Forbes J A, Keller C K, Smith J W, Zeleznock J R, Sevelius H, Beaver W T
Pharmacotherapy. 1986 Sep-Oct;6(5):211-8. doi: 10.1002/j.1875-9114.1986.tb03479.x.
In a double-blind study, 198 outpatients with pain after oral surgery were randomly assigned to treatment with a single oral dose of naproxen sodium 550 mg, codeine sulfate 60 mg, a combination of naproxen sodium 550 mg with codeine sulfate 60 mg, aspirin 650 mg or placebo. Using a self-rating record, subjects rated their pain and its relief hourly for 12 hours after medication. Orthogonal contrasts for the four treatments making up the factorial component showed that the naproxen effect was significant for every measurement of total and peak analgesia; the codeine effect was significant for total and peak pain relief and patients' overall evaluation. The naproxen-codeine interaction was not statistically significant for any measure, which suggests that the analgesic effect of the combination represents the additive effect of its constituents. Based on pairwise comparisons, aspirin was significantly superior to placebo for most measures of effect, naproxen was significantly superior to both aspirin and codeine for all measures and the combination was significantly superior to naproxen for patients' overall evaluation. No more patients experienced adverse effects with aspirin or naproxen than with placebo, but significantly more patients receiving the codeine-containing treatments experienced adverse effects than those receiving aspirin and naproxen.
在一项双盲研究中,198名口腔手术后疼痛的门诊患者被随机分配接受单剂量口服550毫克萘普生钠、60毫克硫酸可待因、550毫克萘普生钠与60毫克硫酸可待因的组合、650毫克阿司匹林或安慰剂治疗。使用自评记录,受试者在用药后12小时内每小时对疼痛及其缓解情况进行评分。构成析因部分的四种治疗的正交对比显示,萘普生对总镇痛和峰值镇痛的每次测量效果均显著;可待因对总疼痛缓解、峰值疼痛缓解及患者总体评价效果显著。萘普生 - 可待因的相互作用对任何测量指标均无统计学意义,这表明该组合的镇痛效果代表了其成分的相加作用。基于两两比较,阿司匹林在大多数效果指标上显著优于安慰剂,萘普生在所有指标上均显著优于阿司匹林和可待因,且该组合在患者总体评价上显著优于萘普生。使用阿司匹林或萘普生出现不良反应的患者并不比使用安慰剂的患者多,但接受含可待因治疗的患者出现不良反应的人数明显多于接受阿司匹林和萘普生治疗的患者。