J Bone Miner Res:近期股骨转子间骨折的老年患者:特立帕肽vs利塞膦酸钠

2017-06-29 门鹏 环球医学资讯

2017年5月,发表在《J Bone Miner Res》的一项由西班牙、意大利、墨西哥等国科学家进行的78周随机临床试验的最终结果表明,近期股骨转子间骨折的老年患者中,特立帕肽比利塞膦酸钠更有效。

2017年5月,发表在《J Bone Miner Res》的一项由西班牙、意大利、墨西哥等国科学家进行的78周随机临床试验的最终结果表明,近期股骨转子间骨折的老年患者中,特立帕肽比利塞膦酸钠更有效。

研究人员旨在呈现一项比较股骨转子间骨折手术后2周内开始特立帕肽20μg/d(QD)和利塞膦酸钠35mg/周(QW)治疗的研究的最终结果。

BMD T得分≤-2.0和25OHD水平≥9.2ngmL的患者被随机分配到26周的双模拟治疗+钙和维生素D的组中,接着进行52周的相同分配的活性药物的开放标签治疗。首要终点为腰椎(LS)BMD自基线到78周时的改变。次要终点和探索性终点为股骨近端BMD的改变、功能、髋部疼痛[Charnley评分和100mm视觉模拟量表(VAS)]、生活质量(简表-36)、放射学结局、安全性。使用重复测量的混合模型(MMRM)和逻辑回归分析数据。

总计,224名患者被随机分组:171人(特立帕肽86人)进行了有效性分析(平均±SD年龄:77±7.7岁,77%为女性)。平均基线LS、股骨颈(FN)和总髋关节(TH)T得分分别为-2.16、-2.63和-2.51。78周时,与利塞膦酸钠相比,特立帕肽组的患者,其LS(+11.08% vs +6.45%;P<0.001)和FN(+1.96% vs -1.19%;P=0.003)的BMD显着性增加更多,TH BMD的组间差异无显着性。6、12、18和26周时,特立帕肽组的患者起立-行走计时测试(TUG)显着性更快(差异:-3.2~-5.9s;总体差异的P=0.045)。TUG测试期间,特立帕肽组的患者18周时100mmVAS的髋部疼痛显着性低(调整差异:-11.3mm,P=0.033;12和26周时为-10.0和-9.3;总体差异的P=0.079)。其他次要结局和探索性结局无差异。特立帕肽组有2例新发髋部骨折,利塞膦酸钠组有7例(P=0.171),并且特立帕肽组具有更频繁的高钙血症和高尿酸血症。

总之,与利塞膦酸钠相比,78周的特立帕肽治疗表现出显着性高的LS和FN BMD增加、较少的疼痛和更快速的TUG测试。

原始出处:
Malouf-Sierra, J., et al.Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial.J Bone Miner Res. 2017 May;32(5):1040-1051. doi: 10.1002/jbmr.3067. Epub 2017 Jan 26.

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    2018-06-14 apoenzyme
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