某院生殖医学中心门诊超说明书用药调查分析

摘 要 目的：分析生殖医学中心门诊超说明书用药情况,为临床合理用药提供参考,并进一步规范临床超说明书用药行为。 方法: 采用回顾性调查法,抽取2018年1~12月生殖医学中心门诊处方中所有超说明书用药处方,根据药品说明书,对超说明书用药处方进行统计分析,查阅相关指南、文献等对其用药合理性进行分析评价。 结果: 超说明书用药类型包括超适应证用药、超剂量用药和超给药途径用药。黄体酮注射液、左卡尼汀口服液、雌二醇/雌二醇地屈孕酮片等均有相关国内外指南推荐,循证医学证据级别较高,其超说明书用药较合理;羟乙基淀粉200/0.5氯化钠注射液、戊酸雌二醇片、辅酶Q10片等其有效等级有效性具有争议;硒酵母片、维生素E胶丸未见相关文献、指南、国内外权威医学专著等报道,属于经验用药。 结论: 某院生殖医学中心门诊超说明书用药的现象广泛存在,虽然多数有循证医学证据支持,但也存在不合理用药现象。医院应重视超说明书用药情况,并建立相关管理制度予以规范,临床医师应当谨慎用药,药师应当严谨审方发药,从而降低超说明书用药带来的执业风险,促进医院合理用药水平。     

超说明书用药管理及药学服务模式探讨

目的:探讨医院超说明书用药管理及药学服务模式,对超说明书用药进行规范管理,促进临床合理用药。方法:对肾内科、风湿免疫科、肿瘤科、儿科和皮肤科5个科室超说明书用药进行管理,并进行分级管理。对临床应用普遍的且不良反应较小的药物论证超说明用药的可行性,如盐酸氨溴索注射液雾化吸入;对不良反应较大的药物,回顾性调查研究用药规范性及不良反应情况,如环磷酰胺。结果:初步建立超说明书用药管理模式和流程及药学服务模式。为超说明书用药管理提供参考。结论:通过超说明书用药管理及药学服务,可以规范用药,促进合理用药。     

某院生殖中心门诊超说明书用药调查分析

摘 要 目的：分析某院生殖中心门诊超说明书用药情况,为临床合理用药提供科学依据,并进一步规范医师的超说明书用药行为。方法: 抽取某院2016年1～12月生殖中心的门诊处方,根据药品说明书内容,对超说明书用药处方进行统计分析,并查询相关文献对超说明书药品进行合理性评价。结果: 共收集到超说明书用药处方4 176张,超说明书用药类型包括超适应证用药、超剂量用药和超给药途径用药。超说明书用药比例排名前3位的药品是阿司匹林肠溶片(42.05%)、地屈孕酮片(27.37%)、左卡尼汀口服溶液(16.02%)。超说明书用药中多数有循证医学证据支持, 但也存在不合理用药现象。结论: 该院生殖中心超说明书用药现象普遍存在,医院应重视超说明书用药情况,并建立相关管理制度予以规范,从而降低超说明书用药的法律风险,促进医院合理用药水平。     

医院癌痛病人超说明书用药分析

目的 分析医院癌痛病人超说明书用药的合理性,为临床合理用药提供依据,并进一步规范医院超说明书用药行为.方法 随机抽取2016年上半年300份癌痛病人的住院病历,通过查阅药品说明书、临床诊疗指南、文献等对其中超说明书用药的合理性进行分析评价.结果 医院癌痛病人超说明书用药共计59例,用药类型包括超适应证用药、超适应人群用药、超给药途径用药、超给药间隔用药等,部分有国内外指南推荐,有高证据级别文献支持或理论依据支持.结论 医院癌痛病人超说明书用药现象较为普遍,且基本合理,医院应进一步规范超说明书用药行为,以提高临床合理用药水平.     

新生儿超说明书用药现状分析与风险对策

目的 对某院新生儿科住院患儿超说明用药状况进行回顾性分析,查找用药风险因素,为降低用药风险以及促进医院优化超说明书用药政策提供基础数据.方法 利用等数分配法随机抽取新生儿科病例及其医嘱作为研究对象,统计且分析患儿基本信息和超说明书发生率、用药类型、使用情况和药品不良反应/事件的发生率.结果 2018年该院新生儿科超说明...     

由“超说明书用药”思考药品的科学监管

目的 为“超说明书用药”的监管提供解决思路,为我国药品的科学监管提供有益参考.方法 从法学、药事管理学角度剖析“超说明书用药”在我国存在的特殊原因和规制难点.结果与结论 对“超说明书用药”的监管应借助各方力量,疏堵结合,对药品监管更要从研发、审批、不良反应监测、上市后再评价及再注册等方面进一步提高效率,促进各环节的衔接.     

某院呼吸科3种常用抗菌药物超说明书用药现状分析及干预策略

目的:分析医院呼吸科常用抗菌药物超说明书用药现状,并探究其相关干预策略.方法:选取医院呼吸科住院患者(2020年1月—12月)1 068例病历资料,统计其抗菌药物超说明书用药以及各类抗菌药物超说明书的用药率、用药类型、给药途径等内容,根据国家食品药品监督管理总局(CFDA)发布的最新专家共识、指南与药品说明书要求,判断...     

欧盟超说明书用药驱动因素分析及对我国的启示

目的：分析欧盟超说明书用药驱动因素，以期为我国超说明书用药的监管提供有价值的科学信息。方法：通过文献研究的理论方法分析了欧盟超说明书用药现象的驱动因素，并采用案例分析法对安维汀的超说明书用药案例进行了进一步说明。结果：欧盟超说明书用药的驱动因素来自监管、医疗保健系统、医生以及患者等四个层面。结论：超说明书用药的驱动因素众多，但根本驱动因素来源于未满足的医疗需求。最终决定超说明书用药的是医生和患者，其他驱动因素均影响这一决策过程，因此应从不同层面消除不合理的超说明书用药驱动因素，同时加强对合理的超说明书用药情况的监管和指导。     

某医院门诊超说明书用药情况调查与分析

目的 了解某医院门诊超说明书用药情况并进行处方分析,促进临床安全合理用药.方法 分层随机抽取某医院2014年9月至2015年2月每月门诊处方共3000张,以药品说明书为依据,对超说明书用药情况进行统计和分析.结果 统计出超说明书处方278张,占抽取处方总数的9.27％.其中排名前三位的超说明书用药类型是超适应证用药,占31.65％;超给药剂量,占28.78％;超给药频次,占16.55％.超说明书用药前三位的科室是皮肤科(26.62％)、消化科(19.06％)、妇产科(17.63％).结论 该院门诊超说明书用药比例较高,建议加强制度规范和采取防范措施减少超说明书用药的安全风险.     

超说明书用药的现状及其法律风险

目的:推动超说明书用药立法,以保障超说明书用药的规范性与合法性。方法:对目前国内外超说明书用药现状及立法情况、潜在危害、法律风险及国内因超说明书用药而引发的医疗纠纷案例等进行分析。结果与结论:超说明书用药的现象在临床上普遍存在,但对于超说明书用药的合理性与规范性,只有部分国家在法律层面明确规定是否允许超说明书用药;在国内,各方还缺乏统一的认识,更缺乏明确的法律依据,绝大部分超说明书用药管理规定仅仅是医院内部的规章制度及不具有法律效力的行业专家共识;涉及超说明书用药纠纷案时,《中国药典》、药品说明书、《临床诊疗指南》及《临床技术操作规范》等是法律判定的主要参考依据,除此之外的超说明书用药则是医疗过错判定的依据。故我国目前超说明书用药缺乏法律基础,医务人员需谨慎对待超说明书用药的法律风险。建议有关各方积极推动立法,为超说明书用药提供法律保障。     

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.

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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.     

Pharmacological treatment of COVID-19: an opinion paper

The precocity and efficacy of the vaccines developed so far against COVID-19 has been the most significant and saving advance against the pandemic. The development of vaccines has not prevented, during the whole period of the pandemic, the constant search for therapeutic medicines, both among existing drugs with different indications and in the development of new drugs. The Scientific Committee of the COVID-19 of the Illustrious College of Physicians of Madrid wanted to offer an early, simplified and critical approach to these new drugs, to new developments in immunotherapy and to what has been learned from the immune response modulators already known and which have proven effective against the virus, in order to help understand the current situation.     

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.