Endocrine Unit, Massachusetts General Hospital, Boston, MA 02114, USA.
Harvard Orthopaedic Trauma Initiative, Massachusetts General Hospital, Boston, MA 02114, USA.
J Clin Endocrinol Metab. 2023 Oct 18;108(11):e1282-e1288. doi: 10.1210/clinem/dgad295.
Zoledronic acid (ZA) administered during the initial hospitalization for a fragility fracture improves the osteoporosis pharmacotherapy rate. Distinguishing the safety profile of inpatient ZA (IP-ZA) in this context is crucial if this approach is to be widely adopted.
To study the acute safety profile of IP-ZA.
An observational study of patients admitted to the Massachusetts General Hospital with fragility fractures who were eligible to receive IP-ZA. Patients were treated with or without IP-ZA. Acetaminophen, either as a single pre-ZA dose or standing multiple-doses-per-day regimen for 48 hours or longer after ZA infusion, was also administered along with protocolized vitamin D and calcium supplementation. Changes in body temperature, serum creatinine, and serum calcium were measured.
A total of 285 consecutive patients, meeting inclusion and exclusion criteria, are included in this analysis; 204 patients received IP-ZA. IP-ZA treatment was associated with a transient mean rise of body temperature of 0.31 °C on the day following its administration. Temperatures above 38 °C were seen in 15% of patients in the IP-ZA group and 4% in the nontreated group. Standing multiple-doses-per-day but not a single pre-ZA dose of acetaminophen effectively prevented this temperature increase. IP-ZA did not affect serum creatinine levels. Mean levels of serum total calcium and albumin-corrected calcium decreased by 0.54 mg/dL and 0.40 mg/dL, respectively, at their nadirs (Day 5). No patient experienced symptomatic hypocalcemia.
IP-ZA along with standing multiple-doses-per-day acetaminophen, administered to patients in the immediate postfracture period, is not associated with significant acute adverse effects.
在脆性骨折的初始住院期间给予唑来膦酸（ZA）可提高骨质疏松症药物治疗率。如果广泛采用这种方法，区分这种情况下住院 ZA（IP-ZA）的安全性概况至关重要。
研究 IP-ZA 的急性安全性概况。
这是一项对因脆性骨折入住马萨诸塞州综合医院且有资格接受 IP-ZA 治疗的患者进行的观察性研究。患者接受或未接受 IP-ZA 治疗。在给予 ZA 输注后 48 小时或更长时间内，给予对乙酰氨基酚（无论是单次 IP-ZA 前剂量还是每日多次剂量），同时还给予了方案化的维生素 D 和钙补充剂。测量体温、血清肌酐和血清钙的变化。
共纳入 285 例符合纳入和排除标准的连续患者，其中 204 例接受了 IP-ZA 治疗。IP-ZA 治疗后，患者体温在给药后第 1 天平均升高 0.31°C。在 IP-ZA 组中，有 15%的患者体温超过 38°C，而未治疗组中为 4%。使用每日多次剂量而非单次 IP-ZA 前剂量的对乙酰氨基酚可有效预防这种体温升高。IP-ZA 不会影响血清肌酐水平。血清总钙和白蛋白校正钙的平均水平分别在最低点（第 5 天）下降 0.54mg/dL 和 0.40mg/dL。没有患者出现症状性低钙血症。
在骨折后立即给予 IP-ZA 和每日多次剂量的对乙酰氨基酚，同时给予患者，与明显的急性不良事件无关。
