶点

近年来,由于各种原因真菌感染发病率明显升高,当前临床上使用的抗真菌药物都存在一定的毒副作用且出现越来越多的耐药菌株,寻找新的药物作用靶点,研发新的、高效、安全的抗真菌药物成了当务之急。现着重对抗真菌药物的几个新的药物作用靶点包括真菌细胞壁、延长因子以及双组分信号转导蛋白等进行详细阐述。     

利奈唑胺C 环结构改造研究进展

首个唑烷酮类抗菌药利奈唑胺自2000 年上市以来,其耐药性问题日趋严重,开发新型唑烷酮类抗菌药物成为研究热点之一。综述了近年来对利奈唑胺C 环进行的结构改造及相关衍生物的研究进展,旨在为唑烷酮类抗菌药的深入研发提供参考。     

The withdrawal of antimicrobial treatment as a mechanism for defeating resistant microorganisms

Antimicrobial resistance is a major concern in health care and farming settings throughout the world. The level of antimicrobial resistance continues to increase and the requirement for a novel and possibly dramatic change in therapy choices is required. One possible mechanism for overcoming resistance is the actual removal of antimicrobial treatment from the therapeutic armoury. This review examines the potential for success of a policy advocating the reduction of antimicrobial use and additionally the withdrawal of such treatments. Evidence from agriculture suggests that the removal of certain drugs from animal husbandry can result in concomitant falls in certain drug resistances in human patients.     

The possible impact of human embryonic stem cells on safety pharmacological and toxicological assessments in drug discovery and drug development

The successful establishment of human embryonic stem cell (hESC) lines has raised high expectation for their future applications. The major focus of hESC research has been on their potential use in replacement therapies. However, the most immediate application of hESCs may be in establishment of humanised in vitro tests, which have potential to reduce problems of interspecies variations in safety assessments. Improved prediction of human hazard would increase patient safety and reduce the number of laboratory animals needed for toxicological and safety pharmacological testing, leading to improved efficiency of drug discovery and development in term of cost and time. The current review describes some of the newest research programmes on the use of hESCs for safety evaluations of conventional drugs. It provides an overview of the possible impact of hESCs and their derivates on regulatory drug safety assessments and discusses the potential effects on the product pipeline organisation. The review additionally summarizes initiatives in establishing quality criteria for hESC expansion and differentiation. Such criteria are necessary in order to achieve high standardisation and throughput of pharmacological and toxicological tests. Finally, it will discuss the actions needed to scientifically prove the relevance and reliability of safety tests based on hESCs.     

Organ-on-chip models: Implications in drug discovery and clinical applications

Before a lead compound goes through a clinical trial, preclinical studies utilize two-dimensional (2D) in vitro models and animal models to study the pharmacodynamics and pharmacokinetics of that lead compound. However, these current preclinical studies may not accurately represent the efficacy and safety of a lead compound in humans, as there has been a high failure rate of drugs that enter clinical trials. All of these failures and the associated costs demonstrate a need for more representative models of human organ systems for screening in the preclinical phase of drug development. In this study, we review the recent advances in in vitro modeling including three-dimensional (3D) organoids, 3D microfabrication, and 3D bioprinting for various organs including the heart, kidney, lung, gastrointestinal tract (intestine–gut–stomach), liver, placenta, adipose, retina, bone, and brain as well as multiorgan models. The availability of organ-on-chip models provides a wealth of opportunities to understand the pathogenesis of human diseases and provide a potentially better model to screen a drug, as these models utilize a dynamic 3D environment similar to the human body. Although there are limitations of organ-on-chip models, the emergence of new technologies have refined their capability for translational research as well as precision medicine.     

Targeting cell signaling pathways for drug discovery: an old lock needs a new key

In this age of targeted therapy, the failure of most current drug-discovery efforts to yield safe, effective, and inexpensive drugs has generated widespread concern. Successful drug development has been stymied by a general focus on target selection rather than clinical safety and efficacy. The very process of validating the targets themselves is inefficient and in many cases leads to drugs having poor efficacy and undesirable side effects. Indeed, some rationally designed drugs (e.g., inhibitors of receptor tyrosine kinases, tumor necrosis factor (TNF), cyclooxygenase-2 (COX-2), vascular endothelial growth factor (VEGF), bcr-abl, and proteasomes) are ineffective against cancers and other inflammatory conditions and produce serious side effects. Since any given cancer carries mutations in an estimated 300 genes, this raises an important question about how effective these targeted therapies can ever be against cancer. Thus, it has become necessary to rethink drug development strategies. This review analyzes the shortcomings of rationally designed target-specific drugs against cancer cell signaling pathways and evaluates the available options for future drug development.     

Cyclodextrins in drug delivery: An updated review

The purpose of this review is to discuss and summarize some of the interesting findings and applications of cyclodextrins (CDs) and their derivatives in different areas of drug delivery, particularly in protein and peptide drug delivery and gene delivery. The article highlights important CD applications in the design of various novel delivery systems like liposomes, microspheres, microcapsules, and nanoparticles. In addition to their well-known effects on drug solubility and dissolution, bioavailability, safety, and stability, their use as excipients in drug formulation are also discussed in this article. The article also focuses on various factors influencing inclusion complex formation because an understanding of the same is necessary for proper handling of these versatile materials. Some important considerations in selecting CDs in drug formulation such as their commercial availability, regulatory status, and patent status are also summarized. CDs, because of their continuing ability to find several novel applications in drug delivery, are expected to solve many problems associated with the delivery of different novel drugs through different delivery routes. Published: October 14, 2005     

Cunninghamella--a microbial model for drug metabolism studies--a review

Drug metabolism studies constitute an important and necessary step in the evaluation of drug efficacy and safety. In vivo drug metabolism studies suffer from many disadvantages. Hence there is a rise in validation of in vitro microbial models. This review describes the transformation studies of drugs by the fungus, Cunninghamella and correlating them with the metabolism/biotransformation in animal systems and providing technical methods to develop microbial models. Emphasis is laid on the potential of Cunninghamella fungus to mimic mammalian drug biotransformations and to use as in vitro model for drug metabolism studies and for further toxicological and pharmacological studies of metabolites.     

Modeling opportunities in comparative oncology for drug development

Successful development of novel cancer drugs depends on well-reasoned scientific drug discovery, rigorous preclinical development, and carefully conceived clinical trials. Failure in any of these steps contributes to poor rates of approval for new drugs to treat cancer. As technological and scientific advances have opened the door to a variety of novel approaches to cancer drug discovery and development, preclinical models that can answer questions about the activity and safety of novel therapies are increasingly necessary. The advance of a drug to clinical trials based on information from preclinical models presupposes that the models convey informative data for future use in human patients with cancer. The study of novel cancer drugs using in vitro models is highly controllable, reproducible, relatively inexpensive, and linked to high throughput. However, these models fail to reproduce many of the complex features of human cancer. Mouse models address some of these limitations but have important biological differences from human cancer. The integration of studies using pet dogs with spontaneously occurring tumors as models in the development path can answer questions not adequately addressed in conventional models and is therefore gaining attention and interest in drug development communities. The study of novel cancer drugs in dogs with naturally occurring tumors allows drug assessment in a cancer that shares many fundamental features with the human cancer condition, and thus provides an opportunity to answer questions that inform the cancer drug development path in ways not possible in more conventional models.     

细菌耐药专刊序言

抗生素是人类对抗病原微生物感染的重要"武器"。然而,抗生素的大规模使用导致细菌耐药性不断增强并广泛传播。细菌耐药不仅是医学问题,同时也是社会和经济问题,涉及公共卫生、环境污染、食品安全等诸多领域。本专刊从临床耐药与流行病学、动物及环境耐药、细菌耐药机制、抗菌药物研发和耐药防控策略等角度对细菌耐药性问题进行了较系统的综述和探讨,为全面认识细菌耐药现状、深入开展耐药机制研究并制定综合防控策略等提供参考。     

西藏拉萨地区常见致病菌及其耐药性分析

目的研究2009年至2011年西藏拉萨地区主要医院的常见致病菌及其耐药性情况。方法采集拉萨市临床医院细菌感染性疾病临床标本1 200份进行致病菌的分离。采用法国梅里埃-ATB菌种鉴定仪对分离的菌株鉴定到种,参照2010年CLSI推荐方法进行耐药性分析。结果对拉萨地区主要临床医院的感染者标本分离鉴定出332株临床致病菌,其中细菌304株(91.57%),真菌28株(8.43%)。病原细菌分布主要为革兰阳性球菌97株,占29.22%;革兰阴性杆菌200株,占60.24%;其他菌7株,占2.11%。凝固酶阴性葡萄球菌对苯唑西林﹑头孢曲松和环丙沙星的耐药率分别为72%﹑40%和44%。大肠埃希菌对氨苄西林﹑哌拉西林和头孢唑林耐药率分别为83%﹑53%和43%。克雷伯菌属对氨苄西林﹑头孢唑林耐药率分别为86%和58%。铜绿假单胞菌和不动杆菌对亚胺培南的耐药率分别高达20%和19%。结论拉萨地区的细菌感染及其耐药菌株分布较为广泛,该地区应加强常规临床致病菌的耐药性监测以指导临床医师合理使用抗菌药物。     

Animal experimentation: a rational approach towards drug development

Man's observation of animals as objects of study undoubtedly began in prehistoric times. The first recorded attempt involving the use of live animals for research was by Ersistratis in Alexandria in 300 B.C. Animal investigation has clearly made possible the enormous advances in drug development in this century. A cursory review of any modern text book of pharmacology or medicine will attest the many drugs currently available to benefit mankind in the struggle to eradicate and control diseases. The main purpose of this article is to describe some of the experimental work on animals which contributed to the discovery and development of drugs benefiting human beings and other animal species. Since animal experimentation has occupied a focal position in all the research leading to useful drugs, one will appreciate that it will be necessary to limit the discussion to certain aspects of this broad and interesting topic. With this in mind, an attempt is made to relate briefly the nature of animal investigations which were instrumental in the development of major classes of drugs. Some attention has also been focused on legislation's on animal experimentation of some developed countries with emphasis on India and to views on animal experimentation. We hope this article will stimulate the minds of the scientists for a rational debate on the future of animal experimentation.