住院患者药品不良反应报告分析

目的:了解住院患者发生药品不良反应(ADRs)的情况。方法:按患者的年龄、性别、用药情况及ADRs的主要表现、严重程度等进行统计分析。结果:185例报表中,男性87例,女性98例,涉及药品82种,主要为抗感染药物(46.49%),其次为中药制剂(16.76%),ADRs主要表现是皮肤及附件损害,其次是循环系统、消化系统。结论:应加强对住院患者ADRs的监测工作,以保证用药安全性。     

Adverse drug events in hospitalized patients A comparison of doctors, nurses and patients as sources of reports

Objective: This study investigated the relative value of adverse drug events reported by doctors, nurses and patients. Methods: The study was conducted on a total of four wards: the paediatric and internal medicine wards (including geriatric patients) of two peripheral hospitals in the Netherlands. Adverse drug events were collected by spontaneous reporting (doctor and nurse reports) and by daily ward visits, during which the patients were interviewed by a hospital pharmacist (patient reports). Criteria for relative value of the reported adverse drug events were the number of potentially serious reactions, the number of reactions not mentioned in the patient information leaflet and the number of reactions reported to new drugs (5 years or less on the Dutch market). No formal causality assessment was applied. Results: Over a period of 2 months in 1996 (Hospital I) and 2 months in 1997 (Hospital II) a total of 620 patients were included in the study and adverse drug events were reported in 179 (29%) of these cases. Doctors reported a statistically significant larger number of serious (26% of all doctor reports; odds ratio (OR) 3.2; confidence interval (CI) 1.2–8.7) and unknown (39%; OR 2.5; CI 1.0–6.0) adverse drug events than patients themselves during the daily ward visit. Doctors also reported more serious and unknown adverse drug events than nurses. Adverse reactions to new drugs were reported during the daily ward visit only (8% of all daily ward visit reports). Conclusion: This study reconfirms that doctors are the main source for reports of serious and unknown adverse drug events in hospitalized patients. However, patients themselves seem to report more adverse reactions to new drugs (during the daily ward visit). By focusing on patients using new drugs, the daily ward visit might become cost-effective. This needs to be explored in future studies. Received: 10 September 1998 / Accepted in revised form: 30 November 1998     

Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR

ObjectivesChildren are more vulnerable to ADRs, and this susceptibility is compounded due to hospitalization. There is a lack of local data regarding the potential risk of ADRs in hospitalized pediatric patients. Therefore, this study is designed to identify the frequent nature, severity of adverse drug reactions, drugs implicated and factors influencing ADRs.MethodsIntensive monitoring study of ADRs was done in hospitalized pediatric patients of King Abdulaziz University Hospital, Jeddah from January to December 2011, with an analogous retrospective study for the preceding year to determine incidence rate, demographic aspects, causality appraisal, polypharmacy, body organs/systems involved and drugs implicated in ADR. Comparison of the two data was done to determine the impact of pharmacovigilance.ResultsIncidence rate of ADRs in retrospective study was (4.50%) and (8.2%) in prospective study. ADR was more in patients who received 5–6 drugs, which was (15.5%) in retrospective study and (22.1%) in prospective study. Regarding age, it was the highest in patients of 0–1 year of age which was (40.7%) in retrospective study and (38.8%) in prospective study. Anti-infective agents were the most frequently involved in ADR (40.8%) in prospective study and (48.2%) and retrospective study. This study also demonstrated that, there was high susceptibility of the skin to the ADR which was (37%) in retrospective study and (42.9%) in prospective study. None of the ADRs proved to be fatal.ConclusionWell premeditated intensive monitoring approach in pharmacovigilance amplifies the ADR detection, which can persuade healthcare providers into more drug safety.     

常用中药注射剂不良反应96例分析

目的分析中药注射剂不良事件(ADE)以及产生药物不良反应(ADR)的临床相关因素。方法采用回顾性研究方法,对我院2006年6月～2010年1月中药注射剂不良反应报告96例进行分析,对其用药情况、年龄、ADR、累及系统-器官等临床相关因素进行汇总分析。结果 96例中用药环节存在不当58例(60.4%),包括不符合适应证或不辨证用药、同一输液瓶续滴未冲洗输液管、超剂量应用和用药次数过多等。正确用药情况下ADR38例(39.6%),其中清热解毒类占44.7%,活血化瘀、改善微循环类占44.7%,补益类占10.5%,一般的不良反应发生率为93.75%,以皮肤反应和胃肠道反应为主。结论用药不当是中药注射剂发生不良反应的主要原因,容易被临床忽视,需要医生遵循中药注射剂的适应证和用法正确合理使用。     

1120例药品不良反应/事件的发生特点与转归分析

目的 调查我院药品不良反应/事件(ADR/ADE)发生情况,分析其发生特点和转归,为临床安全、合理用药提供参考。方法 对我院2018年至2019年上报至国家不良反应监测中心的1 120例药品不良反应/事件报告进行回顾性分析,探索药品不良反应/事件与年龄、性别、体重、药品种类、给药途径的相关性。结果 在1 120例药品不良反应/事件报告中,新的和严重的报告数共989例(88.30%),已知的药品不良反应/事件损害较严重;发生严重药品不良反应/事件的比例与性别、体重无显著相关(P>0.05),而与年龄显著相关(P<0.05),严重药品不良反应/事件患者年龄较大;给药途径以口服(624例,占55.71%)和静脉滴注(374例,占33.39%)为主,口服引起的严重药品不良反应/事件比例较高;报告数最多的药品种类是抗感染药物(298例,占26.61%),严重药品不良反应/事件占比最高的是内分泌系统用药(共143例,严重132例,占92.31%);涉及的器官/系统报告数排前三名分别是代谢及营养疾病(249例,占22.23%)、肝胆疾病(178例,占15.89%)和血管,出血及凝血疾病(...     

Anti-infectives-induced adverse drug reactions in hospitalized patients

OBJECTIVES: To assess the rate and seriousness of adverse drug reactions (ADRs) attributable to anti-infective agents in hospitalized patients; to estimate the likelihood of experiencing anti-infectives-induced ADRs at different length of drug usage in the hospital; to compare different classes of anti-infectives in inducing ADRs; to determine the impact of age and sex on anti-infectives-induced ADRs. DESIGN: Prospective cohort study. PARTICIPANTS: Patients admitted to the infectious diseases department at a university teaching hospital, on Sunday to Wednesday, over a 9 months period, who received at least one anti-infective agent were eligible to enter the study. MAIN OUTCOME MEASURES: Any suspected noxious and untoward medical events, including laboratory tests abnormalities following anti-infective therapy. METHODS: All patients admitted have received at least one anti-infective drug. Anti-infective agents induced ADRs were detected by interviewing patients and daily chart review. The seriousness, causality, and type of reactions were classified based on World Health Organization (WHO) definitions. Chi-square analysis was performed to assess the influence of sex and age on occurring ADRs. Both Kaplan-Meier and life table method were used to estimate the time to occur the ADR in anti-infective users. To compare the estimated risk of ADRs induced by different classes of anti-infectives, odds ratios were estimated. In all classes of anti-infectives, the odds ratio of each class was estimated with regard to anti-tuberculosis agents, which had the highest prevalence of ADRs. RESULTS: During the study period, 460 patients were entered the study. During the same period, 38 ADRs were recognized of which 20 (42%) were serious. The most recognized ADRs were suspected to be induced by anti-tuberculosis agents (29.8%). However in comparing with anti-tuberculosis agents, anti-fungal agents were associated with the highest ADR rate (odds ratio [OR], 4.21; 95% confidence interval [CI], 1.41-1.256) whereas cephalosporines were associated with the lowest rate, (OR, 0.1; 95%CI, 0.04-0.26). The survival analysis shows that the likelihood of experiencing an ADR was increased at first 14 days of drug therapy. Also Chi-square analysis shows that greater risk of anti-infectives-induced ADRs was observed in women. CONCLUSION: The rate of ADRs induced by anti-infective agents in this study was 8.2%. This is higher than a standard (5%) which has been reported in other studies. This study also shows that some of the classes of anti-infective agents like anti-fungals need more attention.     

ADE触发工具在药品不良事件监测中的应用

目的：探索ADE触发工具在医院药品不良事件（ADE）监测中的应用。方法：根据医疗保健研究所（IHI）推出的ADE触发工具及医院具体用药情况,选择19项触发器。自医院电子病历系统随机抽取2015年第三季度出院病历共967份（肿瘤患者和18岁以下患者除外）,回顾性研究患者的用药情况、检验检查指标及病程记录,对触发器显示阳性的患者进行ADE判定和分析,并进行数据统计和分析,评估各触发器信号与ADE发生的相关性。结果：967位患者中触发器阳性者达到417例次,涉及319位患者,确定33位患者发生ADE,ADE检出率为10.34%（33/319）。33例ADE中E级ADE为31例,F级为2例。同时间段医院ADE自愿上报率为0.67%（147/21897）,与经触发器检出的ADE发生率相比,有统计学差异;且在医院ADE自愿上报系统中未检查到此33例ADE患者信息。结论：ADE触发工具对发现ADE具有较强的敏感性,与自愿上报系统相比,可发现更多的ADE,但触发器需要进一步修正。     

Suspected adverse drug events requiring emergency department visits or hospital admissions

Objective: To analyse the contribution of adverse drug events (ADEs) to the overall number of referrals or visits at an emergency department, to determine the proportion of more severe episodes requiring hospital admission and to characterize the different causes of drug-related visits or admissions. Methods: A 1-year prospective collection of data on visits performed at an emergency department. All visits, observed during 1 week every month, were analyzed in order to identify suspected ADEs. The effects of age and sex on the frequency of ADE-related visits and admissions were evaluated. All patients hospitalized because of an ADE were followed up in order to collect information about progress and outcome of the events, which were also assessed in terms of avoidability. Results: Among the 5497 patients who visited the Emergency Department over 1 year, 235 (4.3%) experienced an ADE, 45 of these (19.1%) were subsequently hospitalized, among whom there were five deaths. Dose-related therapeutic failures were the main causes of drug-related admissions (55.6%), whereas adverse drug reactions caused the most frequent drug-related visits to the Emergency Department (63.8%). Although the frequency of drug-drug interactions leading to a visit to the Emergency Department was small (3.8%), this type of event was more severe, because most of these patients were hospitalized. No age/sex effect was observed in the proportion of ADE-related hospital admissions. Twenty-five (1.4% of the total admissions) of the 45 ADE-related admissions were evaluated as preventable, contributing by more than 61% of the overall length of hospital stay. Conclusion: The high proportion of drug therapeutic failures leading to an admission highlights the need for public education, particularly to prevent non-compliance. Received: 14 April 1998 / Accepted in revised form: 5 October 1998     

我院902例药物不良反应报告分析

目的了解我院药品不良反应/事件(ADR/ADE)发生的情况及特征。方法对我院2006年7月~2010年12月收集上报的902例ADR/ADE报告,分别从患者性别及年龄,严重ADR的发生率,ADR/ADE累及系统-器官及主要临床表现,用药途径及诱发ADR/ADE的药品等方面进行统计分析。结果 902例ADR中,有447例(49.6%)是由抗菌药物引起的。其中阿奇霉素是引起ADR的最多的药物(占31.47%),抗菌药物的不良反应累及最多的是皮肤。药物-药物不良反应之间的关系能确定的有79%,撤药后恢复率达到95%。结论在我院的住院患者中,抗菌药物的使用是ADR发生的最常见的诱因,应合理应用抗菌药物,注意监测严重不良反应的发生。     

儿科患者使用喜炎平注射液致不良反应危险因素分析

目的分析儿科患者使用喜炎平注射液致不良反应(ADR)的高危因素。方法分析2013年1月至2015年12月使用喜炎平注射液的1 180例儿科患者的临床资料,分析其ADR发生率,调查相关危险因素,并对其分别进行单因素和多因素Logistic分析。结果 1 180例患者发生ADR 35例,ADR发生率2.97%,临床表现以皮肤及附件损害的过敏性反应为主。Logistic分析结果显示,年龄、过敏史、给药剂量、溶媒种类、给药途径和合并用药是主要危险因素(P<0.05)。结论年龄(<3岁)、有过敏史、超剂量给药、溶媒为0.9%氯化钠注射液、静脉滴注给药和同时合并3种以上药物是喜炎平注射液致ADR的主要危险因素。儿童使用喜炎平注射液时,医生应进行危险因素预判,对可能发生ADR的高危患者进行适当监护,以安全、有效地应用喜炎平注射液。     

上海骨关节疾病患者口服吲哚美辛不良反应危险因子筛选

目的　在上海骨关节疾病患者中筛选吲哚美辛引起不良反应的危险因素。方法　利用回顾性流行病学调查方法 ,调查服用吲哚美辛的骨关节疾病患者的一般情况、原发疾病、疾病家族史、服用非甾体抗炎药前生活质量评估、饮食习惯、生活方式、非甾体抗炎药服用情况和不良反应发生情况等 ,通过单因素和多因素分析从中筛选吲哚美辛不良反应发生的相关因素。结果　上海骨关节疾病患者中口服吲哚美辛的不良反应发生率为 48 1%。因子“合并药物治疗”(比值比 0 166,95%可信区间 0 0 3 7～ 0 74)、“饮酒史”(比值比 0 795,95%可信区间 0 675～ 0 93 7)、“来自于健康问题的何种程度的紧张或压力会影响你的生活” (比值比0 917,95%可信区间 0 848～ 0 992 )评分的降低分别使口服吲哚美辛不良反应发生的危险增高。而因子“与 6mon前比较 ,服用非甾体抗炎药前的健康状况如何” (比值比1 2 3 6,95%可信区间 1 0 2 2～ 1 496)评分的升高将使口服吲哚美辛不良反应发生的危险增高。结论　“合并药物治疗”、“饮酒史”、“与 6mon前比较 ,服用非甾体抗炎药前的健康状况如何”是吲哚美辛不良反应发生的危险因子     

Can preclinical drug development help to predict adverse events in clinical trials?

The development of novel therapeutics is associated with high rates of attrition, with unexpected adverse events being a major cause of failure. Serious adverse events have led to organ failure, cancer development and deaths that were not expected outcomes in clinical trials. These life-threatening events were not identified during therapeutic development due to the lack of preclinical safety tests that faithfully represented human physiology. We highlight the successful application of several novel technologies, including high-throughput screening, organs-on-chips, microbiome-containing drug-testing platforms and humanised mouse models, for mechanistic studies and prediction of toxicity. We propose the incorporation of similar preclinical tests into future drug development to reduce the likelihood of hazardous therapeutics entering later-stage clinical trials.     

儿童使用氨基比林发生药品不良反应及不良事件文献分析

目的 系统评价儿童使用氨基比林不同制剂发生药品不良反应（ADR）或药品不良事件（ADE）在人体器官、严重程度的分布、构成及影响因素。方法 在知网、维普、万方、中国生物医学文献数据库、Pubmed、Embase中检索,检索词为氨基比林、安乃近、去痛片等,加不良反应、不良事件、过敏等自由词进行综合检索。按纳入与排除标准选择文献、提取数据,并按不同类别（年龄、过敏史、涉及系统、联合用药等）统计发生在胎儿期至青春期的儿童使用氨基比林不良反应发生总数、构成比。结果 ①共纳入中文文献484篇,包括个病例,其中发生在儿童的有20例。②共纳入英文献70篇,包括73个病例,其中发生在儿童的有34例。③中、英文报道的药品不良反应/事件主要涉及血液系统、皮肤黏膜系统、泌尿系统、循环系统导致发生休克等全身反应;预后各不相同,有174例痊愈（72.80%）,30例死亡（12.%）,还有14例（.86%）的结局分别为骨髓移植、指及趾截肢、胃大部切除等严重ADR;另有21例（8.79%）预后不详。④多数ADR的用药剂量为常规剂量,但也有医务人员超剂量给药引起的ADE。结论 使用氨基比林可能引起儿童造血系统、泌尿系统等严重伤害,每年都有较多严重ADR甚至死亡案例报道。应尽快淘汰氨基比林这个可能给儿童带来致死毒性的药物。     

A prospective study of adverse drug reactions in hospitalized children

AIMS: There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age. METHODS: An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded. RESULTS: A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR=1.66, 95% CI 1.03-2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs. CONCLUSIONS: Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients.     

老年患者脑梗死的危险因素分析

目的 探讨老年脑梗死患者发病的相关危险因素.方法 回顾性分析2010年10月至2012年3月北京老年医院收治的230例老年脑梗死患者临床资料,另选择150例老年非脑梗死患者作为对照组,采用多元Logistic回归模型分析其病因及危险因素.结果 非梗死组患者中颈动脉粥样硬化、高血压、高同型半胱氨酸血症、脂代谢异常和心房颤动所占比例明显低于脑梗死组患者[53.3％ (80/150)比92.2％ (212/230),59.3％ (89/150)比74.3％ (171/230),16.7％ (25/150)比28.3％ (65/230),30.0％ (45/150)比41.7％(96/230),39.3％ (59/150)比52.2％ (120/230)],差异均有统计学意义(均P＜0.05).高血压病、心房颤动、颈动脉粥样硬化、糖尿病为老年脑梗死主要的危险因素(P ＜0.05或P＜0.01).结论 高血压病、心房纤颤、颈动脉粥样硬化、糖尿病是引起老年脑梗死的危险因素.根据存在的危险因素制订防治方案可有效降低该病的发生.     

肿瘤患者医院感染危险因素的调查分析

目的探讨肿瘤患者医院内感染的临床特点及危险因素,为肿瘤患者,特别是恶性肿瘤患者预防医院感染的发生提供理论依据。方法对某三级肿瘤专科医院的82 318例住院患者中发生医院内感染的796例病例进行回顾性分析,采用SPSS 18.0软件进行基本资料的描述和危险因素的统计分析。结果本院医院感染率为0.97%,纳入分析患者的性别、平均年龄、年龄(<65岁、≥65岁)、科室分布、住院天数(<15 d、15~28 d、>28 d)、手术、抗菌药物治疗和抗肿瘤治疗等比较,差异有统计学意义(P<0.05);感染部位以呼吸道感染为主(408例,占51%),其次为腹部和消化道(145例,占18%)、手术部位(104例,13%)及泌尿道感染(53例,7%)。病原菌以革兰阴性杆菌为主,总计332株,占62.06%,真菌感染较为严重,总计95株,占17.75%,以白色念珠菌为主。结论男性、高龄、住院时间长、接受放射治疗、抗肿瘤治疗是肿瘤专科医院医院感染的危险因素。     

某院药物临床试验不良事件监控质量调查

目的:分析及评价某院药物临床试验不良事件监控质量.方法:对照不良事件监控的质量评分标准,调查2007-2013年结题的Ⅱ~Ⅲ期项目中不良事件监控的质量得分及各要素的年均得分率.并对2007-2013年发生的15例严重不良事件(SAE)监控情况进行分析.结果:总体上,某院药物临床试验不良事件监控质量得分及各要素得分率均呈现逐年增长的趋势.2011年某院针对不良事件的监控实施展开全面整改工作,整改前存在的问题主要集中在:启动会培训缺失或不完整、实验检查类不良事件收集的遗漏、SAE获知的滞后性、SAE报告表原件的遗失、不良事件源文件记录的缺失或不完整.通过完善规章制度、建立应急预案、强化伦理审查力度、强化试验前不良事件的预防措施、加强机构办公室及科室的监控力度等措施,某院不良事件的监控质量显著提高.结论:加强临床试验机构对不良事件的监控作用,依靠临床试验各部门的共同努力,不断完善安全性监控体系,才能提高临床试验的质量和水平.