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首页> 外文期刊>Journal of paediatrics and child health >Protocol for a single patient therapy plan: A randomised, double-blind, placebo-controlled N-of-1 trial to assess the efficacy of cannabidiol in patients with intractable epilepsy
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Protocol for a single patient therapy plan: A randomised, double-blind, placebo-controlled N-of-1 trial to assess the efficacy of cannabidiol in patients with intractable epilepsy

机译：单一患者治疗计划的协议：随机，双盲，安慰剂控制的N-1试验，以评估大麻癫痫患者患者的疗效

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Aim This paper describes the use of the single patient therapy plan (SPTP). The SPTP has been designed to assess the efficacy at an individual level of a commercially available cannabinoid product, cannabidiol, in reducing seizure frequency in paediatric patients with intractable epilepsy. Methods The SPTP is a randomised, double-blind, placebo-controlled N-of-1 trial designed to assess the efficacy of treatment in a neurology outpatient setting. The primary objective of the SPTP is to assess the efficacy of cannabidiol in reducing seizure frequency in each patient with intractable epilepsy, with change in seizure frequency being the primary outcome of interest. The analysis adopts a Bayesian approach, which provides results in the form of posterior probabilities that various levels of benefit (based on the primary outcome measure, seizure frequency) have been achieved under active treatment compared to placebo, accompanied by decision rules that provide thresholds for deciding whether treatment has been successful in the individual patient. The SPTP arrangement is most accurately considered part of clinical practice rather than research, since it is aimed at making clinical treatment decisions for individual patients and is not testing a hypothesis or collecting aggregate data. Therefore, Human Research Ethics Committee approval was considered not to be required, although it is recommended that hospital Clinical Ethics Committees provide ethical oversight. Conclusion:These SPTP resources are made available so that they may inform clinical practice in the treatment of severe epilepsy or adapted for use in other conditions.
机译：目的本文介绍了单一患者治疗计划（SPTP）的使用。SPTP的目的是在个体水平上评估市售大麻素产品大麻素二醇在降低难治性癫痫患儿癫痫发作频率方面的疗效。方法SPTP是一项随机、双盲、安慰剂对照的N-of-1试验，旨在评估神经病学门诊患者的治疗效果。SPTP的主要目的是评估坎那比妥在降低难治性癫痫患者发作频率方面的疗效，发作频率的变化是主要的结果。该分析采用贝叶斯方法，该方法以后验概率的形式提供结果，即与安慰剂相比，在积极治疗下取得了不同程度的益处（基于主要疗效指标、发作频率），同时还提供了决策规则，用于确定个体患者的治疗是否成功。SPTP安排被最准确地视为临床实践而非研究的一部分，因为它旨在为个别患者做出临床治疗决定，而不是检验假设或收集汇总数据。因此，虽然建议医院临床伦理委员会提供伦理监督，但认为不需要人类研究伦理委员会的批准。结论：这些SPTP资源是可用的，因此它们可以为治疗严重癫痫的临床实践提供信息，或适用于其他情况。

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