前列腺素预防非甾体抗炎药所致小肠损伤：一项通过胶囊内镜评估的随机对照试验试点研究
Prevention of nonsteroidal anti-inflammatory drug-induced small-intestinal injury by prostaglandin: a pilot randomized controlled trial evaluated by capsule endoscopy.
作者信息
Fujimori Shunji, Seo Tsuguhiko, Gudis Katya, Ehara Akihito, Kobayashi Tsuyoshi, Mitsui Keigo, Yonezawa Masaoki, Tanaka Shu, Tatsuguchi Atsushi, Sakamoto Choitsu
机构信息
Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
出版信息
Gastrointest Endosc. 2009 Jun;69(7):1339-46. doi: 10.1016/j.gie.2008.08.017. Epub 2009 Feb 24.
BACKGROUND
There is no known preventive agent against nonsteroidal anti-inflammatory drug (NSAID) induced small-intestinal injury.
OBJECTIVE
To evaluate by capsule endoscopy whether coadministration of prostaglandin (PG) can prevent small-intestinal damage induced by short-term NSAID treatment.
DESIGN
Single-blind, randomized, controlled trial.
SETTING
All procedures were performed at Nippon Medical School.
SUBJECTS
Thirty-four healthy male volunteers.
METHODS
All subjects were randomly assigned to 2 groups: an NSAID-control group, who underwent NSAID (diclofenac sodium, 25 mg 3 times daily) and omeprazole (20 mg once daily) treatment, and an NSAID-PG group, who received PG (misoprostol, 200 microg 3 times daily) in addition to the same NSAID-omeprazole treatment. Eligible subjects, 15 per group, underwent capsule endoscopy before and 14 days after treatment.
MAIN OUTCOME MEASUREMENTS
The number of mucosal breaks at capsule endoscopy.
RESULTS
NSAID treatment significantly increased the mean (SD) number of mucosal breaks per subject, from a basal level of 0.1 +/- 0.3 up to 2.9 +/- 6.3 lesions in the NSAID-control group (P = .012). In contrast, there was no significant change in the mean number of mucosal breaks before and after PG cotreatment (P = 0.42). Thus, the mean number of posttreatment mucosal breaks per subject was significantly higher in the NSAID-control group than in the NSAID-PG group (P = .028). There was a significant increase in the percentage of subjects in the NSAID-control group, with at least 1 mucosal break after treatment (from 6.7% to 53.3%), whereas there was no change in the incidence of mucosal breaks in the NSAID-PG group, which remained at 13.3%. (P = .002).
LIMITATIONS
Single-center, open-label study.
CONCLUSIONS
PG cotherapy reduced the incidence of small-intestinal lesions induced by a 2-week administration of diclofenac sodium.
背景
目前尚无已知的预防非甾体抗炎药（NSAID）所致小肠损伤的药物。
目的
通过胶囊内镜评估前列腺素（PG）联合使用能否预防短期NSAID治疗引起的小肠损伤。
设计
单盲、随机、对照试验。
地点
所有检查均在日本医科大学进行。
研究对象
34名健康男性志愿者。
方法
所有受试者随机分为2组：NSAID对照组，接受NSAID（双氯芬酸钠，每日3次，每次25mg）和奥美拉唑（每日1次，每次20mg）治疗；NSAID-PG组，除接受相同的NSAID-奥美拉唑治疗外，还接受PG（米索前列醇，每日3次，每次200μg）治疗。每组15名符合条件的受试者在治疗前和治疗14天后接受胶囊内镜检查。
主要观察指标
胶囊内镜检查时黏膜破损的数量。
结果
NSAID治疗使NSAID对照组每位受试者黏膜破损的平均（标准差）数量从基线水平的0.1±0.3显著增加至2.9±6.3处损伤（P = 0.012）。相比之下，PG联合治疗前后黏膜破损的平均数量无显著变化（P = 0.42）。因此，NSAID对照组每位受试者治疗后黏膜破损的平均数量显著高于NSAID-PG组（P = 0.028）。NSAID对照组中治疗后至少有1处黏膜破损的受试者百分比显著增加（从6.7%增至53.3%），而NSAID-PG组黏膜破损的发生率无变化，仍为13.3%（P = 0.002）。
局限性
单中心、开放标签研究。
结论
PG联合治疗降低了双氯芬酸钠2周给药所致小肠损伤的发生率。
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