关于我省药品监管事业单位内部控制问题的研究

针对我省药品监管事业单位内部控制问题。提出我省药品监管事业单位内部控制存在的问题,主要是内部控制意识不高、内部控制制度欠缺、内部控制执行不畅和内部控制监督不力,提出了解决事业单位内部控制问题的对策,主要是提高内部控制意识、完善内部控制制度、加强内部控制执行和建立内部监督机构。探讨了我省药品监管事业单位内部控制问题的解决对策,旨在说明事业单位内部控制的重要性,以期为内部控制的制定提供参考。     

健全医院内部会计控制制度的探讨

内部会计控制制度是医院现代化管理的重要组成部分,是科学与技术迅猛发展以及管理理论与管理水平不断提高的产物,是为保证医院实现经营目标、提高会计信息质量、保护国家财产物资的安全与完整、确保有关法律法规和规章制度的贯彻执行等而制定和实施的一系列控制方法、措施和程序规范的总称。医院内部会计控制制度,涉及医院经营活动的各个领域,主要包括预算控制、收入控制、支出控制、货币资金控制、药品及库存物资控制、固定资产控制、工程项目控制、对外投资控制、债权债务控制、财务电子信息化控制和监督检查。     

对过期药品控制方法的探讨

目的:探讨过期药品的控制方法。方法:分析过期药品的危害和我国目前对过期药品的处理办法,运用管理学的控制理论探讨如何全面控制过期药品。结果与结论:可以综合运用前馈控制、同期控制和反馈控制,实现对过期药品的全面控制。     

微生物实验室的监督和管理

目的微生物检验在传染性疾病及相关疾病的预防和诊断治疗中起着越来越重要的作用。方法要注意在日常工作中开展质量控制,包括室间质量控制和室内质量控制。结果室间质量控制是各实验室之间进行质量控制的一种手段。室间质量控制是建立在室内质量控制基础上的,做好室内质量控制直接关系到日常工作的质量。结论质量监督和质量管理的有效实施,以发现控制和纠正检验检测活动中的异常变异,确保检测数据准确、可靠,不断提高检验工作水平和实验室的信誉。     

饮食控制联合有氧运动对社区糖尿病控制的有效性

目的分析饮食控制联合有氧运动对社区糖尿病控制的有效性。方法选取本社区糖尿病患者42例,将患者随机分为两组各21例,观察组在进行药物治疗的同时,进行饮食控制与有氧运动干预,对照组只进行药物治疗,观察两组的血糖控制效果。结果观察组患者比对照组患者血糖控制效果更好,结果比较有显著性差异（P〈0．05）。结论饮食控制联合有氧运动对于社区糖尿病控制有显著效果,患者血糖控制效果良好,值得推广应用。     

浅谈护理部对护理质量的控制

目的探讨护理部对护理质量的科学有效控制。方法结合医院护理质量管理实际,总结归纳了质量控制的具体做法。结果通过科学确立标准,制定规范,进行自我控制、关键控制、逐级控制、反馈控制,使护理质量收到了良好的效果。结论上述质控方法对护理部实施护理质量控制具有参考价值。     

医院工程项目管理中的质量控制五要素

医院工程项目管理中的质量控制主要表现为施工组织和施工现场的质量控制,控制的内容包括工艺质量控制和产品质量控制。影响质量控制的因素主要有“人、材料、机械、方法和环境”等五大方面。因此,对这五方面因素严格控制,是保证医院工程质量的关键。     

口腔科的感染控制新进展

目的评价口腔科感染控制新方法的可行性。方法通过对口腔科感染控制的重要意义,制定可行的控制措施,要遵循"标准预防"的原则,重视感染控制链中的各个环节的介绍,来提高医护人员对口腔科感染控制的认识。结果口腔科感染控制新方法效果好。结论口腔科感染控制新方法切实可行。     

糖尿病孕妇血糖控制状况对围产结局的影响

目的探讨糖尿病孕妇血糖控制状况对围产结局的影响。方法选择2004年3月至2014年3月产科住院分娩的正常孕产妇98例为对照组;选择同期分娩的患者203例糖尿病孕妇为观察组。根据血糖控制情况将观察组中血糖控制不良的96例设为控制不良组、将血糖控制较好的107例设为控制良好组。观察3组不良妊娠结局与围产儿并发症的发生率。结果血糖控制不良组在孕妇妊高征、羊水过多、感染、胎膜早破、酮症酸中毒、产后出血及剖宫产率均高于血糖控制理想组和对照组,而血糖控制理想组与正常对照组比较,除剖宫产率外,差异其他无统计学意义（P＞0．05）。血糖控制不良组低血糖、新生儿窒息、呼吸窘迫、巨大胎儿、低体质量、围产儿死亡率高于控制理想组,控制理想组与对照组比较差异无统计学意义（P＞0．05）。结论糖尿病孕妇的血糖控制水平与围产结局密切相关,血糖控制较好可使糖尿病孕妇母儿并发症与正常孕产妇接近。积极有效的糖尿病治疗和血糖控制,对糖尿病孕妇的围产结局具有重要影响。     

休哈特控制图在药品水分含量测定中的应用

目的利用休哈特控制图对水分测定过程进行质量控制,以便实验室及时发现检测过程中存在的问题,并积极采取措施确保检测过程受控。方法采用卡尔费休法测定水分,将水分测定数据绘制成休哈特控制图,并用于水分测定过程的质量控制。结果利用休哈特控制图有助于及时发现检测过程中的异常因素,有效控制水分检测结果质量,保证检测数据的准确、可靠。结论休哈特控制图可作为水分测定质量控制的重要手段。     

Kinetik der Elimination von 2-Propanol und seines Metaboliten Aceton bei Hund und Ratte

Zusammenfassung Die Eliminationskinetik von 2-Propanol und dessen Metaboliten Aceton wird in Versuchen an Hund und Ratte nach Gabe von 1,0 g/kg 2-Propanol i.v. bzw. i.p. festgelegt. Die Elimination von 2-Propanol und Aceton folgt einem einfachen Exponentialgesetz. Der Acetonplasmaspiegel in der Zeit nach 2-Propanolgabe kann durch die Bateman-Funktion mit hinreichender Genauigkeit beschrieben werden. Ein Vergleich mit der Eliminationscharakteristik von Methanol und Äthanol zeigt, daß jeder dieser drei Alkohole bei seiner Elimination einer anderen Kinetik folgt.

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Elimination of 2-propanol in dogs and rats

Summary The kinetics of elimination of 2-propanol and its metabolite acetone were determined in experiments on dogs and rats after administration of 1,0 g/kg 2-propanol i.v. and i.p. respectively. 2-propanol and acetone are eliminated according to a simple exponential function. The concentration of acetone in plasma following administration of 2-propanol can be described satisfactorily by the Bateman-function. Comparing the characteristics of elimination of methanol and ethanol to those of 2-propanol it becomes evident that each of these alcohols follows a different pattern in its elimination.

Mit Unterstützung der Deutschen Forschungsgemeinschaft.     

HPLC法测定不同产地地龙中尿嘧啶、次黄嘌呤、尿苷、肌苷的含量

目的:测定不同产地、品种的地龙药材中尿嘧啶、次黄嘌呤、尿苷、肌苷的含量,建立地龙质量控制的客观指标。方法:用0.9%生理盐水超声提取地龙药材,采用反相高效液相色谱法,Waters Symmetry C₁₈色谱柱（150mm×4.6mm,5μm）,以0.01mol·L^-1磷酸二氢钾溶液和50%甲醇为流动相,流速为0.8ml·min^-1,梯度洗脱,检测波长254nm,柱温27℃,同时测定尿嘧啶、次黄嘌呤、尿苷、肌苷等4种成分的含量。结果:尿嘧啶的线性范围为0.75～24.00μg·ml^-1（r=0.9993）,平均回收率99.82%,RSD=2.34%（n=6）;次黄嘌呤的线性范围2.50～80.00μg·ml^-1（r=0.9992）,平均回收率101.93%,RSD=1.45%（n=6）;尿苷的线性范围1.25～40.00μg·ml^-1（r=0.9992）,平均回收率97.53%,RSD=1.73%（n=6）;肌苷的线性范围5.00～160.00μg·ml^-1（r=0.9991）,平均回收率102.06%,RSD=2.44%（n=6）。结论:该方法重复性,回收率好,可用于地龙药材中尿嘧啶等4种成分的含量测定。     

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.     

Drug education: myth and reality

Recently there has been an increase in Australian public funds for drug education. The accompanying rhetoric asserts that it is to enable abstinence among young people. This contradicts some State Government education guidelines endorsing harm minimization. A literature search of the key electronic databases, drug agency libraries, the Internet and reference lists identified evaluation research in school‐based drug education. There is little evidence to support the new public rhetoric. The predictors of adolescent drug use are social and personal; schools can have little effect on these. Four models of drug education are described. Schools, however, mix‐and‐match activities from different models, and exposure is too slight for major effects on behaviours. Although methodological difficulties affect findings, none of the drug education models show consistent behavioural effects over time. There is a mismatch between the new public rhetoric and the evaluation research literature. Reasons for this are explored, including that there are two stakeholder groups, one with exaggerated ideological anti‐drug messages and the other with more realistic perspectives about what schools can reasonably achieve. The paradox is that the rhetoric is needed for continued funding, yet this same rhetoric sets up criteria which doom drug education to failure.     

Metabolism and excretion of (S)-6-(3-cyclopentyl-2-(4-trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid (PF-04991532), a hepatoselective glucokinase activator,in humans: confirmation of the MIST potential noted in first-in-Human metabolite scouting studies

1. The absorption, metabolism, and excretion of a single oral 450-mg dose of [¹⁴C]-(S)-6-(3-cyclopentyl-2-(4-trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid (PF-04991532), a hepatoselective glucokinase activator, was investigated in humans. Mass balance was achieved with ～94.6% of the administered dose recovered in urine and feces. The total administered radioactivity excreted in feces and urine was 70.6% and 24.1%, respectively. Unchanged PF-04991532 collectively accounted for ～47.2% of the dose excreted in feces and urine, suggestive of moderate metabolic elimination in humans.

2. The biotransformation pathways involved acyl glucuronidation (M1), amide bond hydrolysis (M3), and CYP3A4-mediated oxidative metabolism on the cyclopentyl ring in PF-04991532 yielding monohydroxylated isomers (M2a–d). Unchanged PF-04991532 was the major circulating component (64.4% of total radioactivity) whereas M2a–d collectively represented 28.9% of the total plasma radioactivity.

3. Metabolites M2a–d were not detected systemically in rats and dogs, the preclinical species for the toxicological evaluation of PF-04991532. In contrast, cynomologus monkeys dosed orally with unlabeled PF-04991532 revealed M2a–d in circulation, whose UV abundance was comparable to the profile in humans. This observation suggested that monkeys could potentially serve as a non-rodent alternative for studying the toxicity of PF-04991532 and its metabolites M2a–d.

4. The present results are in excellent agreement with our previously generated metabolite scouting data, which provided preliminary evidence for the disproportionate metabolism of PF-04991532 in humans.     

The safety of second-line treatment options for non-small cell lung cancer

Introduction: Non-small-cell lung cancer (NSCLC) patients after first-line therapy ultimately suffer progression. At this time, many patients still have a good performance status and can be considered for further active treatment. Two chemotherapeutic agents, docetaxel and pemetrexed (only in non-squamous histology), and the biological drug anti-epidermal growth factor receptor (EGFR) erlotinib, were approved for clinical use in the second-line treatment of NSCLC patients. In the last few years further new second-line therapies have become available in the clinical practice.

Areas covered: This review will discuss the adverse events of the pivotal trials ledding to the approval of second-line therapies for the treatment of not oncogene-addicted NSCLC patients.

Expert opinion: In recent years, new second-line options for NSCLC are: the anti-EGFR, afatinib (only in squamous NSCLC); the anti-angiogenics, nintedanib (only in lung adenocarcinoma) and ramucirumab, in combination with docetaxel; the immunotherapeutics, nivolumab, pembrolizumab, and atezolizumab. In the second-line approach, the main endpoint of treatment should always be survival, but with great respect for symptoms palliation and preserving patients’ quality of life. Therefore, differing toxicity profiles of the available therapeutic options are often a deciding factor in second-line setting for NSCLC.     

Drug-induced uveitis

Introduction: Drug-induced uveitis is a well described but often overlooked and/or misdiagnosed adverse reaction to medication. There are an increasing number of medications that have been related to the onset of intraocular inflammation. Identification of these inciting agents may decisively help the diagnostic algorithm involving new cases of uveitis.

Areas covered: This review intends to be an updated comprehensive, practical guide for practitioners regarding the main drugs that have been associated with uveitis. A classification proposed by Naranjo et al. in 1981 for establishing potential causality is applied examining possible mechanisms of action. A guide for clinicians about the rationale of these observations when dealing with patients with uveitis is provided.

Expert opinion: Several agents with different routes of administration (systemic, topical and/or intraocular) may cause intraocular inflammation. The mechanism behind ocular inflammation is frequently unknown. Clinicians should be aware of the potential drug effect to optimize diagnosis and management of such patients.     

Validated chromatographic method for the simultaneous determination of eight drugs (morphine,ropivacaine, bupivacaine,baclofen, clonidine,sufentanil, fentanyl and ziconotide) for intrathecal analgesia

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Self-injection of barbiturates and benzodiazepines in baboons

Self-injection of three barbiturates, six benzodiazepines, and chlorpromazine was examined in baboons. Intravenous injections of drug were dependent upon completion of 160 lever presses (a 160-response fixed-ratio schedule). A 3-h time-out period followed each injection, permitting a maximum of eight injections per day. Prior to testing each dose of drug, self-injection performance was established with cocaine. Subsequently, a test dose was substituted for cocaine. Amobarbital, pentobarbital, and secobarbital maintained the highest levels of self-injection, which were similar to those maintained by cocaine. Clonazepam, clorazepate, diazepam, flurazepam, medazepam, and midazolam maintained relatively modest levels of self-injection, while chlorpromazine maintained only low levels, which were in the range of vehicle control. Of the six benzodiazepines, midazolam produced the highest levels of self-injection. At the highest self-injected doses, the barbiturates produced anesthesia in contrast to the benzodiazepines, which produced only sedation. None of the drugs affected food intake except for chlorpromazine, which produced dose-related decreases. The differences among the drug classes (i.e., barbiturate, benzodiazepine, phenothiazine) with respect to the maintenance of self-injection correspond well with the results of previous animal and human drug self-administration studies.