Department of Neurology, Academic Medical Center, University of Amsterdam, Netherlands.
Lancet Neurol. 2010 Mar;9(3):245-53. doi: 10.1016/S1474-4422(10)70021-1. Epub 2010 Feb 2.
Pulsed high-dose dexamethasone induced long-lasting remission in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in a pilot study. The PREDICT study aimed to compare remission rates in patients with CIDP treated with high-dose dexamethasone with rates in patients treated with standard oral prednisolone.
In eight neuromuscular centres in the Netherlands and one in the UK, patients aged 18 years or older who had newly diagnosed definite or probable CIDP were randomly assigned to a treatment regimen of either pulsed high-dose dexamethasone or standard oral prednisolone. Randomisation was done with a random number generator. The primary outcome measure was remission at 12 months, defined as improvement of at least three points on the Rivermead mobility index and improvement of at least one point on the inflammatory neuropathy cause and treatment disability scale. Analysis was by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN07779236.
Between December, 2003, and December, 2008, 40 patients were treated: 24 received dexamethasone and 16 received prednisolone. At 12 months, 16 patients were in remission: ten in the dexamethasone group and six in the prednisolone group (odds ratio [OR] 1.2, 95% CI 0.3-4.4). Most adverse events were minor and did not differ substantially between treatment groups; however, sleeplessness and Cushing's face occurred more often in the prednisolone group.
Pulsed high-dose dexamethasone treatment did not induce remission more often than prednisolone treatment. A substantial proportion of patients were in remission at 12 months in both treatment groups. High-dose dexamethasone could be considered as induction therapy in CIDP, but comparison with intravenous immunoglobulin treatment is needed.
The Prinses Beatrix Fonds (MAR01-0213) and the Department of Neurology, Academic Medical Center.
在一项初步研究中，脉冲式高剂量地塞米松可使慢性炎症性脱髓鞘性多发性神经病（CIDP）患者长期缓解。PREDICT 研究旨在比较 CIDP 患者接受高剂量地塞米松治疗与接受标准口服泼尼松龙治疗的缓解率。
在荷兰的 8 个神经肌肉中心和英国的 1 个中心，招募年龄在 18 岁及以上、新诊断为明确或可能的 CIDP 的患者，将其随机分配至脉冲式高剂量地塞米松或标准口服泼尼松龙治疗方案。采用随机数发生器进行随机分组。主要结局指标为 12 个月时的缓解率，定义为 Rivermead 运动指数至少改善 3 分，炎症性神经病病因和治疗残疾量表至少改善 1 分。采用意向治疗进行分析。该试验在 Current Controlled Trials 注册，编号为 ISRCTN07779236。
2003 年 12 月至 2008 年 12 月，共纳入 40 例患者：24 例接受地塞米松治疗，16 例接受泼尼松龙治疗。12 个月时，16 例患者处于缓解状态：地塞米松组 10 例，泼尼松龙组 6 例（比值比[OR]1.2，95%CI0.3-4.4）。大多数不良事件为轻度，两组间差异无显著差异；然而，失眠和库欣面容在泼尼松龙组更常见。
脉冲式高剂量地塞米松治疗诱导缓解的频率并不高于泼尼松龙治疗。两组患者在 12 个月时均有相当比例的患者处于缓解状态。高剂量地塞米松可作为 CIDP 的诱导治疗，但需要与静脉注射免疫球蛋白治疗进行比较。
普林斯顿·贝蒂娜·福斯基金会（MAR01-0213）和阿姆斯特丹学术医学中心神经内科。
