Ashworth Nigel L, Peloso Paul M, Muhajarine Nazeem, Stang Maryrose
Division of Physical Medicine and Rehabilitation, University of Alberta, Edmonton, Alberta, Canada.
J Rheumatol. 2005 Nov;32(11):2212-7.
To identify the unbiased differences in the risk of hospitalization with peptic ulcer disease (PUD) or gastrointestinal (GI) hemorrhage among populations using 4 nonsteroidal antiinflammatory drugs (NSAID): nabumetone, Arthrotec, diclofenac plus a cytoprotective agent dispensed separately (diclo+coRx), and naproxen.
A population based historical cohort study using linked data from provincial healthcare databases. The population of the province of Saskatchewan, Canada, entitled to drug plan benefits in 1995 was eligible (roughly 91% of 1 million people). Participants were identified if they filled a prescription for one of the 4 study NSAID (18,424 individuals). They were then followed for 6 months to determine outcomes. Logistic regression was used to produce estimates of the risk of admission to hospital with a primary diagnosis of PUD or GI hemorrhage associated with the study drugs unbiased by known confounders.
Compared to Arthrotec the adjusted odds of hospitalization for PUD for participants taking nabumetone was 2.6 (95% CI 1.0-6.6), diclo+coRx 6.8 (95% CI 3.5-13.4), and naproxen 7.9 (95% CI 3.9-15.9). Compared to nabumetone the adjusted odds of hospitalization for PUD for participants taking diclo+coRx was 2.7 (95% CI 1.2-6.0) and naproxen 3.1 (95% CI 1.3-7.1). No significant differences were noted in terms of admissions for GI hemorrhage.
Participants taking nabumetone and Arthrotec had significantly lower risk of hospitalization for PUD than those taking the other study drugs. Arthrotec was superior to nabumetone in a head to head comparison and especially when compared with the diclo+coRx and naproxen groups. No short term differences were seen in the rates of admission for GI hemorrhage. It appears that inherent gastroprotective strategies with Arthrotec and to a lesser extent with nabumetone do translate into decreased serious GI side effects at the population level in the short term.
确定使用4种非甾体抗炎药（NSAID）的人群中，患消化性溃疡病（PUD）或胃肠道（GI）出血而住院风险的无偏差异。这4种药物分别是：萘丁美酮、奥湿克、双氯芬酸加单独配发的细胞保护剂（双氯芬酸+联合用药）和萘普生。
一项基于人群的历史性队列研究，使用来自省级医疗数据库的关联数据。加拿大萨斯喀彻温省1995年有权享受药物计划福利的人群符合条件（约100万人中的91%）。如果参与者开具了4种研究性NSAID中任何一种的处方（18424人），则将其识别出来。然后对他们进行6个月的随访以确定结果。使用逻辑回归来估计因PUD或GI出血作为主要诊断而住院的风险，该风险与研究药物相关，且不受已知混杂因素的影响。
与奥湿克相比，服用萘丁美酮的参与者患PUD住院的校正比值比为2.6（95%置信区间1.0 - 6.6），双氯芬酸+联合用药为6.8（95%置信区间3.5 - 13.4），萘普生为7.9（95%置信区间3.9 - 15.9）。与萘丁美酮相比，服用双氯芬酸+联合用药的参与者患PUD住院的校正比值比为2.7（95%置信区间1.2 - 6.0），萘普生为3.1（95%置信区间1.3 - 7.1）。在GI出血住院方面未观察到显著差异。
服用萘丁美酮和奥湿克的参与者患PUD住院的风险显著低于服用其他研究药物的参与者。在直接比较中，奥湿克优于萘丁美酮，尤其是与双氯芬酸+联合用药组和萘普生组相比。在GI出血住院率方面未观察到短期差异。看来奥湿克以及程度稍轻的萘丁美酮所具有的内在胃保护策略，在短期内确实能在人群层面上减少严重的GI副作用。
