应用风险评估表筛选并确立风险预警机制的意义

目的：本研究对目前临床护理工作风险评估表单进行整理,筛选风险因素,建立一套综合的、量化的风险预警机制,为推动医院风险管理,减少医患纠纷提供可借鉴的方法。方法：通过中国知网、中文维普网及万方数据库检索护理风险事件涉及的跌倒、压疮、精神方面及基础健康状况等方面的相关报道,结合风险评估表单。采用德尔菲（Delphi）法进行专家咨询,并根据专家意见调整表单内容,筛选出风险预警指标、确定各级指标权重、建立护理风险评估表。结果：护理风险综合评估表包括：两项一级指标,自然因素和住院因素;14项二级指标,年龄、饮食、皮肤、视力、活动、排便、神志、心理意识、理解沟通、疼痛、疾病诊断、管道、用药、穿刺针类型及部位;34个程度分级。结论：临床护理风险因素预警指标的确立为临床护理风险评估和管理提供了科学的依据,为建立护理风险评估管理信息化系统打下了基础。     

基于熵权物元分析模型的城市生态安全综合评价

随着城市化进程的加快,人口膨胀,交通拥挤,环境破坏,大气污染,能源短缺等一系列生态问题严重制约着城市的可持续发展,影响着城市的生态安全。针对城市生态安全的问题,论文以郑州市为例,采用物元分析和熵权法,建立城市生态安全熵权物元模型,首先通过熵权法对郑州市2001-2004年的指标数据进行处理并计算出相应的权重,再通过物元分析法对郑州市2001年城市生态安全状况进行综合评价,结果表明郑州市2001年的城市生态处于较不安全状态,评价结果客观、科学,不仅为解决城市生态安全问题提供了一种有效的评价方法,而且能够为明确城市的发展状况,制定下一步发展战略提供依据。     

154例药品不良反应监测报告分析

目的：分析我院2009和2010年收集的154例药品不良反应（ADR）报告,以期了解不良反应发生的特点和规律,减少或避免不良反应的重复发生,为临床科室合理用药提供参考。方法：采用回顾性分类统计方法,对我院2009和2010两年上报的154例报告就ADR分布与年龄、给药途径、药物分类、累及系统及器官等方面的关系进行统计分析。结果：154例不良反应报告中以抗微生物药物和中药注射剂为主,分别占44．81％和20．78％。ADR临床表现以变态反应为主,其中儿童和老年患者居多（33．12％和48．05％）,以静脉滴注方式为主（91．55％）,临床表现主要以皮肤及其附件损伤最常见（75．97％）。结论：应加强ADR监测上报工作,并及时向临床科室反馈,提高临床安全用药意识,确保临床用药安全。     

牙龈卟啉单胞菌影响牙龈上皮细胞miR-155-5p通过JAK/STAR信号通路作用牙周炎的机制

目的 通过生物信息学对GEO数据库进行分析筛选miRNA后运用分子生物学手段验证并对机制进行深入探讨,为未来牙周炎治疗的生物标志物筛选及靶向治疗提供理论依据.方法 通过生物信息学分析GEO数据库发现牙周炎患者中差异表达的miRNA.在DIANA生信预测网站中发现了与JAK/STAT信号传导方式有关的miRNA.随后,T...     

津河水质现状分析与富营养化评价

对津河进行了调查监测, 在此基础上分析了污染现状, 分别以熵权法、综合定权法和改进AHP 定权法优化的海明距离模糊法对其富营养化程度进行评价, 并与模糊评价法和海明距离模糊法的评价结果进行对比。结果表明, 津河中溶解性无机氮(DIN)和溶解性无机磷(DIP)分别是氮和磷的主要存在形式, 在6-8 月水质较差, 7-9 月暴发水华,总体处于中营养或轻富营养状态。海明距离模糊法在城市景观河流水质评价中是可行的, 并且具有简洁和可以表征同一水质级别中污染程度大小的优势。以熵权法和综合权重法改进的海明距离模糊法具有更好的区分度, 改进AHP 定权法适于评价水质变化较大的水体。     

从一起案例谈药品不良反应的相关问题

药品不良反应是在预防治疗疾病或调节生理机能过程中,给予正常用法和用量的药品时所出现的有害的和与用药目的无关的反应。我国应逐步完善相关法律,以规范药品生产,维护消费者的权益。     

154例药品不良反应监测报告分析

目的:分析我院2009和2010年收集的154例药品不良反应(ADR)报告,以期了解不良反应发生的特点和规律,减少或避免不良反应的重复发生,为临床科室合理用药提供参考。方法:采用回顾性分类统计方法,对我院2009和2010两年上报的154例报告就ADR分布与年龄、给药途径、药物分类、累及系统及器官等方面的关系进行统计分析。结果:154例不良反应报告中以抗微生物药物和中药注射剂为主,分别占44.81%和20.78%。ADR临床表现以变态反应为主,其中儿童和老年患者居多(33.12%和48.05%),以静脉滴注方式为主(91.55%),临床表现主要以皮肤及其附件损伤最常见(75.97%)。结论:应加强ADR监测上报工作,并及时向临床科室反馈,提高临床安全用药意识,确保临床用药安全。     

基于格网的东江流域生态安全空间综合评价

通过统计以往关于生态安全评价的文献,从众多指标中筛选出应用频率较高的指标作为构建生态安全评价指标体系的基础,运用压力-状态-响应(P-S-R)模型,采用熵权法确定评价指标的权重,建立了基于格网的东江流域生态安全评价指标体系,并用综合评分法对东江流域的生态安全状况进行了评价。结果表明:东江流域生态安全由2000年的较安全等级下降为2004年的较不安全等级,到2008年改善为很安全等级。可见,基于对照比较筛选以确定生态安全评价指标,可在很大程度上克服目前生态安全评价指标体系缺乏统一标准的不足;基于格网的生态安全评价,可消除行政界线变动带来的影响,并可反映区域内部的空间差异性,从而提高了研究结果的可信度。     

熵权理论在定量评价农业气象综合灾情中的应用

针对气象灾害综合评价中客观存在的模糊性和多因素相互联系及相互制约性,将信息论中的熵值理论引入灾害综合评价,提出利用熵权法对多评价因子赋权的新思路,使得权值的分配有了一定的理论依据,建立了基于熵权的灾害综合评价模型,并用此模型对福建省近25年的农业气象灾害进行定量评价。结果表明:1999年灾情最重,而1984年灾情最轻;进一步分析发现,80年代的灾情较轻,而90年代的灾情较重,且灾情呈现加大趋势.实例验证基于熵权的综合评判法用于农业气象灾害评价是合理可行的,建议加强对福建省防范低温冻害和台风的研究。     

基于模糊综合评判法的医院费用规制效果综合评价

??????? 目的 评价我国医疗费用规制策略效果,筛选优先干预策略。方法 运用模糊综合评判法对医院费用的重要规制手段：医疗服务定价方式、药品流通体制、医疗保险支付方式的重要性、可操作性、失效程度、干预迫切性四个维度进行综合评价。 结果 导致我国医疗费用控制效果不佳的首要原因在于药品流通体制的管制失效;现行医保支付方式对医疗费用的规制作用不强,这是导致快速上涨的医疗费用难以得到有效遏制控制的第二位原因。 结论 改善我国医疗费用规制效果的优先策略是进一步强化药品流通体制规制改革的推进力度;其次,亟待深化医保制度支付方式的费用控制机制探索,发挥医保制度作为第三方对医疗费用的重要规制作用。     

双膦酸盐类药物致不良反应回顾性分析

目的:分析双膦酸盐类药物所致不良反应情况。方法:检索中国期刊全文数据库(CNKI)、万方数据库(Wan Fang)、中文科技期刊数据库(VIP)2004年1月至2013年8月国内有关双膦酸盐致不良反应的个案报道,按年龄、性别、原发病、药物名称、给药途径、不良反应发生时间、临床表现症状、治疗与转归等进行分类统计分析。结果:48例不良反应包括运动系统、消化系统、感官系统、循环系统、神经系统及全身性损害,高年龄段与女性发生率较高。结论:临床上应重视双膦酸盐类药物所致不良反应,坚持合理用药。     

Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions

We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline) were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2–10 months for known ADRs and 19–44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0–122.5 days and 185.5–306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release.     

Errors in medication history at hospital admission: prevalence and predicting factors

Background

Data on adverse drug reactions (ADRs) related to antiretroviral (ARV) use in public health practice are few indicating the need for ART safety surveillance in clinical care.

Objectives

To evaluate the incidence, type and risk factors associated with adverse drug reactions (ADRs) among patients on antiretroviral drugs (ARV).

Methods

Patients initiated on ARVs between May 2006 and May 2009 were evaluated in a retrospective cohort analysis in three health facilities in Nigeria. Regimens prescribed include nucleoside backbone of zidovudine (AZT)/lamivudine (3TC), stavudine (d4T)/3TC, or tenofovir (TDF)/3TC in combination with either nevirapine (NVP) or efavirenz (EFV). Generalized Estimating Equation (GEE) model was used to identify risk factors associated with occurrence of ADR.

Results

2650 patients were followed-up for 2456 person-years and reported 114 ADRs (incidence rate = 4.6/100 person-years).There were more females 1706(64%) and 73(64%) of the ADRs were reported by women. Overall, 61(54%) of ADRs were reported by patients on AZT with 54(47%) of these occurring in patients on AZT/NVP. The commonest ADRs reported were pain 25(30%) and skinrash 10(18%). Most ADRs were grade 1(39%) with only 1% being life threatening (grade 4). Adjusted GEE analysis showed that ADR was less likely to occur in patients on longer duration of ART compared to the first six months on treatment; 6-12 months AOR 0.38(95% CI:0.16-0.91) and 12-24 months AOR 0.34(95% CI:0.16-0.73) respectively. Compared to patients on TDF, ADR was less likely to occur in patients on d4T and AZT AOR 0.18(95% CI 0.05-0.64) and AOR 0.24(95% CI:0.7-0.9) respectively. Age, gender and CD4 count were not significantly associated with ADRs.

Conclusion

ADRs are more likely to occur within the first six months on treatment. Close monitoring within this period is required to prevent occurrence of severe ADR and improve ART adherence. Further research on the tolerability of tenofovir in this environment is recommended.     

Bias in Spontaneous Reporting of Adverse Drug Reactions in Japan

Background

Attitudes of healthcare professionals regarding spontaneous reporting of adverse drug reactions (ADRs) in Japan are not well known, and Japan’s unique system of surveillance, called early post-marketing phase vigilance (EPPV), may affect these reporting attitudes. Our objectives were to describe potential effects of EPPV and to test whether ADR seriousness, prominence, and frequency are related to changes in reporting over time.

Methods

A manufacturer’s database of spontaneous ADR reports was used to extract data from individual case safety reports for 5 drugs subject to EPPV. The trend of reporting and the time lag between ADR onset and reporting to the manufacturer were examined. The following indices for ADRs occurring with each drug were calculated and analyzed to assess reporting trends: Serious:Non-serious ratio, High prominence:Low prominence ratio, and High frequency:Low frequency ratio.

Results

For all 5 drugs, the time lag between ADR onset and reporting to the manufacturer was shorter in the EPPV period than in the post-EPPV period. All drugs showed higher Serious:Non-serious ratios in the post-EPPV period. No specific patterns were observed for the High prominence:Low prominence ratio. The High frequency:Low frequency ratio for peginterferon alpha-2a and sevelamer hydrochloride decreased steadily throughout the study period.

Conclusions

Healthcare professionals may be more likely to report serious ADRs than to report non-serious ADRs, but the effect of event prominence on reporting trends is still unclear. Factors associated with ADR reporting attitude in Japan might be different from those in other countries because of EPPV and the involvement of medical representatives in the spontaneous reporting process. Pharmacovigilance specialists should therefore be cautious when comparing data between different time periods or different countries. Further studies are needed to elucidate the underlying mechanism of spontaneous ADR reporting in Japan.     

A Structure-Based Approach for Mapping Adverse Drug Reactions to the Perturbation of Underlying Biological Pathways

Adverse drug reactions (ADR), also known as side-effects, are complex undesired physiologic phenomena observed secondary to the administration of pharmaceuticals. Several phenomena underlie the emergence of each ADR; however, a dominant factor is the drug''s ability to modulate one or more biological pathways. Understanding the biological processes behind the occurrence of ADRs would lead to the development of safer and more effective drugs. At present, no method exists to discover these ADR-pathway associations. In this paper we introduce a computational framework for identifying a subset of these associations based on the assumption that drugs capable of modulating the same pathway may induce similar ADRs. Our model exploits multiple information resources. First, we utilize a publicly available dataset pairing drugs with their observed ADRs. Second, we identify putative protein targets for each drug using the protein structure database and in-silico virtual docking. Third, we label each protein target with its known involvement in one or more biological pathways. Finally, the relationships among these information sources are mined using multiple stages of logistic-regression while controlling for over-fitting and multiple-hypothesis testing. As proof-of-concept, we examined a dataset of 506 ADRs, 730 drugs, and 830 human protein targets. Our method yielded 185 ADR-pathway associations of which 45 were selected to undergo a manual literature review. We found 32 associations to be supported by the scientific literature.     

我院2010年度药物不良反应分析

目的分析药物不良反应(ADR)发生的特点与规律,促进临床合理用药。方法回顾性分析2010年1~12月我院上报的401份ADR报告,按患者年龄、性别、给药途径、引起ADR的药品种类、涉及器官或系统以及临床表现等进行统计、分析。结果静脉给药较其他给药途径更易发生ADR(336例,占83.89%);抗感染药物引发ADR的比例最高(159例,占39.65%),其次为营养药、消化系统药物及抗肿瘤药物;头孢菌素类药物是引发ADR的主要抗菌药物(15种,28.85%),其次为青霉素类(10种,19.23%)。ADR主要累及皮肤及附件损害为主,其次涉及到消化系统以及神经系统损害。结论临床科室应重视ADR监测,减少ADR的发生,提高合理用药水平。     

2009 年-2010 年我院212 例不良反应报告分析

目的:总结医院药品不良反应(ADR)发生的特点。方法:通过ADR网上检索工具统计2009年1月～2010年12月不良反应报告表,采用回顾性分析全院不良反应分布情况。结果:60岁以上老年人ADR发生率较高(27.36%);静脉滴注方式导致的不良反应例数最多(75.00%);导致不良反应的药品以抗微生物药物最多(45.28%);临床表现以皮肤及其附件损害和全身性损害为主(44.35%)。结论:全院不良反应工作有所提高,但仍应加强全院用药监测工作,确保患者用药安全。     

临床危急值与药品不良反应的关联性研究分析

目的:通过监测临床危急值提高药品不良反应(ADR)的上报质量。方法:分析临床药物治疗与出现临床危急值之间的联系,确定可疑的ADR病例。结果:调查中共发现23例疑似ADR报告,占调查期间总上报ADR例数的24.73%;主要ADR表现为血小板减少(13例),其次是尿素升高(5例);给药途径主要为静脉滴注(涉及21例),涉及品种以抗菌药物为主。结论:通过加强对临床危急值的监测,可以提高ADR的报告的质量,减少ADR的漏报率。     

Development of an Adverse Drug Reaction Risk Assessment Score among Hospitalized Patients with Chronic Kidney Disease

Background

Adverse drug reactions (ADRs) represent a major burden on the healthcare system. Chronic kidney disease (CKD) patients are particularly vulnerable to ADRs because they are usually on multiple drug regimens, have multiple comorbidities, and because of alteration in their pharmacokinetics and pharmacodynamic parameters. Therefore, one step towards reducing this burden is to identify patients who are at increased risk of an ADR.

Objective

To develop a method of identifying CKD patients who are at increased risk for experiencing ADRs during hospitalisation.

Materials and Methods

Factors associated with ADRs were identified by using demographic, clinical and laboratory variables of patients with CKD stages 3 to 5 (estimated glomerular filtration rate, 10–59 ml/min/1.73 m²) who were admitted between January 1, 2012, and December 31, 2012, to the renal unit of Dubai Hospital. An ADR risk score was developed by constructing a series of logistic regression models. The overall model performance for sequential models was evaluated using Akaike Information Criterion for goodness of fit. Odd ratios of the variables retained in the best model were used to compute the risk scores.

Results

Of 512 patients (mean [SD] age, 60 [16] years), 62 (12.1%) experienced an ADR during their hospitalisation. An ADR risk score included age 65 years or more, female sex, conservatively managed end-stage renal disease, vascular disease, serum level of C-reactive protein more than 10 mg/L, serum level of albumin less than 3.5 g/dL, and the use of 8 medications or more during hospitalization. The C statistic, which assesses the ability of the risk score to predict ADRs, was 0.838; 95% CI, 0.784–0.892).

Conclusion

A score using routinely available patient data can be used to identify CKD patients who are at increased risk of ADRs.     

DITOP: drug-induced toxicity related protein database

MOTIVATION: Drug-induced toxicity related proteins (DITRPs) are proteins that mediate adverse drug reactions (ADRs) or toxicities through their binding to drugs or reactive metabolites. Collection of these proteins facilitates better understanding of the molecular mechanisms of drug-induced toxicity and the rational drug discovery. Drug-induced toxicity related protein database (DITOP) is such a database that is intending to provide comprehensive information of DITRPs. Currently, DITOP contains 1501 records, covering 618 distinct literature-reported DITRPs, 529 drugs/ligands and 418 distinct toxicity terms. These proteins were confirmed experimentally to interact with drugs or their reactive metabolites, thus directly or indirectly cause adverse effects or toxicities. Five major types of drug-induced toxicities or ADRs are included in DITOP, which are the idiosyncratic adverse drug reactions, the dose-dependent toxicities, the drug-drug interactions, the immune-mediated adverse drug effects (IMADEs) and the toxicities caused by genetic susceptibility. Molecular mechanisms underlying the toxicity and cross-links to related resources are also provided while available. Moreover, a series of user-friendly interfaces were designed for flexible retrieval of DITRPs-related information. The DITOP can be accessed freely at http://bioinf.xmu.edu.cn/databases/ADR/index.html. SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.