Chen Chih-Yen, Lu Ching-Liang, Luo Jiing-Chyuan, Chang Full-Young, Lee Shou-Dong, Lai Yung-Ling
Division of Gastroenterology, Taipei Veterans General Hospital and School of Medicine, National Yang-Ming University, No. 201, Sec. 2, Shih-Pai Road, Taipei 112, Taiwan, China.
World J Gastroenterol. 2005 May 28;11(20):3112-7. doi: 10.3748/wjg.v11.i20.3112.
Esomeprazole, an oral S-form of omeprazole, has been a greater acid inhibitor over omeprazole in treating acid-related diseases. Only less published data is available to confirm its efficacy for Asian people. Therefore, a perspective, double-blind, randomized comparison of esomeprazole tablets 40 mg (Nexium) vs omeprazole capsules 20 mg (Losec) in treating Chinese subjects with erosive/ulcerative reflux esophagitis (EE) was conducted.
A total of 48 EE patients were enrolled and randomized into two treatment groups under 8-wk therapy: 25 receiving esomeprazole, while another 23 receiving omeprazole treatment. Finally, 44 completed the whole 8-wk therapy.
The difference in healing EE between two groups was 22.7% (72.7% vs 50.0%), not reaching significant value (P = 0.204). The median of the first time needed in relieving heartburn sensation was 1 d for both groups and the remission rates for heartburn on the 1st d after treatment were 77.3% and 65%, respectively (NS). The scores of various reflux relieving symptoms evaluated either by patients or by investigators were not different. Regarding drug safety, 28% of esomeprazole group and 26.1% of omeprazole group reported at least one episode of adverse effects, while constipation and skin dryness were the common side effects in both groups (NS).
Esomeprazole 40 mg is an effective and safe drug at least comparable to omeprazole in treating Chinese EE patients.
埃索美拉唑是奥美拉唑的口服S型异构体，在治疗酸相关性疾病方面比奥美拉唑具有更强的抑酸作用。目前仅有较少的公开数据证实其对亚洲人群的疗效。因此，开展了一项前瞻性、双盲、随机对照研究，比较40毫克埃索美拉唑片（耐信）与20毫克奥美拉唑胶囊（洛赛克）治疗中国糜烂性/溃疡性反流性食管炎（EE）患者的效果。
共纳入48例EE患者，随机分为两组，接受为期8周的治疗：25例接受埃索美拉唑治疗，另外23例接受奥美拉唑治疗。最终，44例患者完成了整个8周的治疗。
两组之间EE愈合率的差异为22.7%（72.7%对50.0%），未达到显著差异（P = 0.204）。两组缓解烧心感所需的首次中位时间均为1天，治疗后第1天烧心的缓解率分别为77.3%和65%（无显著性差异）。患者或研究者评估的各种反流缓解症状评分无差异。在药物安全性方面，埃索美拉唑组28%和奥美拉唑组26.1%的患者报告至少出现一次不良反应，便秘和皮肤干燥是两组常见的副作用（无显著性差异）。
40毫克埃索美拉唑在治疗中国EE患者方面是一种有效且安全的药物，至少与奥美拉唑相当。
