Abstract：
Mefenamic acid is a non‑steroidal anti‑inflammatory drug exhibiting a wide range of anti‑inflammatory, antipyretic, analgesic and probable antiviral activities. The present study evaluated the efficacy of treatment with mefenamic acid combined with standard medical care vs. standard medical care plus a placebo in ambulatory patients with coronavirus disease 2019 (COVID‑19; nasal/oropharyngeal swabs reverse transcription‑PCR test results positive for severe acute respiratory syndrome coronavirus 2). The present study is a phase II prospective, two‑arm, parallel‑group, randomized, double‑blind placebo‑controlled clinical trial which analyzed 36 patients. Two aspects were evaluated during the 14‑day follow‑up period: i) The time for reaching a patient acceptable symptom state (PASS), and ii) the last day of each COVID‑19 symptom presentation. Adverse effects were evaluated. The clinical severity for all the patients in the study was mild (88.9%) and moderate (11.1%). The control (placebo) group achieved PASS on day 8.0±1.3, compared with day 4.4±0.8 in the mefenamic acid group (P=0.020, Kaplan‑Meier analyses using log‑rank tests). Patients that received mefenamic acid plus standard medical care had a ~16‑fold higher probability of achieving PASS on day 8 (adjusted RR, 15.57; 95% CI, 1.22‑198.71; P=0.035), compared with the placebo plus standard medical care group. All symptoms lasted for fewer days in the mefenamic acid group, compared with the placebo group; however, only the symptoms of headache (P=0.008), retro‑orbital eye pain (P=0.049), and sore throat (P=0.029) exhibited statistically significant differences. The experimental treatment produced no severe adverse effects. On the whole, the present study demonstrates that the administration of mefenamic acid markedly reduced the symptomatology and time to reach PASS in ambulatory patients with COVID‑19. Due to its probable antiviral effects and potent anti‑inflammatory mechanisms, mefenamic acid may prove to be useful in the treatment of COVID‑19, in combination with other drugs, including the new antivirals (remdesivir, molnupiravir, or favipiravir). However, future studies are also required to confirm these findings.
摘要：
甲芬那酸是一种非甾体抗炎药，具有广泛的抗炎作用，退烧药,镇痛和可能的抗病毒活性。本研究评估了甲芬那酸联合标准医疗治疗的疗效。2019年门诊冠状病毒病患者的标准医疗服务加安慰剂（COVID-19；鼻/口咽拭子逆转录PCR检测结果对严重急性呼吸综合征冠状病毒2呈阳性）。本研究是第二阶段前瞻性的，双臂，平行组，随机化，双盲安慰剂对照临床试验，分析了36名患者。在14天的随访期间评估了两个方面：i）达到患者可接受症状状态（PASS）的时间，和ii）每个COVID-19症状呈现的最后一天。评价不良反应。研究中所有患者的临床严重程度为轻度（88.9％）和中度（11.1％）。对照组（安慰剂）在第8.0±1.3天达到PASS，而甲芬那酸组为第4.4±0.8天（P=0.020，Kaplan-Meier分析使用对数秩检验）。接受甲芬那酸加上标准医疗护理的患者在第8天达到PASS的概率高出约16倍（调整后的RR，15.57；95%CI，1.22-198.71；P=0.035），与安慰剂加标准医疗护理组相比。甲芬那酸组中所有症状持续的天数较少,与安慰剂组相比；然而，只有头痛的症状（P=0.008），眶后眼痛（P=0.049），喉咙痛(P=0.029)差异有统计学意义。实验治疗没有产生严重的不良反应。总的来说,本研究表明，甲芬那酸的给药显著降低了COVID-19非卧床患者的症状和达到PASS的时间。由于其可能的抗病毒作用和有效的抗炎机制，甲芬那酸可能与其他药物联合治疗COVID-19，包括新的抗病毒药物(remdesivir,Molnupiravir,或法皮拉韦)。然而,未来的研究也需要证实这些发现.
