23种常用中药、天然药物注射剂简介(一)

近年来,中药、天然药物注射剂品种的临床应用日益广泛,不良事件也频频发生.近期,国家食品药品监督管理局、卫生部先后下发了<中药、天然药物注射剂基本技术要求>、<已上市中药注射剂变更研究指导原则>、<注射剂无菌保证工艺研究的评价原则>、<中药注射剂安全性再评价工作方案>和<关于进一步加强中药注射剂生产和临床使用管理的通知>等文件,以保障使用中药、天然药物注射剂患者的用药安全.     

2011年度我院中药注射剂不良反应分析

对我院2011年度临床使用中药注射剂发生的不良反应的资料进行统计分析和研究讨论。结果全年共发生不良反应134例,占0.0182%;均得到及时有效处理,无死亡和致残致畸病例。中药注射剂临床使用广泛,但存在部分不良反应,原因复杂;应提高药品质量、加强日常监管、临床合理用药、制定防范措施、科学合理处置,以降低不良反应率。     

696例中药注射剂不良反应分析

目的:了解中药注射剂不良反应发生情况、特点及规律,为临床合理用药提供参考。方法:采用回顾性研究方法,收集2008年国内公开发表的医药杂志报道的中药注射剂不良反应进行统计分析。结果:在中药注射剂的不良反应中,中老年人的不良反应发生率较高;引起不良反应的品种主要为治疗心脑血管疾病和上呼吸道感染的药物;不良反应以皮肤及其附件损害、全身性损害为主,涉及刺五加注射剂、双黄连注射剂、丹参注射剂、清开灵注射剂等49个品种。结论:应重视中药注射剂的不良反应,完善、充实药品上市后的再评价体系,加强中药注射剂各环节的监管,提高合理用药水平。     

中药注射剂发生不良反应的原因分析与护理对策

目的总结中药注射剂不良反应的特点,分析原因,对临床用药提供参考。方法对2016年1月至2017年12月使用中药注射剂发生不良反应的120例患者进行回顾性总结,分析患者的性别、年龄、给药时间、注射方式与发生不良反应的关系,并将受累器官系统与临床情况作统计。结果中药注射剂不良反应(ADR)在60岁以上患者中易于发生,ADR出现时间大部分出现在给药1 h以内;采用静脉输液方式出现ADR比例高于肌内注射;ADR主要造成皮肤与附件受累,第二为呼吸系统受累。结论对中药注射剂使用应熟悉药物适用范围,减少联合使用出现的不良反应,并加强监控中药注射剂制药质量,保证药物使用的安全性。     

中药注射剂不良反应的临床分析与护理干预

目的对中药注射剂的不良反应进行护理干预分析，促进临床合理用药。方法应用回顾性研究方法对60例中药注射剂不良反应进行护理干预分析。结果发生不良反应的中药注射剂有15种。在发生不良反应／事件中有药物本身因素、患者本身因素及临床用药因素。结论应用中药注射剂要辨证施治，规范用药，合理用药，对发生不良反应者应及早发现及时处置，确保用药安全。     

中药注射剂不良反应与不合理用药问题分析

目的分析中药注射剂的不合理用药问题以及不良反应问题。方法选择我院2018年7月-2019年7月期间接诊的300例中药注射剂患者,分析患者的不良反应和不合理用药问题。结果300例中药注射剂患者中,不良反应发生率为(32/300)10.67%。研究显示,患者不良反应发生5-30 min较多,不良反应出现的部位主要包括:用药部位局部、皮肤、消化、循环、运动和过敏性系统。结论分析中药注射剂治疗中患者出现的不良反应,重视中药注射剂的安全使用,可以降低中药注射剂不良反应情况。     

中药注射剂静脉输液安全管理

目的:探讨制定并执行中药注射剂静脉输液规范的必要性和重要性,以减少中药注射剂ADR发生,保证患者输液安全。方法:分析2008年医院中药注射剂ADR报告;制定"中药注射剂静脉输液规范",并在该院内科系统10个病区落实执行。结果:2008年该院内科常用3类中药注射剂共发生56例不良反应,占总例数的77.8%;2009年内科常用3类中药注射剂不良反应减少21例(P<0.05),静脉炎和发热反应亦减少(P<0.05)。讨论:在输注中药注射剂时执行"规范"是必要且重要的,此外加强医院对中药注射剂临床使用的管理与监督,发挥临床药师的作用也是减少ADR发生的重要因素。     

中药注射剂临床应用干预前后对照分析

目的:了解干预前后对中药注射剂临床应用的合理性、有效性与安全性情况以及干预措施实施的效果。方法:选取实施干预前的2009年11月全部出院病历以及干预后的2010年11月全部出院病历,进行干预前后中药注射剂临床应用的合理性、有效性与安全性的对照研究。结果:干预后中药注射剂使用率下降,由干预前的38.09%下降为干预后的31.09%(P<0.01);干预后用药不合理性表现形式显著改善,用药无适应证、剂量超量、疗程不当、联合用药不当、溶媒选择不当、混合配伍等用药不合理现象都有所改善;不良反应/事件发生率降低,由干预前的3.04%下降为干预后的0.66%(P<0.01),临床疗效提高,由干预前的89.00%上升为干预后的98.35%(P<0.01);人均中药注射剂费用由637.35元下降为398.11元。结论:医院采取的干预措施有效、可行,提高了中药注射剂使用的合理性、有效性与安全性,降低了中药注射剂药品费用,能降低药物不良反应/事件,提高疗效,为临床药师参与临床、开展中药注射剂合理用药指导工作提供了切入点。     

静脉输入中药制剂的安全管理

中药注射剂是近年来发展较快的中药新剂型之一.随着中药注射剂品种的增多和临床应用范围的扩大,不良反应的报道也越来越多,其质量与安全问题越来越引起人们的关注.如何安全合理的使用中药注射剂,是我们共同研究的新内容.现就中药注射剂静脉输入的安全管理,报道如下.     

中药注射剂不良反应270例分析和预防

目的：分析中药制剂输液不良反应,为临床安全使用中药注射剂提供科学依据。方法：回顾性分析北京航天中心总医院2007-01／2009—06上报的270例中药注射剂不良反应（ADR）报告表。结果：中老年患者不良反应发生率相对较高,中药注射剂引发的不良反应临床表现多样,涉及人体各个系统,包括消化系统、血液系统、循环系统等。临床表现以全身性过敏反应最为多见。结论：应控制药品质量,加强用药观察,严格掌握适应证,使临床用药更加合理,发挥中药注射剂的治疗效果,同时避免不良反应的发生。     

中药注射剂不良反应及临床合理用药

我国中药注射剂（traditional Chinese medicine injection,CMI）的不良反应涉及国家批准的109个品种。主要不良反应（ADR）包括全身过敏反应、过敏性休克、急性血管内溶血、肝肾功能损害、皮肤损害、心功能损害、呼吸系统损害、胃肠道反应等。引起药物ADR的因素包括：医务工作者对CMIADR重视度不够、中药注射液成分复杂、过敏反应物质不确定、患者特殊体质,尤以儿童和老年人不合理用药现象较重。因此,应从合理选择药物适应症、把握用药方法、避免加大药物浓度、不能随意增加用药剂量和改变用药途径、选择合适的溶媒等方面加强CMI的临床合理使用,减少ADR发生。     

The Alendronate Conundrum: Balancing the Competing Influences for Truly Informed Consent About Drug Safety in an Era of Rapid Change

This commentary highlights critical decision points regarding the responsibilities of the key stakeholders—pharmaceutical companies, the US Food and Drug Administration, clinicians, and patients—regarding the communication of the risk of a medication. It addresses responsibility for remaining current about emerging drug reactions that often cannot be appreciated during the initial approval period of new drugs and biologics. Further complicating the issue are the medical systems that limit a clinician's time and bandwidth to keep abreast of emerging adverse reactions and to engage in an informed consent process with a lay patient who often has a limited understanding of medical terms and quantitative methods that can provide context for understanding rare complications and adverse drug reactions. Nevertheless, the risk of not finding an amenable way forward for all stakeholders is a descent into the unending crippling malpractice settlements that will only inexorably raise the costs of health care and encourage the exodus of clinicians from the profession.     

ENT Self-Test

Abstract

The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.     

HLA-B*1502 allele is associated with a cross-reactivity pattern of cutaneous adverse reactions to antiepileptic drugs

The US Food and Drug Administration has recommended genetic screening for the human leucocyte antigen-B (HLA-B)*1502 allele in patients of Asian ethnicity before starting carbamazepine therapy, to avoid the fatal adverse treatment-related events associated with this drug. The association between cross-reactivity to antiepileptic drugs (AEDs) and the HLA-B*1502 allele has been only rarely reported. Here, two cases of cross-reactivity to AEDs, where cutaneous adverse drug reactions (cADRs) developed in female Han Chinese patients with epilepsy who tested positive for the HLA-B*1502 allele, are described. If the genetic association could be confirmed in larger studies, the HLA-B*1502 allele should be tested for in any patient experiencing cADRs, to avoid crossreactivity to AEDs.     

Improving the reporting of adverse drug reactions in the hospital setting

The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.     

Unapproved drugs in the united states and the food and drug administration

Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA). The Pure Food and Drug Act of 1906 was the first comprehensive federal legislation covering drug regulation. Intervening legislation, such as the Federal Food, Drug, and Cosmetic Act of 1938 and Kefauver-Harris Amendments in 1962, was later instituted. In June 2006, a century after the development of the FDA as an enforcement body, an initiative was undertaken to remove unapproved drugs from the marketplace. The Marketed Unapproved Drugs — Compliance Policy Guide outlines enforcement policies aimed at efficiently and rationally bringing all unapproved and illegally marketed drugs into the approval process, or discontinuing their manufacture, distribution, and sale. The FDA has been actively pursuing control of unapproved drugs in recent years, with an approach concentrating on drug safety to ensure optimal public health and consumer protection.     

Health effects associated with medical glove use

Adverse reactions to medical gloves represent an important public health issue. Accordingly, there is increasing interest in understanding the information reported to the US Food and Drug Administration (FDA) describing health effects associated with the use of medical gloves. This article provides a retrospective analysis and summary of health effects associated with medical glove use reported to the FDA. The FDA's medical device adverse event databases were searched via computer using keywords to identify reports of reactions associated with any type of medical glove. Demographic and clinical information abstracted from these reports was used to perform frequency and trend analyses. The reported medical glove-related events, including the noted trends in reporting, suggest the need for further study and continued monitoring of such reports. AORN J 76 (July 2002) 88-96.     

Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?

The regulatory processes by which industry obtains approval for marketing and sales of medical devices from the United States Food and Drug Administration is distinct from the drug approval pathways, poorly understood by clinicians, and widely criticized by clinical investigators and industrial sponsors of new technology. This paper reviews the most common pathways for obtaining such approval for endovascular devices used in the treatment of peripheral arterial disease. Unique issues pertinent to clinical trials carried out in this area are highlighted. Future directions for evolution of the regulatory process consonant with the mandated requirements for demonstration of safety and efficacy are discussed.     

Drug control authorities in China

OBJECTIVE: To provide an overview of China's drug control authorities. DATA SOURCES: South Pharmaceutical Economy Institute. DATA SYNTHESIS: China's drug control authorities include the State Food and Drug Administration (SFDA), which primarily oversees drug administration; the State Development and Reform Commission (SDRC), which is responsible for the drug price administration; and the Provincial Administration for Industry and Commerce, cooperating with the Provincial Food and Drug Administration, to regulate drug advertisements. Although the drug control authorities presented here have played important roles in drug administration and have obtained outstanding achievements in the past several years, they are also hindered by their respective problems and try to explore the solutions. CONCLUSIONS: Other countries may confront the problems described here. It is therefore necessary to learn the current situation of drug control authorities in China, as well as the measures being taken to improve the situation. This understanding will aid countries seeking to enter China's pharmaceutical market.