Department of Internal Medicine, University of Messina, Messina, Italy.
Calcif Tissue Int. 2012 Apr;90(4):279-85. doi: 10.1007/s00223-012-9577-6. Epub 2012 Feb 16.
The acute-phase response (APR) is a frequent occurrence after infusion of zoledronic acid and is caused by activation of γδ T cells. Vitamin D receptor is expressed in immune cells, and vitamin D has immunomodulatory properties. The aim of this prospective study was to test the effect of vitamin D (cholecalciferol) on the incidence of APR and intensity of pain in women undergoing infusion of zoledronic acid for postmenopausal osteoporosis. 60 women were enrolled and randomized into two groups. At baseline, 30 women received an oral bolus of cholecalciferol (300,000 IU), while another 30 women received placebo. On day 5 both groups were treated with a single infusion of zoledronic acid (5 mg) and received a daily supplementation of calcium (1,000 mg) and vitamin D (800 IU). Patients were clinically evaluated and inflammatory markers were assayed before zoledronic acid administration and every 24 h for the following 2 days. The onset of APR has been defined by the occurrence of fever or at least one of the typical symptoms, such as musculoskeletal pain after zoledronic acid infusion. Intensity of pain was measured by a one-dimensional scale (0 = no pain, 10 = unbearable pain). APR developed in 66.6% of patients, with no significant difference between groups. The vitamin group experienced less musculoskeletal pain [median 1 (0-4) vs. 2 (1-8), P < 0.05] and exhibited lower inflammatory markers (P < 0.005 vs. placebo). Our data demonstrate that cholecalciferol at a dose of 300,000 IU reduces the intensity of musculoskeletal pain after infusion of zoledronic acid for postmenopausal osteoporosis.
急性相反应（APR）是唑来膦酸输注后常见的现象，是由 γδ T 细胞激活引起的。维生素 D 受体存在于免疫细胞中，维生素 D 具有免疫调节作用。本前瞻性研究旨在检测维生素 D（胆钙化醇）对接受唑来膦酸治疗绝经后骨质疏松症的女性 APR 发生率和疼痛强度的影响。共纳入 60 例女性，并随机分为两组。基线时，30 例女性给予口服胆钙化醇（30 万 IU），另 30 例女性给予安慰剂。第 5 天两组均给予唑来膦酸（5mg）单次输注，并每日补充钙（1000mg）和维生素 D（800IU）。在给予唑来膦酸前和之后的 2 天内每 24 小时进行临床评估和炎症标志物检测。APR 的发生定义为发热或唑来膦酸输注后至少出现一种典型症状，如肌肉骨骼疼痛。疼痛强度通过一维量表（0=无痛，10=无法忍受的疼痛）进行测量。APR 在 66.6%的患者中发生，两组之间无显著差异。维生素组的肌肉骨骼疼痛程度较轻[中位数 1（0-4）比 2（1-8），P<0.05]，炎症标志物较低（与安慰剂相比，P<0.005）。我们的数据表明，30 万 IU 的胆钙化醇剂量可减轻绝经后骨质疏松症患者接受唑来膦酸输注后的肌肉骨骼疼痛强度。
