Vestergaard P, Jorgensen N R, Mosekilde L, Schwarz P
The Osteoporosis Clinic, Department of Endocrinology, Aarhus University Hospital, Aarhus C, Denmark.
Osteoporos Int. 2007 Jan;18(1):45-57. doi: 10.1007/s00198-006-0204-0. Epub 2006 Sep 2.
The effects of parathyroid hormone (PTH) alone or in combination with antiresorptive therapy on changes in bone mineral density (BMD) and fracture risk were studied.
Randomised placebo controlled trials were retrieved from the PubMed, Web of Science or Embase databases.
PTH alone or in combination with antiresorptive drugs reduced vertebral [relative risk (RR)=0.36, 95% confidence interval (CI): 0.28-0.47, 2p<0.01] and non-vertebral (RR=0.62, 95% CI: 0.48-0.82, 2p<0.01) fracture risk and increased spine BMD by 6.6% (95% CI: 5.2-8.1%, 2p<0.01) and hip BMD non-significantly by 1.0% (95% CI: -0.1 to 2.1%, 2p=0.08) during 11-36 months of follow-up (13 trials). The gain in spine and hip BMD tended to increase with the length of the PTH treatment. No significant effect of study duration on fracture risk could be demonstrated. The major adverse events were hypercalcaemia, nausea and discomfort at the injection sites. Only limited data are currently available on fracture risk reduction with PTH plus antiresorptive therapies.
Although the number of studies on non-vertebral fractures is limited, our pooled analysis revealed that PTH alone or in combination with antiresorptive drugs would appear to be able to reduce the risk of vertebral and non-vertebral fractures and to increase spine and perhaps hip BMD. However, these analyses were based on cross-sectional data--i.e. based on indirect comparisons--and further studies with a direct comparison of study duration are necessary. No studies comparing PTH, PTH plus antiresorptive drugs and antiresorptive drug versus placebo in a factorial design are available; consequently, we were unable to draw any conclusions on the superiority of PTH plus antiresorptive drug versus antiresorptive drug or PTH alone with respect to BMD or fractures.
研究甲状旁腺激素(PTH)单独使用或与抗吸收治疗联合使用对骨密度(BMD)变化和骨折风险的影响。
从PubMed、科学网或Embase数据库中检索随机安慰剂对照试验。
在11 - 36个月的随访期间(13项试验),单独使用PTH或与抗吸收药物联合使用可降低椎体骨折风险[相对风险(RR)=0.36,95%置信区间(CI):0.28 - 0.47,P<0.01]和非椎体骨折风险(RR = 0.62,95% CI:0.48 - 0.82,P<0.01),并使脊柱骨密度增加6.6%(95% CI:5.2 - 8.1%,P<0.01),髋部骨密度无显著增加,增加了1.0%(95% CI:-0.1至2.1%,P = 0.08)。脊柱和髋部骨密度的增加趋势随着PTH治疗时间的延长而增加。未证明研究持续时间对骨折风险有显著影响。主要不良事件为高钙血症、恶心和注射部位不适。目前关于PTH加抗吸收治疗降低骨折风险的数据有限。
尽管关于非椎体骨折的研究数量有限,但我们的汇总分析显示,单独使用PTH或与抗吸收药物联合使用似乎能够降低椎体和非椎体骨折的风险,并增加脊柱以及可能髋部的骨密度。然而,这些分析基于横断面数据——即基于间接比较——因此有必要进行关于研究持续时间的直接比较的进一步研究。尚无采用析因设计比较PTH、PTH加抗吸收药物和抗吸收药物与安慰剂的研究;因此,我们无法就PTH加抗吸收药物相对于抗吸收药物或单独使用PTH在骨密度或骨折方面的优越性得出任何结论。