Mechanisms of neuropathic pain and their implications for the design of clinical trials
Mechanisms of neuropathic pain and their implications for the design of clinical trials
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DOI：
10.1212/wnl.65.12_suppl_4.s66
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发表时间：
2005-12-01
期刊：
影响因子：
9.9
通讯作者：
Rowbotham, MC
中科院分区：
文献类型：
--
作者：
Rowbotham, MC
以机制为基础的治疗方法是诱人的，但许多实际问题阻碍了其实施。虽然许多新的治疗方法已经进入临床试验，随机对照试验已经变得更大和更复杂，但由于成本、受试者的风险、所需时间和所用技术的有效性的原因，潜在的疼痛机制的试验前测试几乎从未进行过。大多数注册临床试验都是在带状疱疹后神经痛和痛性糖尿病神经病变患者中进行的，但由于没有更多关于疼痛机制的信息，这两种疾病的结果如何完全推广到其他类型的慢性神经性疼痛患者中仍不确定。给出了研究设计和可能的解决方案的例子。
A mechanism-based approach to treatment is alluring, but numerous practical problems impede its implementation. Although many new therapies have entered clinical trials, and randomized controlled trials have become larger and more sophisticated, pre-trial testing of underlying pain mechanisms is almost never performed for reasons of cost, risk to subjects, time required, and validation of the techniques used. Most registration clinical trials are performed in patients with post-herpetic neuralgia and painful diabetic neuropathy, but without more information on pain mechanisms, it remains uncertain how fully results in those two disorders can be generalized to patients with other types of chronic neuropathic pain. Examples of study designs and potential solutions are presented.