日本消化器病学会 アーカイブシステム

セッション情報 The 4th International Forum

I　Drug-associated GI Injury：Advances of the pathogenesis and recent clinical topics　2. Recent clinical topics（b）Bowel injuries
タイトル IFI-2b-3：

A randomized, double-blinded, placebo-controlled, multicenter trial, healing effect of rebamipide in patients with low-dose aspirin and/or non-steroidal anti-inflammatory drug induced small bowel injury
演者 Kurokawa　Sei（Department of Gastroenterology, Sapporo-Kosei General Hospital, Japan）
共同演者 Katsuki　Shinichi（Department of Gastroenterology, Sapporo-Kosei General Hospital, Japan）, Kato　Mototsugu　（Department of Gastroenterology, Sapporo-Kosei General Hospital, Japan）
抄録 BACKGROUND：It is not clear what kind of drug is appropriate to heal NSAID-induced enteropathy. Several reports showed the preventive effect of prostaglandin analogue or inducer using healthy subjects who took NSAIDs. However there was no report for healing effect and for patients. The aim of this study was to evaluate the healing effect of rebamipide in patients with NSAIDs-induced enteropathy. In addition, we evaluated for nutritional parameter.
METHODS：This study was conducted as a randomized, double-blinded, placebo-controlled, multicenter trial. Study protocol was approved by each hospital’s ethical committees. Patients with LDA and/or NSAID more than 3 months were enrolled. Patients with enteropathy were divided into the placebo and the rebamipide groups. Rebamipide 100mg three times daily was administered during 4 weeks. Capsule endoscopies were performed at 0 and 4 week. The number of small intestinal ulcer and erosion were evaluated. Total protein was analyzed as nutritional parameter.
RESULT：Sixty one participants were completed this study. Change in number of small intestinal erosion in the rebamipide group was -2.5±3.4, and 2.1±3.9 in the placebo group（P＜0.0001）. Change in number of small intestinal ulcer in the rebamipide group was -0.5±1.6, and 0.1±0.7 in the placebo group（P=0.024）. Change in serum total protein levels in the rebamipide group was 0.06±0.36, and -0.27±0.34 in the placebo group（P=0.0005）.
CONCLUSIONS：Rebamipide has not only the healing effect for NSAIDs-induced enteropathy compared with placebo, but the improvement of nutritional condition. These results showed a tentative therapeutical strategy for chronic NSAIDs users.
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