Department of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan.
BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.
Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective and common treatment for chronic pain disorders, but long-term use is associated with risk of potentially life-threatening gastrointestinal adverse events (AEs). The proton pump inhibitor esomeprazole has been found to be effective for gastroprotection in NSAID users, but few long-term studies have been conducted in Japan.
This was an open-label, multicentre, single-arm, prospective 1-year study of treatment with esomeprazole (20 mg once daily) in Japanese patients (aged ≥20 years) with endoscopic evidence of previous peptic ulcer and receiving daily oral NSAID therapy (at a stable dose) for a chronic condition. Eligibility was not dictated by type of oral NSAID. The primary objective was to determine long-term safety and tolerability of esomeprazole. Efficacy for prevention of peptic ulcers was also determined (Kaplan-Meier method). All statistical analyses were descriptive.
A total of 130 patients (73.1% women, mean age 62.1 years, 43.8% Helicobacter pylori-positive) received treatment with esomeprazole in addition to long-term NSAID therapy (most commonly for rheumatoid arthritis [n=42] and osteoarthritis [n=34]). Loxoprofen, meloxicam and diclofenac were the most commonly used NSAIDs; cyclo-oxygenase (COX)-2 selective agents were used by 16.2% of patients (n=21). Long-term compliance with esomeprazole (capsule counts) was >75% for the majority of patients. Although 16.9% of patients (n=22) experienced AEs judged to be possibly related to treatment with esomeprazole, they were mostly mild and transient. The most commonly reported possibly treatment-related AEs were abnormal hepatic function, headache, increased γ-glutamyltransferase levels and muscle spasms (2 patients each). Overall, 95.9% (95% confidence interval: 92.3, 99.4) of patients remained ulcer free at 1 year.
Long-term treatment with esomeprazole (20 mg once daily) is well tolerated and efficacious for preventing ulcer recurrence in Japanese NSAID users with a history of peptic ulcer.
ClinicalTrials.gov identifier NCT00595517.
非甾体抗炎药（NSAIDs）是治疗慢性疼痛疾病的有效且常用的药物，但长期使用与潜在威胁生命的胃肠道不良事件（AE）风险相关。质子泵抑制剂埃索美拉唑已被证明可有效预防 NSAID 使用者的胃损伤，但在日本进行的长期研究较少。
这是一项在日本患者中进行的开放性、多中心、单臂、前瞻性、为期 1 年的埃索美拉唑（20mg 每日一次）治疗研究，这些患者有内镜检查证实的既往消化性溃疡病史，并且正在接受每日口服 NSAID 治疗（剂量稳定）用于治疗慢性疾病。口服 NSAID 的类型并不决定入选条件。主要目的是确定埃索美拉唑的长期安全性和耐受性。还确定了预防消化性溃疡的疗效（Kaplan-Meier 法）。所有统计分析均为描述性的。
共有 130 名患者（73.1%为女性，平均年龄 62.1 岁，43.8%为幽门螺杆菌阳性）接受了埃索美拉唑治疗，同时还接受了长期 NSAID 治疗（最常见的疾病是类风湿关节炎[42 例]和骨关节炎[34 例]）。洛索洛芬、美洛昔康和双氯芬酸是最常用的 NSAIDs；环氧化酶（COX）-2 选择性药物在 16.2%的患者（21 例）中使用。大多数患者埃索美拉唑（胶囊计数）的长期依从性>75%。尽管 16.9%的患者（22 例）发生了AE，这些 AE 被认为可能与埃索美拉唑治疗有关，但它们大多是轻微和短暂的。报告的可能与治疗相关的最常见 AE 是肝功能异常、头痛、γ-谷氨酰转移酶水平升高和肌肉痉挛（各 2 例）。总体而言，95.9%（95%置信区间：92.3，99.4）的患者在 1 年内保持无溃疡状态。
长期使用埃索美拉唑（20mg 每日一次）治疗日本 NSAID 使用者，预防有消化性溃疡病史的患者溃疡复发，耐受性良好且有效。
ClinicalTrials.gov 标识符 NCT00595517。
