Fujimori Shunji, Hanada Ryuzo, Hayashida Mari, Sakurai Toshiyuki, Ikushima Ippei, Sakamoto Choitsu
*Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Bunkyo-ku †Medical Co. LTA Sumida Hospital, Sumida-ku ‡The Third Department of Internal Medicine, Kyorin University School of Medicine, Mitaka §Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Shinjuku, Tokyo, Japan.
J Clin Gastroenterol. 2016 Mar;50(3):218-26. doi: 10.1097/MCG.0000000000000372.
The aim of this study was to compare celecoxib with loxoprofen for protection of small intestine.
RCT studies report that COX-2 selective inhibitor celecoxib induces fewer small intestinal injuries than nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Loxoprofen is a prodrug nonselective NSAID developed to protect upper gastrointestinal tract.
A total of 150 healthy volunteers (40 to 70 y) were enrolled. After medical checkup including laboratory data, subjects were randomly assigned to celecoxib (200 mg daily) or loxoprofen (180 mg daily) plus lansoprazole (15 mg daily). All drugs were prepared using inactive capsules. After randomization, all subjects were first examined by baseline capsule endoscopy (CE). After 14 days, subjects underwent posttreatment CE. We compared baseline and posttreatment CE findings of the 2 groups. All CE data were evaluated blindly by 3 reviewers. Pretreatment and posttreatment laboratory variables were also compared.
A total of 74 subjects (49±6 y, F/M: 36/38) were enrolled in celecoxib group and 76 subjects (49±7 y, F/M: 39/37)in loxoprofen group. Five in celecoxib group and 4 in loxoprofen group were excluded from CE analysis mainly due to incomplete CE. The percentage of subjects with at least 1 posttreatment mucosal break was lower in celecoxib group (10%) than in loxoprofen group (49%) (P<0.0001). A total of 0.3±1.0 posttreatment small intestinal mucosal breaks were detected in the celecoxib group, and 6.8±21.5 in the loxoprofen group (P<0.0001). Posttreatment hemoglobin concentration in loxoprofen group (5.1% reduction) was lower compared with celecoxib group (2.1% reduction) (P=0.006).
In terms of protection of small intestine from NSAIDs toxicity, celecoxib monotherapy was superior to loxoprofen+lansoprazole combination therapy (UMIN: 000007936).
本研究旨在比较塞来昔布与洛索洛芬对小肠的保护作用。
随机对照试验研究报告称，COX-2选择性抑制剂塞来昔布比非选择性非甾体抗炎药（NSAIDs）引起的小肠损伤更少。洛索洛芬是一种开发用于保护上消化道的前体药物非选择性NSAIDs。
共纳入150名健康志愿者（40至70岁）。在进行包括实验室数据在内的医学检查后，受试者被随机分配至塞来昔布组（每日200毫克）或洛索洛芬组（每日180毫克）加兰索拉唑组（每日15毫克）。所有药物均使用无活性胶囊制备。随机分组后，所有受试者首先接受基线胶囊内镜检查（CE）。14天后，受试者接受治疗后CE检查。我们比较了两组的基线和治疗后CE检查结果。所有CE数据均由3名审阅者进行盲法评估。还比较了治疗前和治疗后的实验室变量。
塞来昔布组共纳入74名受试者（49±6岁，女性/男性：36/38），洛索洛芬组共纳入76名受试者（49±7岁，女性/男性：39/37）。塞来昔布组有5名受试者、洛索洛芬组有4名受试者被排除在CE分析之外，主要原因是CE检查不完整。塞来昔布组治疗后至少有1处黏膜破损的受试者百分比（10%）低于洛索洛芬组（49%）（P<0.0001）。塞来昔布组治疗后共检测到0.3±1.0处小肠黏膜破损，洛索洛芬组为6.8±21.5处（P<0.0001）。洛索洛芬组治疗后的血红蛋白浓度降低（降低5.1%），低于塞来昔布组（降低2.1%）（P=0.006）。
在保护小肠免受NSAIDs毒性方面，塞来昔布单药治疗优于洛索洛芬+兰索拉唑联合治疗（UMIN：000007936）。
