Jean Brown Research Inc., Salt Lake City, UT 84049, USA.
Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144.
To evaluate the analgesic effects of etoricoxib and comparator agents on the second and third days after oral surgery.
There were 588 patients initially randomized to placebo (n=46), etoricoxib 120 mg once daily (n=97), etoricoxib 90 mg once daily (n=191), ibuprofen 600 mg every 6 hours (n=192), and acetaminophen 600 mg/codeine 60 mg (A/C) every 6 hours (n=62) after third-molar extraction (≥2, ≥1 impacted) in a double-blind controlled trial. Patients were allowed flexible dosing on days 2 and 3; 46, 96, 190, 192, and 56 patients on placebo, etoricoxib 120 mg, etoricoxib 90 mg, ibuprofen, and A/C, respectively, continued to Day 2 of the study. Outcomes included Average and Worst Recall Pain Assessments (0 to 10 scale) and Global Assessments of Study Medication (0 to 4 scale). Rescue medication (acetaminophen 325 mg up to 4 times daily) usage was evaluated. Adverse experiences were collected and evaluated.
Average Pain Recall scores were lower than placebo for all active treatments on Day 2 but only for etoricoxib 120 and 90 mg on Day 3. Worst Pain Recall scores were lower than placebo for only etoricoxib 120 and 90 mg on Day 2; all treatment groups were similar on day 3. Rescue medicine was used on day 2 in 57% of placebo patients, whereas use in active treatments ranged from 18% to 23%; for Day 3, rescue was used in 22% of placebo patients, whereas use in active treatments ranged from 14% to 20%. Differences in mean Patient's Global Assessment of Study Medication scores were significant for etoricoxib versus placebo (P<0.001) and for etoricoxib versus A/C (P<0.010). Nausea and vomiting were among the most common adverse events with higher frequency in the A/C group.
Pain control was most favorable for the etoricoxib doses and ibuprofen. Global Assessments of Study Medication continued to differentiate the treatments and demonstrated greater efficacy for etoricoxib on Days 2 and 3 compared with placebo and A/C (NCT00694369).
评估依托考昔和对照药物在口腔手术后第二天和第三天的镇痛效果。
共有 588 例患者最初随机分配至安慰剂组（n=46）、依托考昔 120mg 每日一次组（n=97）、依托考昔 90mg 每日一次组（n=191）、布洛芬 600mg 每 6 小时一次组（n=192）和扑热息痛 600mg/可待因 60mg（A/C）每 6 小时一次组（n=62），用于接受下颌第三磨牙（≥2 个，≥1 个阻生）拔除的双盲对照试验。在第 2 天和第 3 天，患者可灵活使用药物；分别有 46、96、190、192 和 56 例患者继续接受安慰剂、依托考昔 120mg、依托考昔 90mg、布洛芬和 A/C 治疗至研究的第 2 天。结局指标包括平均和最差回忆疼痛评估（0 至 10 分）和研究药物总体评估（0 至 4 分）。评估了急救药物（扑热息痛 325mg 每日最多 4 次）的使用情况。收集并评估了不良反应事件。
在第 2 天，与安慰剂相比，所有活性治疗组的平均疼痛回忆评分均较低，但仅依托考昔 120mg 和 90mg 在第 3 天如此；在第 2 天，只有依托考昔 120mg 和 90mg 组的最差疼痛回忆评分低于安慰剂组；第 3 天，所有治疗组均相似。在第 2 天，安慰剂组有 57%的患者使用了急救药物，而在活性治疗组中，使用比例为 18%至 23%；在第 3 天，安慰剂组有 22%的患者使用了急救药物，而在活性治疗组中，使用比例为 14%至 20%。依托考昔与安慰剂相比（P<0.001）和依托考昔与 A/C 相比（P<0.010），患者对研究药物总体评估的差异有统计学意义。恶心和呕吐是最常见的不良反应，A/C 组发生频率更高。
依托考昔和布洛芬的止痛效果最佳。对研究药物的总体评估继续区分了这些治疗方法，并显示依托考昔在第 2 天和第 3 天的疗效优于安慰剂和 A/C（NCT00694369）。
