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成人急性非特异性下腰痛镇痛药物的疗效和安全性比较:系统评价和网络荟萃分析。

Comparative effectiveness and safety of analgesic medicines for adults with acute non-specific low back pain: systematic review and network meta-analysis.

机构信息

School of Health Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.

Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, NSW, Australia.

出版信息

BMJ. 2023 Mar 22;380:e072962. doi: 10.1136/bmj-2022-072962.

Abstract

OBJECTIVE

To evaluate the comparative effectiveness and safety of analgesic medicines for acute non-specific low back pain.

DESIGN

Systematic review and network meta-analysis.

DATA SOURCES

Medline, PubMed, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and World Health Organization's International Clinical Trials Registry Platform from database inception to 20 February 2022.

ELIGIBILITY CRITERIA FOR STUDY SELECTION

Randomised controlled trials of analgesic medicines (eg, non-steroidal anti-inflammatory drugs, paracetamol, opioids, anti-convulsant drugs, skeletal muscle relaxants, or corticosteroids) compared with another analgesic medicine, placebo, or no treatment. Adults (≥18 years) who reported acute non-specific low back pain (for less than six weeks).

DATA EXTRACTION AND SYNTHESIS

Primary outcomes were low back pain intensity (0-100 scale) at end of treatment and safety (number of participants who reported any adverse event during treatment). Secondary outcomes were low back specific function, serious adverse events, and discontinuation from treatment. Two reviewers independently identified studies, extracted data, and assessed risk of bias. A random effects network meta-analysis was done and confidence was evaluated by the Confidence in Network Meta-Analysis method.

RESULTS

98 randomised controlled trials (15 134 participants, 49% women) included 69 different medicines or combinations. Low or very low confidence was noted in evidence for reduced pain intensity after treatment with tolperisone (mean difference -26.1 (95% confidence intervals -34.0 to -18.2)), aceclofenac plus tizanidine (-26.1 (-38.5 to -13.6)), pregabalin (-24.7 (-34.6 to -14.7)), and 14 other medicines compared with placebo. Low or very low confidence was noted for no difference between the effects of several of these medicines. Increased adverse events had moderate to very low confidence with tramadol (risk ratio 2.6 (95% confidence interval 1.5 to 4.5)), paracetamol plus sustained release tramadol (2.4 (1.5 to 3.8)), baclofen (2.3 (1.5 to 3.4)), and paracetamol plus tramadol (2.1 (1.3 to 3.4)) compared with placebo. These medicines could increase the risk of adverse events compared with other medicines with moderate to low confidence. Moderate to low confidence was also noted for secondary outcomes and secondary analysis of medicine classes.

CONCLUSIONS

The comparative effectiveness and safety of analgesic medicines for acute non-specific low back pain are uncertain. Until higher quality randomised controlled trials of head-to-head comparisons are published, clinicians and patients are recommended to take a cautious approach to manage acute non-specific low back pain with analgesic medicines.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42019145257.

摘要

目的

评估急性非特异性下腰痛的镇痛药物的比较疗效和安全性。

设计

系统评价和网络荟萃分析。

数据来源

从数据库建立到 2022 年 2 月 20 日,检索了 Medline、PubMed、Embase、CINAHL、CENTRAL、ClinicalTrials.gov、clinicialtrialsregister.eu 和世界卫生组织国际临床试验注册平台。

纳入研究的标准

与另一种镇痛药、安慰剂或无治疗相比,镇痛药物(如非甾体抗炎药、对乙酰氨基酚、阿片类药物、抗惊厥药、骨骼肌松弛剂或皮质类固醇)的随机对照试验。报告急性非特异性下腰痛(<6 周)的成年患者(≥18 岁)。

数据提取和综合

主要结局是治疗结束时的腰痛强度(0-100 量表)和安全性(治疗期间报告任何不良事件的参与者人数)。次要结局是腰痛特异性功能、严重不良事件和治疗中断。两名审查员独立确定研究、提取数据并评估偏倚风险。采用随机效应网络荟萃分析,并采用网络荟萃分析置信度评估方法评估置信度。

结果

98 项随机对照试验(15134 名参与者,49%为女性)纳入了 69 种不同的药物或组合。托培司酮(治疗后疼痛强度降低 26.1(95%置信区间 -34.0 至 -18.2))、阿克洛芬酸加替扎尼定(-26.1(-38.5 至 -13.6))、普瑞巴林(-24.7(-34.6 至 -14.7))和其他 14 种药物与安慰剂相比,降低疼痛强度的证据可信度为低或极低。在几种药物的效果无差异方面,可信度为低或极低。曲马多(风险比 2.6(95%置信区间 1.5 至 4.5))、对乙酰氨基酚加缓释曲马多(2.4(1.5 至 3.8))、巴氯芬(2.3(1.5 至 3.4))和对乙酰氨基酚加曲马多(2.1(1.3 至 3.4))与安慰剂相比,增加不良事件的风险具有中等至非常低的可信度。与其他药物相比,这些药物增加不良事件风险的可信度为中等至低。对药物类别进行二次分析和次要结局也存在中等至低可信度。

结论

急性非特异性下腰痛的镇痛药物的比较疗效和安全性尚不确定。在公布更高质量的头对头比较随机对照试验之前,建议临床医生和患者谨慎使用镇痛药物治疗急性非特异性下腰痛。

系统评价注册

PROSPERO CRD42019145257。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f9a/10540836/3930afc9681a/wewm072962.f1.jpg

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