Surrogate end points in clinical trials.

Surrogate end points in clinical trials.
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临床试验中的替代终点。

DOI:
10.1136/bmj.302.6768.63
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发表时间:
1991
影响因子:
--
通讯作者:
S. Ellenberg
S. Ellenberg
中科院分区:
医学1区
文献类型:
--
作者:
S. Ellenberg

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对114例短暂性全面遗忘症患者、109例基于社区的正常对照者以及212例短暂性脑缺血发作患者进行了病例对照比较。这项严谨研究的结果不支持短暂性全面遗忘症由脑血管原因引起。首先,短暂性全面遗忘症患者和正常对照者之间血管危险因素的患病率没有显著差异;其次,短暂性全面遗忘症患者和短暂性脑缺血发作患者在血管危险因素方面不匹配;第三,在随访期间,短暂性脑缺血发作患者发生血管事件的几率和死亡率比短暂性全面遗忘症患者高得多。另一方面,偏头痛在短暂性全面遗忘症患者中比在两个对照组中更为常见,尽管癫痫的患病率没有差异。不幸的是,这些信息无法使我们对短暂性全面遗忘症的病因得出确切结论,在大多数情况下病因仍然不确定。血栓栓塞性疾病可能是少数病例的病因,偏头痛和癫痫可能是另外一些病例的病因。在实际层面,尽管这种疾病是良性的,而且一般可以让患者放心,但没有治疗方法可以降低复发风险。到目前为止,基于短暂性脑缺血发作理论,我自己给患者的建议是在遗忘发作后六个月内不应开车。然而,根据最近的证据,斯旺西的发证机构现在建议对普通驾驶执照持有者没有限制,对职业驾驶执照持有者限制一年。 N.E.卡特利奇 泰恩河畔纽卡斯尔大学神经科学学院神经病学高级讲师,泰恩河畔纽卡斯尔NE2 4HH
performed a case-control comparison of 114 patients with transient global amnesia, 109 normal community based controls, and 212 patients with transient ischaemic attacks.2 The results of this careful study do not support a cerebrovascular cause for transient global amnesia. Firstly, there were no significant differences in the prevalence of vascular risk factors between the patients with transient global amnesia and normal controls; secondly, those with transient global amnesia and those with transient ischaemic attack were not matched for vascular risk factors; and, thirdly, during follow up patients subject to transient ischaemic attacks had a much greater incidence of vascular events and a higher mortality than those subject to transient global amnesia. On the other hand, migraine was more common in those with transient global amnesia than in those in both control groups, though there were no differences in the prevalence of epilepsy. Unfortunately this information does not enable us to reach a firm conclusion about the cause of transient global amnesia, which in most cases remains uncertain. Thromboembolic disease may be the cause in a few cases, and migraine and epilepsy might account for some more. At a practical level no treatment will reduce the risk of recurrence, though the condition is benign and in general the patient can be reassured. Up to now, believing the transient ischaemic attack theory, my own advice to patients has been that they should not drive for six months after an episode of amnesia. Based on the recent evidence, however, the licensing authority in Swansea now recommends no restrictions to holders of an ordinary driving licence and a one year restriction to holders of a vocational licence. N E F CARTLIDGE Senior Lecturer in Neurology, School of Neurosciences, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4HH
用齐多夫定治疗的艾滋病和艾滋病相关综合症患者的生存替代标记。
DOI: 10.1136/bmj.302.6768.73
发表时间: 1991
期刊: BMJ (Clinical research ed.)
影响因子: --
作者:
Jacobson,MA;Bacchetti,P;Kolokathis,A;Chaisson,RE;Szabo,S;Polsky,B;Valainis,GT;Mildvan,D;Abrams,D;Wilber,J
通讯作者: Wilber,J