特立帕肽与骨盆骨折愈合：一项 2 期随机对照试验。
Teriparatide and pelvic fracture healing: a phase 2 randomized controlled trial.
机构信息
Hospital for Special Surgery, New York, NY, USA.
Department of Epidemiology, Columbia University, New York, NY, USA.
出版信息
Osteoporos Int. 2022 Jan;33(1):239-250. doi: 10.1007/s00198-021-06065-4. Epub 2021 Aug 12.
UNLABELLED
Pelvic fracture patients were randomized to blinded daily subcutaneous teriparatide (TPTD) or placebo to assess healing and functional outcomes over 3 months. With TPTD, there was no evidence of improved healing by CT or pain reduction; however, physical performance improved with TPTD but not placebo (group difference p < 0.03).
INTRODUCTION
To determine if teriparatide (20 μg/day; TPTD) results in improved radiologic healing, reduced pain, and improved functional outcome vs placebo over 3 months in pelvic fracture patients.
METHODS
This randomized, placebo-controlled study enrolled 35 patients (women and men >50 years old) within 4 weeks of pelvic fracture and evaluated the effect of blinded TPTD vs placebo over 3 months on fracture healing. Fracture healing from CT images at 0 and 3 months was assessed as cortical bridging using a 5-point scale. The numeric rating scale (NRS) for pain was administered monthly. Physical performance was assessed monthly by Continuous Summary Physical Performance Score (based on 4 m walk speed, timed repeated chair stands, and balance) and the Timed Up and Go (TUG) test.
RESULTS
The mean age was 82, and >80% were female. The intention to treat analysis showed no group difference in cortical bridging score, and 50% of fractures in TPTD-treated and 53% of fractures in placebo-treated patients were healed at 3 months, unchanged after adjustment for age, sacral fracture, and fracture displacement. Median pain score dropped significantly in both groups with no group differences. Both CSPPS and TUG improved in the teriparatide group, whereas there was no improvement in the placebo group (group difference p < 0.03 for CSPPS at 2 and 3 months).
CONCLUSION
In this small randomized, blinded study, there was no improvement in radiographic healing (CT at 3 months) or pain with TPTD vs placebo; however, there was improved physical performance in TPTD-treated subjects that was not evident in the placebo group.
背景
为了确定特立帕肽（20 μg/天；TPTD）是否能在 3 个月内改善骨盆骨折患者的影像学愈合、减轻疼痛和提高功能预后，与安慰剂相比。
方法
这是一项随机、安慰剂对照研究，纳入了 4 周内发生骨盆骨折的 35 名患者（年龄＞50 岁的女性和男性），并评估了 3 个月内盲法 TPTD 与安慰剂对骨折愈合的影响。骨折愈合情况通过 0 个月和 3 个月的 CT 图像进行评估，采用 5 分制评估皮质桥接。每月进行数字评定量表（NRS）疼痛评分。每月通过连续综合身体表现评分（基于 4 米步行速度、定时重复坐站和平衡）和计时起立行走测试（TUG）评估身体表现。
结果
平均年龄为 82 岁，＞80%为女性。意向治疗分析显示，皮质桥接评分无组间差异，TPTD 治疗组和安慰剂治疗组的 50%骨折在 3 个月时愈合，校正年龄、骶骨骨折和骨折移位后无变化。两组的疼痛评分中位数均显著下降，且无组间差异。特立帕肽组的 CSPPS 和 TUG 均有改善，而安慰剂组则无改善（CSPPS 在 2 个月和 3 个月时组间差异 p＜0.03）。
结论
在这项小型随机、双盲研究中，与安慰剂相比，TPTD 并未改善影像学愈合（3 个月时 CT）或疼痛；然而，TPTD 治疗组的身体表现有所改善，而安慰剂组则没有。
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