Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial
Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial
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DOI：
10.1016/s1474-4422(08)70221-7
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发表时间：
2008-11-01
期刊：
影响因子：
48
通讯作者：
Jonsson, Lars
中科院分区：
文献类型：
--
作者：
Engstrom, Mats;Berg, Thomas;Jonsson, Lars
背景：以前的皮质类固醇或抗病毒治疗贝尔麻痹的试验动力不足或随访不足。本研究的目的是比较泼尼松龙和伐昔洛韦的短期和长期影响的恢复受影响的面神经在大量patients.Methods在这个随机，双盲，安慰剂对照，多中心试验，患者年龄18至75岁谁寻求照顾直接或转介从急诊科或全科医生在72小时内发病的急性，单侧，对2001年5月至2006年9月期间的周围性面神经麻痹患者进行评估。患者被随机分配到8个排列区组中，接受安慰剂加安慰剂;每天60 mg泼尼松龙，持续5天，然后每天减少10 mg（总治疗时间为10天）加安慰剂; 1000 mg伐昔洛韦，每天3次，持续7天加安慰剂;或泼尼松龙（10天）加伐昔洛韦（7天）。随访12个月。主要结局事件是面部功能完全恢复的时间，采用区域Sunnybrook量表评分100分进行评估。ClinicalTrials.gov839名患者被随机分配，829名被纳入改良意向治疗分析：206名患者接受安慰剂+安慰剂，210名患者接受泼尼松龙+安慰剂，207名患者接受伐昔洛韦+安慰剂，206名患者接受泼尼松龙+伐昔洛韦。与413例未接受泼尼松龙治疗的患者相比，416例接受泼尼松龙治疗的患者的恢复时间显著缩短（风险比1.40，95%CI 1.18至1.64; p
Background Previous trials of corticosteroid or antiviral treatments for Bell's palsy have been underpowered or have had insufficient follow-up. The aim of this study was to compare the short-term and long-term effects of prednisolone and valaciclovir in the recovery of the affected facial nerve in a large number of patients.Methods In this randomised, double-blind, placebo-controlled, multicentre trial, patients aged 18 to 75 years who sought care directly or were referred from emergency departments or general practitioners within 72 h of onset of acute, unilateral, peripheral facial palsy, between May, 2001, and September, 2006, were assessed. Patients were randomly assigned in permuted blocks of eight to receive placebo plus placebo; 60 mg prednisolone per day for 5 days then reduced by 10 mg per day (for a total treatment time of 10 days) plus placebo; 1000 mg valaciclovir three times per day for 7 days plus placebo; or prednisolone (10 days) plus valaciclovir (7 days). Follow-up was for 12 months. The primary outcome event was time to complete recovery of facial function, as assessed with a regional Sunnybrook scale score of 100 points. Analysis was by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00510263.Findings Of 839 patients who were randomly assigned, 829 were included in the modified intention-to-treat analysis: 206 received placebo plus placebo, 210 prednisolone plus placebo, 207 valaciclovir plus placebo, and 206 prednisolone plus valaciclovir. Time to recovery was significantly shorter in the 416 patients who received prednisolone compared with the 413 patients who did not (hazard ratio 1.40, 95% CI 1.18 to 1.64; p