Department of Orthopaedic Surgery, Medical College of Hallym University, Gyeonggi-do, Republic of Korea.
Department of Orthopedic Surgery, Hanyang University College of Medicine, Seoul, Republic of Korea.
PLoS One. 2020 Jan 27;15(1):e0226184. doi: 10.1371/journal.pone.0226184. eCollection 2020.
Selective cyclooxygenase-2 inhibitors (celecoxib) can minimize the gastrointestinal complications related to non-steroidal anti-inflammatory drug (NSAID) use. NAXOZOL is a new combination formulation designed to provide sequential delivery of a non-enteric-coated, immediate-release esomeprazole strontium tetrahydrate 20 mg mantle followed by an enteric-coated naproxen 500 mg core. However, there have been no studies comparing NAXOZOL to celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis. This study was undertaken to compare the effects of NAXOZOL and celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis.
The randomized enrolled patients were divided into two treatment groups: a NAXOZOL group and a celecoxib group. All participants received treatments (NAXOZOL, 500/20 mg (naproxen 500 mg, esomeprazole strontium tetrahydrate 20 mg) twice per day versus celecoxib, 200 mg daily) on a 1:1 allocation basis for 12 weeks. The primary outcome was the Leeds Dyspepsia Questionnaire (LDQ) score used for non-inferiority testing. Secondary outcome measures included the Gastrointestinal Symptom Rating Scale (GSRS) score, Visual Analogue Scale (VAS) score, European Quality of Life-5 dimensions (EQ-5D) scale and the EQ-5D Visual Analogue Scale (EQ VAS). Other outcome measures included the use of supplementary or rescue drugs, and the incidence of adverse events.
The baseline-adjusted LDQ scores immediately after 12 weeks of treatment in NAXOZOL group were not inferior to those in celecoxib group. The overall change in the baseline-adjusted GSRS score, VAS score, EQ-5D, and EQ VAS was not different between the two groups. The usage of supplementary drugs and the drug-related incidence of adverse events were not different. However, the days to use rescue drug were longer in celecoxib group than in NAXOZOL group.
NAXOZOL was not inferior to celecoxib in protecting the gastrointestinal tract and providing pain relief in patients with osteoarthritis.
选择性环氧化酶-2 抑制剂（塞来昔布）可最大程度减少非甾体抗炎药（NSAID）使用相关的胃肠道并发症。NAXOZOL 是一种新的组合制剂，旨在提供非肠溶、速释埃索美拉唑镁四水合物 20mg 包衣层的序贯给药，随后是肠溶萘普生 500mg 核心。然而，尚未有研究比较 NAXOZOL 与塞来昔布在骨关节炎患者中的胃肠道保护和缓解疼痛方面的效果。本研究旨在比较 NAXOZOL 和塞来昔布在骨关节炎患者中的胃肠道保护和缓解疼痛方面的效果。
这项随机纳入的患者被分为两组治疗组：NAXOZOL 组和塞来昔布组。所有参与者均接受治疗（NAXOZOL，500/20mg（萘普生 500mg，埃索美拉唑镁四水合物 20mg），每日两次，与塞来昔布，200mg，每日一次），按 1:1 分配，为期 12 周。主要结局指标是用于非劣效性检验的利兹消化不良问卷（LDQ）评分。次要结局指标包括胃肠道症状评分量表（GSRS）评分、视觉模拟评分（VAS）评分、欧洲生活质量-5 维度（EQ-5D）量表和 EQ-5D 视觉模拟评分（EQ VAS）。其他结局指标包括辅助或抢救药物的使用情况以及不良事件的发生率。
治疗 12 周后，NAXOZOL 组的基线调整后的 LDQ 评分不劣于塞来昔布组。两组的基线调整后的 GSRS 评分、VAS 评分、EQ-5D 和 EQ VAS 的总体变化无差异。辅助药物的使用情况和与药物相关的不良事件发生率也无差异。然而，塞来昔布组使用抢救药物的天数长于 NAXOZOL 组。
NAXOZOL 在保护骨关节炎患者的胃肠道和缓解疼痛方面与塞来昔布不劣效。
