Valacyclovir and prednisolone treatment for Bell's palsy: A multicenter, randomized, placebo-controlled study
Valacyclovir and prednisolone treatment for Bell's palsy: A multicenter, randomized, placebo-controlled study
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DOI：
10.1097/01.mao.0000265190.29969.12
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发表时间：
2007-04-01
影响因子：
2.1
通讯作者：
Yamakawa, Kazuhiro
中科院分区：
文献类型：
--
作者：
Hato, Naohito;Yamada, Hiroyuki;Yamakawa, Kazuhiro
目的：研究伐昔洛韦和泼尼松龙与安慰剂和泼尼松龙治疗贝尔氏麻痹的效果相比，不包括带状疱疹无症状带状疱疹。研究设计：前瞻性，多中心，随机安慰剂对照研究。设置：6个学术三级转诊中心。患者：最终，221例贝尔氏麻痹患者在发病后7天内接受治疗。进行血清学和聚合酶链反应检查以区分贝尔麻痹和带状疱疹。干预措施：患者接受伐昔洛韦治疗，（剂量，1，000 mg/d，连续5天）加泼尼松龙（VP [n = 114]）或安慰剂+泼尼松龙（PP [n = 107]）口服给药。主要结果测量：从麻痹中恢复被定义为使用Yanagihara 40分评分系统评分高于36分，没有面部挛缩或联动。结果：VP组总有效率（96.5%）明显优于PP组（89.7%）（P < 0.05）。通过对面瘫初始严重程度进行分类，分析患者的恢复率。在完全性或重度麻痹病例中，VP和PP治疗的恢复率分别为95.7%（n = 92）和86.6%（n = 82），VP治疗的恢复率明显优于PP（p < 0.05）。万乃洛韦和泼尼松龙治疗贝尔麻痹的疗效更好，但无疱疹性带状疱疹除外，比传统的强的松龙疗法更有效据我们所知，这是第一个对照研究的抗病毒剂治疗足够数量的贝尔麻痹病例的基础上的病因学背景。
Objective: To investigate the effects of valacyclovir and prednisolone in comparison with those of placebo and prednisolone for the treatment of Bell's palsy, excluding zoster sine herpete.Study Design: Prospective, multicenter, randomized placebo-controlled study.Setting: Six academic tertiary referral centers.Patients: Ultimately, 221 patients with Bell's palsy who were treated within 7 days of the onset. Serological and polymerase chain reaction examinations were performed to distinguish Bell's palsy from zoster sine herpete.Intervention: The patients were treated with either valacyclovir (dosage, 1,000 mg/d for 5 days) plus prednisolone (VP [n = 114]) or placebo plus prednisolone (PP [n = 107]) administered orally.Main Outcome Measure: Recovery from the palsy was defined as a score higher than 36 using Yanagihara 40-point scoring system without facial contracture or synkinesis. The patients were followed up until complete recovery occurred or for more than 6 months in cases with a poor prognosis.Results: The overall rate of patient recovery among those treated with VP (96.5%) was significantly better (p < 0.05) than the rate among those treated with PP (89.7%). The rate of patient recovery was also analyzed by classifying the initial severity of facial palsy. In cases of complete or severe palsy, the rates of patients treated with VP and PP who recovered were 95.7% (n = 92) and 86.6% (n = 82), respectively; the recovery rate for treatment with VP was significantly better than that with PP (p < 0.05).Conclusion: The valacyclovir and prednisolone therapy was more effective in treating Bell's palsy, excluding zoster sine herpete, than the conventional prednisolone therapy. To our knowledge, this is the first controlled study of an antiviral agent in the treatment of a sufficient number of Bell's palsy cases based on an etiologic background.