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A nationwide randomized, double-blind, placebo-controlled physicians' trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers.
Alcohol ( IF 2.3 ) Pub Date : 2019-11-02 , DOI: 10.1016/j.alcohol.2019.10.006
Masahiko Hara 1 , Kenichi Hayashi 2 , Tetsuhisa Kitamura 3 , Michitaka Honda 4 , Masatake Tamaki 5
Affiliation  

Hangovers are associated with negative economic consequences due to decreased job performance or frequent visits to physicians. Thus, a new strategy for the alleviation of hangover-related symptoms is needed to avoid this detriment to society. The purpose of this nationwide randomized, double-blind, placebo-controlled physicians' trial was to evaluate the efficacy of loxoprofen sodium for the alleviation of fatigue, headache, and nausea after hangover. A total of 229 participants were randomized to receive loxoprofen sodium (60 mg once orally) or placebo. The study was closed when the first 150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers. The primary endpoint was set as the difference in severity of general fatigue before and 3 h after taking the test drugs and was evaluated using a visual analogue scale. Secondary endpoints included difference in severity of headache, nausea, and incidence of adverse events. The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men, and both groups were comparable for baseline characteristics. The alleviation of general fatigue did not differ statistically between the loxoprofen and placebo groups (24 [14-49] vs. 19 [9-35], p = 0.07). However, the alleviation of headache was statistically greater in the loxoprofen group (25 [10-50] vs. 10 [2-30], adjusted difference 14, 95% confidence interval 8-21, p < 0.001), whereas, there was no difference in nausea (7 [0-27] vs. 10 [0-24], p = 0.68). The incidence of adverse symptoms such as epigastric discomfort was also comparable between groups (2.7% vs. 3.9%, p = 0.25). Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea.

中文翻译:

洛索洛芬在宿醉后治疗疲劳,头痛和恶心的全国性随机,双盲,安慰剂对照医师试验。

由于工作表现下降或经常去看医生,宿醉会带来负面的经济后果。因此,需要一种减轻宿醉相关症状的新策略来避免这种危害社会的行为。这项全国性的随机,双盲,安慰剂对照医师试验的目的是评估洛索洛芬钠缓解宿醉后疲劳,头痛和恶心的功效。总共229名参与者被随机分配接受洛索洛芬钠(口服一次60毫克)或安慰剂。当前150名参与者(洛索洛芬组n = 74,安慰剂组n = 76)出现宿醉时,该研究结束。主要终点设定为服用试验药物之前和之后3小时的总体疲劳严重程度差异,并使用视觉模拟量表进行评估。次要终点包括头痛,恶心和不良事件发生率的差异。研究参与者为34岁(四分位间距; 30-39岁),男性为92.0%,两组的基线特征相当。洛索洛芬组和安慰剂组之间的一般疲劳缓解没有统计学差异(24 [14-49] vs. 19 [9-35],p = 0.07)。然而,洛索洛芬组的头痛缓解在统计学上更大(25 [10-50] vs. 10 [2-30],校正差异14,95%置信区间8-21,p <0.001),而恶心没有差异(7 [0-27]与10 [0-24],p = 0.68)。两组之间的不良症状如上腹部不适的发生率也相当(2.7%比3.9%,p = 0.25)。洛索洛芬钠可有效缓解宿醉后的头痛,但不能缓解全身疲劳或恶心。
更新日期:2019-11-01
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