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用于急性下背痛的非甾体抗炎药。

Non-steroidal anti-inflammatory drugs for acute low back pain.

作者信息

van der Gaag Wendelien H, Roelofs Pepijn Ddm, Enthoven Wendy Tm, van Tulder Maurits W, Koes Bart W

机构信息

Erasmus Medical Center, Department of General Practice, Rotterdam, Netherlands.

University Medical Center Groningen, University of Groningen, Department of Health Sciences, Community and Occupational Medicine, Groningen, Netherlands.

出版信息

Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD013581. doi: 10.1002/14651858.CD013581.

Abstract

BACKGROUND

Acute low back pain (LBP) is a common health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used in the treatment of LBP, particularly in people with acute LBP. In 2008, a Cochrane Review was published about the efficacy of NSAIDs for LBP (acute, chronic, and sciatica), identifying a small but significant effect in favour of NSAIDs compared to placebo for short-term pain reduction and global improvement in participants with acute LBP. This is an update of the previous review, focusing on acute LBP.

OBJECTIVES

To assess the effects of NSAIDs compared to placebo and other comparison treatments for acute LBP.

SEARCH METHODS

We searched CENTRAL, MEDLINE, Embase, PubMed, and two trials registers for randomised controlled trials (RCT) to 7 January 2020. We also screened the reference lists from relevant reviews and included studies.

SELECTION CRITERIA

We included RCTs that assessed the use of one or more types of NSAIDs compared to placebo (the main comparison) or alternative treatments for acute LBP in adults (≥ 18 years); conducted in both primary and secondary care settings. We assessed the effects of treatment on pain reduction, disability, global improvement, adverse events, and return to work.

DATA COLLECTION AND ANALYSIS

Two review authors independently selected trials to be included in this review, evaluated the risk of bias, and extracted the data. If appropriate, we performed a meta-analysis, using a random-effects model throughout, due to expected variability between studies. We assessed the quality of the evidence using the GRADE approach. We used standard methodological procedures recommended by Cochrane.

MAIN RESULTS

We included 32 trials, with a total of 5356 participants (age range 16 to 78 years). Follow-up ranged from one day to six months. Studies were conducted across the globe, the majority taking place in Europe and North-America. Africa and the Eastern Mediterranean region were not represented. We considered seven studies at low risk of bias. Performance and attrition were the most common biases. There was often a lack of information on randomisation procedures and allocation concealment (selection bias); studies were prone to selective reporting bias, since most studies did not register their trials. Almost half of the studies were industry-funded. There is moderate quality evidence that NSAIDs are slightly more effective in short-term (≤ 3 weeks) reduction of pain intensity (visual analogue scale (VAS), 0 to 100) than placebo (mean difference (MD) -7.29 (95% confidence interval (CI) -10.98 to -3.61; 4 RCTs, N = 815). There is high quality evidence that NSAIDs are slightly more effective for short-term improvement in disability (Roland Morris Disability Questionnaire (RMDQ), 0 to 24) than placebo (MD -2.02, 95% CI -2.89 to -1.15; 2 RCTs, N = 471). The magnitude of these effects is small and probably not clinically relevant. There is low quality evidence that NSAIDs are slightly more effective for short-term global improvement than placebo (risk ratio (RR) 1.40, 95% CI 1.12 to 1.75; 5 RCTs, N = 1201), but there was substantial heterogeneity (I² 52%) between studies. There is very low quality evidence of no clear difference in the proportion of participants experiencing adverse events when using NSAIDs compared to placebo (RR 0.86, 95% CI 0.63 to 1.18; 6 RCTs, N = 1394). There is very low quality evidence of no clear difference between the proportion of participants who could return to work after seven days between those who used NSAIDs and those who used placebo (RR 1.48, 95% CI 0.98 to 2.23; 1 RCT, N = 266). There is low quality evidence of no clear difference in short-term reduction of pain intensity between those who took selective COX-2 inhibitor NSAIDs compared to non-selective NSAIDs (mean change from baseline -2.60, 95% CI -9.23 to 4.03; 2 RCTs, N = 437). There is moderate quality evidence of conflicting results for short-term disability improvement between groups (2 RCTs, N = 437). Low quality evidence from one trial (N = 333) reported no clear difference between groups in the proportion of participants experiencing global improvement. There is very low quality evidence of no clear difference in the proportion of participants experiencing adverse events between those who took COX-2 inhibitors and non-selective NSAIDs (RR 0.97, 95% CI 0.63 to 1.50; 2 RCTs, N = 444). No data were reported for return to work.

AUTHORS' CONCLUSIONS: This updated Cochrane Review included 32 trials to evaluate the efficacy of NSAIDs in people with acute LBP. The quality of the evidence ranged from high to very low, thus further research is (very) likely to have an important impact on our confidence in the estimates of effect, and may change the estimates. NSAIDs seemed slightly more effective than placebo for short-term pain reduction (moderate certainty), disability (high certainty), and global improvement (low certainty), but the magnitude of the effects is small and probably not clinically relevant. There was no clear difference in short-term pain reduction (low certainty) when comparing selective COX-2 inhibitors to non-selective NSAIDs. We found very low evidence of no clear difference in the proportion of participants experiencing adverse events in both the comparison of NSAIDs versus placebo and selective COX-2 inhibitors versus non-selective NSAIDs. We were unable to draw conclusions about adverse events and the safety of NSAIDs for longer-term use, since we only included RCTs with a primary focus on short-term use of NSAIDs and a short follow-up. These are not optimal for answering questions about longer-term or rare adverse events.

摘要

背景

急性下背痛(LBP)是一个常见的健康问题。非甾体抗炎药(NSAIDs)常用于LBP的治疗,尤其是急性LBP患者。2008年,发表了一篇关于NSAIDs治疗LBP(急性、慢性和坐骨神经痛)疗效的Cochrane系统评价,发现与安慰剂相比,NSAIDs在短期减轻急性LBP患者疼痛和整体改善方面有小但显著的效果。这是之前评价的更新版,重点关注急性LBP。

目的

评估NSAIDs与安慰剂及其他对照治疗相比对急性LBP的效果。

检索方法

我们检索了CENTRAL、MEDLINE、Embase、PubMed以及两个试验注册库,纳入截至2020年1月7日的随机对照试验(RCT)。我们还筛选了相关综述和纳入研究的参考文献列表。

选择标准

我们纳入了评估一种或多种NSAIDs与安慰剂(主要对照)或成人(≥18岁)急性LBP替代治疗相比的RCT;研究在初级和二级医疗机构中进行。我们评估了治疗对疼痛减轻、残疾、整体改善、不良事件和恢复工作的影响。

数据收集与分析

两位综述作者独立选择纳入本综述的试验,评估偏倚风险,并提取数据。如果合适,我们进行了Meta分析,由于研究间预期存在变异性,全程使用随机效应模型。我们使用GRADE方法评估证据质量。我们采用Cochrane推荐的标准方法程序。

主要结果

我们纳入了32项试验,共5356名参与者(年龄范围16至78岁)。随访时间从1天到6个月不等。研究在全球范围内开展,大多数在欧洲和北美进行。非洲和东地中海地区没有研究纳入。我们认为7项研究偏倚风险较低。实施和失访是最常见的偏倚。随机化程序和分配隐藏(选择偏倚)方面往往缺乏信息;研究容易出现选择性报告偏倚,因为大多数研究未注册其试验。几乎一半的研究由行业资助。有中等质量证据表明,NSAIDs在短期(≤3周)减轻疼痛强度(视觉模拟量表(VAS),0至100)方面比安慰剂略有效(平均差(MD)-7.29(95%置信区间(CI)-10.98至-3.61;4项RCT,N = 815)。有高质量证据表明,NSAIDs在短期改善残疾(罗兰·莫里斯残疾问卷(RMDQ),0至24)方面比安慰剂略有效(MD -2.02,95%CI -2.89至-1.15;2项RCT,N = 471)。这些效果的幅度较小,可能无临床意义。有低质量证据表明,NSAIDs在短期整体改善方面比安慰剂略有效(风险比(RR)1.40,95%CI 1.12至1.75;5项RCT,N = 1201),但研究间存在较大异质性(I² 52%)。有极低质量证据表明,使用NSAIDs与安慰剂相比,经历不良事件的参与者比例无明显差异(RR 0.86,95%CI 0.63至1.18;6项RCT,N = 1394)。有极低质量证据表明,使用NSAIDs与安慰剂的参与者在7天后恢复工作的比例无明显差异(RR 1.48,95%CI 0.98至2.23;1项RCT,N = 266)。有低质量证据表明,服用选择性COX-2抑制剂NSAIDs与非选择性NSAIDs相比,在短期减轻疼痛强度方面无明显差异(从基线的平均变化-2.60,95%CI -9.23至4.03;2项RCT,N = 437)。有中等质量证据表明,两组在短期残疾改善方面结果相互矛盾(2项RCT,N = 437)。一项试验(N = 333)的低质量证据报告,两组在经历整体改善的参与者比例方面无明显差异。有极低质量证据表明,服用COX-2抑制剂与非选择性NSAIDs的参与者在经历不良事件的比例方面无明显差异(RR 0.97,95%CI 0.63至1.50;2项RCT,N = 444)。未报告恢复工作的数据。

作者结论

这项更新的Cochrane系统评价纳入了32项试验,以评估NSAIDs对急性LBP患者的疗效。证据质量从高到极低不等,因此进一步研究很可能对我们对效应估计的信心产生重要影响,并且可能改变估计值。NSAIDs在短期减轻疼痛(中等确定性)、残疾(高确定性)和整体改善(低确定性)方面似乎比安慰剂略有效,但效果幅度较小,可能无临床意义。比较选择性COX-2抑制剂与非选择性NSAIDs时,在短期减轻疼痛方面无明显差异(低确定性)。我们发现,在NSAIDs与安慰剂比较以及选择性COX-2抑制剂与非选择性NSAIDs比较中,经历不良事件的参与者比例无明显差异的证据质量极低。由于我们仅纳入了主要关注NSAIDs短期使用和短期随访的RCT,因此无法得出关于NSAIDs长期使用的不良事件和安全性的结论。这些对于回答关于长期或罕见不良事件的问题并非最佳选择。

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