Sipe J, Dunn L
Department of Neuroimmunology, Guy's, King's and St Thomas' School of Medicine, Guy's Hospital, London, UK, SE1 9RT.
Cochrane Database Syst Rev. 2001(2):CD001869. doi: 10.1002/14651858.CD001869.
The most common disorder of the facial nerve is acute idiopathic facial paralysis or Bell's palsy and there may be significant morbidity or incomplete recovery associated with severe cases. Although the cause remains unknown, recent evidence suggests a possible association with Herpes simplex virus (HSV) infection. To test this hypothesis clinically four clinical trials have used aciclovir, an antiviral agent, either alone or in combination with corticosteroids to treat Bell's palsy.
To assess the efficacy of aciclovir for treating Bell's palsy and to evaluate any adverse effects of the drug treatment.
Search of the Cochrane Neuromuscular Disease Group register, MEDLINE, EMBASE and LILACS databases for randomised trials. We also contacted authors of identified trials.
Randomised or quasi-randomised trials of aciclovir therapy, alone or in combination with any other drug, in patients with Bell's palsy.
We identified four randomised trials. One author extracted the data and the other checked them. We wrote to all the authors of the trials identified. No additional data were obtained.
Only two studies met our inclusion criteria and provided results from 200 patients. One study evaluated aciclovir with corticosteroid versus steroid alone and the other study evaluated aciclovir alone versus corticosteroid. PRIMARY OUTCOME Proportion of patients with incomplete recovery after one year: These data were not available. However an analysis was performed on data reported at the end of the study period, three (De Diego 1998) or four months (Adour 1996) after the start of treatment. The results from the Adour study significantly favoured the treatment group whilst the De Diego study significantly favoured the control group. Adverse events: This analysis was not performed as the data were not reported. Complete facial paralysis six months after start of treatment: Only one patient had complete paralysis upon entering only one of the studies (De Diego 1998). This patient was assigned to the control group and the level of recovery attained was not reported. Motor synkinesis/Crocodile tears one year after start of treatment: Data were available up to a maximum of four months after onset of paralysis. One study reported a significant difference between the treatment groups in favour of the aciclovir group and the other demonstrated an inconclusive result.
REVIEWER'S CONCLUSIONS: More data are needed from a large multicentre randomised controlled and blinded study with at least 12 months' follow up before a definitive recommendation can be made regarding the routine use of aciclovir in Bell's palsy.
面神经最常见的疾病是急性特发性面神经麻痹或贝尔麻痹,严重病例可能会出现显著的发病率或恢复不完全的情况。尽管病因尚不清楚,但最近的证据表明可能与单纯疱疹病毒(HSV)感染有关。为了在临床上验证这一假设,四项临床试验使用了抗病毒药物阿昔洛韦单独或与皮质类固醇联合治疗贝尔麻痹。
评估阿昔洛韦治疗贝尔麻痹的疗效,并评估药物治疗的任何不良反应。
检索Cochrane神经肌肉疾病组登记册、MEDLINE、EMBASE和LILACS数据库以查找随机试验。我们还联系了已识别试验的作者。
阿昔洛韦治疗贝尔麻痹患者的随机或半随机试验,单独使用或与任何其他药物联合使用。
我们识别出四项随机试验。一位作者提取数据,另一位作者进行核对。我们写信给已识别试验的所有作者,但未获得额外数据。
只有两项研究符合我们的纳入标准,并提供了200名患者的结果。一项研究评估了阿昔洛韦联合皮质类固醇与单独使用皮质类固醇的效果,另一项研究评估了单独使用阿昔洛韦与皮质类固醇的效果。主要结局:一年后恢复不完全的患者比例:这些数据不可用。然而,对治疗开始后三个月(De Diego 1998)或四个月(Adour 1996)研究期末报告的数据进行了分析。Adour研究的结果显著有利于治疗组,而De Diego研究的结果显著有利于对照组。不良事件:由于未报告数据,未进行此项分析。治疗开始六个月后完全性面神经麻痹:只有一名患者在仅一项研究(De Diego 1998)入组时患有完全性麻痹。该患者被分配到对照组,未报告其恢复程度。治疗开始一年后运动联带运动/鳄鱼泪:数据最多可获取至麻痹发作后四个月。一项研究报告治疗组之间存在显著差异,有利于阿昔洛韦组,另一项研究结果不明确。
在就阿昔洛韦在贝尔麻痹中的常规使用做出明确推荐之前,需要来自一项至少随访12个月的大型多中心随机对照双盲研究的更多数据。