The Efficacy and Safety of Pelubiprofen in the Treatment of Acute Upper Respiratory Tract Infection: A Multicenter, Randomized, Double-Blind, Non-Inferiority Phase III Clinical Trial Compared to Loxoprofen

被引：0

作者：

Jang, An Soo ^{[1
]}

Kim, Sang Hoon ^{[2
]}

Lee, Sang Pyo ^{[3
]}

Na, Moon Jun ^{[4
]}

Yoo, Kwang Ha ^{[5
]}

Park, Chang Han ^{[6
]}

Park, Seong Yeon ^{[7
]}

Choi, Byoung Whui ^{[8
]}

机构：

[1] Soonchunhyang Univ, Bucheon Hosp, Dept Internal Med, Bucheon 14584, South Korea

[2] Nowon Eulji Univ, Eulji Univ, Sch Med, Dept Internal Med, Seoul 01830, South Korea

[3] Gachon Univ, Gil Med Ctr, Dept Internal Med, Incheon 21565, South Korea

[4] Konyang Univ Hosp, Dept Internal Med, Daejeon 35365, South Korea

[5] Konkuk Univ, Med Ctr, Dept Internal Med, Seoul 05030, South Korea

[6] Sungae Hosp, Dept Internal Med, Seoul 07354, South Korea

[7] Dongguk Univ, Ilsan Hosp, Dept Internal Med, Goyang 10326, South Korea

[8] Chung Ang Univ, Gwangmyeong Hosp, Soha Healthcare Ctr, Dept Internal Med, Gwangmyeong 14353, South Korea

来源：

JOURNAL OF CLINICAL MEDICINE | 2025年 / 14卷 / 05期

关键词：

pelubiprofen; loxoprofen; efficacy; randomized controlled trial; safety; NSAIDs; URTIs; fever; SYMPTOMS;

D O I：

10.3390/jcm14051450

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

<bold>Background/Objectives:</bold> Acute upper respiratory tract infections (URTIs) are common illnesses that cause significant discomfort due to symptoms such as fever, headache, sore throat, and muscle pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for symptom relief due to their anti-inflammatory, analgesic, and antipyretic properties. Pelubiprofen, a new NSAID, has not been extensively evaluated for its efficacy and safety in treating URTI-related symptoms, particularly fever. This study aimed to demonstrate that pelubiprofen is not inferior to loxoprofen in reducing fever in patients with URTIs. <bold>Methods</bold>: This phase III, multicenter, randomized, double-blind, parallel-group, active-controlled, non-inferiority trial involved 181 adults with URTI-related fever (>= 38.0 degrees C), who were randomly assigned to receive pelubiprofen or loxoprofen at a 1:1 ratio. The primary end point was decreasing axillary temperature 4 h post-dose. Secondary end points included fever reduction, pain relief based on the visual analog scale (VAS), and safety. <bold>Results:</bold> Of the 181 participants, 130 (pelubiprofen [n = 61] and loxoprofen group [n = 69]) underwent randomization. The mean reduction in axillary temperature at 4 h post-dose was comparable between the two groups (-0.08 +/- 0.62 degrees C). The lower bound of the 97.5% one-sided confidence interval was -0.30 degrees C, which is greater than the non-inferiority margin of 0.35 degrees C, demonstrating the non-inferiority of pelubiprofen to loxoprofen. The secondary outcomes showed no significant differences in efficacy or safety (p > 0.05). <bold>Conclusions</bold>: Pelubiprofen is not inferior to loxoprofen in reducing fever associated with URTIs and is a safe and effective treatment option. Registration: (ClinicalTrials.gov identifier: NCT01779271).

引用

页数：12

共 8 条

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