挪威奥斯陆大学附属医院Lars Christian Haugli Bråten研究小组，分析了抗生素治疗慢性腰痛和Modic改变患者的疗效（AIM研究）。相关论文2019年10月16日在线发表于《英国医学杂志》。

研究组在挪威6家医院的门诊部进行了一项双盲、平行组、安慰剂对照的多中心试验。2015年6月至2017年9月，研究组共招募了180名慢性腰痛、既往有椎间盘突出症和1型或2型椎体终板（Modic）改变的患者。将患者随机分配，分别接受口服阿莫西林或安慰剂进行治疗3个月。采用罗兰-莫里斯残疾问卷（RMDQ）评分（0-24分）对疗效进行评估。

治疗1年后，阿莫西林组和安慰剂组间RMDQ评分的差值为1.6分。二次分析中，两组间1型Modic改变患者的RMDQ评分差为-2.3分，2型Modic改变患者的RMDQ评分差为-0.1分。阿莫西林组中有56%的患者发生至少一件药物相关不良反应，安慰剂组中有31%。

该研究表明，对于慢性腰痛和既往有椎间盘突出的Modic改变的患者，与安慰剂相比，阿莫西林并不能提供更好的临床获益，二次分析和敏感性分析均支持该结论。

附：英文原文

Title: Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial

Author: Lars Christian Haugli Brten, Mads Peder Rolfsen, Ansgar Espeland, Monica Wigemyr, Jrg Amus, Anne Froholdt, Anne Julsrud Haugen, Gunn Hege Marchand, Per Martin Kristoffersen, Olav Lutro, Sigrun Randen, Maja Wilhelmsen, Bendik Slagsvold Winsvold, Thomas Istvan Kadar, Thor Einar Holmgard, Maria Dehli Vigeland, Nils Vetti, ystein Petter Nygaard, Benedicte Alexandra Lie, Christian Hellum, Audny Anke, Margreth Grotle, Elina Iordanova Schistad, Jan Sture Skouen, Lars Grvle, Jens Ivar Brox, John-Anker Zwart, Kjersti Storheim

Issue&Volume: 2019/10/16

Abstract: 

Objective To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes).

Design Double blind, parallel group, placebo controlled, multicentre trial.

Setting Hospital outpatient clinics at six hospitals in Norway.

Participants 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017.

Interventions Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription.

Main outcome measures The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4.

Results In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was −1.6 (95% confidence interval −3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was −2.3 (−4.2 to−0.4, P=0.02) for patients with type 1 Modic changes and −0.1 (−2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group.

Conclusions In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes.

DOI: 10.1136/bmj.l5654

Source: https://www.bmj.com/content/367/bmj.l5654