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Unit 4 Adverse Drug Reactions,1.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.藥物不良反應(yīng)是正常的治療劑量造成不必要的影響是偉大的模仿疾病和藥物不良反應(yīng),出現(xiàn)不同的臨床癥狀和體征的藥物。,2.Classification,The classification proposed by Rawlins and Thompson divides reactions into type A and type B. 2.1 Type A reactions ,which constitute the great majority of adverse drug reactions, are usually a consequence of the drugs main pharmacological effect (bleeding from warfarin) or a low therapeutic index (nausea from digoxin), and they are therefore predictable, They are doserelated and usually mild, although they may be serious or even fatal (intracranial bleeding from warfarin). Such reactions are usually due to incorrect dosage (too much or too long), for the individual patient or to disordered pharmacokinetics, usually impaired drug elimination. The term “side-effects” is often applied to minor type-A reactions.羅林斯和湯普森提出的分類(lèi)劃分為A型和B型反應(yīng) 2.1類(lèi)型反應(yīng),構(gòu)成絕大多數(shù)藥物不良反應(yīng),藥物的主要藥理效應(yīng)(華法林出血)或一個(gè)低的治療指數(shù)(惡心地高辛)的后果,以及他們因此可預(yù)見(jiàn)的,他們是劑量相關(guān)的,通常是溫和的,雖然他們可能是嚴(yán)重的,甚至是致命的(顱內(nèi)出血華法林)。這樣的反應(yīng)通常是由于不正確的劑量(過(guò)多或過(guò)長(zhǎng)),個(gè)別病人或無(wú)序的藥代動(dòng)力學(xué),通常藥物消除受損。術(shù)語(yǔ)“副作用”小A型反應(yīng)往往是應(yīng)用。,2.2 Type-B Type-B (idiosyncratic) reactions are not predictable from the drugs main pharmacological action, are not dose-related 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(特質(zhì))的反應(yīng)是不可預(yù)測(cè)的藥物的主要藥理作用,劑量無(wú)關(guān),是嚴(yán)重的,死亡率相當(dāng)。基本的病理生理B型反應(yīng)差,如果在所有的理解,往往有遺傳或免疫學(xué)基礎(chǔ)。 B型反應(yīng)很少出現(xiàn)的(1:1000-1:1000治療對(duì)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 tardive 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 discontinuation of treatment with clonidine, benzodiazepines, tricyclic antidepressants or beta-adrenoreceptor antagonists. 由于特定的藥物相互作用的藥物不良反應(yīng)進(jìn)行了研究。另外三個(gè)小類(lèi)別藥品不良反應(yīng)已被提出。 1 C型連續(xù)反應(yīng),由于長(zhǎng)期使用藥物(抗精神病藥物有關(guān)的遲發(fā)性運(yùn)動(dòng)障礙或鎮(zhèn)痛劑腎?。?2型D-延遲反應(yīng)(烷化劑導(dǎo)致癌變,或維甲酸相關(guān)致畸) 使用E-3型反應(yīng),如皮質(zhì)類(lèi)固醇激素停藥后,腎上腺皮質(zhì)功能不全或可樂(lè)定,苯二氮卓類(lèi),三環(huán)類(lèi)抗抑郁藥或-腎上腺素受體拮抗劑治療停藥后的戒斷癥狀。,There are between 30000 and 40000 medicinal products available directly or on prescription in the UK, A recent survey suggested that approximately 80% of adults take some kind of medication during any 2-week period, Exposure to drugs in the population is thus substantial ,and the incidence of adverse reactions must be viewed in this context有30000和40000之間的醫(yī)藥產(chǎn)品可直接或在英國(guó),最近的一項(xiàng)調(diào)查表明,約80的成年人在任何2個(gè)星期的期間內(nèi),采取某種藥物的處方,因此藥物在人口暴露可觀,不良反應(yīng)的發(fā)生率,在這種情況下,必須被視為,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 appreciable 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 the first 110day). A型反應(yīng)beliveved的負(fù)責(zé)急性入院的3和23的普遍做法協(xié)商。在醫(yī)院,臨床顯著的不良反應(yīng),估計(jì)所有招生complicate1020,延長(zhǎng)住院時(shí)間和造成的痛苦和死亡,以及浪費(fèi)資源了為數(shù)可觀的,他們是最常見(jiàn)和最嚴(yán)重的新生兒,老人,婦女,肝或腎臟疾病的患者,以及個(gè)人的歷史以前的藥物不良反應(yīng),藥物不良反應(yīng)常發(fā)生在治療早期(在第110天)。,The drugs most commonly implicated are digoxin, antimicrobials, diurectics, potassium salt replacements, analgesics, sedatives and major tranquillizers, insulin, aspirin, glucocorticosteroids, antihypertensives and warfarin 最常用牽連的藥物有地高辛的抗菌劑,diurectics,鉀的鹽替代品,止痛劑,鎮(zhèn)靜劑和主要鎮(zhèn)靜劑,胰島素,阿司匹林,糖皮質(zhì)激素,抗高血壓藥和華法林,3 Factors involved in the Etiology of Adverse Drug Reactions Can Be Classified as Follows 1 patient factors Intrinsic: 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 .參與藥品不良反應(yīng)的病因的因素可以歸類(lèi)為如下 1患者因素 內(nèi)在: 年齡,新生兒,嬰幼兒和老人 性荷爾蒙環(huán)境 遺傳異常 上一頁(yè)藥物不良反應(yīng),過(guò)敏,過(guò)敏性疾病 器官功能障礙疾病的存在 人格和習(xí)慣含酒精,吸毒者,尼古丁,遵守。,Extrinsic: Environment-sun Xenobiotics (drugs, herbicides) Malnutrition 2.Prescriber factors Incorrect drug or drug combination Incorrect route of administration Incorrect dose Incorrect duration of therapy 3.Drug factors Drug-drug interactions Pharmaceutical-batch problems, shelf-life, incorrect dispensing外在: 環(huán)境陽(yáng)光外來(lái)物質(zhì)(藥物,除草劑)營(yíng)養(yǎng)不良 2.Prescriber因素 不正確的藥物或藥物組合不正確的給藥途徑不正確的劑量 不正確的治療時(shí)間 3.Drug因素 藥物相互作用藥品批次的問(wèn)題,保質(zhì)期,不正確配藥,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 offer 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.藥品不良反應(yīng)監(jiān)測(cè)/監(jiān)控藥物警戒 藥物安全性的評(píng)價(jià)是復(fù)雜的,有很多方法用于監(jiān)測(cè)藥物的不良反應(yīng)。這些每個(gè)人都有自己的優(yōu)點(diǎn)和缺點(diǎn),并沒(méi)有一個(gè)單一的系統(tǒng)可以提供絕對(duì)的安全,輿論預(yù)期。理想的方法將確定藥物的不良反應(yīng),具有高度的敏感性和特異性,并作出迅速的反應(yīng)。,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 of 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.檢測(cè)罕見(jiàn)但嚴(yán)重的藥物不良反應(yīng),但不會(huì)被淹沒(méi)常見(jiàn)的,發(fā)病的誘發(fā)因素,將一起量化續(xù)監(jiān)視是強(qiáng)制性的一種新的藥物已經(jīng)上市,這是不可避免的,經(jīng)初步測(cè)試人類(lèi)在藥物開(kāi)發(fā)中的藥品,雖然不包括許多不良影響,無(wú)法識(shí)別少見(jiàn)的不良影響。已經(jīng)出臺(tái)的各種早期檢測(cè)方法,盡可能迅速地識(shí)別藥品不良反應(yīng)。,5 Phase I/II/III Trials Early (Phase I/II) trials are important for assessing the tolerability and dose-response relationship of new therapeutic agents, However, these studies are very insensitive at detecting adverse reactions because they are performed on relatively few subjects(200300).This is illustrated by the failure to detect the serious toxicity of several drugs (practolor, benoxaprofen , temafloxacin ,felbamate, dexfenfluramine and fenfluramin troglitazone) before marketing. However, phase III clinical trials can establish the incidence of common adverse reactions and relate this to therapeutic benefit. 5 I / II期/ III期臨床試驗(yàn) 早期(I / II期試驗(yàn))評(píng)估耐受性和新的治療藥物的劑量 - 反應(yīng)關(guān)系很重要,但是,這些研究是非常不敏感,在檢測(cè)不良反應(yīng),因?yàn)樗鼈儽粓?zhí)行的對(duì)象相對(duì)較少(200300名)。所示的故障檢測(cè)幾種藥物的嚴(yán)重毒性(苯惡洛芬practolor,替馬沙星,非氨酯,右芬氟拉明和曲格列fenfluramin)前營(yíng)銷(xiāo)。然而,III期臨床試驗(yàn)可以建立常見(jiàn)的不良反應(yīng)的發(fā)生率和治療效果。,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,

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