A randomized controlled trial of prednisone in Alzheimer's disease
A randomized controlled trial of prednisone in Alzheimer's disease
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DOI：
10.1212/wnl.54.3.588
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发表时间：
2000-02-08
期刊：
影响因子：
9.9
通讯作者：
Thal, LJ
中科院分区：
文献类型：
--
作者：
Aisen, PS;Davis, KL;Thal, LJ
背景：实验室和流行病学研究表明，抗炎/免疫抑制治疗可能是有效的治疗AD。在初步研究中，发现低至中等剂量泼尼松的方案抑制AD受试者的外周炎症标志物而无不良反应。研究方法：我们进行了一项随机、安慰剂对照的多中心试验，以确定泼尼松治疗是否能减缓AD患者认知功能下降的速度。积极治疗方案包括每日20 mg的泼尼松初始剂量，持续4周，逐渐减少至每日10 mg的维持剂量，持续1年，然后在另外16周内逐渐停药。主要结果指标是AD评估量表认知子量表的1年变化。结果：共有138名受试者被随机分配到药物组和安慰剂组。在主要意向治疗分析中，或在仅考虑完成者的次要分析中，泼尼松和安慰剂治疗组之间的认知下降没有差异。与安慰剂组相比，接受泼尼松治疗的受试者表现出行为下降。结论：小剂量泼尼松治疗AD疗效不佳。
Background: Laboratory and epidemiologic studies suggest that anti-inflammatory/immunosuppressive therapy may be useful in the treatment of AD. In preliminary studies, a regimen of low to moderate dose prednisone was found to suppress peripheral inflammatory markers without adverse effects in subjects with AD. Methods: We conducted a randomized, placebo-controlled multicenter trial to determine whether prednisone treatment slowed the rate of cognitive decline in AD. The active treatment regimen consisted of an initial dose of 20 mg of prednisone daily for 4 weeks tapered to a maintenance dose of 10 mg daily for 1 year, followed by gradual withdrawal during an additional 16 weeks. The primary outcome measure was the 1-year change in the cognitive subscale of the AD Assessment Scale. Results: A total of 138 subjects were randomized to the drug and placebo groups. There was no difference in cognitive decline between the prednisone and placebo treatment groups in the primary intent-to-treat analysis, or in a secondary analysis considering completers only. Subjects treated with prednisone showed behavioral decline compared with those in the placebo group. Conclusion: A low-dose regimen of prednisone is not; useful in the treatment of AD.