Nevitt Michael C, Chen Peiqi, Dore Robin K, Reginster Jean-Yves, Kiel Douglas P, Zanchetta Jose R, Glass Emmett V, Krege John H
University of California San Francisco, San Francisco, CA, USA.
Osteoporos Int. 2006 Feb;17(2):273-80. doi: 10.1007/s00198-005-2013-2. Epub 2005 Sep 2.
Vertebral fractures are the most common osteoporotic fracture and may result in back pain with functional limitations and diminished quality of life. Teriparatide [rhPTH (1-34)] has been shown to increase bone mass and reduce the risk of vertebral and other osteoporotic fractures. The aim of this study was to evaluate the effects of teriparatide on the risk of back pain in patients with osteoporosis. A systematic review of the literature was performed, and five trials were identified and included in our analyses. All trials were randomized, double-blinded, and parallel with either new vertebral fracture (n=1) or bone mineral density as the primary endpoint (n=4). Four studies were in postmenopausal women with osteoporosis, and one was in men with idiopathic or hypogonadal osteoporosis. Two trials were placebo controlled, two trials were alendronate controlled, and one trial involved teriparatide plus hormone replacement therapy versus hormone replacement therapy alone. Reports of back pain, defined as new or worsened back pain after initiating the study drug, were obtained from adverse event databases, and the risk of back pain was analyzed using a multivariate Cox proportional hazards model. Results were not statistically heterogeneous (P=0.60) across trials, and there were no differences between groups administered teriparatide 20 or 40 mcg/day doses (P=0.64). The rates of back pain, moderate or severe back pain, and severe back pain per 100 patient-years were numerically lower in the teriparatide versus comparator groups in each study. Compared with the pooled comparator, patients in the pooled teriparatide group had reduced risk for any back pain [relative risk, 0.66 (95% CI, 0.55-0.80)], moderate or severe back pain [relative risk, 0.60 (95% CI, 0.48-0.75)] and severe back pain [relative risk, 0.44 (95% CI, 0.28-0.68)]. Separate meta-analyses comparing teriparatide versus placebo or antiresorptive drugs gave similar results. In conclusion, patients randomized to teriparatide had a reduced risk of new or worsening back pain compared to patients randomized to placebo, hormone replacement therapy or alendronate.
椎体骨折是最常见的骨质疏松性骨折，可能导致背痛，伴有功能受限和生活质量下降。特立帕肽[重组人甲状旁腺激素(1-34)]已被证明可增加骨量，并降低椎体及其他骨质疏松性骨折的风险。本研究的目的是评估特立帕肽对骨质疏松症患者背痛风险的影响。我们对文献进行了系统回顾，确定了五项试验并纳入分析。所有试验均为随机、双盲且平行设计，其中一项试验以新发椎体骨折为主要终点(n = 1)，四项试验以骨密度为主要终点(n = 4)。四项研究针对绝经后骨质疏松症女性，一项研究针对特发性或性腺功能减退性骨质疏松症男性。两项试验为安慰剂对照，两项试验为阿仑膦酸钠对照，一项试验涉及特立帕肽加激素替代疗法与单独使用激素替代疗法的比较。背痛报告定义为开始研究药物后出现新的或加重的背痛，从不良事件数据库中获取，并使用多变量Cox比例风险模型分析背痛风险。各试验结果在统计学上无异质性(P = 0.60)，每日给予20或40微克特立帕肽剂量的组间无差异(P = 0.64)。在每项研究中，特立帕肽组每100患者年的背痛、中度或重度背痛以及重度背痛发生率在数值上均低于对照药物组。与合并的对照药物相比，合并的特立帕肽组患者出现任何背痛的风险降低[相对风险，0.66(95%CI，0.55 - 0.80)]，中度或重度背痛风险降低[相对风险，0.60(95%CI，0.48 - 0.75)]，重度背痛风险降低[相对风险，0.44(95%CI，0.28 - 0.68)]。比较特立帕肽与安慰剂或抗吸收药物的单独荟萃分析得出了类似结果。总之，与随机接受安慰剂、激素替代疗法或阿仑膦酸钠的患者相比，随机接受特立帕肽治疗的患者出现新的或加重的背痛的风险降低。
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