Cryer B, Miller P, Petruschke R A, Chen E, Geba G P, Papp A E
Department of Medicine, University of Texas Southwestern Medical School, Dallas, TX 75216, USA.
Aliment Pharmacol Ther. 2005 Mar 1;21(5):599-607. doi: 10.1111/j.1365-2036.2005.02378.x.
Both oral bisphosphonates and non-steroidal anti-inflammatory drugs have the potential to irritate the upper gastrointestinal mucosa, and are frequently used by the same patient population.
To determine the rate of upper gastrointestinal adverse events with once weekly alendronate 70 mg and concomitant non-steroidal anti-inflammatory drug use.
A post hoc analysis was performed on 222 patients who received both medications concomitantly during a 3-month placebo-controlled study. A total of 450 (224 alendronate; 226 placebo) postmenopausal women and men with osteoporosis were randomized. Concomitant non-steroidal anti-inflammatory drug users were defined as patients who received > or =7 continuous days of any dose of a dual cyclo-oxygenase-1 and cyclo-oxygenase-2 inhibiting non-steroidal anti-inflammatory drug, a selective cyclo-oxygenase-2 inhibitor, or aspirin. A survival analysis was performed, and significance assessed. Logistic regression was used to assess consistency of treatment effect on rate of upper gastrointestinal adverse events across non-steroidal anti-inflammatory drug subgroups.
Similar percentages of alendronate (52.7%) and placebo (46.0%) patients used non-steroidal anti-inflammatory drugs regularly. Among concomitant non-steroidal anti-inflammatory drug users, 11 alendronate and 11 placebo patients experienced upper gastrointestinal adverse events (9.3% and 10.8%, respectively, P = 0.744). Logistic regression revealed no significant interaction (P = 0.722) between alendronate and concomitant non-steroidal anti-inflammatory drug use.
Based on this subgroup analysis, once weekly alendronate 70 mg used concomitantly with non-steroidal anti-inflammatory drugs, did not increase upper gastrointestinal adverse events relative to placebo over 3-months.
口服双膦酸盐类药物和非甾体抗炎药均有可能刺激上消化道黏膜，且常被同一患者群体使用。
确定每周一次服用70毫克阿仑膦酸钠并同时使用非甾体抗炎药时上消化道不良事件的发生率。
对在一项为期3个月的安慰剂对照研究中同时接受这两种药物治疗的222例患者进行事后分析。共有450名（224例阿仑膦酸钠组；226例安慰剂组）绝经后骨质疏松症女性和男性被随机分组。同时使用非甾体抗炎药的患者定义为接受任何剂量的双重环氧化酶-1和环氧化酶-2抑制性非甾体抗炎药、选择性环氧化酶-2抑制剂或阿司匹林连续≥7天的患者。进行生存分析并评估显著性。使用逻辑回归评估在非甾体抗炎药亚组中治疗对上消化道不良事件发生率的效果一致性。
阿仑膦酸钠组（52.7%）和安慰剂组（46.0%）定期使用非甾体抗炎药的患者比例相似。在同时使用非甾体抗炎药的患者中，11例阿仑膦酸钠组患者和11例安慰剂组患者发生了上消化道不良事件（分别为9.3%和10.8%，P = 0.744）。逻辑回归显示阿仑膦酸钠与同时使用非甾体抗炎药之间无显著交互作用（P = 0.722）。
基于该亚组分析，在3个月的时间里，每周一次服用70毫克阿仑膦酸钠并同时使用非甾体抗炎药，与安慰剂相比，并未增加上消化道不良事件的发生。
