adverse-drug-reaction-药学英语课件

1、 Unit 4 Adverse Drug Reactions1.Definition Adverse drug reactions are unwanted effects caused by normal therapeutic doses .Drugs are great mimics of diseases, and adverse drug reactions present with diverse clinical signs and symptoms.药物不良反应是正常的治疗剂量造成不必要的影响是伟大的模仿疾病和药物不良反应，出现不同的临床症状和体征的药物。 atopyn.特应性

2、benoxaprofen苯恶洛芬benzodiazepines苯二氮卓类；苯二氮杂卓类；dexfenfluramine右芬氟拉明digoxinn.异羟洋地黄毒苷，地高辛（一种强心剂）felbamate非尔氨酯fenfluraminen.（抑制食欲以治疗肥胖的）芬氟拉明herbiciden.除草剂idiosyncraticadj.特质的，独特的 特殊的 特异体质的 特异反应的intracranialadj.头颅内的，颅骨内的lethargyn.昏睡 没精打采 懒洋洋 嗜眠症mitoxantrone米托蒽醌neonataladj.新生的，初生的neurolepticadj.安定（精神）的nephr

3、opathyn.肾病polymorphismn.多型现象，多态性 多机组合形式 多形性practololn.普拉洛尔，心得宁temafloxacin替马沙星thiaziden.噻嗪化物，噻嗪类（利尿药，尤用于降低血压）tranquillizersn.镇定剂，精神安定剂( tranquillizer的名词复数 )troglitazone医曲格列酮2.2 Type-B Type-B (idiosyncratic) reactions are not predictable from the drugs main pharmacological action, are not dose-relate

4、d and are severe, with a considerable mortality. The underlying pathophysiology of type B reactions is poorly if at all understood, and often has a genetic or immunological basis. Type B reactions occur infrequently(1:1000-1:1000 treated subjects being typical) B型（特质）的反应是不可预测的药物的主要药理作用，剂量无关，是严重的，死亡率

5、相当。基本的病理生理B型反应差，如果在所有的理解，往往有遗传或免疫学基础。 B型反应很少出现的（1:1000-1:1000治疗对象是典型） Adverse drug reactions due to specific drug-drug interactions are studied. Three further minor categories of adverse drug reactions have been proposed. 1 Type C-continuous reactions due to long-term drug use (neuroleptic-related t

6、ardive dyskinesia or analgesic nephropathy) 2 Type D-delayed reactions (alkylating agents leading to carcinogenesis, or retinoid-associated teratogenesis ) 3 Type E-end-of-use reactions such as adrenocortical insufficiency following withdrawal of corticosteroids, or withdrawal syndromes following di

7、scontinuation of treatment with clonidine, benzodiazepines, tricyclic antidepressants or beta-adrenoreceptor antagonists. 由于特定的药物相互作用的药物不良反应进行了研究。另外三个小类别药品不良反应已被提出。1 C型连续反应，由于长期使用药物（抗精神病药物有关的迟发性运动障碍或镇痛剂肾病）2型D-延迟反应（烷化剂导致癌变，或维甲酸相关致畸）使用E-3型反应，如皮质类固醇激素停药后，肾上腺皮质功能不全或可乐定，苯二氮卓类，三环类抗抑郁药或-肾上腺素受体拮抗剂治疗停药后的戒断症状

8、。 Type A reactions are beliveved to be responsible for up to 3%of acute hospital admissions and 2%3%of consultations in general practice. In hospital, clinically significant adverse reactions are estimated to complicate10%20% of all admissions ,prolonging hospital stay and causing suffering and an a

9、ppreciable number of fatalities, as well as wasting resources, They are the most frequent and severe in neonates, the elderly, women, patients with hepatic or renal disease, and individuals with a history of previous adverse drug reactions, Adverse drug reactions often occur early in therapy(during

10、the first 110day). A型反应beliveved的负责急性入院的3和23的普遍做法协商。在医院，临床显着的不良反应，估计所有招生complicate1020，延长住院时间和造成的痛苦和死亡，以及浪费资源了为数可观的，他们是最常见和最严重的新生儿，老人，妇女，肝或肾脏疾病的患者，以及个人的历史以前的药物不良反应，药物不良反应常发生在治疗早期（在第110天）。 The drugs most commonly implicated are digoxin, antimicrobials, diurectics, potassium salt replacements, analges

11、ics, sedatives and major tranquillizers, insulin, aspirin, glucocorticosteroids, antihypertensives and warfarin 最常用牵连的药物有地高辛的抗菌剂，diurectics，钾的盐替代品，止痛剂，镇静剂和主要镇静剂，胰岛素，阿司匹林，糖皮质激素，抗高血压药和华法林 3 Factors involved in the Etiology of Adverse Drug Reactions Can Be Classified as Follows1 patient factors Intrins

12、ic: Age-neonatal, infant and elderly Sex-hormonal environment Genetic abnormalities Previous adverse drug reactions, allergy, atopy Presence of organ dysfunction-disease Personality and habits-alcoholic, drug addict, nicotine, compliance .参与药品不良反应的病因的因素可以归类为如下1患者因素内在：年龄，新生儿，婴幼儿和老人性荷尔蒙环境遗传异常上一页药物不良反应

13、，过敏，过敏性疾病器官功能障碍疾病的存在人格和习惯含酒精，吸毒者，尼古丁，遵守。 4 Adverse Drug Reaction Monitoring/ Surveillance Pharmacovigilance The evaluation of drug safety is complex, and there are many methods for monitoring adverse drug reactions. Each of these has its own advantages and shortcomings, and no single system can offe

14、r the absolute security that public opinion expects. The ideal method would identify adverse drug reactions with a high degree of sensitivity and specificity and respond rapidly.药品不良反应监测/监控药物警戒药物安全性的评价是复杂的，有很多方法用于监测药物的不良反应。这些每个人都有自己的优点和缺点，并没有一个单一的系统可以提供绝对的安全，舆论预期。理想的方法将确定药物的不良反应，具有高度的敏感性和特异性，并作出迅速的反

15、应。 It would detect rare but severe adverse drug reactions, but would not be overwhelmed by common ones, the incidence of which would quantify together with predisposing factors, Continued surveillance is mandatory after a new drug has been marketed, as it is inevitable that the preliminary testing o

16、f medicines in humans during drug development, although excluding many ill effects, cannot identify uncommon adverse effects. A variety of early detection methods have been introduced to identify adverse drug reactions as swiftly as possible.检测罕见但严重的药物不良反应，但不会被淹没常见的，发病的诱发因素，将一起量化续监视是强制性的一种新的药物已经上市，这

17、是不可避免的，经初步测试人类在药物开发中的药品，虽然不包括许多不良影响，无法识别少见的不良影响。已经出台的各种早期检测方法，尽可能迅速地识别药品不良反应。 Analysis of the reasons given for dropping out of phase III trials is particularly valuable in establishing whether common events such as headache, constipation, lethargy or male sexual dysfunction are truly drug related,

18、The Medical Research Council Mild Hypertension Study unexpectedly identified impotence as being more commonly associated with thiazide diuretics than with placebo or beta-adrenoreceptor antagonist therapy in this way. III期临床试验的辍学原因的分析是特别有价值的建立，如头痛，便秘，嗜睡或男性性功能障碍常见的事件是否是真正的与毒品有关的医学研究理事会轻度高血压研究意外发现阳痿作为更普遍与噻嗪类利尿剂比这种方式与安慰剂或-肾上腺素受体拮抗剂治疗相关。 The problem of adverse drug reaction recognition is much greater if the reaction resembles spontaneous disease in the population, such that physicians are unlikely to attrib