A discussion of the impact of us chemical regulation legislation on the field of toxicity testing

Proposals for revising the principal United States law governing industrial chemicals, the Toxic Substances Control Act, have been under consideration in the US Congress for the past several years, and some version of such legislation may be passed in the near future. Concurrently, a desire to move away from current testing methods for ethical, scientific, and practical reasons has led to multi-million dollar investments in in vitro and computational toxicology methods and programs. Legislative language has the potential to endorse this transition and facilitate its fruition, or conversely enshrine in vivo testing methods for the foreseeable future. New legislation also has the potential to substantially increase the numbers of animals used in toxicity tests in the near term. However, there are a number of policies that, used effectively, can reduce the overall number of animals used in new toxicity tests. We present recent legislative proposals in the context of current testing programs and discuss their potential impacts on animal use, test method innovation, and achievement of desired legislative objectives. Discussions like these are essential to judiciously select policies that reduce the use of animals in toxicity testing and protect human health and the environment.     

美国反兴奋剂立法及管理文献综述

本文针对美国的反兴奋剂管理机构和具体的管理措施进行了详细介绍,包括反兴奋剂管理相关的法律和部门以及制造、分销、分配、进出口等具体的管理措施。     

Distribution of eye irritation scores of industrial chemicals

Eye irritation results obtained in tests on agricultural and industrial chemicals (raw materials, intermediates, formulation components and sales products) were classified on the basis of an arbitrary breakdown of the scores (which ranged from 0 (no irritation) to a maximum of 110) into six categories. This showed that of the materials (about 600) tested over a 2-year period, 18-31% caused no irritation at all, 42-51% caused minimal irritation (scores of 0.1-10.9), 9-17% were classed as slightly irritant (11.0-25.9) and 8-12% as moderately irritant (26.0-55.9), while 2-6 and 1-5% came into the categories of strong and extreme irritants, respectively (with scores of 56.0-84.0 and 84.1-110). Testing of the last two groups involves the test animals in discomfort, but because of the seriousness of eye damage to man this cannot always be avoided.     

美国处方书写管理制度初探

目的:规范医疗机构的处方书写和调配行为。方法:系统分析美国处方书写管理的相关规定和要求,探讨中、美两国处方书写管理之间的差异。结果与结论:美国处方书写管理规定具有具体、灵活、操作性强和以人为本等特点,我国有必要借鉴其处方书写管理制度,以进一步规范我国医疗机构的处方书写和调配行为。     

The current application of nanotechnology in food and agriculture

The rapid development of nanotechnology has been facilitating the transformations of traditional food and agriculture sectors, particularly the invention of smart and active packaging, nanosensors, nanopesticides and nanofertilizers. Numerous novel nanomaterials have been developed for improving food quality and safety, crop growth, and monitoring environmental conditions. In this review the most recent trends in nanotechnology are discussed and the most challenging tasks and promising opportunities in the food and agriculture sectors from selected recent studies are addressed. The toxicological fundamentals and risk assessment of nanomaterials in these new food and agriculture products are also discussed. We highlighted the potential application of bio-synthesized and bio-inspired nanomaterial for sustainable development. However, fundamental questions with regard to high performance, low toxic nanomaterials need to be addressed to fuel active development and application of nanotechnology. Regulation and legislation are also paramount to regulating the manufacturing, processing, application, as well as disposal of nanomaterials. Efforts are still needed to strengthen public awareness and acceptance of the novel nano-enabled food and agriculture products. We conclude that nanotechnology offers a plethora of opportunities, by providing a novel and sustainable alternative in the food and agriculture sectors.     

抗生素西索米星发酵过程中次要组分的调控

在西索米星产生菌橄榄星孢小单孢菌Ｍ－４１的发酵代谢与产物合成的研究中,发现通过控制种子期菌丝的生长形态、培养基中磷酸盐含量,并在发酵过程中添加合适的抑制剂,可有效地减少发酵液中次要组分ｖｅｒｄａｍｉｃｉｎ的生物合成,增加主要组分西索米星的含量。     

我国药品生产市场准入制度的规制理论分析

目的:探讨我国药品生产市场准入制度存在的必要性和合理性,揭示药品生产市场准入制度的经济学意义,为促进和完善该项制度提供参考。方法:运用规制理论方法建立模型,从定性和定量两个角度进行研究和分析。结果与结论:我国药品生产市场准入制度的存在是必要的,政府应该加强对药品生产市场准入的控制。     

Regulation of adrenergic receptor number following chronic noradrenaline infusion in the rabbit

In order to study noradrenaline-induced regulation of alpha- and beta-adrenoceptors, groups of male New Zealand White rabbits (n = 8) were treated with intravenous noradrenaline (0.09 mol/kg × h) or ascorbate (0.1 %) for I0 days via osmotic minipumps implanted in the femoral vein, and the number of cardiac, lung and lymphocyte beta-adrenoceptors as well as renal and platelet alpha₂-adrenoceptors were determined.

人体阻抗特性产生的物理机制

论述实验"人体阻抗特性的研究"与医学中测量生理指标的紧密联系,并用物理学与医学结合的方法详述了人体的皮肤阻抗及皮下深部组织阻抗的电学特性———容性阻抗特性的物理机制,突出了人体阻抗的大小与电流频率之间的定量关系,最后以实验结果进一步论证了人体阻抗的大小随电流频率增大而减小,即是容性阻抗的特性。     

试论药品管理处罚的归责原则

药品管理处罚应适用过错责任原则,这有利于实现药品管理法的立法目的和药品管理罚处的双重作用,避免了无过失责任原则导致的道德与法律、药品管理法与其它有关法律之间的矛盾和冲突.并就查处药品违法事件过程中如何认定过错作了初步探讨.     

跌倒防范措施在临床工作中的应用

目的 探讨跌倒防范措施在临床工作中的应用.方法 选择2009年11月～2010年7月收住本院的实施系统防跌倒措施的住院患者1471例为防跌倒组,选择2008年11月～2009年7月收住本院的实施系统防跌倒措施前的住院患者1146例为对照组,对照组按照常规护理规范,防跌倒措施仅包括对患者及护理人员的口头宣教,防跌倒组实施医院防跌倒措施的同时,结合本专科特点,将防跌倒措施流程化,具体化,专科化,应用Morse跌倒风险评估量表制订专科跌倒评估指引,并通过提高护理人员的主动预防意识,加强宣教的力度及广度,做好外出患者的防跌倒宣教,避免疾病因素引发跌倒及提供安全的环境,使预防措施更有针对性及有效性.比较两组的跌倒率.结果 对照组发生跌倒事件4例（0.03％）,防跌倒组无一例跌倒事件发生（0.00％）,两组跌倒率差异有统计学意义（P＜0.05）.结论 建立确实有效的跌倒评估指引,严格落实护理措施和宣教内容,特别是针对性的措施,能有效预防跌倒事件发生,保障患者的安全.     

The usefulness of the enzymatic tests in acute poisonings

In the group of 107 patients poisoned by carbon monoxide (18 patients), ethanol (10), barbiturates (18), glutethimide (10), tranquilizers (19), organic solvents (10), salicylates (3), organochlorines (8), and sulfonamides (5) — the activities of 8 serum enzymes were determined for 6 consecutive days of treatment, the enzymes being as follows: aminotransferases, cholinesterase, alkaline phosphatase, lactate, -hydroxybutyrate, glutamate, and sorbitol dehydrogenase. The antipyrine half-life was also assayed.It has been shown that the poisonings by particular groups of poisons do not bring about characteristic changes in the activity of enzymes that might be of any diagnostic value. The intensity of changes was connected with the depth and duration of toxic coma. Most frequently an increase ensued in the activity of AspAt and AlAt in the third 24-hrs period, and an increase in the activity of SDH in the first 24-hrs period.In the group under examination there were 26 drug abusers in whom a shortening of the antipyrine half-life was discovered. They were less responsive to toxic doses of drugs, and the enzymatic changes in them were less distinct. No changes in the activity of tested enzymes, which are characteristic of toxicomania, were found.     

论公平责任原则在我国药品不良反应救济中的适用

运用公平责任原则审理药品不良反应案件能够有效维护患者的权益,督促医药企业、医疗机构加强药品安全管理。运用公平责任原则审理药品不良反应案件还没有得到推广,司法机关有必要加强这方面的工作。该文阐述运用公平责任原则审理药品不良反应案件的必要性与合理性。     

The Formulation of the Principle of Superposition in the Presence of Non-Compliance and Its Applications in Multiple Dose Pharmacokinetics

The principle of superposition is an important tool for studying multiple dose pharmacokinetics. In this paper, the principle of superposition in the presence of noncompliance is formulated generally as a recursive formula. With this powerful tool, we are able to provide a simple proof under general conditions for the fundamental result that steady state AUC is equal to the single-dose AUC for any concentration curve. In another application of the principle of superposition, we establish the relationship between the steady state average concentration and patient compliance index.     

《抗菌药物临床应用指导原则》颁布前后我院抗菌药物应用分析

目的:了解《抗菌药物临床应用指导原则》颁布后,我院抗菌药物的应用情况。方法:运用医院药库计算机网络管理系统收集2003年～2005年抗菌药物门诊、住院处方销售数据,并进行分类、统计、分析。结果:《抗菌药物临床应用指导原则》实施后,我院抗菌药物销售金额比指导原则前下降了10.74%;指导原则前后各类抗菌药物排序情况基本不变;指导原则实施后年度排序前7位都是第23、代头孢菌素,从DDDS来看,注射剂使用远远超过口服制剂。结论:指导原则实施后,我院抗菌药物使用比率有所下降,但总体变化不明显,仍需加强培训和监管力度。     

The impact of the rare disease and Orphan Drug Act in Taiwan

The Rare Disease and Orphan Drug Act (the Act) was enacted in 2000 in Taiwan for the facilitation of the research, development, and accessibility of orphan drugs and special nutritional foods; for the prevention and early diagnosis of rare diseases; and for providing intensive care for patients with rare diseases. The aim was to investigate the impact of the Act on the availability and use of orphan drugs in Taiwan in the hope of identifying the remaining challenges and possible solutions to assist future policy making, which may be applicable in other countries as well. The information and statistics for rare diseases and orphan drugs retrieved from the official annual reports and documents were analyzed. There were 225 diseases recognized as rare diseases, and one-third (75/225) of them were congenital metabolic disorders. Among the 110 designated orphan drugs that could apply for listing in the National Health Insurance (NHI) Pharmaceutical Benefits and Reimbursement Scheme, approximately half (62/110) of them were granted marketing authorization. While the NHI program compulsory for all citizens increased patient accessibility to orphan drugs, the rapidly increasing economic burden became an urgent issue for the government. Emerging gene therapies may be the solution to unmet medical needs and also a financial obstacle to tackle. The Act increased the availability of orphan drugs while the NHI system facilitated patient access, which benefited many patients with rare diseases in Taiwan. However, the soaring economic burden was noticed and was anticipated to aggravate. More communication and cooperation between stakeholders is critical in finding solutions for the long-term sustainability of the NHI system.     

抗菌药物专项整治前后我院肿瘤科应用抗菌药物的合理性评价

目的:调查抗菌药物专项整治方案实施前后我院肿瘤科应用抗菌药物的情况,评价其应用的合理性,分析专项整治后我院肿瘤科抗菌药物应用的改善情况。方法:选择南海区人民医院肿瘤科2010年10-11月与2011年10-11月肿瘤科病历821例,对抗菌药物的用药种类、用药频度、联合用药、用药合理性等进行调查。结果:专项整治前后,我院肿瘤科抗菌药物应用种类以广谱抗菌药为主,用药种类变化差异无显著性,主要类属于第3、4代头孢类及氟喹诺酮类药物。抗菌药物以单用为主,专项整治前后抗菌药物的联用情况差异无显著性。在进行抗菌药物的合理性评价时发现,感染治疗组在专项整治前后合理性差异不显著;预防用药组抗菌药物专项整治后不合理用药的数目较专项整治前降低,结果有统计学意义(P=0.028)。结论:抗菌药物临床应用专项整治活动方案的大范围推广,使我院肿瘤科抗菌药物使用情况得到部分改善,但在累计使用强度及病原学检测等方面仍有待改进。     

抗菌药物临床应用指导原则施行前后我院门诊患者喹诺酮类药物使用情况分析

目的:评估抗菌药物临床应用指导原则施行前后我院门诊病人喹诺酮类药物的使用情况.方法:收集2004年5月至2004年10月和2004年11月至2005年4月全部门诊西药处方分别为62 820张和63 180张,挑选舍喹诺酮类药物的处方分别为3 652张和3 418张,分别对科室、年龄分布、药物利用指数、用药天数、与抗菌药物联合用药等进行统计分析.结果:指导原则施行前后本院喹诺酮类药物的使用都以左氧氟沙星、诺氟沙星、环丙沙星、洛美沙星为主.指导原则施行前后人均使用喹诺酮类药物天数分别为(4.64±3.68)天和(3.2l±2.27)天.指导原则施行后药物利用指数更合乎要求.结论:在指导原则施行后我院门诊喹诺酮类药物在使用对象及与抗菌药物联合应用等方面较施行前合理,但仍存在不合理的现象.     

支原体肺炎患儿心肌酶改变的临床意义

目的：探讨支原体肺炎患儿心肌酶的改变并分析其临床意义。方法：选择本院2008年1月～2010年1月收治的80例支原体肺炎患儿进行回顾性分析,其中25例支原体肺炎患儿的心肌酶（CK-MB）与肌钙蛋白（cTnI）增高;并与同期住院的15例病毒性心肌炎（MP-IgM阴性）患儿疗效对照比较。结果：本组25例婴幼儿支原体肺炎占同期住院支原体肺炎的72%（18/25）,并且随着年龄的增长呈现减少趋势。治疗前后治疗组CK-MB和cTnI较对照组下降显著,差异有统计学意义（P〈0.01）。结论：支原体肺炎发病年龄有小龄化的趋势,患儿除肺部改变外,常伴有心肌酶增高,发展为中毒性心肌炎。因此,治疗支原体肺炎时应监测心肌酶与肌钙蛋白的变化,以便早期发现肺外脏器损害并及时给予治疗。     

美国尝试权法案对临床试验用药物扩大使用制度的新发展

通过查阅美国的法律法规、FDA指南文件和实施准则、新闻报道和国内外文献,本文深入分析尝试权法案的产生背景、内容体系、引发的社会争议及其对已有扩大使用制度的重要突破,为我国相关制度规范的设计和创新提供借鉴.尝试权法案虽然强调放松监管、简化程序和相对风险控制,但更为重要的是拓宽了危重患者的选择权.立足中国国情,我们需全面衡...