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萘普生钠、对乙酰氨基酚与安慰剂治疗术后牙痛的单剂量双盲比较

A single-dose, double-blind comparison of naproxen sodium, acetaminophen, and placebo in postoperative dental pain.

作者信息

Kiersch T A, Halladay S C, Hormel P C

机构信息

Syntex Laboratories, Inc., Palo Alto, California.

出版信息

Clin Ther. 1994 May-Jun;16(3):394-404.

PMID:7923306
Abstract

The analgesic efficacy and duration of action of naproxen sodium 440 mg (n = 92), acetaminophen 1000 mg (n = 89), and placebo (n = 45) were compared in a single-dose, randomized, double-blind, 12-hour study of patients with at least moderate pain secondary to extraction of three or four third molars. Time to remedication, a measure of duration of analgesic effect, was significantly longer (P < 0.001) with naproxen sodium (median, 9.9 hours) than with either acetaminophen (median, 3.1 hours) or placebo (median, 2.0 hours). Naproxen sodium was also superior to acetaminophen for peak pain intensity difference (visual analog scale), summed pain intensity differences, total pain relief, peak pain relief, time to reduction of pain by 50%, and overall rating. The overall percentages of patients reporting adverse events, and the types of events reported, were comparable with the three treatments. Thus naproxen sodium demonstrated superior efficacy and similar tolerability to acetaminophen in this postoperative dental pain model.

摘要

在一项针对因拔除三颗或四颗第三磨牙继发至少中度疼痛患者的单剂量、随机、双盲、12小时研究中,对440毫克萘普生钠(n = 92)、1000毫克对乙酰氨基酚(n = 89)和安慰剂(n = 45)的镇痛效果和作用持续时间进行了比较。再次用药时间是衡量镇痛效果持续时间的指标,萘普生钠组(中位数为9.9小时)的再次用药时间显著长于对乙酰氨基酚组(中位数为3.1小时)或安慰剂组(中位数为2.0小时)(P < 0.001)。在疼痛强度峰值差异(视觉模拟量表)、累计疼痛强度差异、总疼痛缓解程度、疼痛峰值缓解程度、疼痛减轻50%的时间以及总体评分方面,萘普生钠也优于对乙酰氨基酚。报告不良事件的患者总体百分比以及报告的事件类型在三种治疗方法中相当。因此,在这个术后牙科疼痛模型中,萘普生钠显示出优于对乙酰氨基酚的疗效和相似的耐受性。

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