药物致神经毒性的临床检测与评价

Claudio A. Naranjo , Luis Fornazzari , Edward M. Sellers
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引用次数: 7

摘要

1.1. 药物性神经系统疾病是一个比较常见的问题。例如,波士顿合作药物监测项目报告,在11526名住院患者中,14.2%的药物不良反应(adr)是神经系统的。药物可诱发各种综合征,如:意识障碍、精神障碍、头痛、颅神经障碍、运动障碍、精神病、周围神经病变、肌病和自主神经功能障碍。绝大多数不良反应与剂量有关(如镇静催眠药引起的中枢神经系统抑制)。在这些情况下,不良反应的频率和严重程度与给药剂量成正比,因此,可以通过根据患者需要调整剂量来预防和/或治疗不良反应。与剂量无关的不良反应(如各种麻醉药引起的恶性高热)并不常见,反应的发展主要取决于患者易感性的增加。因此,只有不重新给药才能预防不良反应4.4。大多数将特定药物与神经系统不良事件联系起来的证据来自单个病例报告,其中没有对因果关系进行系统评估。最近,一些关于不良反应的有效和可靠的定义被报道(例如Kramer et al, 1979;Naranjo et al, 1981)。这些方法的系统应用大大减少了分析adr案件的模糊性。这些方法可以很容易地被执业医师用于评估和报告疑似药物性神经系统疾病。
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Clinical detection and assessment of drug induced neurotoxicity

  • 1.

    1. Drug-induced neurological disease is a relatively common problem. For example, the Boston Collaborative Drug Surveillance Program reported that in 11,526 hospitalized patients, 14.2% of adverse drug reactions (ADRs) were neurological.

  • 2.

    2. Drugs can induce various syndromes such as: disturbances of consciousness, psychiatric disorders, headache, cranial nerve disorders, movement disorders, psychosis, peripheral neuropathy, myopathy and autonomic dysfunction.

  • 3.

    3. The vast majority of ADRs are dose-related (e.g. CNS depression by sedative-hypnotics). In these cases the frequency and severity of the ADRs is proportional to the administered dose, therefore, they can be prevented and/or treated by adjusting the dosage to patient's needs. Dose-unrelated ADRs (e.g. malignant hyperthermia by various anaesthetic agents) are uncommon and the development of the reaction is mainly dependent on increased patient's susceptibility. Accordingly, the ADR can only be prevented by not readministering the drug.

  • 4.

    4. Most of the evidence associating specific drugs with neurological adverse events comes from single case reports in which no systematic assessment of causality has been made. Recently, valid and reliable definitions of ADRs have been reported (e.g. Kramer et al, 1979; Naranjo et al, 1981). The systematic application of these methods greatly reduce the ambiguity for analyzing alleged cases of ADRs. These methods can be easily applied by practising physicians in the assessment and reporting of suspected drug-induced neurological diseases.

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