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曲马多与氢可酮-对乙酰氨基酚治疗急性肌肉骨骼疼痛的随机双盲临床试验

Tramadol versus hydrocodone-acetaminophen in acute musculoskeletal pain: a randomized, double-blind clinical trial.

作者信息

Turturro M A, Paris P M, Larkin G L

机构信息

Department of Emergency Medicine, The Mercy Hospital of Pittsburgh, PA, USA. turturro+@pitt.edu

出版信息

Ann Emerg Med. 1998 Aug;32(2):139-43. doi: 10.1016/s0196-0644(98)70127-1.

DOI:10.1016/s0196-0644(98)70127-1
PMID:9701294
Abstract

STUDY OBJECTIVE

To evaluate the efficacy of an oral tramadol preparation versus that of an oral hydrocodone-acetaminophen preparation in acute musculoskeletal pain.

METHODS

A randomized, prospective, double-blind clinical trial was conducted in an urban teaching emergency department with an annual census of 41,000. Participants comprised a convenience sample of 68 adult ED patients with acute musculoskeletal pain caused by minor trauma. Thirty-three patients received tramadol (100 mg), and 35 patients received hydrocodone-acetaminophen (5 mg hydrocodone with 500 mg acetaminophen). The drugs were prepared in identical-appearing capsules. Pain was evaluated by a 100-mm visual analog scale (VAS) at baseline and at 30, 60, 90, 120, and 180 minutes after dosing. VAS scores were analyzed by 2-way repeated-measures ANOVA, and nominal data were analyzed by Fisher's exact test.

RESULTS

Mean pain scores did not differ at baseline (tramadol, 68.3+/-21.8; hydrocodone-acetaminophen, 69.1+/-17.8; P=NS) but were significantly lower in the hydrocodone-acetaminophen group beginning at 30 minutes through 180 minutes. There were 6 dropouts as a result of reported inadequate analgesia, 3 in each group (P=NS). The discharge diagnoses and prevalence of side effects did not differ significantly between groups.

CONCLUSION

Tramadol provides inferior analgesia to hydrocodone-acetaminophen in ED patients with acute musculoskeletal pain.

摘要

研究目的

评估口服曲马多制剂与口服氢可酮-对乙酰氨基酚制剂治疗急性肌肉骨骼疼痛的疗效。

方法

在一家年接诊量为41000人次的城市教学急诊科进行了一项随机、前瞻性、双盲临床试验。参与者为68例因轻度创伤导致急性肌肉骨骼疼痛的成年急诊患者的便利样本。33例患者接受曲马多(100毫克),35例患者接受氢可酮-对乙酰氨基酚(5毫克氢可酮与500毫克对乙酰氨基酚)。药物制成外观相同的胶囊。在基线时以及给药后30、60、90、120和180分钟,通过100毫米视觉模拟量表(VAS)评估疼痛程度。VAS评分采用双向重复测量方差分析进行分析,名义数据采用Fisher精确检验进行分析。

结果

基线时平均疼痛评分无差异(曲马多组为68.3±21.8;氢可酮-对乙酰氨基酚组为69.1±17.8;P=无显著性差异),但从30分钟到180分钟,氢可酮-对乙酰氨基酚组的疼痛评分显著更低。因报告镇痛效果不佳有6例退出研究,每组各3例(P=无显著性差异)。两组间出院诊断及副作用发生率无显著差异。

结论

在患有急性肌肉骨骼疼痛的急诊患者中,曲马多的镇痛效果不如氢可酮-对乙酰氨基酚。

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