我院2004~2006年严重药品不良反应报告分析

目的:了解我院严重药品不良反应(ADR)发生的情况和特点,以促进合理用药。方法:对我院2004年6月~2006年12月收集到的25例严重ADR报告,按ADR因果关系判断标准进行分析、评价。结果:涉及药品21种,引起ADR例/次最多的是抗感染药,共12种,其次为中药制剂;所涉及的系统以皮肤及其附件和神经系统最为常见;发现3例新的、严重的为药品说明书或文献未见报道的ADR。结论:严重ADR的发生与多种因素有关,应增强合理用药意识,以减少和避免严重ADR的发生,保证药物治疗安全、有效。     

2006年全国老年人严重药品不良反应报告分析

目的通过对老年人严重药品不良反应病例报告的统计、分析,为促进老年人临床用药安全提供参考。方法采用病例回顾性研究方法对国家药品不良反应监测中心2006年收集到的1844例老年人严重药品不良反应报告进行综合分析。结果严重药品不良反应涉及的药品以抗微生物药物最多,不良反应累及的系统一器官以全身性损害最多,给药途径以静脉给药最多。结论提高合理用药水平,加强药品不良反应监测工作,保障老年人用药安全。     

2006年我院139例药品不良反应报告分析

目的 分析本院药品不良反应报告情况,为临床合理用药提供参考,推进我院药品不良反应监测报告工作的开展.方法 对本院2006年139例药品不良反应报告的有关内容进行统计、分析.结果 医生是药品不良反应报告的主体,抗感染药、注射剂、涉及皮肤及附件的不良反应发生率最高.结论 医院相关专业技术人员应重视ADR检测工作,促进临床合理用药.     

我院2006年药品不良反应报告回顾性分析

目的:推进我院药品不良反应(ADR)监测报告工作的开展。方法:对我院2006年收集到的144例ADR报告进行统计、分析。结果:涉及ADR的药品76种,其中抗感染类药物引起的ADR占总例数的44.4%(64例),抗肿瘤类、神经系统类和中药制剂类药物引起的ADR也较多;静脉途径给药的ADR占70.8%(102例),是引起ADR的主要途径;ADR涉及的器官或系统主要为皮肤及其附件。结论:临床科室应重视ADR的监测和报告工作,以减少和避免ADR的发生。     

2006至2008年某院药品不良反应报告分析

目的分析某院药品不良反应(ADR)发生的特点与一般规律,为临床合理用药提供参考。方法对某院2006至2008年收集的86例ADR报告,从患者年龄、性别、药品种类、给药途径、涉及器官或系统以及临床表现等方面进行统计、分析。结果86例ADR报告中,以静脉滴注给药引发的ADR最多,占总例数的91.86(79例);中成药引起的ADR最多,占总例数的41.9%(36例),其次是抗感染药引起的ADR,占总数的22.09%(19例);ADR表现以全身性损害最为常见,占总例数的38.37%(33例),其次是皮肤及附件损伤,占总例数的27.91%(24例)。结论应慎用注射剂,尤其应慎用中药注射剂,尽量以其他给药方式取代静脉滴注,加强ADR监测意识,确保临床安全、有效、合理地用药,以减少ADR的发生。     

我院2006~2007年药品不良反应报告分析

目的:了解我院药品不良反应(ADR)发生的特点及规律,为临床合理用药提供参考。方法:收集我院2006~2007年上报的1 183例ADR报表,将患者性别、年龄、给药途径、引起ADR的药品种类、临床表现等情况输入Excel表进行统计、分析。结果:1 183例ADR报表中,临床科室上报268例(占22.65%),药学部和中心注射室分别上报462例(占39.05%)、441例(占37.28%);男性ADR发生率略低于女性,31a以上患者ADR发生率较高;静脉给药途径引发的ADR为901例(占76.16%);引起ADR最常见的药物为抗感染药(662例),其次为中药制剂(163例)和心脑血管系统药物(149例);所累及的器官或系统以消化系统损害(301例)最为常见,其次为皮肤及其附件损害(236例)、神经系统损害(224例)。结论:医院应重视ADR监测工作,做好ADR分析评价工作,以保证药物治疗安全有效。     

我国儿童用药不良反应报告分析模式的文献计量分析

摘 要 目的：对我国儿童用药不良反应（ADR）报告分析模式进行初步探析。方法：从中国知网（CNKI）数据库检索并筛选出符合标准的文献183 篇,分别提取关键字段建立数据库,分别从刊出情况（年刊出量、文献量比重、主要刊物分布）、来源情况（发文作者及合作情况、发文机构及合作情况、发文地区及行政等级分布）、内容分析（高频关键词分析、文献数据来源分析、文献主题分布）三个方面对我国儿童用药ADR报告分析类文献进行文献计量和题录信息分析。结果：我国儿童用药ADR报告分析的相关文献发文量逐年增长,且主要分布于药学类刊物,发文机构集中于医院,以机构内合作发文居多,发文主题以常规分析、抗菌药类药物分析和中药及类中药注射剂分析见长。结论：我国儿童ADR报告分析类研究有较大的提升空间,应加快推进我国儿童用药ADR基层监测及规范化建设,重视多中心合作,有效利用我国儿童ADR数据,以期今后在一定程度上减少儿童ADR的发生。     

2006年～2007年我市2881例药品不良反应报告分析

对2006年～2007年丽水市ADR监测中心收集的2881份报告表进行统计、分析.结果 药物不良反应的发生与患者年龄、药物种类、给药途径等有关,其中抗感染药物和中药注射剂引起的ADR较多;静脉给药是引起ADR的主要途径;不良反应累及的系统以皮肤及其附件的损害最多见.     

2006年～2007年我市2881例药品不良反应报告分析

对2006年～2007年丽水市ADR监测中心收集的2881份报告表进行统计、分析.结果药物不良反应的发生与患者年龄、药物种类、给药途径等有关,其中抗感染药物和中药注射剂引起的ADR较多;静脉给药是引起ADR的主要途径;不良反应累及的系统以皮肤及其附件的损害最多见.     

我院2008年215例严重药品不良反应报告分析

目的:了解我院严重药品不良反应(ADR)发生情况与特点,促进合理用药。方法:对我院2008年收集到的215例严重ADR报告,按ADR因果关系判别标准进行分析、评价。结果:严重ADR的发生与性别、年龄无关;口服药物发生最多,其次是静脉滴注;涉及药品21大类,引起ADR例数最多的是抗感染药,共101例(28.21%),其次为解热镇痛抗炎药与抗风湿药,共46例(12.85%),再者为中药,42例(11.73%);ADR累及器官或系统以皮肤及其附件损害为主,共73例(33.49%),其次为肝脏损害,共70例(32.11%);在215例严重ADR中,好转160例,治愈54例,有后遗症1例。结论:严重ADR的发生与多种因素有关,应增强合理用药意识,以减少和避免严重ADR的发生,保障药物治疗安全、有效。     

舒更葡糖不良反应文献分析

目的: 探讨舒更葡糖(sugammadex,SGX)所致不良反应(adverse drug reaction,ADR)的发生规律和特点,为临床合理用药提供参考。方法: 检索中国知网、万方、维普、PubMed以及Web of Science中关于舒更葡糖ADR个案报道相关文献并进行分析。结果: 收集舒更葡糖ADR个案报道45例,其中女性21例,男性24例;11.11%为超剂量用药,20%为用药剂量不足。ADR多在给药10 min内发生,主要表现为过敏、心脏骤停、心动过缓等,在给予肾上腺素、抗组胺药、类固醇激素并对症治疗后好转。17例患者在用药洗脱期后进行了皮肤试验,16例结果显示阳性。结论: 舒更葡糖相关ADR发生迅速,与剂量无明显正相关,多累及免疫系统和心血管系统,临床应用时应加强用药监测,必要时可进行皮肤试验以确定诊断。     

国内利福昔明不良反应的回顾性分析

目的根据国内临床应用利福昔明引起药品不良反应（ADR）的文献,考查利福昔明的安全性。方法通过检索《中国医院数字图书馆》、《中文科技期刊数据库（维普）》,收集2002-2008年临床使用利福昔明的资料,进行统计分析。结果25个临床研究资料共计有1759个临床患者使用利福昔明的病例参加安全性评价,结果发生不良反应计55例次,涉及消化系统、神经系统、心血管系统、泌尿系统、血液系统以及皮肤等多个系统和器官,ADR发生率为3.13%（55/1759）。结论临床使用中,应特别注意利福昔明消化系统、肝胆系统与神经系统方面的ADR,密切监测肝功能。     

Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases

The musculoskeletal system can be a target organ for adverse drug reactions (ADRs). Drug-induced muscle, bone or connective tissue injuries may be due to, i), primary direct drug action, or, ii), undirected consequence of generalized drug-induced disease. Musculoskeletal ADRs may be only temporarily disabling, such as muscle cramps, as well as in other cases may be serious and life-threatening, such as rhabdomyolysis. In the last few years there has been an increasing awareness of musculoskeletal ADRs. Some recent drug safety issues dealt with serious or uncommon musculoskeletal reactions like rhabdomyolysis associated to statins and tendon rupture associated to fluoroquinolones. In this review, we firstly selected those drug classes having a significantly high percentage of musculoskeletal disorder reports in the WHO adverse drug reaction database, maintained by the Uppsala Monitoring Centre. Secondly, the different musculoskeletal ADRs were closely analyzed through the data obtained from an Italian interregional ADRs spontaneous reporting database. The findings on drugs associated to different musculoskeletal disorders, have been integrated with a review of the epidemiological data available in the literature. For the most involved drugs (HMG-CoA reductase inhibitors, fluoroquinolones, corticosteroids, bisphosphonates, retinoids) the underlying musculoskeletal ADR mechanisms were also reviewed and discussed.     

Impact analysis of signals detected from spontaneous adverse drug reaction reporting data.

This paper describes a new method of prioritising signals of potential adverse drug reactions (ADRs) detected from spontaneous reports that is called impact analysis. This is an interim step between signal detection and detailed signal evaluation. Using mathematical screening tools, large numbers of signals may now be detected from spontaneous ADR databases. Regulatory authorities need to rapidly prioritise them and focus on those that are most likely to require significant action. Using two scores ranging from one to 100, each with three input variables, signals may be categorised in terms of the strength of evidence (E) and the potential public health impact (P). In a two-by-two figure with empirically derived cut-off points of ten (the logarithmic mean) for each score, signals are placed in one of four categories (A-D) that are ranked according to their priority (A being the highest and D the lowest). A sensitivity analysis is then performed that tests the robustness of the categorisation in relation to each of the six input variables. A computer program has been written to facilitate the process and reduce error. Further work is required to test the feasibility and value of impact analysis in practice.     

2527例儿童药物不良反应分析

目的 了解该市儿童用药不良反应(ADR)发生的规律,为儿童安全用药提供依据,促进儿童合理用药。方法 采用回顾性分析方法,对该市2015年1月~2017年6月不良反应中心所提供的2 527例儿童不良反应数据进行统计分析。结果 2 527例儿童不良反应中,男性患儿1 544例（61.10%）,女性患儿983例（38.90%）。其中1岁以下患儿发生不良反应例数最多,占总数的28.61%;引起不良反应的药物种类最多的是抗感染类,占23.13%,涉及最多的给药途径是静脉注射,占68.81%,引起不良反应最多的剂型是注射剂,占67.51%;2 527例儿童不良反应中,皮肤及其附件是累及最多的,占48.39%;医生报告不良反应的例数最多,占51%。结论 儿童抗感染药物的不良反应需引起重视,通过明确适应症,规范用药,合理用药,争取预防或减少不良反应的发生。     

某院2009～2011年药品不良反应回顾性分析

目的了解笔者所在医院药品不良反应发生的特点及一般规律,促进临床合理用药。方法采用回顾性研究方法,对笔者所在医院2009～2011年收集的139例ADR报告,分别从患者性别、年龄、给药途径、药品种类、累及器官或系统、临床表现等方面进行统计分析。结果 139例ADR中,抗感染药占45.32%,肝科用药占23.02%。静脉给药引发的ADR例数最多,临床表现以皮肤及其附件损害最多。结论临床应合理使用各类药物,加强ADR监测工作,以减少或避免ADR的发生。     

Temporal trends in spontaneous reporting of unlabelled adverse drug reactions

Aims Trends in spontaneous reporting during the first years on the market were analyzed from a sample of selected drugs, with special attention to unlabelled effects.
Methods Ten drugs were selected giving rise to approximately 100 spontaneous reports each during the first 4 years of marketing. Case reports were identified from the national pharmacovigilance database. A bibliographical score assigned at the time of reporting was used to identify unlabelled effects. Results were expressed as reporting rates.
Results The average reporting rate peaked during the first year of marketing (54.6 per million treatment-months; s.d.:62.8), then progressively decreased during the following years. Unlabelled effects represented 63% of all the spontaneous reports during the first year.
Conclusions Unlabelled adverse effects represent a high proportion of spontaneous reports during the early years of marketing.     

多西他赛所致不良反应报告分析

目的:分析某院多西他赛所致不良反应(adverse drug reaction, ADR)的特点及临床表现,总结ADR发生时的处理措施,为临床安全有效的使用多西他赛提供依据.方法:对某院2007-2013年上报的多西他赛所致ADR进行回顾性分析.结果:某院发生多西他赛所致ADR的患者主要为中老年人(年龄≥45岁).原患疾病以肺癌(32.26%)、乳腺癌(27.42%)及妇科肿瘤(24.19%)为主,因此女性患者较多.临床表现以过敏反应、消化系统反应及骨髓抑制居多.结论:使用多西他赛前,医护人员可以根据患者病情采取一定的预防措施;使用后,一旦发生ADR,需根据ADR的类型,及时有效的处理,只有这样才能更好地保证患者的用药安全.     

Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy

Objective: New incretin-mimetics increased the treatment options for type 2 diabetes mellitus. Studies on the safety of incretin-based therapy showed a risk of hypersensitivity reactions, acute pancreatitis, renal failure, infection, thyroid and pancreas cancer. We contributed to safety assessment of these new drugs by evaluating the spontaneous adverse drug reactions (ADRs) reporting in Italy.

Research and methods: Reports of suspected ADRs associated with incretin-mimetics were selected from the Italian Spontaneous ADR Reporting Database. For a subgroup of cases belonging to the Hospital of Cento (Ferrara), levels of pancreatic enzymes, amylase and lipase, before and after the therapy with the incretin-mimetics were available.

Results: As of December 2012, the reports of ADR associated with hypoglycemic drugs (excluding insulin) were 2443, 1169 (47.85%) concerned the incretin-mimetics. A total of 90 reports described pancreatitis (44) and elevated pancreatic enzymes (46). Out of 90 cases, 34 were serious (37%). Data on amylase/lipase values for 10 patients were provided and an analysis of the published literature was performed.

Conclusions: Our data from the daily clinical practice add up and confirm the information available on the association between incretin-mimetics and pancreatic damage and suggest caution in the prescribing of these new drugs and a close monitoring of exposed patients.     

Quality check of spontaneous adverse drug reaction reporting forms of different countries

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge–rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment. Copyright © 2010 John Wiley & Sons, Ltd.