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Post-marketing management of the use of non-narcotic analgesics. 非麻醉性镇痛药的上市后管理。
Medical toxicology Pub Date : 1986-01-01
O S Miettinen
{"title":"Post-marketing management of the use of non-narcotic analgesics.","authors":"O S Miettinen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>While the use of non-narcotic analgesics is of considerable health benefit to people everywhere, they also represent a health problem. This problem has to do more with the risks associated with individual courses of treatment than with the commonality of those treatments. The public health challenge in post-marketing management of non-narcotic analgesic use, is to promote a pattern of use such that the risks are justifiable by the benefits and are the lowest that can be attained. To achieve such goals it is essential to have scientific knowledge about the benefits and risks and to be able to determine the quality of use in the population as to how proper it is. Current post-marketing management programmes focus largely on regulation, overlooking other equally important basic methods of public health intervention, namely education and service. If it is accepted that mass education is the key element in the proper management of non-narcotic analgesic use, the present emphasis on regulation needs amendment. Such changes will take time, but it is conceivable that ultimately the management goal can be achieved with minimal regulatory intervention.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"125-7"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reporting systems for rare side effects of non-narcotic analgesics in India. Problems and opportunities. 印度非麻醉性镇痛药罕见副作用的报告系统。问题和机会。
Medical toxicology Pub Date : 1986-01-01
R D Kulkarni
{"title":"Reporting systems for rare side effects of non-narcotic analgesics in India. Problems and opportunities.","authors":"R D Kulkarni","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Soon India will launch a fully developed system to monitor adverse drug reactions. The national requirement for this project encompasses 12 regional centres; district hospitals and primary health centres will be affiliated to these. Patient investigation and referrals will be manned by completely trained medical and paramedical personnel. The system is expected to become operational by 1987. Peculiar problems arise in the scientific research of adverse drug related events in India: illiteracy, the strong influence of traditional medicine, over-the-counter drug availability, inadequate numbers of trained personnel, shifting doctor-patient relations and costs. There is an opportunity for rigorous prospective epidemiological investigation in India, since the great majority of the population depends on governmental health support. Detailed drug-related events, timing of exposure and withdrawal can be accurately monitored. Various influential 'non-drug' factors relevant to the drug reaction must be considered in the assessment of any adverse drug reaction.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"110-3"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Acute poisoning due to non-steroidal anti-inflammatory drugs. Clinical features and management. 非甾体类抗炎药引起的急性中毒。临床特点及处理。
Medical toxicology Pub Date : 1986-01-01 DOI: 10.1007/BF03259825
J A Vale, T J Meredith
{"title":"Acute poisoning due to non-steroidal anti-inflammatory drugs. Clinical features and management.","authors":"J A Vale, T J Meredith","doi":"10.1007/BF03259825","DOIUrl":"10.1007/BF03259825","url":null,"abstract":"<p><p>Despite the widespread use of non-steroidal anti-inflammatory drugs (NSAIDs), the current number of reported cases of poisoning is small. However, with the introduction of 'over-the-counter' preparations of NSAIDs in some countries (e.g. ibuprofen in the UK and USA) an increased incidence of acute poisoning from this group of drugs can be expected. Conventionally, NSAIDs are divided into the following groups based on their chemical structure: arylpropionic acids, indole and indene acetic acids, heteroarylacetic acids, fenamates, phenylacetic acids, pyrazolones and oxicams. Unless NSAIDs are ingested in substantial overdose, acute poisoning with these agents does not usually result in significant morbidity or mortality. In most cases the clinical features are mild and confined to the gastrointestinal and central nervous systems, though acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse and cardiac arrest may complicate severe poisoning. Arylpropionic acid derivatives were thought initially to have a low order of toxicity in overdose but, in addition to anticipated gastrointestinal symptoms, headache, tinnitus, hyperventilation, sinus tachycardia, hypoprothrombinaemia, haematuria, proteinuria and acute renal failure have been described. In addition, drowsiness, coma, nystagmus, diplopia, hypothermia, hypotension, respiratory depression and cardiac arrest have been reported in severe cases of poisoning. Oxyphenbutazone and phenylbutazone are considerably more toxic in overdose. Complications of severe poisoning include coma, convulsions, hepatic dysfunction, acute renal failure, sodium and water retention, haematuria, cardiovascular collapse, respiratory alkalosis, metabolic acidosis, hypoprothrombinaemia and thrombocytopenia. In contrast, indomethacin appears to be much less toxic. In addition to gastrointestinal symptoms, indomethacin taken in overdose induces headache, tinnitus, dizziness, lethargy, drowsiness, confusion, disorientation and restlessness. Only 1 case of acute sulindac poisoning has been reported in the literature. A 16-year-old boy was admitted with hypokalaemia (2.2 mmol/L), transient granulocytosis and 'scanty' haematemesis after ingesting 12 g sulindac. No case of acute tolmetin poisoning have been reported. The fenamates (flufenamic acid, meclofenamic acid, mefenamic acid, tolfenamic acid) are, with the exception of mefenamic acid, not as widely prescribed as other groups of NSAIDs. In overdose, mefenamic acid may result in nausea, vomiting, diarrhoea, muscle twitching, convulsions and coma.(ABSTRACT TRUNCATED AT 400 WORDS)</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 1","pages":"12-31"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14660775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Immunotherapy in the poisoned patient. Overview of present applications and future trends. 中毒病人的免疫治疗。概述目前的应用和未来的趋势。
Medical toxicology Pub Date : 1986-01-01 DOI: 10.1007/BF03259827
J B Sullivan
{"title":"Immunotherapy in the poisoned patient. Overview of present applications and future trends.","authors":"J B Sullivan","doi":"10.1007/BF03259827","DOIUrl":"https://doi.org/10.1007/BF03259827","url":null,"abstract":"<p><p>Immunotherapy for reversal of toxicity due to poisons and drugs is not new. However, refinements in antibody isolation and purification as well as the advancement of hybridoma technology and recombinant DNA biotechnology has led to a new generation of immunotherapeutic and diagnostic agents. The advent of monoclonal antibody technology in 1975 heralded the new age of immunopharmacology and immunotoxicology. Monoclonal antibodies designed for a specific antigen resolved the problem of polyclonality and cross-reactivity of traditional antibodies. Along with the production and isolation of active antibody fragments from both polyclonal and human monoclonal sources, as well as the ability to tailor-make chimeric antibodies by recombinant biotechnology, the development of novel immunotherapeutic agents has taken place. Two immunotherapeutic modalities, digoxin-specific antibody fragments (Fab) and snake antivenin, have been available for the clinician's armamentarium for years. Along the same lines of anti-digoxin Fab development, application of newer antibody isolation technology has led to a purified IgG(T) antibody for snake venom poisoning which is still in the developmental stages. Potential future developments in immunotherapeutics must overcome the clinical problems of immunogenicity and adverse reactions to the antibodies. Human monoclonal sources, active antibody fragments, and chimeric antibodies from transfectomas are all potential resolutions to these problems.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 1","pages":"47-60"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/BF03259827","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14660777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 22
Anti-inflammatory drug intake and the risk of ulcer complications. 消炎药的摄入与溃疡并发症的风险。
Medical toxicology Pub Date : 1986-01-01
M J Langman
{"title":"Anti-inflammatory drug intake and the risk of ulcer complications.","authors":"M J Langman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Over the years conflicting data have been produced suggesting that the risk of upper gastrointestinal bleeding or perforation associated with anti-inflammatory drug intake could be negligible or substantial. Opinions have diverged for a number of reasons. Data concerning the use of aspirin have generally failed to include adequate controls or to distinguish analgesic intake which might be causal from that which might be consequential upon the presence of the bleeding lesion. When proper allowance is made, it seems likely that about one-third of aspirin intake in patients with bleeding is equivalent to that in controls and is by deduction non-causal; a further one-third by reference to parallel increases in paracetamol (acetaminophen) intake is non-causal but consequential upon the presence of the bleeding lesion. The remaining one-third is unexplained and likely to be causal. The importance of non-aspirin non-steroidal anti-inflammatory drug (NANSAID) intake has likewise been disputed. Opinions have conflicted because evidence has not generally been available from case-control studies but has been obtained either from simple case series or from the results of post-marketing surveillance. By formal case-control studies it has been possible to show that the risks of ulcer complications in individuals over the age of 60 are appreciable. These risks have not been detected during post-marketing surveillance because the apparently large case series studied during surveillance are dwarfed by the general extent of prescribing, and because elderly people may be particularly at risk and surveillance has not concentrated on this group.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"34-8"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14617571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rare but serious risks associated with non-narcotic analgesics: clinical experience. 与非麻醉性镇痛药相关的罕见但严重的风险:临床经验。
Medical toxicology Pub Date : 1986-01-01
H Kewitz
{"title":"Rare but serious risks associated with non-narcotic analgesics: clinical experience.","authors":"H Kewitz","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Our data show that 1% of patients who required hospital treatment did so due to severe adverse reactions to analgesics. The most frequent adverse reaction was major gastrointestinal bleeding after aspirin, indomethacin, phenylbutazone or naproxen. Thrombocytopenia, second in frequency, was also mainly a complication of aspirin treatment, as was severe vertigo and tinnitus. Allergic reactions and leucopenia or agranulocytosis occurring in single cases only were associated with the use of pyrazolones. Patients with nephropathy were usually taking phenacetin or one of the close derivatives paracetamol or bucetin. Intensive monitoring for adverse reactions to drugs in 6,000 hospitalised patients in medical wards showed that analgesics, although frequently used, did not lead to life-threatening reactions. Gastrointestinal and neurological side effects were the most commonly observed reactions and these occurred more often after aspirin, indomethacin or pentazocine than after dipyrone or tilidine. Preliminary data of an international case-control-study on agranulocytosis and aplastic anaemia suggest that the incidence of agranulocytosis was in the order of 2 to 3 per million users of analgesics per year. Agranulocytosis occurred predominantly with pyrazolones, with a mortality of 1 to 2 per 10 million users per year. A cohort study on the treatment of colic pain in general practice showed that serious events most likely due to adverse reactions to analgesics were bronchospasm, shock fragments or shock. The incidence of these serious events was about 2 in 1,000 treated cases. The relative risk was not increased by treatment with pyrazolones, opioids or other drugs.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"86-92"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Liver damage with non-narcotic analgesics. 非麻醉性镇痛药对肝损害。
Medical toxicology Pub Date : 1986-01-01
L F Prescott
{"title":"Liver damage with non-narcotic analgesics.","authors":"L F Prescott","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Non-narcotic analgesics can produce a variety of hepatic lesions but clinically significant liver damage is uncommon with normal therapeutic use. The pattern of hepatotoxicity caused by the salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol (acetaminophen) and the pyrazolones differs but many of these drugs can cause generalised reactions which involve the liver. Depending on the drugs in question, the risks of liver injury may be conditioned by factors such as age, sex, dose and duration of treatment. Hepatotoxicity associated with the use of salicylates and most NSAIDs has been reported most often in females with collagen diseases but this may simply reflect the greater use of these drugs in such patients. Paracetamol-induced liver damage occurs almost exclusively as a result of overdosage. Except for the microvesicular fatty changes in hepatocytes in patients with Reye's syndrome attributed to salicylate, the acute centrilobular necrosis caused by paracetamol in overdosage and the marked cholestasis produced by benoxaprofen, the pathological changes in hepatic reactions to non-narcotic analgesics are rather variable and nonspecific. About 50% of patients given salicylate in full anti-inflammatory dosage develop minor abnormalities of liver function. There is usually a mild to moderate increase in plasma aminotransferase activity with patchy necrosis and degeneration of hepatocytes. These changes are related to plasma salicylate concentration and are usually rapidly reversible. In a small minority of patients, particularly the young, liver damage is more severe and may be associated with liver failure, acidosis, hypoglycaemia and encephalopathy. This picture closely resembles Reye's syndrome. In overdosage, paracetamol can cause acute hepatic necrosis. Without specific treatment, some 8% of adults suffer severe liver damage with plasma aminotransferase activity greater than 1000 U/L and about 1% die with hepatic failure and encephalopathy. The administration of sulfhydryl compounds such as N-acetylcysteine within 8 to 10 hours effectively prevents liver damage and death. Liver damage has been attributed to the therapeutic use of paracetamol. However, in most reports the dose was excessive and many patients were chronic alcoholics (who seem to be at increased risk). In these cases the features were typical of acute overdosage. A consistent and characteristic pattern of hepatotoxicity is evident with relatively few non-steroidal anti-inflammatory and pyrazolone analgesics. A rank order of relative risk cannot be established and the incidence in relation to use is not known.(ABSTRACT TRUNCATED AT 400 WORDS)</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"44-56"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14669911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adverse reactions and interactions with newer cephalosporin and cephamycin antibiotics. 与较新的头孢菌素和头孢霉素抗生素的不良反应和相互作用。
Medical toxicology Pub Date : 1986-01-01 DOI: 10.1007/BF03259826
S R Norrby
{"title":"Adverse reactions and interactions with newer cephalosporin and cephamycin antibiotics.","authors":"S R Norrby","doi":"10.1007/BF03259826","DOIUrl":"10.1007/BF03259826","url":null,"abstract":"<p><p>In this review, adverse reactions and interactions associated with the use of the newer cephalosporins and cephamycins are surveyed; special emphasis is placed on those reactions specific for some of these newer agents, namely disulfiram-like reactions with alcohol, effects on prothrombin synthesis, and lower gastrointestinal tract reactions. It is apparent that cephalosporins with a 3-methylthiotetrazole side-chain in the cephem nucleus cause clinically significant side effects more frequently than those without such a moiety. While still having a high degree of safety, cephalosporins with this chemical structure clearly have a higher degree of toxicity than those without this side-chain.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 1","pages":"32-46"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14660776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The regulatory challenge. 监管方面的挑战。
Medical toxicology Pub Date : 1986-01-01 DOI: 10.5860/choice.33-0425
P. Lunde
{"title":"The regulatory challenge.","authors":"P. Lunde","doi":"10.5860/choice.33-0425","DOIUrl":"https://doi.org/10.5860/choice.33-0425","url":null,"abstract":"The concepts of drug regulation should ideally be derived from an appropriately defined and broadly agreed national drug and health policy, according to health needs, relevant criteria and the local circumstances. The major long term challenge emerging from these concepts is how to establish a sufficiently comprehensive and functional drug and therapeutic audit as a basis for regulatory and other decisions within the health chain that strike a balance between sociomedical and economic requirements. Such an audit involves three sequential phases: collection and compilation of all relevant facts and premises; data organisation and analyses by competent auditors and decision, implementation, and re-evaluation with subsequent adjustments. Despite extensive international and national efforts during recent years, only fragmentary solutions exist, and only in a few countries. Thus, another major challenge still remains: how to weight and integrate the sometimes quite conflicting interests and scopes of politicians, administrators, the teaching institutions, the health professions, the pharmaceutical manufacturers--and the consumers. All the partners involved have to emphasise that the problems behind the present miseries of global drug use are basically of political and economic nature, although there are considerable limitations imposed by widely varying attitudes and deficient knowledge and criteria. Thus there is a need for joint action and a strengthening of collaboration and communication combined with the best possible elements of professional skills and common sense.","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 1","pages":"121-4"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71048868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 34
Adverse drug reaction reporting. Philippine experience. 药物不良反应报告。菲律宾的经验。
Medical toxicology Pub Date : 1986-01-01
E Ines Cuyegkeng
{"title":"Adverse drug reaction reporting. Philippine experience.","authors":"E Ines Cuyegkeng","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>For almost 20 years, the Philippine Medical Association, and specifically its Committee on Foods, Drugs and Cosmetics, has not been able to successfully gather information on adverse drug reactions (ADRs). The reporting of ADRs began in 1967, using a very comprehensive reporting form, at a time when news items of anaphylactic shock and deaths allegedly from intramuscular injections of penicillin, and subsequent litigation, were appearing. Up until 1973, when there were new initiatives, a few ADR reports were obtained mainly from hospitals who employed Philippine Medical Association committee members. Despite the issuing of directives for co-operation from hospitals, reports were not forthcoming. Involvement of hospital pharmacists and officers of specialist societies subsequent to the arrival of a World Health Organization (WHO) consultant in 1981 resulted in a simplified reporting form. Initial enthusiasm generated some ADR reports, but information was often inadequate and requests for further details were ignored. A new form entitled 'Drug Experience Reporting'--based on the USA FDA example--was introduced in 1984, when the Philippine Pediatric Society on ADR reporting also designed a project for use in hospitals. A change in doctor and patient attitudes is necessary before progress can be made, and a new strategy based on the education of doctors and medical students has been implemented. An important requirement is a mechanism to review and assess ADRs that will satisfy health authorities and maintain confidentiality.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"99-104"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14937664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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