唑来膦酸：降低髋骨折再发及死亡率

Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture
唑来膦酸：降低髋骨折再发及死亡率
ABSTRACT
摘要
Background
背景：
Mortality is increased after a hip fracture, and strategies that improve outcomes are needed.
因髋部骨折后死亡率很高，所以要进一步改进治疗方案。
Methods
方法：
In this randomized, double-blind, placebo-controlled trial, 1065 patients were assigned to receive yearly intravenous zoledronic acid (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgical repair of a hip fracture. All patients (mean age, 74.5 years) received supplemental vitamin D and calcium. The median follow-up was 1.9 years. The primary end point was a new clinical fracture.
此次随机双盲安慰剂对照临床实验中，1065名患者每年接受静注唑来膦酸（5mg），1062名患者接受安慰剂治疗。在髋关节骨折术后90天内，第一次给药。所有患者（平均年龄74.5）均接受补充维生素D和钙。中位随访时间为1.9年。首要终止点为出现新的临床骨折，
Results
结果
The rates of any new clinical fracture were 8.6% in the zoledronic acid group and 13.9% in the placebo group, a 35% risk reduction with zoledronic acid (P=0.001); the respective rates of a new clinical vertebral fracture were 1.7% and 3.8% (P=0.02), and the respective rates of new nonvertebral fractures were 7.6% and 10.7% (P=0.03). In the safety analysis, 101 of 1054 patients in the zoledronic acid group (9.6%) and 141 of 1057 patients in the placebo group (13.3%) died, a reduction of 28% in deaths from any cause in the zoledronic acid group (P=0.01). The most frequent adverse events in patients receiving zoledronic acid were pyrexia, myalgia, and bone and musculoskeletal pain. No cases of osteonecrosis of the jaw were reported, and no adverse effects on the healing of fractures were noted. The rates of renal and cardiovascular adverse events, including atrial fibrillation and stroke, were similar in the two groups.
唑来膦酸组中再发临床骨折率为8.6%，对比组为13.9% ，唑来膦酸组危险度降低35% (P=0.001)；临床椎体骨折率分别为1.7% 和3.8% (P=0.02)，临床非椎体骨折率分别为 7.6% 和 10.7% (P=0.03)。 从统计上看，唑来膦酸组1507名患者中有101名死亡(9.6%) ，对照组1057名患者中141名死亡(13.3%)，唑来膦酸组中各类原因所致死亡下降28%(P=0.01)。唑来膦酸最常见的副作用为发热、肌痛，及骨痛。未见下颌骨坏死，亦未见对骨愈合的不良作用。两组中肾，心血管方面的不良反应发生率，包括房颤和休克，相似。
Conclusions
结论
An annual infusion of zoledronic acid within 90 days after repair of a low-trauma hip fracture was associated with a reduction in the rate of new clinical fractures and with improved survival.
在低创伤性髋部骨折术后90天，每年给予唑来膦酸可以降低骨折再发并可以提高生存率。