91例静脉滴注克林霉素不良反应分析

目的了解和分析静脉滴注克林霉素所致药品不良反应的发生情况及相关的影响因素,为临床安全用药提供参考。方法收集我院2004年12月至2010年12月向北京市药品不良反应监测网络上报的91例有关克林霉素的不良反应报告,对其进行统计、分析。结果克林霉素所致不良反应临床表现较轻微,主要以皮肤及其附件损害,消化系统损害为主,联合用药易发生不良反应。结论克林霉素临床应用中应严格掌握适应证和用法用量,注意患者过敏史、药品稳定性,并做好发生严重不良反应的对症处理。     

Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database

AIMS

To investigate putative associations of reports of memory disorders and suspected drugs.

METHODS

We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of memory loss in the FPVD between January 2000 and December 2009. Noncases were all other reports during the same period. To assess the association between memory impairment and drug intake, we calculated an odds ratio with its 95% confidence interval.

RESULTS

Among the 188 284 adverse drug reactions recorded, we identified 519 cases of memory loss. The sex ratio was 0.6 and the median age was 54 years (range 4–93). The maximal number of cases occurred between 40–49 and 50–59 years. Evolution was favourable in 63% of the cases. We found significant odds ratios for benzodiazepines (alprazolam, bromazepam, prazepam, clonazepam etc.), benzodiazepine-like hypnotics (zolpidem and zopiclone), antidepressants (fluoxetine, paroxetine and venlafaxine), analgesics (morphine, nefopam and tramadol), anticonvulsants (topiramate, pregabalin, levetiracetam etc.), antipsychotics (aripiprazole and lithium) and other drugs, such as trihexyphenidyl, ciclosporin and isotretinoin.

CONCLUSIONS

Our study confirmed an association between memory disorders and some drugs, such as benzodiazepines and anticonvulsants. However, other drugs, such as benzodiazepine-like hypnotics, newer anticonvulsants, serotonin reuptake inhibitor antidepressants, isotretinoin and ciclosporin were significantly associated with memory disorders, although this was not described or poorly described in the literature.Taking account of the limits of this study in the FPVD (under-reporting, notoriety bias etc.), the case/noncase method allows assessment and detection of associations between exposure to drugs and a specific adverse drug reaction, such as memory disorders, and could thus generate signals and orientate us to further prospective studies to confirm such associations.     

药品不良反应监测的定义和范畴研究

目的明确＂药品不良反应监测＂的定义及范畴,厘清药品不良反应监测的概念。方法回顾＂监测＂的语源学,以及作为术语在疾病监测或公共卫生监测中的定义和范畴;回顾药品不良反应监测的历史与实践,以及信息技术发展对其的影响;分析＂药品不良反应监测＂、＂药物警戒＂与＂药物流行病学＂的概念框架。结果＂监测＂的目标是有危害可能的趋向。＂持续＂、＂系统＂、＂收集＂、＂分析＂、＂解释＂、＂传播＂是术语＂监测＂的基本元素。药品不良反应监测从药物获批上市即开始,收集的数据不仅涉及药物的性质,还涉及药品标准、药品生产、药品储存和药品使用。信息技术极大地推动了药品不良反应监测。结论建议定义药品不良反应监测为：一项以药品不良反应为目标的公共卫生项目,由一整套持续、系统性地收集、归整、分析和阐释药品对人体的危害方面的数据（包括相关的志愿报告、电子医疗记录和实验室记录等）并及时向所有应该知道的人（监管部门、医务人员或/和公众）反馈的过程组成。目的是认识药品安全问题的分布特征和变化趋势,鉴别、评价、认识和交流药品非预期的有害作用,进一步认识药品的获益-风险的属性,防范或使药品的有害作用最小化。     

医药类高校开设药物警戒课程的思考

药物警戒已由传统的药品不良反应监测拓展到产品生命周期全过程的管理。目前我国医疗行业从业者对于药物警戒的了解不够深入,医药类高校作为培养专业人才的机构,应开设药物警戒课程,传授药物警戒相关知识,促进我国药物警戒专业人员的培养。本文分析了开设药物警戒课程的必要性、存在难点及对策,以及开设课程应注意的问题。建议高校可以尝试以自修课、选修课的形式开设药物警戒课程。     

我院2012年15例严重药品不良反应报告分析

目的通过对我院严重药品不良反应病例报告的分析,为临床合理用药提供参考。方法采用回顾性研究,对我院2012年度监测到的严重药品不良反应进行分析。结果在2012年468例药品不良反应病例中,严重药品不良反应共计15例（怀疑药品18个）,其中危及生命的4例;导致显著的器官功能的损伤1例;导致住院或者住院时间延长5例;导致其他重要医学事件的5例。结论关注严重药品不良反应药品及其引起机体损害的表现,加强用药监护,促进临床合理用药。     

Hospital admissions for 'drug-induced' disorders in England: a study using the Hospital Episodes Statistics (HES) database

AIMS: To review Hospital Episode Statistics (HES) data for England coded as being 'drug induced' during 1996-2000 and to consider their potential utility for assessing the public health burden of adverse drug reactions (ADRs) and studying drug safety. METHODS: ICD-10 codes including the words 'drug-induced' or 'due to' a medicine or which are recognized to be invariably caused by a drug were extracted along with external cause codes indicating that a drug was implicated (i.e. Y40-59 in ICD-10). We also calculated the proportions of patients with each 'drug-induced' code for whom an external cause code had been applied. RESULTS: During the 5-year study period there were almost 53.8 million hospital admissions in England, of which 44 411 (0.083%) were coded as 'drug-induced' and 168 958 (0.314%) were associated with a relevant external cause code. The numbers of patients with 'drug-induced' codes used were generally stable during the study period (range 7454-8860 per year) but the application of external cause codes increased in each year and by 40% overall (from 24 786 in 1996 to 34 843 in 2000). The overall proportion of 'drug-induced' codes associated with a relevant external cause code was quite low (12-15%) but there was considerable variation between codes. CONCLUSIONS: Comparisons with published studies indicate that HES data grossly underestimate the burden of drug-induced disorders as a cause of hospital admission. There are likely to be multiple underlying reasons including under-recognition, under-recording and limitations of the coding system. The potential of these data for identifying previously unrecognized serious ADRs is limited by constraints on the availability of detailed data regarding individual cases.     

药物不良反应知识库的建设以及统计分析

目的:建立一个药物与不良反应对应关系的知识库,为药物不良反应的监测以及药物不良反应研究提供一个在线资源。方法:首先通过网络爬虫从互联网获取中文的药品说明书数据,然后通过自然语言处理的方法自动从药品说明书中提取相应的不良反应,并构建相应的知识库来存储药品与不良反应的关系,最后对该知识库药品以及药品的分类进行了不良反应的统计分析。结果:建立了一个由3 683个药品和39 583个药品与不良反应关系组成的知识库,统计表明76.6%的药物有明确不良反应,其中94.5%的药物都有多于1个的不良反应;给出了不良反应最多的10种药品以及最常见的不良反应;通过对不良反应最多的100个药物的ATC分类统计显示其中多数属于抗感染药物、心血管药物和抗肿瘤药及免疫制剂三类。结论:搭建了该药物不良反应知识库网站提供免费在线查询和下载http://www.cktp.org:8006/Display/ADE,可以服务于临床药物不良反应监测和相关的不良反应研究。     

基层药物警戒体系建设和科学发展

结合山东省药品不良反应监测的现状,分析了基层开展药物警戒的有利条件和存在的主要问题,探讨了基层药品不良反应监测工作的形势与定位、目标与任务;对基层药物警戒体系的建设和科学发展提出建议。     

北京药物警戒推动工作探究

目的了解北京地区2家药物警戒工作站不良反应监测（ADR）开展现状、科研情况,为开展药物警戒和风险评估提供理论依据。方法采用横断面研究方法,设计调查表,调查北京地区2家药物警戒工作站的情况。结果共回收304份调查表。调查的304位医务人员平均年龄为32岁;对于ADR定义有正确认识的人占94.7%;认为报告临床ADR是工作职责的人占94%。2家药物警戒工作站建立了ADR监测制度和机构,具备了开展ADR监测的设施设备和一定的科研能力。结论药物警戒工作站医务人员对于ADR监测工作有正确的认知和态度,但还需进一步完善信息系统和加强医务人员的培训,以更好地配合开展药物警戒工作。     

临床药师主动参与药品不良反应报告的体会

通过介绍临床药师加强药品不良反应知识宣传及主动参与报告后,药品不良反应报告数量和质量改善的体会,提出由临床药师主动承担不良反应报告,充分发挥临床药师的专业优势,建立由临床药师主导的医院药物警戒体系。     

影响个例药品不良反应报告评价的因素

通过对影响个例药品不良反应报告评价诸如不良反应报告填写的完善程度、我国现有药品不良反应报告评价方法的局限性、联合用药、药品说明书、工作者医药学相关知识素质以及个体因素等多方面因素做一系统分析,旨在对个例药品不良反应报告评价时尽量减少干预因素的影响,以提高评价的准确性。同时对个例药品不良反应评价的重要性及其与药物警戒的关系做一简要阐述。     

Clinical perspectives in drug safety and adverse drug reactions

Adverse drug reactions (ADRs) remain a common clinical problem since they can mimic many diseases and cause significant morbidity and mortality. Judicious prescribing is important to minimize their occurrence. Apart from the recent identification of a few pharmacogenomic biomarkers for serious reactions, many remain unpredictable. Spontaneous reporting continues to play an important role in pharmacovigilance and the value of astute clinical observation and well-documented reports of suspicions of a causal link cannot be underestimated. Many national reporting schemes have developed considerable experience and expertise over many years and have large ADR databases, which are national assets. Despite advances in pharmacovigilance, numerous deficiencies have been identified; postmarketing surveillance remains the weakest link in the regulatory process. Regulatory authorities have tended to act later rather than sooner in response to safety signals, and this, when combined with under-reporting, may have led to exposure of a large number of patients to drug-related harm before restriction or withdrawal. In an attempt to improve vigilance, international surveillance may benefit by moving from its current passive/reactive mode toward active surveillance systems with a prospective, comprehensive and systematic approach to monitoring, collecting, analyzing and reporting data on ADRs. This will include increased pressure on pharmaceutical companies to conduct postmarketing studies. Such an active/proactive approach, while maintaining focus on ADR detection, could also aim to extend knowledge of safety, such that emerging changes in risk–benefit during a drug’s marketed life are effectively communicated to clinicians and patients. Drug safety monitoring and its regulation are now undergoing an overhaul and it is hoped that vigilance, public safety and trust will improve as a result.     

我国药品不良反应的文献计量学研究

目的探索和评价我国有关药品不良反应相关文献的现状,找到发展方向。方法通过中文期刊全文数据库（CNKI）检索出相关文献,对文献的时间分布、期刊分布、作者分布及文献涉及的内容等方面进行评价研究。结果我国对药品不良反应的研究呈增长趋势,现已形成核心作者群,医院和政府机构是文献的主要来源;《中国药物警戒》等5种期刊为药品不良反应的核心期刊;在具体研究内容上基本可以分为7大类,且以要素类和体系类居多;课题基金来源丰富,但多集中于东部地区。结论我国药品不良反应研究工作进展显著,但研究方向和方法仍需改进。     

克林霉素治疗细菌感染60例

目的：评价国产克林霉素磷酸酯的临床疗效和安全性。方法：细菌感染病人６０例（男性３９例，女性２１例；年龄４６±ｓ１７ａ），其中呼吸道感染４９例，尿路感染４例，皮肤软组织感染和急性骨髓炎各３例，败血症１例。用克林霉素磷酸酯１．２～２．４ｇ／ｄ，分２～３次静脉滴注，疗程７～１４ｄ。结果：治疗后临床有效率８５％，痊愈率６２％，细菌清除率９０％，不良反应少而轻微，皮疹和一过性ＡＬＴ升高的发生率分别为５％和２％。结论：国产克林霉素磷酸酯治疗需氧革兰阳性菌感染疗效好且安全。