Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France; Clinical Pharmacology Department INSERM CIC1406, Grenoble Alpes University Hospital, Grenoble, France; UMR 1042-HP2, INSERM, Univ. Grenoble Alpes, Grenoble, France.
Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France.
J Clin Epidemiol. 2021 Jun;134:14-21. doi: 10.1016/j.jclinepi.2021.01.015. Epub 2021 Jan 26.
We aimed at testing if a correlation between adverse drug reactions relative risks estimated from meta-analyses and disproportionality analyses calculated from pharmacovigilance spontaneous reporting systems databases exist, and if methodological choices modify this correlation.
We extracted adverse drug reactions (ADR) odds ratios (ORs) from meta-analyses used as reference and calculated corresponding Reporting Odds Ratios (RORs) from the WHO pharmacovigilance database according to five different designs. We also calculated the relative bias and agreement of ROR compared to ORs.
We selected five meta-analyses which displayed a panel of 13 ADRs. A significant correlation for 7 out of the 13 ADRs studied in the primary analysis was found. The methods for ROR calculation impacted the results but none systematically improved the correlations. Whereas correlation was found between OR and ROR, agreement was poor and relative bias was important.
Despite the large variation in disproportionality analyses results due to design specification, this study provides further evidence that relative risks obtained from meta-analyses and from disproportionality analyses correlate in most cases, in particular for objective ADR not associated with the underlying pathology.
本研究旨在检验从荟萃分析中估计的药物不良反应（ADR）相对风险与从药物警戒自发报告系统数据库中计算的比例失调分析之间是否存在相关性，以及方法学选择是否会改变这种相关性。
我们从荟萃分析中提取了作为参考的ADR 比值比（OR），并根据五种不同的设计，从世界卫生组织药物警戒数据库中计算了相应的报告比值比（ROR）。我们还计算了 ROR 与 OR 相比的相对偏差和一致性。
我们选择了五项荟萃分析，其中展示了 13 种 ADR 的面板。在主要分析中，研究的 13 种 ADR 中有 7 种显示出显著相关性。ROR 计算方法对结果有影响，但没有一种方法能系统地改善相关性。虽然 OR 和 ROR 之间存在相关性，但一致性较差，相对偏差较大。
尽管由于设计规范的不同，比例失调分析的结果存在很大差异，但本研究进一步证明了荟萃分析和比例失调分析中获得的相对风险在大多数情况下是相关的，特别是对于与潜在病理无关的客观 ADR。
