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甲泼尼龙注射治疗腕管综合征:一项随机、安慰剂对照试验。

Methylprednisolone injections for the carpal tunnel syndrome: a randomized, placebo-controlled trial.

出版信息

Ann Intern Med. 2013 Sep 3;159(5):309-17. doi: 10.7326/0003-4819-159-5-201309030-00004.

DOI:10.7326/0003-4819-159-5-201309030-00004
PMID:24026316
Abstract

BACKGROUND

Steroid injections are used in idiopathic carpal tunnel syndrome (CTS), but evidence of efficacy beyond 1 month is lacking.

OBJECTIVE

To assess the efficacy of local methylprednisolone injections in CTS.

DESIGN

Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT00806871).

SETTING

Regional referral orthopedic department in Sweden.

PATIENTS

Patients aged 18 to 70 years with CTS but no previous steroid injections.

INTERVENTION

Three groups (37 patients each) received 80 mg of methylprednisolone, 40 mg of methylprednisolone, or placebo. The patients and treating surgeons were blinded.

MEASUREMENTS

Primary end points were the change in CTS symptom severity scores at 10 weeks (range, 1 to 5) and rate of surgery at 1 year. Three patients had missing 10-week data. All patients had 1-year data.

RESULTS

Improvement in CTS symptom severity scores at 10 weeks was greater in patients who received 80 mg of methylprednisolone and 40 mg of methylprednisolone than in those who received placebo (difference in change from baseline, -0.64 [95% CI, -1.06 to -0.21; P = 0.003] and -0.88 [CI, -1.30 to -0.46; P < 0.001], respectively), but there were no significant differences at 1 year. The 1-year rates of surgery were 73%, 81%, and 92% in the 80-mg methylprednisolone, 40-mg methylprednisolone, and placebo groups, respectively. Compared with patients who received placebo, those who received 80 mg of methylprednisolone were less likely to have surgery (odds ratio, 0.24 [CI, 0.06 to 0.95]; P = 0.042). With time to surgery incorporated, both the 80- and 40-mg methylprednisolone groups had lower likelihood of surgery (hazard ratio, 0.46 [CI, 0.27 to 0.77; P = 0.003] and 0.57 [CI, 0.35 to 0.94; P = 0.026], respectively).

LIMITATION

The study was conducted at 1 center, and wrist splinting had previously failed for all patients.

CONCLUSION

Methylprednisolone injections for CTS have significant benefits in relieving symptoms at 10 weeks and reducing the rate of surgery 1 year after treatment, but 3 out of 4 patients had surgery within 1 year.

PRIMARY FUNDING SOURCE

Region of Scania Research and Development Foundation and Hässleholm Hospital Organization.

摘要

背景

类固醇注射被用于特发性腕管综合征(CTS),但缺乏 1 个月以上疗效的证据。

目的

评估局部甲基强的松龙注射治疗 CTS 的疗效。

设计

随机、安慰剂对照试验。(ClinicalTrials.gov:NCT00806871)。

地点

瑞典地区转诊矫形科。

患者

年龄在 18 至 70 岁之间,患有 CTS,但无既往类固醇注射史。

干预

三组(每组 37 例)分别接受 80mg 甲基强的松龙、40mg 甲基强的松龙或安慰剂。患者和治疗外科医生均设盲。

测量

主要终点是治疗后 10 周 CTS 症状严重程度评分的变化(范围为 1 至 5)和 1 年时的手术率。3 名患者缺失 10 周数据。所有患者均有 1 年的数据。

结果

接受 80mg 甲基强的松龙和 40mg 甲基强的松龙治疗的患者与接受安慰剂治疗的患者相比,在 10 周时 CTS 症状严重程度评分的改善更为明显(从基线的变化差异,-0.64[95%CI,-1.06 至-0.21;P=0.003]和-0.88[CI,-1.30 至-0.46;P<0.001]),但在 1 年时无显著差异。80mg 甲基强的松龙、40mg 甲基强的松龙和安慰剂组的 1 年手术率分别为 73%、81%和 92%。与接受安慰剂治疗的患者相比,接受 80mg 甲基强的松龙治疗的患者手术可能性较低(比值比,0.24[CI,0.06 至 0.95];P=0.042)。纳入手术时间后,80mg 和 40mg 甲基强的松龙组的手术可能性均较低(风险比,0.46[CI,0.27 至 0.77;P=0.003]和 0.57[CI,0.35 至 0.94;P=0.026])。

局限性

该研究仅在 1 个中心进行,所有患者此前腕部夹板治疗均失败。

结论

甲基强的松龙注射治疗 CTS 在缓解症状方面有显著的 10 周益处,并降低治疗后 1 年的手术率,但 4 分之 3 的患者在 1 年内进行了手术。

主要资金来源

斯卡尼亚研究与发展基金会和哈瑟勒霍尔姆医院组织。

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