Department of Medicine, University of Auckland, Auckland, New Zealand.
McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.
J Bone Miner Res. 2023 May;38(5):631-638. doi: 10.1002/jbmr.4802. Epub 2023 Apr 9.
Zoledronate is a potent intravenous bisphosphonate effective in the management of osteoporosis, Paget's disease and skeletal-related events in malignancy. Its most frequent adverse effect is the acute phase response (APR), an inflammatory reaction characterized by fever, musculoskeletal pain, headache, and nausea. This randomized, placebo-controlled, double-blind study investigated the efficacy of a three-day course of dexamethasone 4 mg daily in reducing incidence of APR. Participants (n = 60) were randomized to receive either 4 mg of oral dexamethasone 1.5 hours before zoledronate and once a day for the following 2 days, or placebo. Oral temperature was measured at baseline and three times a day for the following 3 days, and questionnaires assessing symptoms of the APR were completed at baseline and for 3 days following zoledronate. Use of anti-inflammatory medication in the 3 days following zoledronate was recorded. The primary outcome was the temperature change from baseline. There was a significant difference in the primary outcome between the dexamethasone and placebo groups (p < 0.0001), with a mean decrease in temperature of 0.10°C (95% confidence interval [CI], -0.34 to 0.14) in the dexamethasone group compared with a mean increase in temperature of 0.84°C (95% CI, 0.53-1.16) in the placebo group on the evening following zoledronate. There was also a difference in APR-related symptom score over time between the two groups (p = 0.0005), with a median change in symptom score in the dexamethasone group 1 day after zoledronate of 0 (95% CI, 0-1) compared with 3 (95% CI, 0-5) in the placebo group. An increase in temperature of ≥1°C to a temperature of >37.5°C occurred in two of 30 (6.7%) participants in the dexamethasone group compared with 14 of 30 participants (46.7%) in the placebo group (p = 0.0005). This study demonstrates that a 3-day course of dexamethasone substantially reduces the APR following zoledronate infusion. © 2023 American Society for Bone and Mineral Research (ASBMR).
唑来膦酸是一种有效的静脉双膦酸盐，可用于治疗骨质疏松症、 Pagets 病和恶性肿瘤相关的骨骼事件。其最常见的不良反应是急性期反应（APR），这是一种炎症反应，表现为发热、肌肉骨骼疼痛、头痛和恶心。这项随机、安慰剂对照、双盲研究调查了为期三天的每日 4 毫克地塞米松治疗减少 APR 发生率的疗效。参与者（n=60）随机分为两组，一组在唑来膦酸前 1.5 小时口服 4 毫克地塞米松，随后 2 天每天一次，另一组给予安慰剂。在接下来的 3 天中，每天测量口腔温度 3 次，并在唑来膦酸前和之后 3 天完成评估 APR 症状的问卷。记录唑来膦酸后 3 天内抗炎药物的使用情况。主要结局是从基线开始的体温变化。地塞米松组和安慰剂组的主要结局有显著差异（p<0.0001），与安慰剂组相比，地塞米松组在唑来膦酸后一天的体温平均下降 0.10°C（95%置信区间[CI]，-0.34 至 0.14），而安慰剂组的体温平均升高 0.84°C（95% CI，0.53-1.16）。两组 APR 相关症状评分随时间也有差异（p=0.0005），唑来膦酸后一天地塞米松组症状评分中位数为 0（95% CI，0-1），而安慰剂组为 3（95% CI，0-5）。地塞米松组中有 2 名（6.7%）参与者的体温升高≥1°C 至>37.5°C，而安慰剂组中有 14 名（46.7%）参与者（p=0.0005）。这项研究表明，为期三天的地塞米松治疗可显著减少唑来膦酸输注后的 APR。 © 2023 美国骨矿研究学会（ASBMR）。
