United BioSource Corporation, Lexington, MA 02420, USA.
Curr Med Res Opin. 2012 Jan;28(1):89-99. doi: 10.1185/03007995.2011.633990. Epub 2011 Nov 28.
Exposure to over-the-counter (OTC) ibuprofen and other OTC non-steroidal anti-inflammatory drugs (NSAIDs) is substantial. Although the literature on gastrointestinal (GI) safety of NSAID therapy is extensive, the risk profiles of OTC and prescription dosing are seldom separated, and few studies provide risks specific to OTC ibuprofen.
To conduct a literature review to evaluate the risk of GI bleeding events related to OTC ibuprofen use.
Published clinical trials, observational studies, and meta-analyses of OTC ibuprofen use, defined as up to 1200 mg/day or stated as 'over the counter,' reporting endpoints of incidence rates and proportions of GI bleeding events (e.g., GI bleeding-related hospitalizations and deaths) were identified via MEDLINE through 2010. Data from these studies were summarized.
Twenty studies (nine observational, ten clinical trials, one meta-analysis) reporting incidence rates and proportions of a GI bleeding-related event associated with OTC or OTC-specific doses of ibuprofen were included. The frequency of a GI-related hospitalization was <0.2% for patients on OTC-comparable doses. Incidence rates among those using OTC-comparable doses ranged from 0 to 3.19 per 1000 patient-years. The incidence of a GI bleeding-related event increased with age and the use of concomitant medications, and there was a general, though not always statistically significant, ibuprofen dose-response relationship. The relative risk of any GI bleeding-related event ranged from 1.1 to 2.4 for users of OTC-specific doses of ibuprofen compared to non-users.
Studies reported low incidence of GI bleeding events with use of OTC ibuprofen. Few published studies that specifically investigated OTC ibuprofen use were identified. Varying methodologies and definitions of exposure and outcomes prevented direct comparison of many results. Only studies that used the methods herein described were identified. Further research evaluating the risk of GI bleeding events in patients taking OTC-specific ibuprofen use may be useful.
非处方（OTC）布洛芬和其他非甾体抗炎药（NSAIDs）的使用量很大。尽管关于 NSAID 治疗胃肠道（GI）安全性的文献很多，但很少将 OTC 和处方剂量的风险概况分开，并且很少有研究提供特定于 OTC 布洛芬的风险。
进行文献综述，以评估与 OTC 布洛芬使用相关的 GI 出血事件的风险。
通过 MEDLINE 搜索了截至 2010 年发表的关于 OTC 布洛芬使用的临床研究、观察性研究和荟萃分析，定义为每天服用 1200mg 或“OTC”的布洛芬，报告 GI 出血事件的发生率和比例（例如，与 GI 出血相关的住院和死亡）。总结了这些研究的数据。
共纳入了 20 项研究（9 项观察性研究，10 项临床试验，1 项荟萃分析），报告了与 OTC 或 OTC 特定剂量布洛芬相关的 GI 出血相关事件的发生率和比例。服用 OTC 可比剂量的患者胃肠道相关住院的频率<0.2%。使用 OTC 可比剂量的患者发生率范围为 0 至每 1000 患者年 3.19 例。GI 出血相关事件的发生率随年龄和同时使用药物而增加，并且通常存在但并非总是具有统计学意义的布洛芬剂量反应关系。与非使用者相比，使用 OTC 特定剂量布洛芬的患者任何 GI 出血相关事件的相对风险为 1.1 至 2.4。
使用 OTC 布洛芬的研究报告了 GI 出血事件的发生率较低。很少有专门研究 OTC 布洛芬使用的已发表研究。暴露和结局的不同方法和定义阻止了许多结果的直接比较。仅确定了使用本文所述方法的研究。进一步研究评估服用 OTC 特定布洛芬的患者发生 GI 出血事件的风险可能是有用的。
