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口服双膦酸盐的使用与无菌性骨坏死风险:一项巢式病例对照研究。

Use of oral bisphosphonates and the risk of aseptic osteonecrosis: a nested case-control study.

作者信息

Etminan Mahyar, Aminzadeh Kevin, Matthew Ian R, Brophy James M

机构信息

Center for Clinical Epidemiology and Evaluation, Vancouver General Hospital, Vancouver, BC, Canada.

出版信息

J Rheumatol. 2008 Apr;35(4):691-5. Epub 2008 Jan 15.

PMID:18203310
Abstract

OBJECTIVE

To determine whether use of oral bisphosphonates is associated with an increased risk of aseptic osteonecrosis (AON) among a cohort of elderly cardiovascular patients.

METHODS

We conducted a nested case-control study within a previously defined cardiovascular cohort of elderly Quebec patients using linked administrative health databases. Cases were defined as those with the diagnosis of hospitalization secondary to AON at a nonspecified site. For each case, 10 controls were randomly selected and matched to the cases by age, calendar time, and length of followup. The main outcome measure was the risk ratio (RR) of AON among ever-users of oral bisphosphonates compared to that among nonusers. As a quality measure, RR for AON among users of statin and angiotensin-converting enzyme inhibitors (ACE-I) compared to nonusers were also calculated.

RESULTS

The initial cohort consisted of 87,837 subjects. In the primary analysis, the adjusted RR for AON among bisphosphonate users was 2.87 (95% CI 1.71-5.05). The adjusted RR for alendronate, etidronate, and risedronate were 2.87 (95% CI 1.46-5.67), 2.43 (95% CI 1.05-5.62), and 3.34 (95% CI 1.04-10.67), respectively. There were no significant differences in RR for AON among current users (most recent drug exposure within 90 days of diagnosis) and past users (drug exposure between 91 and 365 days before diagnosis) of bisphosphonates. The adjusted RR for both statins and ACE-I were 0.79 (95% CI 0.49-1.07) and 1.16 (95% CI 0.79-1.70), respectively.

CONCLUSION

In this cohort of elderly cardiovascular patients, an association was observed between oral bisphosphonate use and aseptic osteonecrosis. Further research into this putative association is required.

摘要

目的

确定在老年心血管病患者队列中,口服双膦酸盐类药物的使用是否与无菌性骨坏死(AON)风险增加相关。

方法

我们利用关联的行政卫生数据库,在先前定义的魁北克老年心血管病患者队列中开展了一项巢式病例对照研究。病例定义为因非特定部位AON而住院诊断的患者。对于每例病例,随机选取10名对照,并按年龄、日历时间和随访时长与病例进行匹配。主要结局指标是口服双膦酸盐类药物使用者与非使用者相比发生AON的风险比(RR)。作为一项质量指标,还计算了他汀类药物和血管紧张素转换酶抑制剂(ACE-I)使用者与非使用者相比发生AON的RR。

结果

初始队列由87837名受试者组成。在初步分析中,双膦酸盐类药物使用者发生AON的校正RR为2.87(95%CI 1.71 - 5.05)。阿仑膦酸钠、依替膦酸二钠和利塞膦酸钠的校正RR分别为2.87(95%CI 1.46 - 5.67)、2.43(95%CI 1.05 - 5.62)和3.34(95%CI 1.04 - 10.67)。双膦酸盐类药物当前使用者(诊断前90天内最近一次药物暴露)和既往使用者(诊断前91至365天药物暴露)发生AON的RR无显著差异。他汀类药物和ACE-I的校正RR分别为0.79(95%CI 0.49 - 1.07)和1.16(95%CI 0.79 - 1.70)。

结论

在这个老年心血管病患者队列中,观察到口服双膦酸盐类药物的使用与无菌性骨坏死之间存在关联。需要对这种假定的关联进行进一步研究。

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