单剂量口服氯美昔布用于术后疼痛治疗。
Single dose oral lumiracoxib for postoperative pain.
作者信息
Roy Y M, Derry S, Moore R A
机构信息
Pain Research Unit, Cochrane Pain, Palliative and Supportive Care Group, Churchill Hospital, Old Road, Oxford, UK, OX3 7LJ.
出版信息
Cochrane Database Syst Rev. 2007 Oct 17(4):CD006865. doi: 10.1002/14651858.CD006865.
BACKGROUND
Lumiracoxib is a novel selective cyclooxygenase-2 (COX-2) inhibitor. COX-2 inhibitors have been developed to avoid COX-1 related gastrointestinal (GI) problems. Lumiracoxib has analgesic and anti-inflammatory activity comparable with traditional non-steroidal anti-inflammatory drugs (tNSAIDs) in the management of post-operative pain, but with the advantage of better GI tolerability.
OBJECTIVES
To review the analgesic efficacy, duration of analgesia, and adverse effects of a single oral dose of lumiracoxib for moderate to severe postoperative pain in adults and compare it with established analgesics.
SEARCH STRATEGY
We searched CENTRAL (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to March 2007), EMBASE (1974 to 2006), and PubMed (February 2007).
SELECTION CRITERIA
Single oral dose, randomised placebo controlled trials of lumiracoxib, in acute postoperative pain, in adult patients.
DATA COLLECTION AND ANALYSIS
Trials were quality scored and data extracted by two review authors independently. Summed pain relief (TOTPAR) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief. These derived results were used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief.
MAIN RESULTS
Three studies (737 patients) met the inclusion criteria. In total 211 patients were treated with lumiracoxib 400 mg, 51 with lumiracoxib 100 mg, and 161 with placebo. Active comparators were naproxen 500 mg (60 patients), rofecoxib 50 mg (102), celecoxib 200 mg (101), and ibuprofen 400 mg (51). One hundred patients (48%) given lumiracoxib 400 mg had at least 50% pain relief over six hours, compared with 17 (11%) given placebo; RB 4.8 (95% CI 2.9 to 7.9), NNT 2.7 (2.2 to 3.5). Weighted median time to use of rescue medication was 7.4 hours for lumiracoxib 400 mg and 1.8 hours for placebo. Patient global assessment at study endpoint was rated as "excellent" by 71 patients (34%) given lumiracoxib 400 mg and 5 (3%) given placebo. Median time to onset of analgesia was shorter for lumiracoxib 400 mg (0.6 to 1.5 hours) than placebo (>12 hours), and use of rescue medication within 12 hours occurred in 64 patients (58%) given lumiracoxib 400 mg and 100 (91%) given placebo. Adverse events reported were generally mild to moderate in severity, with one serious adverse event reported in a patient given placebo.
AUTHORS' CONCLUSIONS: Lumiracoxib 400 mg given as a single oral dose, is an effective analgesic for acute postoperative pain.
背景
鲁米昔布是一种新型选择性环氧化酶-2（COX-2）抑制剂。研发COX-2抑制剂是为了避免与COX-1相关的胃肠道（GI）问题。在术后疼痛管理方面，鲁米昔布具有与传统非甾体抗炎药（tNSAIDs）相当的镇痛和抗炎活性，但具有更好的胃肠道耐受性。
目的
评价单次口服鲁米昔布对成人中重度术后疼痛的镇痛效果、镇痛持续时间及不良反应，并与已有的镇痛药进行比较。
检索策略
我们检索了Cochrane中心对照试验注册库（CENTRAL，2006年第1期）、医学期刊数据库（MEDLINE，1966年至2007年3月）、荷兰医学文摘数据库（EMBASE，1974年至2006年）及美国国立医学图书馆医学期刊数据库（PubMed，2007年2月）。
选择标准
针对成年患者急性术后疼痛，单次口服剂量、随机、安慰剂对照的鲁米昔布试验。
数据收集与分析
由两位综述作者独立对试验进行质量评分并提取数据。提取总疼痛缓解率（TOTPAR）并转化为二分信息，得出疼痛缓解至少50%的患者数量。这些得出的结果用于计算一名患者实现至少50%疼痛缓解的相对获益（RB）和需治疗人数（NNT）。
主要结果
三项研究（737例患者）符合纳入标准。共有211例患者接受400 mg鲁米昔布治疗，51例接受100 mg鲁米昔布治疗，161例接受安慰剂治疗。活性对照药为5萘普生00 mg（60例患者）、罗非昔布50 mg（102例）、塞来昔布200 mg（101例）和布洛芬400 mg（51例）。接受400 mg鲁米昔布治疗的100例患者（48%）在6小时内疼痛缓解至少50%，而接受安慰剂治疗的患者为17例（11%）；RB为4.8（95%CI 2.9至7.9），NNT为2.7（2.2至3.5）。400 mg鲁米昔布使用解救药物的加权中位时间为7.4小时，安慰剂为1.8小时。在研究终点，接受400 mg鲁米昔布治疗的71例患者（34%）将患者整体评估评为“优秀”，接受安慰剂治疗的为5例（3%）。400 mg鲁米昔布的镇痛起效中位时间（0.6至1.5小时）短于安慰剂（>12小时），接受400 mg鲁米昔布治疗的64例患者（58%）和接受安慰剂治疗的100例患者（91%）在12小时内使用了解救药物。报告的不良事件一般为轻至中度，接受安慰剂治疗的一名患者报告了1例严重不良事件。
作者结论
单次口服400 mg鲁米昔布是急性术后疼痛的有效镇痛药。
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