PDF(Pubmed)
Abstract：
BACKGROUND: Rebamipide has been widely co-prescribed with non-steroidal anti-inflammatory drugs (NSAIDs) in Japan for decades. This study aimed to evaluate the effectiveness of rebamipide in preventing upper gastrointestinal bleeding in new users of NSAIDs without risk factors of NSAID-induced ulcers other than age.
METHODS: A nested case-control study was conducted using medical claims data of 1.66 million inhabitants of 17 municipalities participating in Japan\'s Longevity Improvement & Fair Evidence study. The cohort entry (t0) corresponded to a new user of NSAIDs for osteoarthritis or low back pain. Patients with risk factors of NSAID-induced ulcers other than age were excluded. Cases were defined as patients who underwent gastroscopy for upper gastrointestinal bleeding (occurrence date was defined as index date). A maximum of 10 controls were selected from non-cases at the index date of each case by matching sex, age, follow-up time, and type and dosage of NSAIDs. Exposure to rebamipide was defined as prescription status from t0 to index date: Non-user (rebamipide was not co-prescribed during the follow-up period), Continuous-user (rebamipide was co-prescribed from t0 with the same number of tablets as NSAIDs), and Irregular-user (neither Non-user nor Continuous-user). Conditional logistic regression analysis was conducted to estimate each category\'s odds ratio compared to non-users.
RESULTS: Of 67,561 individuals who met the inclusion criteria, 215 cases and 1,516 controls were selected. Compared with that of Non-users, the odds ratios and 95% confidence interval were 0.65 (0.44-0.96) for Continuous-users and 2.57 (1.73-3.81) for Irregular-users.
CONCLUSIONS: Continuous co-prescription of rebamipide significantly reduced the risk of upper gastrointestinal bleeding in an Asian cohort of new users of NSAIDs with osteoarthritis or low back pain without risk factors other than age.
METHODS: A nested case-control study was conducted using medical claims data of 1.66 million inhabitants of 17 municipalities participating in Japan\'s Longevity Improvement & Fair Evidence study. The cohort entry (t0) corresponded to a new user of NSAIDs for osteoarthritis or low back pain. Patients with risk factors of NSAID-induced ulcers other than age were excluded. Cases were defined as patients who underwent gastroscopy for upper gastrointestinal bleeding (occurrence date was defined as index date). A maximum of 10 controls were selected from non-cases at the index date of each case by matching sex, age, follow-up time, and type and dosage of NSAIDs. Exposure to rebamipide was defined as prescription status from t0 to index date: Non-user (rebamipide was not co-prescribed during the follow-up period), Continuous-user (rebamipide was co-prescribed from t0 with the same number of tablets as NSAIDs), and Irregular-user (neither Non-user nor Continuous-user). Conditional logistic regression analysis was conducted to estimate each category\'s odds ratio compared to non-users.
RESULTS: Of 67,561 individuals who met the inclusion criteria, 215 cases and 1,516 controls were selected. Compared with that of Non-users, the odds ratios and 95% confidence interval were 0.65 (0.44-0.96) for Continuous-users and 2.57 (1.73-3.81) for Irregular-users.
CONCLUSIONS: Continuous co-prescription of rebamipide significantly reduced the risk of upper gastrointestinal bleeding in an Asian cohort of new users of NSAIDs with osteoarthritis or low back pain without risk factors other than age.
摘要：
背景：几十年来，Rebamipide已在日本广泛与非甾体抗炎药（NSAIDs）共同使用。这项研究旨在评估瑞巴派特预防NSAIDs新使用者上消化道出血的有效性，而没有年龄以外的NSAID诱发溃疡的危险因素。
方法：使用参与日本长寿改善和公平证据研究的17个城市的166万居民的医疗索赔数据进行了嵌套病例对照研究。队列条目(t0)对应于骨关节炎或腰背痛的NSAIDs的新用户。排除年龄以外的具有NSAID引起的溃疡危险因素的患者。病例定义为因上消化道出血而接受胃镜检查的患者（发生日期定义为索引日期）。在每个病例的索引日期，通过匹配性别从非病例中最多选择10个对照，年龄,随访时间,以及NSAIDs的类型和剂量。rebamipide暴露被定义为从t0到索引日期的处方状态：非使用者（在随访期间没有共同处方的rebamipide），连续使用者（瑞巴派特从t0开始共同处方，片剂数量与NSAIDs相同），和非正常用户（既不是非用户也不是连续用户）。进行条件逻辑回归分析，以估计每个类别与非使用者相比的比值比。
结果：在符合纳入标准的67,561个人中，选择215例病例和1,516例对照。与非用户相比，连续用户的比值比和95%置信区间分别为0.65(0.44~0.96)和2.57(1.73~3.81).
结论：在亚洲新使用NSAIDs并伴有骨关节炎或腰背痛的队列中，连续服用瑞巴派特可显著降低上消化道出血的风险，无年龄以外的其他危险因素。
方法：使用参与日本长寿改善和公平证据研究的17个城市的166万居民的医疗索赔数据进行了嵌套病例对照研究。队列条目(t0)对应于骨关节炎或腰背痛的NSAIDs的新用户。排除年龄以外的具有NSAID引起的溃疡危险因素的患者。病例定义为因上消化道出血而接受胃镜检查的患者（发生日期定义为索引日期）。在每个病例的索引日期，通过匹配性别从非病例中最多选择10个对照，年龄,随访时间,以及NSAIDs的类型和剂量。rebamipide暴露被定义为从t0到索引日期的处方状态：非使用者（在随访期间没有共同处方的rebamipide），连续使用者（瑞巴派特从t0开始共同处方，片剂数量与NSAIDs相同），和非正常用户（既不是非用户也不是连续用户）。进行条件逻辑回归分析，以估计每个类别与非使用者相比的比值比。
结果：在符合纳入标准的67,561个人中，选择215例病例和1,516例对照。与非用户相比，连续用户的比值比和95%置信区间分别为0.65(0.44~0.96)和2.57(1.73~3.81).
结论：在亚洲新使用NSAIDs并伴有骨关节炎或腰背痛的队列中，连续服用瑞巴派特可显著降低上消化道出血的风险，无年龄以外的其他危险因素。
