布洛芬联合美索巴莫、替扎尼定或巴氯芬治疗急性腰痛的随机、安慰剂对照试验。
A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain.
机构信息
Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY.
Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY.
出版信息
Ann Emerg Med. 2019 Oct;74(4):512-520. doi: 10.1016/j.annemergmed.2019.02.017. Epub 2019 Apr 5.
STUDY OBJECTIVE
Patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and skeletal muscle relaxants. We compare functional outcomes and pain among patients with acute low back pain who were randomized to a 1-week course of ibuprofen plus placebo versus ibuprofen plus 1 of 3 skeletal muscle relaxants: baclofen, metaxalone, and tizanidine.
METHODS
This was a randomized, double-blind, parallel-group, 4-arm study conducted in 2 urban emergency departments (EDs). Patients with nonradicular low back pain for less than or equal to 2 weeks were eligible if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a 24-item inventory of functional impairment caused by low back pain. All participants received 21 tablets of ibuprofen 600 mg, to be taken 3 times a day as needed. Additionally, they were randomized to baclofen 10 mg, metaxalone 400 mg, tizanidine 2 mg, or placebo. Participants were instructed to take 1 or 2 of these capsules 3 times a day as needed. All participants received a 10-minute educational session. The primary outcome was improvement on the Roland-Morris Disability Questionnaire between ED discharge and 1week later. Secondary outcomes included pain intensity 1 week after ED discharge (severe, moderate, mild, or none).
RESULTS
Three hundred twenty patients were randomized. One week later, the mean Roland-Morris Disability Questionnaire score of patients randomized to placebo improved by 11.1 points (95% confidence interval [CI] 9.0 to 13.3), baclofen by 10.6 points (95% CI 8.6 to 12.7), metaxalone by 10.1 points (95% CI 8.0 to 12.3), and tizanidine by 11.2 points (95% CI 9.2 to 13.2). At 1-week follow-up, 30% of placebo patients (95% CI 21% to 41%) reported moderate to severe low back pain versus 33% of baclofen patients (95% CI 24% to 44%), 37% of metaxalone patients (95% CI 27% to 48%), and 33% of tizanidine patients (95% CI 23% to 44%).
CONCLUSION
Adding baclofen, metaxalone, or tizanidine to ibuprofen does not appear to improve functioning or pain any more than placebo plus ibuprofen by 1 week after an ED visit for acute low back pain.
研究目的
对于腰痛患者，常采用非甾体抗炎药和骨骼肌松弛剂进行治疗。我们比较了随机接受为期 1 周治疗的急性腰痛患者的功能结局和疼痛，这些患者分别接受布洛芬加安慰剂与布洛芬加 3 种骨骼肌松弛剂中的 1 种联合治疗：巴氯芬、美沙酮和替扎尼定。
方法
这是一项在 2 家城市急诊部（ED）进行的随机、双盲、平行分组 4 臂研究。如果患者的 Roland-Morris 残疾问卷评分大于 5（24 项与腰痛相关的功能障碍评估问卷），且腰痛持续时间少于或等于 2 周，则认为其患有非神经根性腰痛，符合纳入标准。所有参与者均接受 21 片布洛芬 600mg，按需每日 3 次服用。此外，他们被随机分为巴氯芬 10mg、美沙酮 400mg、替扎尼定 2mg 或安慰剂组。指导参与者按需每日服用 1 或 2 粒这些胶囊。所有参与者均接受了 10 分钟的教育课程。主要结局是 ED 出院后 1 周时 Roland-Morris 残疾问卷的改善情况。次要结局包括 ED 出院后 1 周时的疼痛强度（严重、中度、轻度或无）。
结果
共 320 名患者被随机分组。1 周后，接受安慰剂治疗的患者的 Roland-Morris 残疾问卷评分平均改善 11.1 分（95%置信区间 [CI] 9.0 至 13.3），巴氯芬组改善 10.6 分（95%CI 8.6 至 12.7），美沙酮组改善 10.1 分（95%CI 8.0 至 12.3），替扎尼定组改善 11.2 分（95%CI 9.2 至 13.2）。在 1 周随访时，30%的安慰剂组患者（95%CI 21%至 41%）报告腰痛为中度至重度，而巴氯芬组为 33%（95%CI 24%至 44%），美沙酮组为 37%（95%CI 27%至 48%），替扎尼定组为 33%（95%CI 23%至 44%）。
结论
在 ED 就诊治疗急性腰痛后 1 周，与布洛芬加安慰剂相比，加用巴氯芬、美沙酮或替扎尼定似乎并不能改善功能或疼痛。
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