用于口腔手术疼痛的布洛芬液状凝胶

Ibuprofen liquigel for oral surgery pain.

作者信息

Hersh E V, Levin L M, Cooper S A, Doyle G, Waksman J, Wedell D, Hong D, Secreto S A

机构信息

University of Pennsylvania School of Dental Medicine, Philadelphia 19104-6003, USA.

出版信息

Clin Ther. 2000 Nov;22(11):1306-18. doi: 10.1016/s0149-2918(00)83027-1.

DOI:10.1016/s0149-2918(00)83027-1

PMID:11117655

Abstract

BACKGROUND

Ibuprofen liquigel is a solubilized potassium ibuprofen 200-mg gelatin capsule formulation that was approved for over-the-counter use in 1995.

OBJECTIVE

This study compared the analgesic efficacy and tolerability of ibuprofen liquigel 200 mg, ibuprofen liquigel 400 mg, acetaminophen caplets 1000 mg, and placebo in patients experiencing moderate or severe pain after surgical removal of impacted third molars.

METHODS

This randomized, double-blind, parallel-group, 6-hour study was conducted in 210 patients experiencing moderate or severe postoperative pain. Ratings of pain intensity and pain relief were recorded every 15 minutes for the first hour, at 90 and 120 minutes, and then hourly through hour 6. The onsets of first perceptible relief and meaningful relief were recorded using 2 stopwatches. An analysis of variance model was employed to test for significant differences (P < or = 0.05) between treatment groups with respect to pain relief, pain intensity difference, total pain relief (TOTPAR), and summed pain intensity difference (SPID). Stopwatch measures were analyzed using the Cox proportional hazards model. Drug tolerability was assessed by monitoring the occurrence of adverse events.

RESULTS

During the first 2 hours of the study (TOTPAR 2 and SPID 2), all active treatments were significantly more efficacious than placebo (P < 0.001), with ibuprofen liquigel 200 and 400 mg significantly more efficacious than acetaminophen 1000 mg (P < 0.05 and P < 0.01, respectively). For the entire duration of the study (TOTPAR 6 and SPID 6), only the 2 doses of ibuprofen liquigel were significantly more efficacious than placebo (P < 0.001). Ibuprofen liquigel 200 and 400 mg were also significantly more efficacious than acetaminophen 1000 mg on the summary measures TOTPAR 6 and SPID 6 (P < 0.01 and P < 0.001, respectively). Analysis of the stopwatch data revealed that all active treatments displayed significantly more rapid onsets to confirmed first perceptible relief (P < 0.001 to < 0.05) and meaningful relief (P < 0.001 to < 0.01) than did placebo, with ibuprofen liquigel 400 mg displaying a significantly more rapid onset to meaningful relief than acetaminophen 1000 mg (P < 0.05) and a significantly more rapid onset to confirmed first perceptible relief than acetaminophen 1000 mg (P < 0.001) and ibuprofen liquigel 200 mg (P < 0.01). All adverse events were considered mild or moderate, with an overall incidence of 11.5% in the ibuprofen liquigel 200-mg group, 6.8% in the ibuprofen liquigel 400-mg group, 19.0% in the acetaminophen 1000-mg group, and 25.9% in the placebo group.

CONCLUSIONS

Ibuprofen liquigel provided greater peak and overall analgesic effects and a more rapid onset to analgesia than did acetaminophen 1000 mg.

摘要

背景

布洛芬液胶丸是一种溶解型的200毫克布洛芬钾明胶胶囊制剂，于1995年被批准用于非处方药。

目的

本研究比较了200毫克布洛芬液胶丸、400毫克布洛芬液胶丸、1000毫克对乙酰氨基酚胶囊和安慰剂对拔除阻生第三磨牙后出现中度或重度疼痛患者的镇痛效果和耐受性。

方法

这项随机、双盲、平行组、为期6小时的研究纳入了210例术后中度或重度疼痛患者。在最初1小时内每15分钟记录一次疼痛强度和疼痛缓解评分，在90分钟和120分钟时记录，然后每小时记录一次直至6小时。使用2个秒表记录首次可察觉缓解和有效缓解的开始时间。采用方差分析模型检验各治疗组在疼痛缓解、疼痛强度差异、总疼痛缓解（TOTPAR）和累计疼痛强度差异（SPID）方面的显著差异（P≤0.05）。使用Cox比例风险模型分析秒表测量数据。通过监测不良事件的发生来评估药物耐受性。

结果

在研究的前2小时（TOTPAR 2和SPID 2），所有活性治疗组均比安慰剂组疗效显著更好（P<0.001），200毫克和400毫克布洛芬液胶丸比1000毫克对乙酰氨基酚疗效显著更好（分别为P<0.05和P<0.01）。在研究的整个期间（TOTPAR 6和SPID 6），只有2种剂量的布洛芬液胶丸比安慰剂疗效显著更好（P<0.001）。在总结测量指标TOTPAR 6和SPID 6方面，200毫克和400毫克布洛芬液胶丸也比1000毫克对乙酰氨基酚疗效显著更好（分别为P<0.01和P<0.001）。对秒表数据的分析显示，所有活性治疗组出现确认的首次可察觉缓解（P<0.001至<0.05）和有效缓解（P<0.001至<0.01）的起效时间均比安慰剂组显著更快，400毫克布洛芬液胶丸出现有效缓解的起效时间比1000毫克对乙酰氨基酚显著更快（P<0.05），出现确认的首次可察觉缓解的起效时间比1000毫克对乙酰氨基酚显著更快（P<0.001），比200毫克布洛芬液胶丸显著更快（P<0.01）。所有不良事件均被认为是轻度或中度，200毫克布洛芬液胶丸组的总发生率为11.5%，400毫克布洛芬液胶丸组为6.8%，1000毫克对乙酰氨基酚组为19.0%，安慰剂组为25.9%。