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[自我药疗的药物警戒]

[Pharmacovigilance of self-medication].

作者信息

Montastruc J L, Bagheri H, Geraud T, Lapeyre-Mestre M

机构信息

Service de Pharmacologie Clinique, Centre Hospitalier Universitaire, Faculté de Médecine, Toulouse, France.

出版信息

Therapie. 1997 Mar-Apr;52(2):105-10.

PMID:9231503
Abstract

Self-medication can be defined as obtaining and consuming one (or more) drug (s) without the advice of a physician either for diagnosis, prescription or surveillance of the treatment. Self-medication accounts for around 5 to 10 per cent of drug sales in France. There are few data on side effects of self-medication in France. The side effects of drugs taken by self-medication and reported to the Midi-Pyrenees drugs surveillance centre between January 1993 and June 1996 were investigated in the present study. There were 65 reports, mainly in women (58 per cent), i.e. around 2 per cent of the reports to the regional drugs surveillance centre. The most frequent side effects are neurological (32 per cent: mainly headache, vertigo, agitation, etc.), dermatological (18 per cent, mainly allergy), hepatic (10 per cent), digestive (7 per cent, mainly diarrhoea). There were 10 cases of anaphylactic shock and/or Quincke oedema. The drugs most frequently involved were analgesics and non-steroidal anti-inflammatory drugs (47 cases), neuropsychotropic drugs (7 cases), dermatological drugs (6 cases) or otorhinolaryngological drugs (6 cases).... 'Serious' side effects occurred in 40 per cent of the cases including 3 deaths. 'Severe' side effects were observed in 77 per cent of the reports. This study shows that the side effects of self-medication are relatively frequent and can be serious. They occurred more often in women than in men, mainly with analgesic and anti-inflammatory drugs. These data permit a better analysis of the risk/benefit ratio of self-medication. Drug surveillance studies of self-medication must be developed.

摘要

自我药疗可定义为在没有医生建议的情况下获取和使用一种(或多种)药物,用于诊断、开处方或监测治疗。在法国,自我药疗占药品销售额的5%至10%左右。法国关于自我药疗副作用的数据很少。本研究调查了1993年1月至1996年6月期间自我药疗所服用药物并报告给南比利牛斯药物监测中心的副作用情况。共有65份报告,主要是女性(58%),约占该地区药物监测中心报告的2%。最常见的副作用是神经方面的(32%:主要是头痛、眩晕、激动等)、皮肤方面的(18%,主要是过敏)、肝脏方面的(10%)、消化系统方面的(7%,主要是腹泻)。有10例过敏性休克和/或昆克水肿。最常涉及的药物是镇痛药和非甾体抗炎药(47例)、神经精神药物(7例)、皮肤科药物(6例)或耳鼻喉科药物(6例)……40%的病例出现了“严重”副作用,包括3例死亡。77%的报告中观察到了“重度”副作用。这项研究表明,自我药疗的副作用相对常见且可能很严重。女性比男性更常出现,主要与镇痛药和抗炎药有关。这些数据有助于更好地分析自我药疗的风险/效益比。必须开展自我药疗的药物监测研究。

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