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首页> 外文期刊>The Canadian journal of clinical pharmacology =: Journal canadien de pharmacologie clinique >Confirming false adverse reactions to drugs by performing individualized, randomized trials.
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Confirming false adverse reactions to drugs by performing individualized, randomized trials.

机译：通过进行个性化，随机试验确认对药物的假不良反应。

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One-patient, randomized, double-blind, controlled trials (N-of-1 RCTs) have traditionally been used to assess the efficacy of treatment. At the Drug Safety Clinic, Toronto, this methodology is used to evaluate adverse effects related to medication use, specifically when the symptoms are vague and are in response to more than one medication. Two patients are described with histories of drug allergies to multiple medications; as well, guidelines for conducting N-of-1 trials are summarized. The first patient had a history of prolonged periorbital and generalized weakness lasting up to one week after exposure to a variety of drugs. Because of the ambiguous results of local anesthetic skin testing, an N-of-1 trial was performed using lidocaine without preservative. Two short-lived episodes of blepharospasm and lethargy were observed with placebo; no subjective or objective reaction occurred with active drug. The second patient had a history of prolonged weakness and drowsiness after exposure to many medications; she had been told that she was allergic to all drugs with a benzene ring. During the first N-of-1 trial, generalized weakness was observed with 10 mg of dimenhydrinate and all four placebo doses. During the second N-of-1 challenge using codeine, no unwarranted reactions occurred with either active or placebo drug. Traditional testing of these patients to disprove the clinical symptoms is often difficult because of the anxiety level associated with the patients' past experiences. N-of-1 trials provide a useful alternative for the management of patients with nonspecific symptomatology attributed to drug ingestion.
机译：传统上使用单患者，随机，双盲，对照试验（N项，共1项RCT）评估治疗效果。在多伦多的药物安全诊所，此方法用于评估与药物使用相关的不良反应，特别是当症状模糊且对一种以上药物有反应时。描述了两名患者对多种药物的药物过敏史;同样，总结了进行N-of-1试验的指南。首例患者有眼眶延长和全身无力的病史，在接触各种药物后长达一周。由于局部麻醉剂皮肤测试的结果不明确，因此使用不含防腐剂的利多卡因进行了N-of-1试验。用安慰剂观察到两次短暂性眼睑痉挛和嗜睡。活性药物未发生主观或客观反应。第二名患者在接触许多药物后有长期无力和嗜睡的病史;她被告知她对所有带苯环的药物过敏。在第一个N-of-1试验中，观察到10 mg苯海马汀和全部四剂安慰剂的全身性虚弱。在使用可待因的第二次N-of-1攻击期间，活性药物或安慰剂药物均未发生不必要的反应。由于与患者过去的经历有关的焦虑程度，对这些患者进行传统测试以证明其临床症状通常很困难。 N-of-1试验为治疗归因于药物摄入的非特异性症状患者提供了有用的替代方法。

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