普瑞巴林治疗急性和慢性坐骨神经痛的试验。

Trial of Pregabalin for Acute and Chronic Sciatica.

机构信息

From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).

出版信息

N Engl J Med. 2017 Mar 23;376(12):1111-1120. doi: 10.1056/NEJMoa1614292.

DOI:10.1056/NEJMoa1614292

PMID:28328324

Abstract

BACKGROUND

Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica.

METHODS

We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year.

RESULTS

A total of 209 patients underwent randomization, of whom 108 received pregabalin and 101 received placebo; after randomization, 2 patients in the pregabalin group were determined to be ineligible and were excluded from the analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 95% confidence interval [CI], -0.2 to 1.2; P=0.19). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0 in the placebo group (adjusted mean difference, 0.3; 95% CI, -0.5 to 1.0; P=0.46). No significant between-group differences were observed with respect to any secondary outcome at either week 8 or week 52. A total of 227 adverse events were reported in the pregabalin group and 124 in the placebo group. Dizziness was more common in the pregabalin group than in the placebo group.

CONCLUSIONS

Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group. (Funded by the National Health and Medical Research Council of Australia; PRECISE Australian and New Zealand Clinical Trials Registry number, ACTRN12613000530729 .).

摘要

背景

坐骨神经痛可能会使人丧失活动能力，而有关医学治疗的证据有限。普瑞巴林可有效治疗某些类型的神经病理性疼痛。本研究旨在探讨普瑞巴林是否可减轻坐骨神经痛的严重程度。

方法

我们开展了一项针对坐骨神经痛患者的随机、双盲、安慰剂对照试验，将患者随机分配至每日接受 150 毫克普瑞巴林治疗组（可调整至每日最高 600 毫克）或匹配安慰剂组，治疗时间最长为 8 周。主要结局为第 8 周时腿部疼痛强度评分（10 分制，0 分表示无痛，10 分表示疼痛最剧烈）；次要结局为第 52 周时的腿部疼痛强度评分，这是主要结局的次要时间点。次要结局还包括在 1 年期间的特定时间点评估残疾程度、背痛强度和生活质量。

结果

共有 209 名患者接受了随机分组，其中 108 名患者接受普瑞巴林治疗，101 名患者接受安慰剂治疗；随机分组后，普瑞巴林组中有 2 名患者被确定不符合纳入标准，因此被排除在分析之外。第 8 周时，普瑞巴林组的平均未调整腿部疼痛强度评分为 3.7 分，安慰剂组为 3.1 分（调整后平均差异，0.5；95%置信区间[CI]，-0.2 至 1.2；P=0.19）。第 52 周时，普瑞巴林组的平均未调整腿部疼痛强度评分为 3.4 分，安慰剂组为 3.0 分（调整后平均差异，0.3；95%CI，-0.5 至 1.0；P=0.46）。在第 8 周和第 52 周时，与安慰剂相比，普瑞巴林组在任何次要结局上均未观察到显著的组间差异。普瑞巴林组报告了 227 例不良事件，安慰剂组报告了 124 例。与安慰剂组相比，普瑞巴林组更常出现头晕。