Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy.
Department of Informatics, Systems and Communications, University of Milano-Bicocca, Milan, Italy.
PLoS One. 2013 Dec 9;8(12):e73159. doi: 10.1371/journal.pone.0073159. eCollection 2013.
Oral bisphosphonates (BPs) are the primary agents for the treatment of osteoporosis. Although BPs are generally well tolerated, serious gastrointestinal adverse events have been observed.
To assess the risk of severe upper gastrointestinal complications (UGIC) among BP users by means of a large study based on a network of Italian healthcare utilization databases.
A nested case-control study was carried out by including 110,220 patients aged 45 years or older who, from 2003 until 2005, were treated with oral BPs. Cases were the 862 patients who experienced the outcome (hospitalization for UGIC) until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current use of BPs after adjusting for several covariates. A set of sensitivity analyses was performed in order to account for sources of systematic uncertainty.
The adjusted OR for current use of BPs with respect to past use was 0.94 (95% CI 0.81 to 1.08). There was no evidence that this risk changed either with BP type and regimen, or concurrent use of other drugs or previous hospitalizations.
No evidence was found that current use of BPs increases the risk of severe upper gastrointestinal complications compared to past use.
口服双膦酸盐（BPs）是治疗骨质疏松症的主要药物。尽管 BPs 通常具有良好的耐受性，但已观察到严重的胃肠道不良事件。
通过基于意大利医疗保健利用数据库网络的大型研究，评估 BP 使用者发生严重上胃肠道并发症（UGIC）的风险。
通过纳入 2003 年至 2005 年期间接受口服 BPs 治疗的 110220 名年龄在 45 岁或以上的患者，开展了一项巢式病例对照研究。病例为 862 名发生结局（UGIC 住院）的患者，直至 2007 年。为每个病例随机选择最多 20 名对照。使用条件逻辑回归模型估计与当前 BP 使用相关的比值比（OR），并调整了几个协变量。进行了一系列敏感性分析，以考虑系统不确定性的来源。
当前使用 BPs 相对于过去使用的调整后 OR 为 0.94（95%CI 0.81 至 1.08）。没有证据表明这种风险随着 BP 类型和方案、同时使用其他药物或先前住院而改变。
没有证据表明与过去使用相比，当前使用 BPs 会增加发生严重上胃肠道并发症的风险。
