Comparison of Prevention of NSAID-Induced Gastrointestinal Complications by Rebamipide and Misoprostol: A Randomized, Multicenter, Controlled Trial—STORM STUDY
Soo-Heon Park, Chul-Soo Cho, Oh-Young Lee, Jae-Burn Jun, San-Ren Lin, Li-Ya Zhou, Yao-Zong Yuan, Zhao-Shen Li, Xiao-Hua Hou, Hong-Chuan Zhao, Udom Kachintorn, Chomsri Kositchaiwat, Comson LertkupinitSt.Mary's Hospital, The Catholic University of Korea, Seoul 150-713, Korea. Tel:+82-2-3779-3029, Fax:+82-2-3779-1331, E-mail: psheon@catholic.ac.kr
บทคัดย่อ
Nonsteroidal anti-inflammatory drugs (NSAIDs) have gastrointestinal side effects such as dyspepsia, peptic ulcer, hemorrhage, and perforation. Misoprostol and PPIs have been used to prevent NSAID-induced gastroduodenal indury. Robamipide increases gastric mucus and stimulates the production of endogenous prostaglandins. The prophylactic effect of rebamipide on NSAID-induced gastrointestinal complications is unknown. The aim of this study was to compare NSAID-induced gastrointestinal complications in rebamipide- and misoprostol-treated groups. Patients were randomized to two groups and took a conventional NSAID plus rebamipide or misoprostol for 12 weeks. Gastric mucosal damage was evaluated by endoscopy at screening and the end of the study. The prevalences of active gastric ulcer were 7/176 (3.9 %) in the rebamipide group and 3/156 (1.9%) in the misoprostol group. The prevalences of peptic ulcer were 8/176 (4.5%) in the rebamipide group and 7/156 (4.4%) in the misoprostol group. The cumulative incidences of peptic ulcer in the high-risk subgroup were 6/151 (4.0%) for rebamipide and 6/154 (3.9%) for misoprostol. In conclusion, rebamipide prevented NSAID-induced peptic ulcer as effectively as misoprostol in patients on long-term NSAID therapy. Rebamipide may be a useful therapeutic option for the prevention of NSAID-induced gastrointestinal ulcer because of its therapeutic effect and safety.
ที่มา
Journal of Clinical Biochemistry and Nutrition ปี 2550, March
ปีที่: 40 ฉบับที่ 2 หน้า 148-155
คำสำคัญ
Misoprostol, Clinical trial, Gastrointestinal tract, NSAID, Rebamipide