Sunshine A, Roure C, Olson N, Laska E M, Zorrilla C, Rivera J
New York University Medical Center, New York.
Clin Pharmacol Ther. 1987 Oct;42(4):374-80. doi: 10.1038/clpt.1987.166.
Our purpose was to compare the analgesic efficacy and safety of single oral doses of the combination of ibuprofen 400 mg plus codeine 60 mg and the combination of ibuprofen 200 mg plus codeine 30 mg with ibuprofen 400 mg alone, codeine sulfate 60 mg alone, and placebo. One hundred ninety-five patients with severe pain resulting from episiotomy, cesarean section, or gynecologic surgery completed a randomized, double-blind, stratified, parallel-group study. Patients were observed during a 4-hour period after medication. Based on the sum of the pain intensity differences (SPID), total pain relief (TOTPAR), and most of the hourly direct measures of pain and relief, both doses of the combination and ibuprofen 400 mg alone were statistically superior to placebo. Codeine 60 mg was statistically superior to placebo based on TOTPAR, the global ratings, and a few hourly measures. The mean effect of the combination of ibuprofen 400 mg plus codeine 60 mg was significantly superior to the mean effect of ibuprofen 400 mg alone 1/2, 1, and 2 hours after medication and to the mean effect of ibuprofen 400 mg alone and codeine 60 mg alone for SPID, TOTPAR, and other measures as well. The low-dose combination was significantly more effective than codeine 60 mg for a few hourly measures but was not significantly superior to ibuprofen 400 mg. Based on these findings it appears that the combination of ibuprofen 400 mg plus codeine 60 mg, particularly in the first few hours after medication, is more efficacious than its constituents.
我们的目的是比较单次口服布洛芬400毫克加可待因60毫克、布洛芬200毫克加可待因30毫克的组合与单独使用布洛芬400毫克、单独使用硫酸可待因60毫克及安慰剂的镇痛效果和安全性。195例因会阴切开术、剖宫产或妇科手术导致剧痛的患者完成了一项随机、双盲、分层、平行组研究。在用药后的4小时内对患者进行观察。基于疼痛强度差异总和（SPID）、总疼痛缓解程度（TOTPAR）以及大多数每小时直接测量的疼痛和缓解情况，两种剂量的组合以及单独使用的布洛芬400毫克在统计学上均优于安慰剂。基于TOTPAR、整体评分以及一些每小时的测量结果，可待因60毫克在统计学上优于安慰剂。布洛芬400毫克加可待因60毫克组合的平均效果在用药后1/2小时、1小时和2小时显著优于单独使用布洛芬400毫克的平均效果，在SPID、TOTPAR及其他测量指标方面也优于单独使用布洛芬400毫克和单独使用可待因60毫克的平均效果。低剂量组合在一些每小时的测量指标上比可待因60毫克显著更有效，但并不显著优于布洛芬400毫克。基于这些发现，布洛芬400毫克加可待因60毫克的组合，尤其是在用药后的最初几个小时，似乎比其成分更有效。
