疗效和安全性的外用水杨酸甲酯和薄荷醇在成人患者轻度至中度肌肉拉伤:一项随机、双盲、安慰剂对照、多中心研究与这些相应平行的组织。

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东Y,登T, Furuta K

疗效和安全性的外用水杨酸甲酯和薄荷醇在成人患者轻度至中度肌肉拉伤:一项随机、双盲、安慰剂对照、多中心研究与这些相应平行的组织。

其他。2010年1月,32 (1):34-43。doi: 10.1016 / j.clinthera.2010.01.016。

PubMed ID

20171409 (在PubMed

]

文摘

背景:一个闭塞的补丁配方含有10%水杨酸甲酯和3% l-menthol最近被美国食品和药物管理局批准用于治疗轻度至中度疼痛。尽管反刺激剂的广泛使用,包括水杨酸甲酯和薄荷醇,局部疼痛,疗效和安全性数据发表有关代理单独或结合使用的是有限的。摘要目的:本研究的目的是确定的疗效和安全性补丁含有10%水杨酸甲酯和3%与安慰剂相比l-menthol补丁在成人患者轻度至中度肌肉拉伤。方法:符合条件的患者是男性或女性年龄> = 18年的临床诊断轻度至中度肌肉拉伤。病人被随机分配接受1活跃的补丁或安慰剂补丁应用到皮肤在受影响的区域(即,肩膀,背部上方,上臂,脖子,小腿,大腿,手臂,腹部)。疼痛强度评估在100毫米视觉模拟量表在休息和运动后12小时补丁程序。主要疗效终点是总结疼痛强度差的分数通过8小时(SPID8)运动。包括使用描述性统计分析和方差分析模型。安全数据,包括不良事件,和次要疗效终点也被评估。结果:共有208名患者(104名男性,104名女性; age range, 18-78 years) were randomized to 1 of 2 study groups (105 in the active-patch group [mean age, 37.3 years], 103 in the placebo-patch group [mean age, 38.1 years]). The primary efficacy analysis (SPID8 with movement) indicated that patients receiving the active patch experienced significantly greater pain relief (approximately 40%) than those patients receiving a placebo patch (mean [SD], 182.6 [131.2] vs 130.1 [144.1]; P = 0.005). Analysis of the per-protocol population also found significantly more relief (P = 0.024) in the active-patch group (176.2 [131.4]; n = 92) versus the placebo-patch group (130.2 [144.0]; n = 96). Statistical analysis of secondary efficacy measures supported the primary end-point results. The number of patients experiencing any type of adverse event was comparable between study groups (active patch, 6.7% [7 events]; placebo patch, 5.8% [6 events]). No serious adverse events were reported during the study. CONCLUSION: A single, 8-hour application of a patch containing methyl salicylate and l-menthol provided significant relief of pain associated with mild to moderate muscle strain in these adult patients compared with patients receiving a placebo patch.

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药物

水杨酸甲酯