医疗器械市场监管制度的优化途径分析

医疗器械是与药品一样需要评价风险与利益的产品.我国由于缺乏市场中的有效监管,使得医疗器械市场出现了一些不良现象.如何改进我国的医疗器械监管机制,文章利用西方学者提出的"动态博弈"理论,试图从动态博弈角度分析市场监管制度,以找到适合本国国情的监管机制优化途径.     

医疗器械市场监管制度的优化途径分析

医疗器械是与药品一样需要评价风险与利益的产品.我国由于缺乏市场中的有效监管,使得医疗器械市场出现了一些不良现象.如何改进我国的医疗器械监管机制,文章利用西方学者提出的"动态博弈"理论,试图从动态博弈角度分析市场监管制度,以找到适合本国国情的监管机制优化途径.     

仿制药一致性评价中的博弈及政策建议

目的 探讨政府促进国内制药企业(简称药企)参与仿制药一致性评价的最优决策.方法 利用博弈论方法分析国内药企与政府在仿制药一致性评价问题的博弈均衡.结果 可能会产生两种均衡,一种是地方各级政府相关部门均严格执行一致性评价政策,药企则选择积极参与一致性评价;另一种是地方各级政府相关部门执行政策不统一,如适当"延期",且在省...     

药品市场信用监管的博弈分析

药品市场监管实际上是药品监督管理部门与医药市场主体之间的博弈与反复博弈。从贝叶斯规则与医药市场准入监管、囚徒困境与打假维权、医药市场进入阻挠与反限制竞争等方面对医药企业的监管进行博弈分析,药品监督管理部门通过理性博弈可以大大提高医药市场监管的有效性。笔者还通过对医药监管者的监管博弈分析,认为现有监管的滞后性和弱有效性是我国医药市场违规现象层出不穷的主要原因。对监管者实施强有力的监管可以减少违规操作,使药品监管提高资源配置效率,确保医药市场高效、平稳有序运行的目标更容易实现。     

瑞典专利药价格管理政策的经验启示

目的:为我国政府制定和完善专利药价格管理政策提供参考。方法:阐述瑞典专利药价格管理政策,并对其实施效果进行分析,最后根据我国医疗卫生市场情况,总结经验启示。结果与结论:我国政府在对专利药进行定价和价格管理时应当充分利用市场信息,建立专利药品价格信息监控体系,从而减少定价博弈中的信息不对称,确保社会医疗保险资源的高效利用。     

监察视角下保证基本药物生产的博弈论分析

摘要 从制药企业与政府博弈的角度探索保障基本药物生产的策略。运用博弈理论研究基本药物生产企业与政府管理部门间的博弈,并构建模型进行分析。制药企业不生产基本药物的概率与检查成本、公信力损失、处罚力度以及查实率有关。政府应改进对基本药物生产企业检查的方法,提高查实率,加大处罚力度,同时采取加强对基本药物生产企业扶持、完善相关法规等综合措施保障基本药物的生产。     

对我国医药企业实施GAP与GMP认证中存在问题的思考

医药产业关系到每个国民的切身利益和生命健康,对社会经济稳定发展的作用不容忽视.各国政府在医药产业内的各领域都规定了一定的药事管理法规,设置了较高的准入门槛.近年来,伴随GAP与GMP认证工作的展开,我国医药产业整体得到优化,产业集中度增强,市场运行更加规范.然而,在GAP与GMP认证的实施中仍存在某些问题.本文结合医药产业存在"外部性"和"垄断性"的经济学特征,谈谈政策干预对产业的影响以及如何应对政策可能对产业发展导致的不利影响.     

医药市场博弈中的不正当现象及对策

医疗市场上双方处于博弈的状态,这将导致逆向选择、道德风险、机会主义行为和外部不经济,降低市场效率,通过建立博弈模型,对医药市场的博弈过程及均衡结果进行了分析,并提出了相应对策建议,达到缓解医药市场的博弈状态。     

基于博弈论分析中药饮片质量监管策略

目的:探讨中药饮片质量监管存在的主要问题,并找出有效策略。方法:首先分别构建中药饮片生产经营企业与地方药监部门之间的静态与动态博弈模型,并对其进行纯策略纳什均衡分析和混合策略纳什均衡分析;然后,构建上级监管部门与基层监管部门间的博弈模型,并对此模型进行混合策略分析,以找出与饮片质量相关的监管因素。结果与结论:结合中药饮片质量监管的现状和博弈模型的分析结果,建议现阶段我国中药饮片监管部门应着力推动监管体制改革,降低监管成本(包括引导规模化、集中化的中药材生产和对中药饮片统一实施批准文号管理)、建立系统全面的奖惩体系、建设一支专业化的监管队伍(包括加强基层监管队伍建设和提高人员素质、规范监管部门的执法行为、适当放权与"硬"监督结合起来),并理顺政府监管工作与公众的关系,培养公众的责任意识。     

基于博弈理论的医疗机构中药制剂委托配制行为分析

目的 探讨在推行医疗机构中药制剂委托配制时利益主体间的行为选择因素及委托配制行为的可行性。方法 基于博弈理论,分别构建政府与医疗机构、医疗机构与受托方之间的博弈模型,分析影响委托配制行为的影响因素并提出相应的政策建议。结果 在政府与医疗机构的博弈中,政府实施监管的成本、损失的社会效益和医疗机构获得的财政补贴、惩罚、产品声誉优势是影响配制行为的重要因素;在医疗机构与受托方的博弈中,医疗机构的收益、自行配制的成本和受托方的收益、转型成本也对委托配制行为产生影响。结论 医疗机构中药制剂委托配制行为具有可行性,各利益主体间找到利润均衡点,就能够实现医疗机构中药制剂的良性循环。     

Efficacy of gut lavage,hemodialysis, and hemoperfusion in the therapy of paraquat or diquat intoxication

Clinical and in vitro investigations were carried out to test the efficacy of gut lavage, hemodialysis, and hemoperfusion in the treatment of poisoning with paraquat or diquat. In a patient suffering from diquat intoxication 130 times more diquat was removed by gut lavage 30 h after ingestion than was removed by complete aspiration of the gastric contents.Determination of in vitro clearances for paraquat and diquat by hemodialysis showed that, at serum concentrations of 1–2 ppm, such as are frequently encountered in poisoning in man, toxicologically relevant quantities of herbicide cannot be removed from the body. At a concentration of 20 ppm, on the other hand, hemodialysis proved to be effective, the clearance being 70 ml/min at a blood flow rate of 100 ml/min. The efficacy of hemoperfusion with coated activated charcoal was on the whole better. Especially at concentrations around 1–2 ppm, the clearance values for hemoperfusion were some 5–7 times higher than those for hemodialysis.In a patient suffering from paraquat poisoning, both hemodialysis as well as hemoperfusion were carried out. The in vitro results could be confirmed: At serum concentrations of paraquat less than 1 ppm no clearance could be obtained by hemodialysis while by hemoperfusion with activated charcoal quite high clearance values were measured and the serum level dropped down to zero.

---

Zusammenfassung Klinische Untersuchungen und Laboratoriumsversuche wurden durchgeführt, um die Wirksamkeit von Darmspülung, Hämodialyse und Hämoperfusion bei Paraquat- und Deiquat-Vergiftungen zu prüfen.Bei einem Patienten wurde 30 Std nach Deiquat-Aufnahme durch Darmspülung 130mal mehr Deiquat entfernt als durch vollständige Aspiration des Mageninhaltes. In vitro-Versuche ergaben, daß bei Blutserumkonzentrationen von 1–2 ppm, die bei Vergiftungen oft gemessen werden, durch Hämodialyse keine toxikologisch relevanten Paraquat- oder Deiquat-Mengen entfernt werden können. Dagegen erwies sich die Hämodialyse bei 20 ppm und einer Blutumlaufgeschwindigkeit von 100 ml/min mit einer Clearance von 70 ml/min als wirksam. Die Hämoperfusion mit beschicheter Aktivkohle war in diesen Versuchen aber eindeutig überlegen, denn insbesondere bei Konzentrationen um 1–2 ppm waren die Clearance-Werte 5–7mal höher als bei der Hämodialyse.Die in vitro-Ergebnisse wurden bei einem Patienten mit einer Paraquat-Vergiftung bestätigt: Bei Konzentrationen unter 1 ppm war die Hämodialyse wirkungslos, während durch Hämoperfusion relativ hohe Clearance-Werte erreicht wurden, so daß der Serumspiegel rasch unter die Nachweisgrenze abfiel.

     

In vitro studies on sterically stabilized liposomes (SL) as enzyme carriers in organophosphorus (OP) antagonism

This study describes a new approach for organophosphorous (OP) antidotal treatment by encapsulating an OP hydrolyzing enzyme, OPA anhydrolase (OPAA), within sterically stabilized liposomes. The recombinant OPAA enzyme was derived from Alteromonas strain JD6. It has broad substrate specificity to a wide range of OP compounds: DFP and the nerve agents, soman and sarin. Liposomes encapsulating OPAA (SL)* were made by mechanical dispersion method. Hydrolysis of DFP by (SL)* was measured by following an increase of fluoride ion concentration using a fluoride ion selective electrode. OPAA entrapped in the carrier liposomes rapidly hydrolyze DFP, with the rate of DFP hydrolysis directly proportional to the amount of (SL)* added to the solution. Liposomal carriers containing no enzyme did not hydrolyze DFP. The reaction was linear and the rate of hydrolysis was first order in the substrate. This enzyme carrier system serves as a biodegradable protective environment for the recombinant OP-metabolizing enzyme, OPAA, resulting in prolongation of enzymatic concentration in the body. These studies suggest that the protection of OP intoxication can be strikingly enhanced by adding OPAA encapsulated within (SL)* to pralidoxime and atropine.     

Aquatic Insects and Trace Metals: Bioavailability,Bioaccumulation, and Toxicity

Abstract

The uptake of metals from food and water sources by insects is thought to be additive. For a given metal, the proportions taken up from water and food will depend both on the bioavailable concentration of the metal associated with each source and the mechanism and rate by which the metal enters the insect. Attempts to correlate insect trace metal concentrations with the trophic level of insects should be made with a knowledge of the feeding relationships of the individual taxa concerned. Pathways for the uptake of essential metals, such as copper and zinc, exist at the cellular level, and other nonessential metals, such as cadmium, also appear to enter via these routes. Within cells, trace metals can be bound to proteins or stored in granules. The internal distribution of metals among body tissues is very heterogeneous, and distribution patterns tend to be both metal and taxon specific. Trace metals associated with insects can be both bound on the surface of their chitinous exoskeleton and incorporated into body tissues. The quantities of trace meals accumulated by an individual reflect the net balance between the rate of metal influx from both dissolved and particulate sources and the rate of metal efflux from the organism. The toxicity of metals has been demonstrated at all levels of biological organization: cell, tissue, individual, population, and community. Much of the literature pertaining to the toxic effects of metals on aquatic insects is based on laboratory observations and, as such, it is difficult to extrapolate the data to insects in nature. The few experimental studies in nature suggest that trace metal contaminants can affect both the distribution and the abundance of aquatic insects. Insects have a largely unexploited potential as biomonitors of metal contamination in nature. A better understanding of the physico-chemical and biological mechanisms mediating trace metal bioavailability and exchange will facilitate the development of general predictive models relating trace metal concentrations in insects to those in their environment. Such models will facilitate the use of insects as contaminant biomonitors.     

Alzheimer’s disease – current trends in basic and clinical research. Highlights from the 16th ECNP

Advances in the molecular biological knowledge of neuronal nicotinic acetylcholine receptors (nAChRs) have led to a growing interest by the pharmaceutical industry in the development of novel compounds that selectively modulate nAChR function. The ability of (-)-nicotine, an activator of nAChRs, to enhance attentional aspects of cognition in animals and humans, to exert neuroprotective and anxiolytic-like effects, and presumably to mediate the negative correlation between smoking and Alzheimer's (and Parkinson's) Disease, has focused interest on the potential therapeutic utility of modulators of nAChR function for treatment of some of the deficits associated with these progressive, neurodegenerative conditions. Numerous compounds are known which activate nAChRs and which might serve as lead compounds toward the development of such agents. The pharmacologic diversity of neuronal nAChR subtypes suggests the possibility of developing selective compounds which would have more favourable side-effect profiles than existing agents. This broader class of agents, collectively called cholinergic channel modulators (ChCMs), is anticipated to encompass compounds which would have more favourable side-effect profiles than existing agents, which generally exhibit low selectivity. This selectivity may be achieved by preferentially activating some subtypes of nAChRs (i.e., Cholinergic Channel Activators, ChCAs) or inhibiting the function of other subtypes (Cholinergic Channel Inhibitors, ChCIs). An overview of the biology of nAChRs and the rationale for the use of ChCMs for the treatment of dementia related to neurodegenerative diseases are presented, followed by a discussion of lead compounds and compounds under consideration for clinical evaluation.     

Steroidal sapogenin contents in some domestic plants

In order to find out the values of the steroid resources for the future use. the compositions and contents of steroidal sapogenins from 13 domestic plants have been investigated. As a result,Dioscorea nipponica, D. quinqueloba andSmilax china were found to have large amount of diosgenin. And pennogenin inTrillium kamtschaticum andParis verticillata, yuccagenin inAllium fistulosum, hecogenin inAgave americana and neochlorogenin inSolanum nigum were appeared to be major steroidal sapogenins.