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罗米司亭和艾曲波帕治疗免疫性血小板减少症:间接比较的方法。

Romiplostim and eltrombopag for immune thrombocytopenia: methods for indirect comparison.

机构信息

Universityof Sheffield, Sheffield, United Kingdom.

出版信息

Int J Technol Assess Health Care. 2012 Jul;28(3):249-58. doi: 10.1017/S0266462312000414.

Abstract

OBJECTIVES

Immune thrombocytopenia (ITP) causes increased platelet destruction and suboptimal platelet production, increasing risk of bleeding. This analysis uses a Bayesian metaregression model to indirectly compare effectiveness of the thrombopoietin mimetics romiplostim and eltrombopag for increasing platelet counts, and contrasts the results with those of non-Bayesian approaches.

METHODS

Ten databases were searched during 2010. Placebo-controlled trials of 24 weeks' duration were included. An indirect comparison was undertaken using Bayesian metaregression, which includes all trials in a single model. This was compared with previous analyses in which data for each intervention were combined using simple pooling, logistic regression or meta-analysis, followed by indirect comparison of pooled values using the Bucher method.

RESULTS

Two trials of romiplostim and one of eltrombopag were included. The indirect evidence suggests romiplostim significantly improves overall platelet response compared with eltrombopag. Bayesian metaregression gave an odds ratio (OR) for eltrombopag versus romiplostim of 0.11 (95 percent credible interval 0.02-0.66); p values and Bayesian posterior probabilities ranged from 0.01 to 0.05 for all analyses. There was no significant difference in durable platelet response in any of the analyses, although the direction of effect favored romiplostim (OR = 0.15; 95 percent credible interval, 0.01-1.88); p values and Bayesian posterior probabilities ranged from 0.08 to 0.40 across analyses. Results were relatively consistent between analyses.

CONCLUSIONS

Bayesian metaregression generated similar results to other indirect comparison methods, and may be considered the most robust as it incorporates all data in a single model and accounts appropriately for parameter uncertainty.

摘要

目的

免疫性血小板减少症(ITP)导致血小板破坏增加和血小板生成不足,增加出血风险。本分析采用贝叶斯荟萃回归模型间接比较促血小板生成素模拟物罗米司亭和艾曲波帕增加血小板计数的疗效,并与非贝叶斯方法的结果进行对比。

方法

在 2010 年期间检索了 10 个数据库。纳入了为期 24 周的安慰剂对照试验。采用贝叶斯荟萃回归进行间接比较,该方法将所有试验纳入单个模型中。这与之前的分析进行了比较,之前的分析采用简单的合并、逻辑回归或荟萃分析合并每个干预的数据,然后使用 Bucher 方法间接比较合并值。

结果

纳入了两项罗米司亭试验和一项艾曲波帕试验。间接证据表明,与艾曲波帕相比,罗米司亭显著改善了总体血小板反应。贝叶斯荟萃回归得出的艾曲波帕与罗米司亭的比值比(OR)为 0.11(95%可信区间 0.02-0.66);所有分析的 p 值和贝叶斯后验概率范围为 0.01-0.05。在任何分析中,持久的血小板反应均无显著差异,尽管效果方向有利于罗米司亭(OR=0.15;95%可信区间 0.01-1.88);所有分析的 p 值和贝叶斯后验概率范围为 0.08-0.40。分析结果之间相对一致。

结论

贝叶斯荟萃回归生成的结果与其他间接比较方法相似,并且由于它将所有数据纳入单个模型中,并适当考虑参数不确定性,因此可能被认为是最稳健的方法。

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