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骨质疏松症女性中的抗吸收剂:根据循证方法确定统计学等效性。

Anti-reabsorptive agents in women with osteoporosis: determining statistical equivalence according to evidence-based methods.

作者信息

Messori Andrea, Fadda Valeria, Maratea Dario, Trippoli Sabrina, Marinai Claudio

机构信息

HTA Unit, Area Vasta Centro Toscana Regional Health System, Via San Salvi 12, 50100, Florence, Italy.

Department of Pharmaceutical Logistics, ESTAV Toscana Centro, Regional Health Service, 50100, Florence, Italy.

出版信息

J Endocrinol Invest. 2014 Aug;37(8):769-773. doi: 10.1007/s40618-014-0124-3. Epub 2014 Jul 10.

Abstract

BACKGROUND

In the present study, we undertook an equivalence analysis on the effectiveness of the main anti-reabsorptive agents indicated for women with osteoporosis.

METHODS

Our methodology was a combination of meta-analysis (both pair-wise meta-analysis and network meta-analysis) and equivalence testing. The end-point was the incidence on new vertebral fractures. The anti-reabsorptive agents examined included alendronate, zoledronate, ibandronate, risedronate, and denosumab.

RESULTS

Our analysis involved nine randomized trials. Ten head-to-head indirect comparisons were examined through network meta-analysis and the respective values of RR were estimated. The 95 % confidence intervals for RR remained within the interval of a relative ±40 % variation for all comparisons that involved alendronate, risedronate, ibandronate, and denosumab. In contrast, the comparisons involving zoledronate satisfied a post hoc margin up to ±67 %.

CONCLUSION

Our results confirm that most of these anti-reabsorptive drugs (namely, alendronate, risedronate, ibandronate, and denosumab) are equivalent according to reasonable equivalence margins.

摘要

背景

在本研究中,我们对用于骨质疏松症女性的主要抗吸收药物的有效性进行了等效性分析。

方法

我们的方法是荟萃分析(成对荟萃分析和网络荟萃分析)与等效性检验的结合。终点是新椎体骨折的发生率。所研究的抗吸收药物包括阿仑膦酸盐、唑来膦酸盐、伊班膦酸盐、利塞膦酸盐和地诺单抗。

结果

我们的分析涉及9项随机试验。通过网络荟萃分析检查了10项直接比较,并估计了各自的RR值。对于所有涉及阿仑膦酸盐、利塞膦酸盐、伊班膦酸盐和地诺单抗的比较,RR的95%置信区间保持在相对±40%变化的区间内。相比之下,涉及唑来膦酸盐的比较满足高达±67%的事后界值。

结论

我们的结果证实,根据合理的等效界值,这些抗吸收药物中的大多数(即阿仑膦酸盐、利塞膦酸盐、伊班膦酸盐和地诺单抗)是等效的。

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