adversedrugreaction药学英语
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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.
11
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 .
12
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
9
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 1~10day).
3
herbicide
n.除草剂
idiosyncratic intracranial
adj.特质的,独特的 特殊的 特异体质的 特异反应的
adj.头颅内的,颅骨内的
lethargy
n.昏睡 没精打采 懒洋洋 嗜眠症
mitoxantrone 米托蒽醌
neonatal
adj.新生的,初生的
neuroleptic adj.安定(精神)的
7
Adverse drug reactions due to specific drug-drug interactions are studied. Three further minor categories of adverse drug reactions have been proposed.
13
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
4
5
6
2.2 Type-B Type-B (idiosyncratic) reactions are not
predictable from the drug’s 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)
respond rapidly.
14
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.
8
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
adverse_drug_reaction_药学英语 1
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.
15
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(200~300).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.
2
atopy
n.特应性
benoxaprofen 苯恶洛芬
benzodiazepi 苯二氮卓类i ne
右芬氟拉明
digoxin
n.异羟洋地黄毒苷,地高辛(一种强心剂)
felbamate
非尔氨酯
fenfluramine n.(抑制食欲以治疗肥胖的)芬氟拉明
10
The drugs most commonly implicated are digoxin, antimicrobials, diurectics, potassium salt replacements, analgesics, sedatives and major tranquillizers, insulin, aspirin, glucocorticosteroids, antihypertensives and warfarin
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.
11
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 .
12
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
9
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 1~10day).
3
herbicide
n.除草剂
idiosyncratic intracranial
adj.特质的,独特的 特殊的 特异体质的 特异反应的
adj.头颅内的,颅骨内的
lethargy
n.昏睡 没精打采 懒洋洋 嗜眠症
mitoxantrone 米托蒽醌
neonatal
adj.新生的,初生的
neuroleptic adj.安定(精神)的
7
Adverse drug reactions due to specific drug-drug interactions are studied. Three further minor categories of adverse drug reactions have been proposed.
13
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
4
5
6
2.2 Type-B Type-B (idiosyncratic) reactions are not
predictable from the drug’s 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)
respond rapidly.
14
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.
8
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
adverse_drug_reaction_药学英语 1
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.
15
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(200~300).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.
2
atopy
n.特应性
benoxaprofen 苯恶洛芬
benzodiazepi 苯二氮卓类i ne
右芬氟拉明
digoxin
n.异羟洋地黄毒苷,地高辛(一种强心剂)
felbamate
非尔氨酯
fenfluramine n.(抑制食欲以治疗肥胖的)芬氟拉明
10
The drugs most commonly implicated are digoxin, antimicrobials, diurectics, potassium salt replacements, analgesics, sedatives and major tranquillizers, insulin, aspirin, glucocorticosteroids, antihypertensives and warfarin