Prospective, randomized single-blind, multicenter comparison of the analgesic efficacy of flurbiprofen/ thiocolchicoside and ibuprofen in myalgia complaints in SARS-CoV-2 patients

Safa Dönmez, Erdal Tekin, Ahmet Burak Erdem, Alp Şener, Ahmet Coşkun
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Abstract

Introduction: Myalgia is a common symptom in patients with COVID-19. NSAIDs perform pain suppression mechanisms by suppressing prostaglandin synthesis through inhibition of cyclooxygenase enzyme (COX). Thiocolchicoside activates GABA and Glycine receptors at the spinal level and exerts a myorelaxant effect. The aim of this study is to compare the analgesic efficacy of two drugs, the active ingredients of which are ibuprofen and flurbiprofen/ thiocolchicoside. Method: The study was designed according to a multicenter, prospective, randomized, controlled clinical trial model. A power analysis was performed based on the study of Derosa et al. including patients with myalgia complaints(11). By accepting 80% power and 5% type-1 error, the number of patients to be included in each group was calculated as at least 68. We planned to include 100 patients in each group, taking into account data losses and patients who may drop out of the study during follow-up (n=200). Results: According to the results of the study, the difference between baseline and 2nd day NRS and the difference between baseline and 3rd day NRS were found to be statistically significantly higher in the group using ibuprofen 800 mg retard TB (P<0.05). Conclusion: In the treatment and follow-up of patients with COVID-19 and myalgia complaints, ibuprofen 800 mg retard tb can be preferred primarily because its effectiveness is superior and no side effects are observed.
氟比洛芬/硫代葡萄糖苷与布洛芬治疗SARS-CoV-2患者肌痛的前瞻性、随机、单盲、多中心比较
肌痛是COVID-19患者的常见症状。非甾体抗炎药通过抑制环氧化酶(COX)来抑制前列腺素的合成,从而实现疼痛抑制机制。硫代秋糖苷在脊髓水平激活GABA和甘氨酸受体,并发挥肌肉松弛作用。本研究的目的是比较两种药物的镇痛效果,这两种药物的有效成分是布洛芬和氟比洛芬/硫代秋糖苷。方法:采用多中心、前瞻性、随机对照临床试验模式。根据Derosa等人的研究,包括有肌痛主诉的患者,进行了功效分析(11)。通过接受80%的功率和5%的1型误差,计算出每组纳入的患者人数至少为68人。考虑到数据丢失和随访期间可能退出研究的患者,我们计划每组纳入100例患者(n=200)。结果:根据研究结果,布洛芬800 mg组的基线与第2天NRS的差异以及基线与第3天NRS的差异均有统计学意义(p < 0.05)。结论:在新冠肺炎合并肌痛主诉患者的治疗与随访中,因其疗效优越且无不良反应,可优先选择布洛芬800mg缓期治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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