Therapeutic Evaluation Unit, Pharmaceutical Outcomes Programme, the Child and Family Research Institute, Vancouver, BC.
CMAJ. 2012 May 15;184(8):E431-4. doi: 10.1503/cmaj.111752. Epub 2012 Apr 2.
There have been several published reports of inflammatory ocular adverse events, mainly uveitis and scleritis, among patients taking oral bisphosphonates. We examined the risk of these adverse events in a pharmacoepidemiologic cohort study.
We conducted a retrospective cohort study involving residents of British Columbia who had visited an ophthalmologist from 2000 to 2007. Within the cohort, we identified all people who were first-time users of oral bisphosphonates and who were followed to the first inflammatory ocular adverse event, death, termination of insurance or the end of the study period. We defined an inflammatory ocular adverse event as scleritis or uveitis. We used a Cox proportional hazard model to determine the adjusted rate ratios. As a sensitivity analysis, we performed a propensity-score-adjusted analysis.
The cohort comprised 934,147 people, including 10,827 first-time users of bisphosphonates and 923,320 nonusers. The incidence rate among first-time users was 29/10,000 person-years for uveitis and 63/10,000 person-years for scleritis. In contrast, the incidence among people who did not use oral bisphosphonates was 20/10,000 person-years for uveitis and 36/10,000 for scleritis (number needed to harm: 1100 and 370, respectively). First-time users had an elevated risk of uveitis (adjusted relative risk [RR] 1.45, 95% confidence interval [CI] 1.25-1.68) and scleritis (adjusted RR 1.51, 95% CI 1.34-1.68). The rate ratio for the propensity-score-adjusted analysis did not change the results (uveitis: RR 1.50, 95% CI 1.29-1.73; scleritis: RR 1.53, 95% CI 1.39-1.70).
People using oral bisphosphonates for the first time may be at a higher risk of scleritis and uveitis compared to people with no bisphosphonate use. Patients taking bisphosphonates must be familiar with the signs and symptoms of these conditions, so that they can immediately seek assessment by an ophthalmologist.
已有数项研究报告称，口服双膦酸盐类药物可引起眼部炎症性不良反应，主要为葡萄膜炎和巩膜炎。我们在一项药物流行病学队列研究中，调查了这些不良反应的发生风险。
我们进行了一项回顾性队列研究，纳入了 2000 年至 2007 年间在不列颠哥伦比亚省看眼科医生的居民。在队列中，我们确定了所有首次使用口服双膦酸盐类药物且随访至首次出现眼部炎症性不良反应、死亡、保险终止或研究结束的患者。我们将眼部炎症性不良反应定义为巩膜炎或葡萄膜炎。我们使用 Cox 比例风险模型确定了调整后的率比值。作为敏感性分析，我们进行了倾向评分调整分析。
队列共纳入 934147 人，其中 10827 人为首次使用双膦酸盐类药物者，923320 人为非使用者。首次使用者的葡萄膜炎和巩膜炎发生率分别为 29/10000 人年和 63/10000 人年。相比之下，未使用口服双膦酸盐类药物者的葡萄膜炎和巩膜炎发生率分别为 20/10000 人年和 36/10000 人年（伤害人数：分别为 1100 人和 370 人）。首次使用者葡萄膜炎（调整后的相对风险 [RR] 1.45，95%置信区间 [CI] 1.25-1.68）和巩膜炎（调整后的 RR 1.51，95% CI 1.34-1.68）的发生风险升高。倾向评分调整分析的率比值未改变结果（葡萄膜炎：RR 1.50，95% CI 1.29-1.73；巩膜炎：RR 1.53，95% CI 1.39-1.70）。
与未使用双膦酸盐类药物者相比，首次使用口服双膦酸盐类药物者发生巩膜炎和葡萄膜炎的风险可能更高。使用双膦酸盐类药物的患者必须熟悉这些疾病的症状和体征，以便能够立即寻求眼科医生评估。
