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布洛芬和/或对乙酰氨基酚用于拔除下颌智齿后的止痛。

Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth.

作者信息

Bailey Edmund, Worthington Helen V, van Wijk Arjen, Yates Julian M, Coulthard Paul, Afzal Zahid

机构信息

Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Coupland III Building, Oxford Road, Manchester, UK, M13 9PL.

出版信息

Cochrane Database Syst Rev. 2013 Dec 12;2013(12):CD004624. doi: 10.1002/14651858.CD004624.pub2.


DOI:10.1002/14651858.CD004624.pub2
PMID:24338830
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11561150/
Abstract

BACKGROUND: Both paracetamol and ibuprofen are commonly used analgesics for the relief of pain following the surgical removal of lower wisdom teeth (third molars). In 2010, a novel analgesic (marketed as Nuromol) containing both paracetamol and ibuprofen in the same tablet was launched in the United Kingdom, this drug has shown promising results to date and we have chosen to also compare the combined drug with the single drugs using this model. In this review we investigated the optimal doses of both paracetamol and ibuprofen via comparison of both and via comparison with the novel combined drug. We have taken into account the side effect profile of the study drugs. This review will help oral surgeons to decide on which analgesic to prescribe following wisdom tooth removal. OBJECTIVES: To compare the beneficial and harmful effects of paracetamol, ibuprofen and the novel combination of both in a single tablet for pain relief following the surgical removal of lower wisdom teeth, at different doses and administered postoperatively. SEARCH METHODS: We searched the Cochrane Oral Health Group'sTrials Register (to 20 May 2013); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 4); MEDLINE via OVID (1946 to 20 May 2013); EMBASE via OVID (1980 to 20 May 2013) and the metaRegister of Controlled Trials (to 20 May 2013). We checked the bibliographies of relevant clinical trials and review articles for further studies. We wrote to authors of the identified randomised controlled trials (RCTs), and searched personal references in an attempt to identify unpublished or ongoing RCTs. No language restriction was applied to the searches of the electronic databases. SELECTION CRITERIA: Only randomised controlled double-blinded clinical trials were included. Cross-over studies were included provided there was a wash out period of at least 14 days. There had to be a direct comparison in the trial of two or more of the trial drugs at any dosage. All trials used the third molar pain model. DATA COLLECTION AND ANALYSIS: All trials identified were scanned independently and in duplicate by two review authors, any disagreements were resolved by discussion, or if necessary a third review author was consulted. The proportion of patients with at least 50% pain relief (based on total pain relief (TOTPAR) and summed pain intensity difference (SPID) data) was calculated for all three drugs at both two and six hours postdosing and meta-analysed for comparison. The proportion of participants using rescue medication over both six and eight hours was also collated and compared. The number of patients experiencing adverse events or the total number of adverse events reported or both were analysed for comparison. MAIN RESULTS: Seven studies were included, they were all parallel-group studies, two studies were assessed as at low risk of bias and three at high risk of bias; two were considered to have unclear bias in their methodology. A total of 2241 participants were enrolled in these trials.Ibuprofen was found to be a superior analgesic to paracetamol at several doses with high quality evidence suggesting that ibuprofen 400 mg is superior to 1000 mg paracetamol based on pain relief (estimated from TOTPAR data) and the use of rescue medication meta-analyses. The risk ratio for at least 50% pain relief (based on TOTPAR) at six hours was 1.47 (95% confidence interval (CI) 1.28 to 1.69; five trials) favouring 400 mg ibuprofen over 1000 mg paracetamol, and the risk ratio for not using rescue medication (also favouring ibuprofen) was 1.50 (95% CI 1.25 to 1.79; four trials).The combined drug showed promising results, with a risk ratio for at least 50% of the maximum pain relief over six hours of 1.77 (95% CI 1.32 to 2.39) (paracetamol 1000 mg and ibuprofen 400 mg) (one trial; moderate quality evidence), and risk ratio not using rescue medication 1.60 (95% CI 1.36 to 1.88) (two trials; moderate quality evidence).The information available regarding adverse events from the studies (including nausea, vomiting, headaches and dizziness) indicated that they were comparable between the treatment groups. However, we could not formally analyse the data as it was not possible to work out how many adverse events there were in total. AUTHORS' CONCLUSIONS: There is high quality evidence that ibuprofen is superior to paracetamol at doses of 200 mg to 512 mg and 600 mg to 1000 mg respectively based on pain relief and use of rescue medication data collected at six hours postoperatively. The majority of this evidence (five out of six trials) compared ibuprofen 400 mg with paracetamol 1000 mg, these are the most frequently prescribed doses in clinical practice. The novel combination drug is showing encouraging results based on the outcomes from two trials when compared to the single drugs.

摘要

背景:对乙酰氨基酚和布洛芬都是拔除下颌智齿(第三磨牙)后常用的镇痛药。2010年,一种新型镇痛药(商品名为Nuromol)在英国上市,该药物每片同时含有对乙酰氨基酚和布洛芬,迄今为止已显示出良好的效果,我们选择使用该模型将这种复方药物与单一药物进行比较。在本综述中,我们通过对两种药物进行比较以及与新型复方药物进行比较,研究了对乙酰氨基酚和布洛芬的最佳剂量。我们考虑了研究药物的副作用情况。本综述将有助于口腔外科医生决定在拔除智齿后开具哪种镇痛药。 目的:比较对乙酰氨基酚、布洛芬以及两种药物制成的新型复方片剂在不同剂量下术后使用时对缓解下颌智齿拔除术后疼痛的有益和有害作用。 检索方法:我们检索了Cochrane口腔健康小组试验注册库(截至2013年5月20日);Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》2013年第4期);通过OVID检索MEDLINE(1946年至2013年5月20日);通过OVID检索EMBASE(1980年至2013年5月20日)以及对照试验元注册库(截至2013年5月20日)。我们检查了相关临床试验和综述文章的参考文献以寻找进一步的研究。我们写信给已识别的随机对照试验(RCT)的作者,并搜索个人参考文献以试图识别未发表或正在进行的RCT。对电子数据库的检索未设语言限制。 选择标准:仅纳入随机对照双盲临床试验。交叉研究若有至少14天的洗脱期则纳入。试验中必须对两种或更多试验药物在任何剂量下进行直接比较。所有试验均采用第三磨牙疼痛模型。 数据收集与分析:所有识别出的试验由两位综述作者独立且重复扫描,如有分歧通过讨论解决,必要时咨询第三位综述作者。计算所有三种药物在给药后2小时和6小时时至少有50%疼痛缓解的患者比例(基于总疼痛缓解(TOTPAR)和疼痛强度差值总和(SPID)数据),并进行荟萃分析以作比较。还整理并比较了6小时和8小时内使用急救药物的参与者比例。分析报告的发生不良事件的患者数量或不良事件总数或两者以作比较。 主要结果:纳入了7项研究,均为平行组研究,2项研究被评估为低偏倚风险,3项为高偏倚风险;2项在方法学上的偏倚被认为不明确。这些试验共纳入2241名参与者。发现布洛芬在几个剂量下都是比对乙酰氨基酚更优的镇痛药,高质量证据表明基于疼痛缓解(根据TOTPAR数据估计)和急救药物使用的荟萃分析,400 mg布洛芬优于1000 mg对乙酰氨基酚。6小时时至少50%疼痛缓解(基于TOTPAR)的风险比为1.47(95%置信区间(CI)1.28至1.69;5项试验),表明400 mg布洛芬优于1000 mg对乙酰氨基酚,未使用急救药物的风险比(也有利于布洛芬)为1.50(95%CI 1.25至1.79;4项试验)。复方药物显示出良好的效果,6小时内最大疼痛缓解至少50%的风险比为1.77(95%CI 1.32至2.39)(对乙酰氨基酚1000 mg和布洛芬400 mg)(1项试验;中等质量证据),未使用急救药物的风险比为1.60(95%CI 1.36至1.88)(2项试验;中等质量证据)。研究中关于不良事件(包括恶心、呕吐、头痛和头晕)的可用信息表明,各治疗组之间具有可比性。然而,我们无法正式分析数据,因为无法算出总共有多少不良事件。 作者结论:基于术后6小时收集的疼痛缓解和急救药物使用数据,有高质量证据表明布洛芬在200 mg至512 mg以及600 mg至1000 mg剂量下比对乙酰氨基酚更优。大部分此类证据(6项试验中的5项)将400 mg布洛芬与1000 mg对乙酰氨基酚进行了比较,这是临床实践中最常用的处方剂量。与单一药物相比,基于两项试验的结果,新型复方药物显示出令人鼓舞的效果。

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