Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: A double-blind, randomized, placlebo-controlled study
Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: A double-blind, randomized, placlebo-controlled study
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DOI：
10.1016/s0002-9343(03)00116-5
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发表时间：
2003-05-01
影响因子：
5.9
通讯作者：
Rosenthal, N
中科院分区：
文献类型：
--
作者：
Bennett, RA;Kamin, M;Rosenthal, N
目的：评估组合镇痛片（37.5 mg 曲马多/325 mg 对乙酰氨基酚）治疗纤维肌痛的有效性和安全性。 方法：这项为期 91 天的多中心、双盲、随机、安慰剂对照研究将曲马多/对乙酰氨基酚组合片与安慰剂进行了比较。主要结果变量是累计停药时间（Kaplan-Meier 分析）。研究结束时的次要指标包括疼痛、疼痛缓解、总压痛点、肌痛、健康状况和纤维肌痛影响问卷评分。 结果：在参加研究的 315 名受试者中，313 名受试者（294 名女性 [94%]，平均 [+/- SD] 年龄，50 +/- 10 岁）完成了至少一项随机化后疗效评估（曲马多/对乙酰氨基酚：n = 156；安慰剂：n） = 157）。与安慰剂相比，曲马多/对乙酰氨基酚治疗组因任何原因停止治疗的情况较少见（48% vs. 62%，P = 0.004）。在研究结束时，接受曲马多/对乙酰氨基酚治疗的受试者的疼痛也显着减轻（视觉模拟评分为 0 至 100，P 为 53 +/- 32 对比 65 +/- 29）
PURPOSE: To evaluate the efficacy and safety of a combination analgesic tablet (37.5 mg tramadol/325 mg acetaminophen) for the treatment of fibromyalgia pain.METHODS: This 91-day, multicenter, double-blind, randomized, placebo-controlled study compared tramadol/acetaminophen combination tablets with placebo. The primary outcome variable was cumulative time to discontinuation (Kaplan-Meier analysis). Secondary measures at the end of the study included pain, pain relief, total tender points, myalgia, health status, and Fibromyalgia Impact Questionnaire scores.RESULTS: Of the 315 subjects who were enrolled in the study, 313 (294 women [94%], mean [+/- SD] age, 50 +/- 10 years) completed at least one postrandomization efficacy assessment (tramadol/acetaminophen: n = 156; placebo: n = 157). Discontinuation of treatment for any reason was less common in those treated with tramadol/acetaminophen compared with placebo (48% vs. 62%, P = 0.004). Tramadol/acetaminophen-treated subjects also had significantly less pain at the end of the study (53 +/- 32 vs. 65 +/- 29 on a visual analog scale of 0 to 100, P