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[埃索美拉唑20毫克每日两次治疗胃食管反流病相关非心源性胸痛的疗效:一项开放标签随机试验研究]

[Therapeutic Response to 20 mg of Esomeprazole Twice Daily in Patients with Gastroesophageal Reflux Disease-related Non-cardiac Chest Pain: An Open-Label Randomized Pilot Study].

作者信息

Choi Jae Kyun, Shim Hyun Ik, Shin Cheol Min, Yoon Hyuk, Park Young Soo, Kim Nayoung, Lee Dong Ho

机构信息

Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.

Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Korean J Gastroenterol. 2020 Jun 25;75(6):333-340. doi: 10.4166/kjg.2020.75.6.333.

Abstract

BACKGROUND/AIMS: Non-cardiac chest pain (NCCP) is defined as recurrent angina pectoris-like pain without evidence of coronary heart disease, and is usually related to esophageal diseases, such as gastroesophageal reflux disease (GERD). Proton pump inhibitors (PPIs) are important for diagnosis and treatment. Many studies have been conducted on the use of PPIs in patients with GERD-related NCCP. In contrast to standard-dose esomeprazole, the efficacy of half-dose esomeprazole twice daily (BD) has not been established. This study compared the efficacies of the two esomeprazole regimens in GERD-related NCCP.

METHODS

In this prospective, open-label study, 37 participants with GERD-related NCCP were randomized to receive either 20 mg of esomeprazole BD (n=21) (esomeprazole BD group) or 40 mg once daily (n=16) (esomeprazole once daily [OD] group) for 4 weeks. In both groups, the chest pain score, which was calculated based on the frequency and severity, was evaluated before and 2 and 4 weeks after administering the medication.

RESULTS

The chest pain score significantly improved in both groups (p<0.001). The proportion of patients with chest pain score improvement >50% was 7.7% higher in the esomeprazole BD group than in the esomeprazole OD group (95.2% vs. 87.5%), but the difference was not significant.

CONCLUSIONS

Esomeprazole BD was as effective as esomeprazole OD in improving GERD-related NCCP. Although statistically insignificant, the percentage of patients with >50% reduction in the chest pain score was higher in the esomeprazole BD group than in the esomeprazole OD group. Large-scale studies will be needed to assess these findings further.

摘要

背景/目的:非心源性胸痛(NCCP)被定义为反复出现的类似心绞痛的疼痛,但无冠心病证据,通常与食管疾病有关,如胃食管反流病(GERD)。质子泵抑制剂(PPIs)对诊断和治疗很重要。关于PPIs在GERD相关NCCP患者中的应用已开展了许多研究。与标准剂量的埃索美拉唑相比,每日两次半剂量埃索美拉唑(BD)的疗效尚未确定。本研究比较了两种埃索美拉唑治疗方案对GERD相关NCCP的疗效。

方法

在这项前瞻性、开放标签研究中,37例GERD相关NCCP参与者被随机分为接受20mg埃索美拉唑BD(n = 21)(埃索美拉唑BD组)或40mg每日一次(n = 16)(埃索美拉唑每日一次[OD]组)治疗4周。两组在给药前、给药后2周和4周时,均根据发作频率和严重程度计算胸痛评分并进行评估。

结果

两组胸痛评分均显著改善(p < 0.001)。埃索美拉唑BD组胸痛评分改善>50%的患者比例比埃索美拉唑OD组高7.7%(95.2%对87.5%),但差异无统计学意义。

结论

埃索美拉唑BD在改善GERD相关NCCP方面与埃索美拉唑OD同样有效。虽然在统计学上无显著差异,但埃索美拉唑BD组胸痛评分降低>50%的患者百分比高于埃索美拉唑OD组。需要开展大规模研究以进一步评估这些结果。

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