丹参、双氯芬酸钠和β-七叶皂甙钠联用治疗严重偏头痛疗效分析

目的：探讨丹参，双氯芬酸钠和β-叶皂甙钠联合治疗严重偏头痛的疗效。方法：用丹参、双氯芬酸钠（诺福丁）和β－七叶皂甙钠联用治疗严重偏头痛51例，观察其临床疗效，并与双氯芬酸钠治疗严重偏头痛62例进行对比。结果：联合用药组与双氯芬酸钠单用组总有效率及控制率差异显性（P＜0．01）。结论：丹参、双氯芬酸钠、β－七叶皂甙钠联用治疗严重偏头痛疗效确切。     

药物不良反应与药物不良反应事件

药物不良反应(ADRs)和药物不良反应事件(ADEs)是ADRs监测和临床医疗实践涉及的两个重要基本概念，正确区分和识别意义重大。该文对ADRs和ADEs概念、特征界定、药品-ADRs因果关系判定及相关重大问题进行了介绍。     

45例环丙沙星不良反应调查分析

环丙沙星不良反应(ADRs)以胃肠道反应最常见,主要表现为食欲不振、恶心、呕吐、腹泻、腹痛等.随着临床应用范围的扩大,其他有关的ADRs报道日渐增多.现就近几年国内应用环丙沙星出现的ADRs综合分析如下.     

650例患者临床使用抗菌药物致不良反应发生的相关因素分析及其对合理用药的影响

目的:分析临床使用抗菌药物致患者药物不良反应(ADR)发生的相关因素及其对合理用药的影响。方法:选取2018年1月—2019年1月间临床使用抗菌药物治疗后出现不良反应患者650例资料,分析患者使用抗菌药物的品种、不良反应发生的症状对患者年龄段的影响。结果:650例出现ADRs的患者中,经分析发现年龄段在50~75岁之间患者抗菌药物ADRs发生率为最高;左氧氟沙星、头孢曲松和头孢西丁为引发ADRs的主要抗菌药物;恶心、瘙痒和皮疹为抗菌药物致相关不良反应的主要症状。结论:抗菌药物引发的相关不良反应症状,大多为不合理使用所致,临床使用抗菌药物时应密切观察患者ADRs发生的症状,合理配伍,以确保患者用药的安全性。     

瑞舒伐他汀致不良反应41例国内外病例报告分析

目的:分析瑞舒发他汀致不良反应的特点及相关因素,为临床安全用药提供参考。方法:检索国内外医药数据库,下载病例报告原文,统计病例报告中的相关数据,分析瑞舒发他汀致不良反应的相关因素,讨论其致不良反应的机制。结果:共检索到病例报告41例45例次不良反应,发现瑞舒发他汀致不良反应主要累及消化系统(肝损害)和神经肌肉系统(横纹肌溶解症);高龄患者和剂量过大与影响CPY450代谢酶的药物联用是其主要致ADRs的相关因素。结论:注意高龄患者的用药监测,尽量使用最低有效治疗剂量,避免与影响CYP450代谢酶的药物联用,是避免或减轻其ADRs的重要措施。     

双氯芬酸钠贴片联合硫酸氨基葡萄糖治疗骨性关节炎的疗效观察

目的探讨双氯芬酸钠贴片联合硫酸氨基葡萄糖治疗骨性关节炎的疗效及不良反应。方法采用单盲、随机、对照的实验方法,治疗组予以双氯芬酸贴片联合硫酸氨基葡萄糖,对照组予以双氯芬酸钠缓释片。治疗四周后评价药物疗效及不良反应。结果治疗组与对照组比较,治疗组的总有效率明显高于对照组,两组差异有统计学意义,试验组的不良反应发生率明显低于对照组,差异有统计学意义。结论双氯芬酸钠贴片联合硫酸氨基葡萄糖治疗骨性关节炎的方案能提高疗效,降低不良反应发生率,效果显著,值得临床推广。     

抗菌药物不合理用药致不良反应发生的相关因素分析与干预策略

目的:分析抗菌药物致不良反应(ADRs)发生的相关因素与干预策略。方法:采用回顾性分析的方法,分析2009年1月—2013年12月间深圳市龙华新区中心医院抗菌药物所致ADRs患者病历资料、不合理用药种类、ADRs表现形式、ADRs分类以及不合理用药与ADRs的相关性。结果:677例ADRs患者中,抗菌药物ADRs患者544例占80.35%,男性患者的发生率为58.27%高于女性41.73%,<18岁的发生率为55.51%高于其他年龄段;头孢菌素类药物为27.45%高于其他类抗菌药物;头孢菌素类所致ADRs的发生率为56.07%高于其他类抗菌药物;不合理用药原因居前3位的分别是给药时间过长、给药浓度过高和滴速过快,其中给药时间过长所致ADRs发生率为59.38%高于其他不合理给药方式;ADRs居前3位的分别是泌尿系统、消化系统、皮肤及软组织,其中泌尿系统的发生率为61.03%高于其他系统;经Person相关性分析表明,抗菌药物给药时间过长、给药浓度过高、滴速过快、剂量不当均与泌尿系统、心血管系统等各类ADRs呈正相关性。结论:医院抗菌药物致ADRs现象不容乐观,应深入分析其发生原因,从社会层面与医院层面入手,给予针对性干预措施,以减少抗菌药物的ADRs发生。     

107例药物不良反应的临床相关因素分析

目的分析药物不良反应（ADRs）的相关因素,为临床合理安全的使用药物、减少药源性疾病的发生提供参考。方法用回顾性分析方法对医院2006-2007年收集的ADRs病例报告情况进行分析。结果107例ADRs中以抗菌药物引发的ADRs居首位（35例次,32.7%）,中药制剂占第2位（20例次,18.7%）。中枢神经系统药物占第3位（14例,13.1%）;ADRs受累的器官/系统中皮肤及附件的损害居首位（50.5%）。结论老年患者,有严重基础病患者,不合理的联合用药,不合理的配伍与ADRs的发生密切相关。     

408例抗菌药物致不良反应病例的报告分析

目的:分析医院抗菌药物致药物不良反应(ADRs)的特点和原因,供临床合理用药参考。方法:收集医院2006年1月—2015年4月间通过网络系统向国家药品不良反应监测中心上报的408份抗菌药物致ADRs报表,按患者性别、年龄、涉及药物、给药途径、ADRs涉及的器官或系统及转归等进行统计和分析。结果:408份ADRs报表中,共涉及抗菌药物物37种,居首位的是头孢菌素类共13种222例;ADRs的临床表现为皮肤及其附件损害最为常见为323例占79.26%;其次是心血管系统损害为26例占6.37%;以静脉滴注给药途径引起的ADRs最常见为388例占95.10%;绝大多数ADRs转归较好为407例,99.75%。结论:医务工作人员应严格使用抗菌药物以及静脉用药,加强对患者的用药监测,减少ADRs对患者的损害。     

警惕中西药联用产生的药物不良性相互作用

随着我国中西医结合工作的深入开展 ,临床上中西药联用防治疾病的情况日趋普遍 ,并已成为我国临床医生的用药特色。有些中西药联用 ,确实收到了比单用中药或西药都达不到的疗效。但有些中西药联用 ,可能产生不良反应 ,甚至危及生命安全。值得注意的是 ,盲目的中西药联用在临床上时常出现 ,存在着很大的用药不安全隐患 ,故笔者呼吁临床医生和药师 ,要警惕中西药联用产生的药物不良性相互作用。1　中西药联用产生的常见药物不良性相互作用1 1　引起中药或西药疗效降低或消失有些中西药联用后可在胃肠道形成难溶性物质 ,影响药物吸收 ,从而引起…     

Spontaneous reporting of adverse drug reactions to non-steroidal anti-inflammatory drugs

Non-steroidal anti-inflammatory drugs (NSAIDs) are the third most commonly prescribed group of drugs in Spain. We present here the profile of adverse drug reactions (ADRs) attributed to them and reported to the Spanish System of Pharmacovigilance (SSPV) between 1983 and 1991, together with a preliminary analysis of topical, slow-release (SR) and enteric-coated (EC) preparations.Out of 18 348 reports of ADRs included in the SSPV database, 1609 (8.8%) implicated an NSAID. NSAIDs ranked second after antibiotics (15.1% of all reports) among the most commonly implicated drugs. Half of the patients were more than 55 years old, and 60% were women.Diclofenac (364 reports), piroxicam (282), indomethacin (197), naproxen (155), and ketoprofen (137) were the most commonly implicated NSAIDs in reports of ADRs.The most commonly reported ADRs were gastrointestinal (39%), cutaneous (20%), and those affecting the central and peripheral nervous system (9%). Seven reactions had a fatal outcome, and 138 were considered life threatening. Forty-nine reports included previously undescribed ADRs.There were 98 reports describing ADRs attributed to topical NSAIDs; 5 of these described 11 general reactions, such as duodenal ulcer, gastrointestinal bleeding, diarrhoea, dyspnoea, facial oedema, aggravation of bronchospasm, and angioedema.One hundred and sixty-eight reports referred to SR and EC preparations. The ratio of gastrointestinal to non-gastrointestinal reactions to SR-EC diclofenac was higher in the case of SR-EC diclofenac than in the case of plain diclofenac (P=0.037); similarly, the ratio of CNS to non-CNS reactions to SR-EC indomethacin was also higher than the corresponding ratio with plain indomethacin (P=0.002). Although differential selective reporting of these preparations cannot be excluded, these results raise doubts about the relative safety of SR and EC preparations of NSAIDs in practice.     

Adverse drug reactions: Can consumers provide early warning?

In order to investigate the potential value of a drug monitoring system based on consumer reports we asked community pharmacists to distribute previously validated event report forms to users of two popular non-steroidal anti-inflammatory drugs (NSAIDs), piroxicam and diclofenac, in the Hunter Region of New South Wales, Australia. Although response rates were low, comparisons of replies from NSAID users and drug-free subjects in the community identified a range of established symptomatic reactions from NSAIDs affecting the gastrointestinal tract, central nervous system and lower urinary tract. In comparison, analysis of adverse reaction reports from health professionals revealed a tendency to report more severe but rarer reactions affecting the upper gastrointestinal tract, liver, skin and haematological system. It is likely that a system based on consumer reports could augment current sources of information on adverse drug effects by revealing reactions which are important to consumers and yet often evade detection during pre-marketing clinical trials. Such a system might also have a capacity to generate very early signals of previously unsuspected symptomatic reactions with new drugs.     

抗骨质疏松药物不良反应回顾性分析

目的：分析抗骨质疏松药物引起不良反应的原因。方法：检索国内外期刊2000～2008年有关抗骨质疏松药物所致不良反应的个案报道及综述。结果：抗骨质疏松药物的不良反应发生率不高，程度较轻，常见于胃肠道不适。结论：可通过合理配伍，联合用药来减少不良反应发生率；如长期用药，其安全性需密切关注。     

328例药品不良反应分析

目的:通过对328例药品不良反应(adverse drug reactions,ADR)进行统计分析,为临床合理用药提供参考。方法:应用Excel电子表格和手工检索,按照患者的年龄、性别、药品类别、剂型、不良反应表现等情况进行统计、分析。结果:328例报告中,女性居多,涉及药物128种,发生ADR主要由抗病原微生物药引起,其次是中药制剂。ADR表现主要为胃肠道反应,用药剂型主要是注射剂。结论:应重视对抗病原微生物药、中药注射剂及抗肿瘤药致不良反应的监测,以确保用药的安全性。     

双膦酸盐类药物不良反应及应用评价

目的：双膦酸盐类（Diphosphonate）药物是近年发展起来的一类抗代谢性骨病新药,主要用于骨质疏松症、恶性肿瘤骨转移及高钙血症等。虽然此类药物产生的不良反应大部分是较轻微的,且是暂时性的。但随着其应用的日益广泛,该类药物对胃肠道、眼部、颚骨坏死、肌肉骨骼疼痛及肾脏等一些严重不良反应已引起人们的关注。本文对其不良反应与应用进行阐述和评价。方法：采用国内外文献检索方法。结果及结论：在临床上预防双膦酸盐类药物的不良反应,使患者更好地配合治疗,以达到最佳疗效。     

545例药品不良反应报告分析

目的:探讨药品不良反应(ADR)的发生情况,为临床用药提供参考。方法:对山东省肥城矿业中心医院上报的545例药品不良反应分别从年龄、给药途径、药品种类、ADR临床表现等方面进行分析和评价。结果:545例药品不良反应共涉及9大类药品,其中抗感染药引起的ADR最多为288例,占52.84%;给药途径中静脉用药引起的ADR为340例,占62.38%;临床所累及器官和(或)系统以皮肤及其附件最常见,其次是胃肠道反应,最严重的是死亡、过敏性休克、高热等。结论:必须重视药品不良反应监测工作,加强药师与临床的沟通交流,减少或避免药品不良反应的发生。     

Adverse drug reactions and polypharmacy in the elderly in general practice

Objectives: The risk of adverse drug reactions (ADRs) increases with the number of drugs used. Most studies refer to potential interactions; the results regarding the severity of occurring and registered ADRs are inconsistent. Therefore, we examined the relevance of drug-induced problems in the elderly in general practice and their association with polypharmacy. Design: Retrospective cross-sectional analysis of prospectively collected data. Setting: Three family practices participating in the medication and morbidity Registration Network Groningen (RNG). Methods: From 2185 elderly patients (>64 years) medication and morbidity data were collected over the period of 2 years (1994 and 1995). Polypharmacy was defined as the long-term simultaneous use of two or more drugs. Adverse reactions recognised as such were coded as a separate `diagnosis' A85. The most risky drug groups and the most prevalent diseases in relation to ADRs were studied. Results: The incidence of ADRs in general practice was 5.7 per 100 elderly patients and the prevalence 6.1 per 100. Moderate polypharmacy was more frequent in the elderly who experienced adverse effects; no other differences in degree of polypharmacy could be found. The elderly who experienced adverse reactions used overall more different drugs (14.4 ± 7.6, of which 1.5 ± 1.5 were used long term) than the other elderly patients (8.1 ± 5.7, of which 1.0 ± 1.5 were long term). The incidence of ADRs increased non-significantly with the number of drugs used long term. Antibiotics, antihypertensives and non-steroidal anti-inflammatory drugs were mainly responsible for gastrointestinal complaints (nausea, diarrhoea and stomach pain) and rash. In the cases of treating urinary tract infections and sleeping disorders, there was a significantly high risk of ADRs. Slightly more at risk for adverse drug reactions were older patients with coronary heart disease or asthma/chronic obstructive pulmonary disease. Conclusion: Most of the ADRs observed in general practice turn out to be rather harmless. This is in agreement with outpatient studies, though not with hospital studies. An increased risk of adverse effects with the number of drugs used simultaneously, as reported in other studies, was not confirmed in our study. This study however is limited to actually registered effects. Received: 4 December 1998 / Accepted in revised form: 10 June 1999     

Effect of drug release rate on therapeutic outcomes: formulation dependence of gastrointestinal toxicity of diclofenac in the rat

- The use of the non-steroidal anti-inflammatory drug, diclofenac, is associated with occasional serious side effects in the gastrointestinal (GI) tract. We examined the effect of altering the site of release of diclofenac sodium on GI tract side effects. Dissolution and pharmacokinetic studies were carried out to substantiate the sustained-release nature of crushed sustained release tablet. Adult male Sprague–Dawley rats were administered diclofenac 10 mg/kg orally as either immediate-release or sustained-release preparations. Upper and lower GI permeability, as a surrogate marker of toxicity, were measured using sucrose and ⁵¹Cr-EDTA, respectively. Immediate- and sustained-release preparations similarly increased upper GI permeability. The induced toxicity in the lower GI tract, however, caused by the sustained-release formulation lasted longer than that of the immediate release formulation. Since both immediate- and sustained-release preparations of diclofenac increased sucrose permeability, the upper GI damage caused by diclofenac may be attributable mainly to a systemic mechanism. The prolonged lower GI toxicity following the sustained-release preparation may be related to a greater residence time therein.     

Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980-2003

AIM: To examine trends in the rate of repeat adverse drug reactions (ADRs) causing hospitalization in older Australians and to identify the most common ADRs and drugs most often implicated in repeat and first-time ADRs. METHODS: Analysis of routinely collected hospital record administrative data, with International Classification of Diseases external cause codes for ADRs extracted from the Western Australia (WA) Hospital Morbidity Data System and WA Death Register, for people aged > or =60 years in 1980-2003. RESULTS: A total of 37 296 people aged > or =60 years with an ADR-related hospitalization were identified. Among them, 6853 (18.4%) patients had 10 212 repeat ADRs. Repeat ADRs consistently increased from 1980 and reached 30.3% of all ADRs by 2003. The mean time interval declined with each successive repeat ADR (810, 606 and 299 days for the first, second and higher ranked repeat episodes, respectively). The most common repeat ADRs were nausea/vomiting (8.0%), haemorrhage due to anticoagulants (5.5%), drug-induced osteoporosis (4.8%) and poisoning by cardiovascular agents (3.9%). The drugs most often involved in repeat ADRs were cardiovascular agents (15.6%), antineoplastic drugs (11.0%), corticoids (10.1%), anticoagulants (8.6%), antirheumatics/nonsteroidal anti-inflammatory drugs (5.1%) and opioids (4.9%). The trends of anticoagulants and antineoplastic drugs implicated in repeat ADRs were still rising at the end of the study. The specific drug classes involved in repeat ADRs differed in relative importance from first-time ADRs. CONCLUSIONS: Repeat ADR-related hospitalizations have consistently increased in elderly Australians from 1980 to 2003. Strategies to ensure the safer use of medicines, in particular anticoagulants, in this population are warranted.     

非甾体抗炎药致重症药疹文献汇总分析

目的：以临床实例出发探讨非甾体抗炎药致重症药疹的特点和关联性,为临床用药安全提供参考。方法：通过检索1970-2017年国内外期刊数据库公开报道的非甾体抗炎药致重症药疹的病例,提取文献中患者年龄、性别、致ADR药物、重症药疹类型等信息进行统计和分析。结果：非甾体抗炎药致重症药疹文献49篇,共计病例49例。其中单一用药致重症药疹病例有27例,联合用药22例;49例非甾体抗炎药致重症药疹中发生率最高为对乙酰氨基酚,其次为吡罗昔康、布洛芬、依托考昔;非甾体抗炎药致重症药疹平均潜伏期为（7.88±10.42）d,其中致药物超敏反应综合征潜伏期最长,可长达（36.50±14.20）d;大部分患者停药后好转,1例因中毒性表皮坏死松解征死亡。结论：非甾体抗炎药致重症药疹具有潜在的危险性,临床应用时应提高警惕,以减少重症药疹给患者带来的危害。