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[慢性非癌性疼痛中的阿片类药物——阿片类药物有区别吗?对至少为期四周的阿片类药物随机直接比较中的疗效、耐受性和安全性进行的系统评价与荟萃分析]

[Opioids in chronic noncancer pain-are opioids different? A systematic review and meta-analysis of efficacy, tolerability and safety in randomized head-to-head comparisons of opioids of at least four week's duration].

作者信息

Lauche R, Klose P, Radbruch L, Welsch P, Häuser W

机构信息

Abteilung für Naturheilkunde und Integrative Medizin, Kliniken Essen-Mitte, Medizinische Fakultät, Universität Duisburg-Essen, Essen, Deutschland.

出版信息

Schmerz. 2015 Feb;29(1):73-84. doi: 10.1007/s00482-014-1432-4.

DOI:10.1007/s00482-014-1432-4
PMID:25376545
Abstract

BACKGROUND

We updated a systematic review on the comparative efficacy, tolerability and safety of opioids and of their routes of application in chronic noncancer pain (CNCP).

METHODS

We screened MEDLINE, Scopus and the Cochrane Central Register of Controlled Trials (CENTRAL) up until October 2013, as well as the reference sections of original studies and systematic reviews of randomized controlled trials (RCTs) of opioids in CNCP. We included randomized head-to-head comparisons of opioids (opioid of the sponsor of the study versus standard opioid) of at least 4 week's duration. Using a random effects model, absolute risk differences (RD) were calculated for categorical data and standardized mean differences (SMD) for continuous variables. The quality of evidence was rated by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

RESULTS

We included 13 RCTs with 6748 participants. Median study duration was 15 weeks (range 4-56 weeks). Hydromorphone, morphine, oxymorphone and tapentadol were compared to oxycodone; fentanyl to morphine and buprenorphine to tramadol. In pooled analysis, there were no significant differences between the two groups of opioids in terms of mean pain reduction (low-quality evidence), the patient global impression to be much or very much improved outcome (low-quality evidence), physical function (very low-quality evidence), serious adverse events (moderate-quality evidence) or mortality (moderate-quality evidence). There was no significant difference between transdermal and oral application of opioids in terms of mean pain reduction, physical function, serious adverse events, mortality (all low-quality evidence) or dropout due to adverse events (very low-quality).

CONCLUSION

Pooled head-to-head comparisons of opioids (opioid of the sponsor of the study versus standard opioid) provide no rational for preferring one opioid and/or administration route over another in the therapy of patients with CNCP. The English full-text version of this article is freely available at SpringerLink (under "Supplemental").

摘要

背景

我们更新了一项关于阿片类药物及其应用途径在慢性非癌性疼痛(CNCP)中的比较疗效、耐受性和安全性的系统评价。

方法

我们检索了截至2013年10月的MEDLINE、Scopus和Cochrane对照试验中央注册库(CENTRAL),以及阿片类药物在CNCP中的原始研究和随机对照试验(RCT)系统评价的参考文献部分。我们纳入了至少为期4周的阿片类药物随机头对头比较(研究主办方的阿片类药物与标准阿片类药物)。使用随机效应模型,计算分类数据的绝对风险差异(RD)和连续变量的标准化均值差异(SMD)。证据质量采用推荐分级、评估、制定与评价(GRADE)方法进行评级。

结果

我们纳入了13项RCT,共6748名参与者。研究的中位持续时间为15周(范围4 - 56周)。将氢吗啡酮、吗啡、羟吗啡酮和曲马多与羟考酮进行比较;芬太尼与吗啡比较,丁丙诺啡与曲马多比较。在汇总分析中,两组阿片类药物在平均疼痛减轻(低质量证据)、患者总体印象为明显或非常明显改善的结局(低质量证据)、身体功能(极低质量证据)、严重不良事件(中等质量证据)或死亡率(中等质量证据)方面无显著差异。在平均疼痛减轻、身体功能、严重不良事件、死亡率(均为低质量证据)或因不良事件导致的退出率(极低质量)方面,阿片类药物的经皮给药和口服给药之间无显著差异。

结论

阿片类药物(研究主办方的阿片类药物与标准阿片类药物)的汇总头对头比较结果表明,在CNCP患者的治疗中,没有理由优先选择一种阿片类药物和/或给药途径而不是另一种。本文的英文全文版本可在SpringerLink(在“补充材料”下)免费获取。

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本文引用的文献

1
[Opioids in chronic osteoarthritis pain. A systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks duration].[阿片类药物用于慢性骨关节炎疼痛。对至少持续4周的随机安慰剂对照研究中的疗效、耐受性和安全性进行的系统评价与荟萃分析]
Schmerz. 2015 Feb;29(1):47-59. doi: 10.1007/s00482-014-1451-1.
2
A Model-Based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-Malignant Pain.基于模型的荟萃分析比较曲马多和酒石酸布托啡诺用于治疗慢性非恶性疼痛的疗效和耐受性。
Pain Ther. 2014 Jun;3(1):31-44. doi: 10.1007/s40122-014-0023-5. Epub 2014 Feb 13.
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羟考酮/纳洛酮与曲马多在伴有神经病理性成分的慢性下腰痛中的疗效与耐受性平衡:一项对12周前瞻性开放标签观察中随机选取的常规数据的盲终点分析
J Pain Res. 2016 Nov 11;9:1001-1020. doi: 10.2147/JPR.S112418. eCollection 2016.
4
Quality of life under oxycodone/naloxone, oxycodone, or morphine treatment for chronic low back pain in routine clinical practice.在常规临床实践中,羟考酮/纳洛酮、羟考酮或吗啡治疗慢性下腰痛的生活质量。
Int J Gen Med. 2016 Feb 24;9:39-51. doi: 10.2147/IJGM.S94685. eCollection 2016.
5
[S3 guidelines on long-term opioid treatment in non-cancer pain. Recommendations for opioid use in clinical rheumatology].[S3非癌性疼痛长期阿片类药物治疗指南。临床风湿病学中阿片类药物使用的建议]
Z Rheumatol. 2016 Mar;75(2):128-32. doi: 10.1007/s00393-015-1686-y.
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[Opioids for noncancer pain in the elderly].[老年人非癌性疼痛的阿片类药物治疗]
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Schmerz. 2015 Feb;29(1):109-30. doi: 10.1007/s00482-014-1463-x.
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Schmerz. 2015 Feb;29(1):96-108. doi: 10.1007/s00482-014-1452-0.
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[Methodology of the development of the updated LONTS guidelines for long-term administration of opioids in noncancer pain].[更新后的非癌性疼痛长期使用阿片类药物的LONTS指南制定方法]
Schmerz. 2015 Feb;29(1):8-34. doi: 10.1007/s00482-014-1462-y.
Opioids compared to placebo or other treatments for chronic low-back pain.
与安慰剂或其他治疗方法相比,阿片类药物用于治疗慢性腰痛。
Cochrane Database Syst Rev. 2013 Aug 27;2013(8):CD004959. doi: 10.1002/14651858.CD004959.pub4.
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J Pain Res. 2013 Jul 4;6:513-29. doi: 10.2147/JPR.S47182. Print 2013.
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Expert Opin Pharmacother. 2013 Feb;14(3):269-77. doi: 10.1517/14656566.2013.767331.
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Pain Physician. 2013 Jan;16(1):27-40.
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Pain Med. 2013 Jan;14(1):75-83. doi: 10.1111/pme.12011.
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Eur J Pain. 2013 Jan;17(1):5-15. doi: 10.1002/j.1532-2149.2012.00170.x. Epub 2012 May 28.
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Systematic review of efficacy and safety of buprenorphine versus fentanyl or morphine in patients with chronic moderate to severe pain.系统评价布比卡因与芬太尼或吗啡治疗慢性中重度疼痛患者的疗效和安全性。
Curr Med Res Opin. 2012 May;28(5):833-45. doi: 10.1185/03007995.2012.678938. Epub 2012 Apr 25.