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不同吸入性糖皮质激素治疗哮喘有效性的间接比较分析中常用对照物的作用。

Effect of common comparators in indirect comparison analysis of the effectiveness of different inhaled corticosteroids in the treatment of asthma.

作者信息

Kunitomi Taro, Hashiguchi Masayuki, Mochizuki Mayumi

机构信息

Faculty of Pharmacy, Keio University, Tokyo, Japan; Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.

Faculty of Pharmacy, Keio University, Tokyo, Japan.

出版信息

PLoS One. 2015 Mar 20;10(3):e0120836. doi: 10.1371/journal.pone.0120836. eCollection 2015.

Abstract

PURPOSE

Indirect comparison (IC) and direct comparison (DC) of four inhaled corticosteroid (CS) treatments for asthma were conducted, and the factors that may influence the results of IC were investigated. Among those factors, we focused on the effect of common comparator selection in the treatment of asthma, where little control group bias or placebo effect is expected.

METHOD

IC and DC were conducted using the change from baseline in forced expiratory volume in 1 s (FEV1(L)) as an outcome parameter. Differences between inhaled CS were evaluated to compare the results of IC and DC. As a common comparator for IC, placebo (PLB) or mometasone (MOM) was selected. Whether the results of IC are affected by the selection of a common comparator and whether the results of IC and DC are consistent were examined.

RESULTS

23 articles were identified by a literature search. Our results showed that ICs yielded results similar to DCs in the change from baseline of FEV1(L). No statistically significant difference was observed in inconsistency analysis between ICs and DCs. It was clinically and statistically confirmed that ICs with PLB and those with MOM did not differ in terms of the results of FEV1(L) analysis in this dataset.

CONCLUSION

This study demonstrated that ICs among inhaled CS can deliver results consistent with those of DCs when using the change from baseline in FEV1(L) as an outcome parameter in asthma patients. It was also shown that using an active comparator has similar results if there is no effect of control group bias. It should be emphasized that the investigation of control group bias is a key factor in conducting relevant ICs so that an appropriate common comparator can be selected.

摘要

目的

对四种用于治疗哮喘的吸入性糖皮质激素(CS)疗法进行间接比较(IC)和直接比较(DC),并研究可能影响IC结果的因素。在这些因素中,我们重点关注了在哮喘治疗中选择共同对照物的效果,因为预计其中几乎不存在对照组偏倚或安慰剂效应。

方法

以1秒用力呼气容积(FEV1(L))相对于基线的变化作为结果参数进行IC和DC。评估吸入性CS之间的差异以比较IC和DC的结果。作为IC的共同对照物,选择了安慰剂(PLB)或莫米松(MOM)。检验IC结果是否受共同对照物选择的影响,以及IC和DC的结果是否一致。

结果

通过文献检索确定了23篇文章。我们的结果表明,在FEV1(L)相对于基线的变化方面,IC得出的结果与DC相似。在IC和DC之间的不一致性分析中未观察到统计学上的显著差异。在该数据集中,临床和统计学均证实,使用PLB的IC和使用MOM的IC在FEV1(L)分析结果方面没有差异。

结论

本研究表明,在哮喘患者中,以FEV1(L)相对于基线的变化作为结果参数时,吸入性CS中的IC得出的结果与DC一致。还表明,如果不存在对照组偏倚的影响,使用活性对照物会有相似的结果。应当强调的是,对对照组偏倚的调查是进行相关IC的关键因素,以便能够选择合适的共同对照物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e9ca/4368804/c54b57f62146/pone.0120836.g001.jpg

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