Apfelbaum Jeffrey L, Desjardins Paul J, Brown Mark T, Verburg Kenneth M
Department of Anesthesia and Critical Care, University of Chicago Medical Center, Chicago, IL 60637, USA.
Clin J Pain. 2008 Nov-Dec;24(9):784-92. doi: 10.1097/AJP.0b013e31817a717c.
To determine the analgesic efficacy of 1-day and multiple-day dosing regimens of parecoxib sodium (parecoxib) after bunionectomy in 2 randomized placebo-controlled studies.
The first double-blind study assessed the efficacy of intravenous parecoxib 40 mg followed by an additional dose of parecoxib 20 mg, parecoxib 40 mg followed by placebo, or 2 placebo doses over 1 day. In the second study, all patients received parecoxib 40 mg and a second dose of 20 mg on day 1. On days 2 and 3, patients were randomized to parecoxib 20 mg once daily and placebo once daily, parecoxib 20 mg twice daily, or placebo twice daily. Rescue medication (hydrocodone 5 mg/acetaminophen 500 mg) was available throughout both studies.
In the single-day study, patients receiving parecoxib had significantly improved summed pain intensity difference through 24 hours, time-weighted sum of total pain relief through 24 hours, and Patient's Global Evaluation of Study Medication (PGESM) scores compared with those given placebo. In the multiday study, patients given parecoxib had significantly improved summed pain intensity through 24 hours and PGESM scores compared with patients receiving placebo. The incidence of adverse events was lower in the parecoxib groups than in the placebo group on days 2 and 3.
Parecoxib treatment, in conjunction with supplemental analgesia given as needed, provided effective pain relief over 1 to 3 days in the bunionectomy model of postoperative analgesia. Bunionectomy is a useful model for testing multiple-day analgesic therapy.
在两项随机、安慰剂对照研究中，确定帕瑞昔布钠（帕瑞昔布）1日给药方案和多日给药方案在拇囊炎切除术后的镇痛效果。
第一项双盲研究评估了静脉注射40mg帕瑞昔布，随后追加20mg帕瑞昔布剂量、40mg帕瑞昔布随后给予安慰剂，或1天内给予2次安慰剂剂量的疗效。在第二项研究中，所有患者在第1天接受40mg帕瑞昔布和第二剂20mg帕瑞昔布。在第2天和第3天，患者被随机分为每日1次20mg帕瑞昔布和每日1次安慰剂、每日2次20mg帕瑞昔布或每日2次安慰剂。在两项研究中均备有急救药物（5mg氢可酮/500mg对乙酰氨基酚）。
在单日研究中，与给予安慰剂的患者相比，接受帕瑞昔布的患者在24小时内的总疼痛强度差值、24小时内总疼痛缓解的时间加权总和以及患者对研究药物的整体评估（PGESM）评分均有显著改善。在多日研究中，与接受安慰剂的患者相比，给予帕瑞昔布的患者在24小时内的总疼痛强度和PGESM评分有显著改善。在第2天和第3天，帕瑞昔布组的不良事件发生率低于安慰剂组。
在拇囊炎切除术后镇痛模型中，帕瑞昔布治疗联合按需给予的补充镇痛措施，在1至3天内提供了有效的疼痛缓解。拇囊炎切除术是测试多日镇痛疗法的有用模型。
