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特立帕肽治疗停药后,背痛发生风险的降低持续至少30个月:一项荟萃分析。

Reduction in the risk of developing back pain persists at least 30 months after discontinuation of teriparatide treatment: a meta-analysis.

作者信息

Nevitt M C, Chen P, Kiel D P, Reginster J-Y, Dore R K, Zanchetta J R, Glass E V, Krege J H

机构信息

University of California, San Francisco, San Francisco, CA, USA.

出版信息

Osteoporos Int. 2006;17(11):1630-7. doi: 10.1007/s00198-006-0177-z. Epub 2006 Aug 8.

Abstract

INTRODUCTION

Teriparatide [rhPTH (1-34)] reduces fracture risk, and in a published meta-analysis of clinical trials, teriparatide-treated patients had reduced incidence of back pain relative to placebo or to antiresorptive drugs. The aim of this study was to evaluate back pain in teriparatide-treated versus comparator-treated patients during an interval including controlled clinical trials plus 30 months of additional follow-up.

METHODS

A meta-analysis of four completed randomized, double-blinded trials of teriparatide [rhPTH (1-34)] versus comparator was performed. A multivariate Cox proportional hazards model was used to assess the heterogeneity of results and to estimate the relative risk of back pain.

RESULTS

Patients in the pooled teriparatide group had reduced risk for any back pain [relative risk, 0.73 (95% CI, 0.61-0.87)], moderate or severe back pain [0.72 (0.58-0.89)], and severe back pain [0.39 (0.25-0.61)] compared with pooled controls, from initiation of the study drug through the end of follow-up. Sensitivity analysis showed that the results were robust to the removal of each individual trial from the meta-analysis. Separate meta-analyses comparing teriparatide versus placebo or antiresorptive drugs gave similar results.

CONCLUSIONS

Teriparatide-treated patients had a reduced incidence of back pain versus those receiving a comparator during an observation encompassing clinical trials plus 30 months of posttreatment observation.

摘要

引言

特立帕肽[重组人甲状旁腺激素(1-34)]可降低骨折风险,在一项已发表的临床试验荟萃分析中,与安慰剂或抗吸收药物相比,接受特立帕肽治疗的患者背痛发生率降低。本研究的目的是评估在包括对照临床试验及额外30个月随访期的时间段内,接受特立帕肽治疗的患者与接受对照治疗的患者的背痛情况。

方法

对四项已完成的特立帕肽[重组人甲状旁腺激素(1-34)]与对照药物的随机双盲试验进行荟萃分析。使用多变量Cox比例风险模型评估结果的异质性,并估计背痛的相对风险。

结果

从研究药物开始使用至随访结束,汇总的特立帕肽组患者发生任何背痛的风险降低[相对风险,0.73(95%CI,0.61-0.87)],中度或重度背痛风险降低[0.72(0.58-0.89)],重度背痛风险降低[0.39(0.25-0.61)],与汇总的对照组相比。敏感性分析表明,从荟萃分析中剔除每项单独试验后,结果仍然稳健。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。

结论

在包括临床试验及30个月治疗后观察期的观察中,与接受对照治疗的患者相比,接受特立帕肽治疗的患者背痛发生率降低。

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