口服类固醇治疗腕管综合征的随机临床试验：长期随访
A randomised clinical trial of oral steroids in the treatment of carpal tunnel syndrome: a long term follow up.
作者信息
Chang M-H, Ger L-P, Hsieh P F, Huang S-Y
机构信息
Section of Neurology, Taichung Veterans General Hospital and Department of Neurology, National Yang-Ming University, Taipei, Taiwan.
出版信息
J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):710-4. doi: 10.1136/jnnp.73.6.710.
OBJECTIVES
To determine the efficacy of a two week and a four week course of oral steroids in the conservative treatment of carpal tunnel syndrome.
METHODS
109 patients with carpal tunnel syndrome were randomly divided into two treatment groups: (1) two weeks of prednisolone 20 mg daily followed by two weeks of prednisolone 10 mg daily (n = 53); (2) two weeks of prednisolone 20 mg daily and two weeks of placebo (n = 56). A symptom questionnaire was used to rate the five major symptoms of carpal tunnel syndrome (numbness, pain, weakness/clumsiness, tingling, and nocturnal awakening) on a scale of 0 (nil) to 10 (severe); the resulting global symptom score was used to evaluate the efficacy of treatment. Assessments were made at baseline and at one, three, six, nine, and 12 months. Electrodiagnosis was repeated at the end of the study to validate improvement.
RESULTS
In an intention to treat analysis at the end of the study, improvement in the four week treatment group was achieved in 66.0% of the patients after one month and in 49.0% at the end of the study; in the two week treatment group, the respective values were 48.2% and 35.7%. In the four week treatment group, 51% were considered treatment failures (including those lost to follow up, receiving surgery, or with mild or no improvement), compared with 64.3% for the two week group. Though the percentage improvement was higher in the four week group, the difference did not reach a statistical significance. Persistence of improvement was 74.2% in the four week group v 74.1% in the two week group, suggesting no difference in the long term effect. Efficacy analysis showed no significant difference in global symptom score reduction between the two groups. Follow up electrodiagnosis showed significant improvement in all measured variables except for the amplitude of compound muscle action potentials.
CONCLUSIONS
Short term low dose oral steroid are effective treatment for carpal tunnel syndrome. The dose of steroids and the duration treatment are not key determinants of efficacy.
目的
确定为期两周和四周的口服类固醇疗程在保守治疗腕管综合征中的疗效。
方法
109例腕管综合征患者被随机分为两个治疗组：（1）每日服用泼尼松龙20mg，持续两周，随后每日服用泼尼松龙10mg，持续两周（n = 53）；（2）每日服用泼尼松龙20mg，持续两周，随后服用两周安慰剂（n = 56）。使用症状问卷对腕管综合征的五种主要症状（麻木、疼痛、无力/笨拙、刺痛和夜间觉醒）进行评分，评分范围为0（无）至10（严重）；所得的总体症状评分用于评估治疗效果。在基线以及1、3、6、9和12个月时进行评估。在研究结束时重复进行电诊断以验证改善情况。
结果
在研究结束时的意向性分析中，四周治疗组在一个月后有66.0%的患者病情得到改善，在研究结束时为49.0%；在两周治疗组中，相应的值分别为48.2%和35.7%。在四周治疗组中，51%被视为治疗失败（包括失访、接受手术或改善轻微或无改善的患者），而两周治疗组为64.3%。尽管四周治疗组的改善百分比更高，但差异未达到统计学意义。四周治疗组的改善持续率为74.2%，两周治疗组为74.1%，表明长期效果无差异。疗效分析显示两组在总体症状评分降低方面无显著差异。随访电诊断显示除复合肌肉动作电位幅度外，所有测量变量均有显著改善。
结论
短期低剂量口服类固醇是治疗腕管综合征的有效方法。类固醇的剂量和治疗持续时间不是疗效的关键决定因素。
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