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患者对注射用帕瑞昔布用于术后镇痛的镇痛效果及安全性的整体评价:一项定量系统评价

Patients' global evaluation of analgesia and safety of injected parecoxib for postoperative pain: a quantitative systematic review.

作者信息

Kranke Peter, Morin Astrid M, Roewer Norbert, Eberhart Leopold H

机构信息

*Department of Anesthesiology, University of Würzburg, Germany; and †Department of Anesthesiology, University of Marburg, Germany.

出版信息

Anesth Analg. 2004 Sep;99(3):797-806. doi: 10.1213/01.ANE.0000133139.68208.92.

Abstract

Parecoxib is the only parenterally administered cyclooxygenase-2-selective inhibitor available. We performed a systematic review, including full reports of randomized comparisons of parecoxib compared with any other analgesic intervention for prophylaxis or treatment of postoperative pain. Dichotomous data on patients' global evaluation of their analgesic regimen were extracted by means of the fraction of patients who rated their medication as "good" or "excellent." For safety analysis, data on any reported adverse effects were extracted. Relative risk (RR), number needed to treat (NNT), or number-needed-to-harm were calculated with 95% confidence intervals (CI). Data from 9 trials of 50 initially screened were finally analyzed. One thousand thirteen patients were randomized to receive parecoxib, 218 patients were allocated to an active control, and 507 patients received a placebo. With prophylactic administration, the pooled NNT to obtain the desired outcome ("good"/"excellent" rating) with parecoxib 20 and 40 mg compared with placebo was 4.5 (RR, 1.42; 95% CI, 0.91-2.24) and 4.0 (RR, 1.40; 95% CI, 1.10-1.79), respectively. In the treatment trials, the NNT to obtain the outcome of interest with parecoxib 20 mg was 2.1 (RR, 3.44; 95% CI, 1.49-7.96), 5.3 (RR, 1.43; 95% CI, 1.01-2.02), and -8.3 (RR, 0.85; 95% CI, 0.75-0.97) for the comparisons with placebo, morphine, and ketorolac, respectively. The corresponding NNT for treatment with parecoxib 40 mg was 1.7 (RR, 4.65; 95% CI, 2.04-10.61), 3.7 (RR, 1.62; 95% CI, 1.21-2.16), and 50 (RR, 1.03; 95% CI, 0.89-1.18) for the comparisons with placebo, morphine, and ketorolac, respectively. Overall adverse effects for parecoxib 20 and 40 mg were not different from those with placebo, morphine, or ketorolac. These results suggest a favorable profile for parecoxib compared with inactive or active controls. The optimal dose, timing, and frequency of administration need to be determined.

摘要

帕瑞昔布是唯一可胃肠外给药的环氧化酶 -2 选择性抑制剂。我们进行了一项系统评价,纳入了帕瑞昔布与其他任何镇痛干预措施用于预防或治疗术后疼痛的随机对照研究的完整报告。通过将其镇痛方案评为“良好”或“优秀”的患者比例来提取患者对镇痛方案总体评价的二分数据。为进行安全性分析,提取了所有报告的不良反应数据。计算相对危险度(RR)、需治疗人数(NNT)或需伤害人数,并给出 95%置信区间(CI)。最终分析了最初筛选的 50 项试验中的 9 项数据。1013 例患者被随机分配接受帕瑞昔布,218 例患者被分配至活性对照组,507 例患者接受安慰剂。预防性给药时,与安慰剂相比,帕瑞昔布 20mg 和 40mg 获得期望结果(“良好”/“优秀”评分)的合并 NNT 分别为 4.5(RR,1.42;95%CI,0.91 - 2.24)和 4.0(RR,1.40;95%CI,1.10 - 1.79)。在治疗性试验中,与安慰剂、吗啡和酮咯酸相比,帕瑞昔布 20mg 获得感兴趣结果的 NNT 分别为 2.1(RR,3.44;95%CI,1.49 - 7.96)、5.3(RR,1.43;95%CI,1.01 - 2.02)和 -8.3(RR,0.85;95%CI,0.75 - 0.97)。帕瑞昔布 40mg 治疗时,与安慰剂、吗啡和酮咯酸相比,相应的 NNT 分别为 1.7(RR,4.65;95%CI,2.04 - 10.61)、3.7(RR,1.62;95%CI,1.21 - 2.16)和 50(RR,1.03;95%CI,0.89 - 1.18)。帕瑞昔布 20mg 和 40mg 的总体不良反应与安慰剂、吗啡或酮咯酸无差异。这些结果表明与无活性或活性对照相比,帕瑞昔布具有良好的特征。其最佳剂量、给药时间和频率有待确定。

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