慢性下腰痛伴椎体骨水肿（Modic 型 1 改变）患者的抗生素治疗：疗效的双盲随机对照临床试验。
Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy.
机构信息
Research Department, Spine Centre of Southern Denmark, Institute of Regional Health Services Research, Lillebaelt Hospital, University of Southern Denmark, Middelfart, Denmark.
出版信息
Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13.
PURPOSE
Modic type 1 changes/bone edema in the vertebrae are present in 6 % of the general population and 35-40 % of the low back pain population. It is strongly associated with low back pain. The aim was to test the efficacy of antibiotic treatment in patients with chronic low back pain (>6 months) and Modic type 1 changes (bone edema).
METHODS
The study was a double-blind RCT with 162 patients whose only known illness was chronic LBP of greater than 6 months duration occurring after a previous disc herniation and who also had bone edema demonstrated as Modic type 1 changes in the vertebrae adjacent to the previous herniation. Patients were randomized to either 100 days of antibiotic treatment (Bioclavid) or placebo and were blindly evaluated at baseline, end of treatment and at 1-year follow-up.
OUTCOME MEASURES
Primary outcome, disease-specific disability, lumbar pain. Secondary outcome leg pain, number of hours with pain last 4 weeks, global perceived health, EQ-5D thermometer, days with sick leave, bothersomeness, constant pain, magnetic resonance image (MRI).
RESULTS
144 of the 162 original patients were evaluated at 1-year follow-up. The two groups were similar at baseline. The antibiotic group improved highly statistically significantly on all outcome measures and improvement continued from 100 days follow-up until 1-year follow-up. At baseline, 100 days follow-up, 1-year follow-up the disease-specific disability-RMDQ changed: antibiotic 15, 11, 5.7; placebo 15, 14, 14. Leg pain: antibiotics 5.3, 3.0, 1.4; placebo 4.0, 4.3, 4.3. Lumbar pain: antibiotics 6.7, 5.0, 3.7; placebo 6.3, 6.3, 6.3. For the outcome measures, where a clinically important effect size was defined, improvements exceeded the thresholds, and a trend towards a dose-response relationship with double dose antibiotics being more efficacious.
CONCLUSIONS
The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.
目的
在一般人群中，有 6%的人存在椎体 Modic 1 型改变/骨水肿，在腰痛人群中，这一比例为 35-40%。它与腰痛密切相关。本研究旨在检测抗生素治疗对慢性腰痛（>6 个月）和 Modic 1 型改变（骨水肿）患者的疗效。
方法
这是一项双盲 RCT 研究，纳入 162 例患者，这些患者唯一已知的疾病是慢性腰痛，持续时间超过 6 个月，并且在先前的椎间盘突出症后出现椎体邻近的 Modic 1 型改变的骨水肿。患者被随机分为抗生素治疗组（100 天使用 Bioclavid）或安慰剂组，并在基线、治疗结束时和 1 年随访时进行盲法评估。
结局测量
主要结局为疾病特异性残疾、腰痛。次要结局为腿痛、过去 4 周疼痛的小时数、总体健康感知、EQ-5D 温度计、病假天数、困扰程度、持续疼痛、磁共振成像（MRI）。
结果
162 例患者中有 144 例在 1 年随访时进行了评估。两组在基线时相似。抗生素组在所有结局测量上均有高度统计学意义的改善，且这种改善从 100 天随访持续到 1 年随访。在基线时、100 天随访时、1 年随访时，疾病特异性残疾-RMDQ 改变：抗生素组 15、11、5.7；安慰剂组 15、14、14。腿痛：抗生素组 5.3、3.0、1.4；安慰剂组 4.0、4.3、4.3。腰痛：抗生素组 6.7、5.0、3.7；安慰剂组 6.3、6.3、6.3。对于定义了有临床意义的效应大小的结局测量，改善程度超过了阈值，并且存在与双剂量抗生素更有效相关的剂量反应关系趋势。
结论
与安慰剂相比，本研究中的抗生素方案对伴有 Modic I 的慢性腰痛患者（CLBP）的所有主要和次要结局均更有效。
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