University of Melbourne Department of Medicine and Bone & Mineral Service, The Royal Melbourne Hospital, Melbourne, 3050 Victoria, Australia.
Osteoporos Int. 2012 Feb;23(2):503-12. doi: 10.1007/s00198-011-1563-8. Epub 2011 Feb 19.
Patients treated with intravenous zoledronic acid 5 mg for osteoporosis may experience post-dose influenza-like symptoms. Oral acetaminophen/paracetamol or ibuprofen administered 4 h post-infusion reduced the proportion of patients with increased oral temperature and worsening post-infusion symptom scores vs. placebo, thus providing an effective strategy for the treatment of such symptoms.
Once-yearly intravenous zoledronic acid 5 mg is a safe and effective treatment for postmenopausal osteoporosis. This study assessed whether transient influenza-like post-dose symptoms associated with intravenous infusion of zoledronic acid can be reduced by post-dose administration of acetaminophen/paracetamol or ibuprofen.
In an international, multicenter, randomized, double-blind, double-dummy parallel-group study, bisphosphonate-naïve postmenopausal women with osteopenia (n = 481) were randomized to receive zoledronic acid 5 mg + acetaminophen/paracetamol (n = 135), ibuprofen (n = 137) or placebo (n = 137), or placebo + placebo (n = 72). Acetaminophen/paracetamol and ibuprofen were administered every 6 h for 3 days beginning 4 h post-infusion.
The proportion of patients with increased oral temperature (≥1°C above 37.5°C) and with worsening post-infusion symptom scores over 3 days was significantly lower in patients receiving ibuprofen (36.8% and 48.5%) or acetaminophen/paracetamol (37.3% and 46.3%) vs. those receiving placebo (63.5% and 75.9%, respectively; all p < 0.0001) compared with background rates of 11.1% and 16.7%, respectively, in the absence of any active treatment. Overall incidence of adverse events was comparable for patients receiving acetaminophen/paracetamol or ibuprofen.
Oral acetaminophen/paracetamol or ibuprofen effectively managed the transient influenza-like symptoms associated with zoledronic acid 5 mg.
接受静脉注射唑来膦酸 5 毫克治疗骨质疏松症的患者可能会出现注射后类似流感的症状。与安慰剂相比，在注射后 4 小时给予口服对乙酰氨基酚/扑热息痛或布洛芬可降低体温升高和注射后症状评分恶化的患者比例，从而为治疗此类症状提供了有效的策略。
每年一次静脉注射唑来膦酸 5 毫克是治疗绝经后骨质疏松症的安全有效的方法。本研究评估了静脉输注唑来膦酸后短暂的流感样症状是否可以通过输注后给予对乙酰氨基酚/扑热息痛或布洛芬来减轻。
在一项国际、多中心、随机、双盲、双模拟、平行组研究中，将 481 名骨质疏松症初治的绝经后女性随机分为唑来膦酸 5 毫克+对乙酰氨基酚/扑热息痛（n=135）、布洛芬（n=137）或安慰剂（n=137）组，或安慰剂+安慰剂（n=72）组。对乙酰氨基酚/扑热息痛和布洛芬每 6 小时给药一次，共 3 天，从注射后 4 小时开始。
与安慰剂组相比，接受布洛芬（分别为 36.8%和 48.5%）或对乙酰氨基酚/扑热息痛（分别为 37.3%和 46.3%）的患者中，体温升高（比 37.5°C 升高≥1°C）和 3 天内注射后症状评分恶化的患者比例显著降低（所有 p<0.0001），而在没有任何活性治疗的情况下，分别为 11.1%和 16.7%。接受对乙酰氨基酚/扑热息痛或布洛芬的患者的总体不良事件发生率相当。
口服对乙酰氨基酚/扑热息痛或布洛芬可有效治疗唑来膦酸 5 毫克引起的短暂流感样症状。
