Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH's-Hertogenbosch, The Netherlands.
Pharmacoepidemiol Drug Saf. 2010 Jan;19(1):26-32. doi: 10.1002/pds.1865.
To study the influence of media attention about statins and ADRs on the level of disproportionality, expressed as the reporting odds ratio (ROR) for statins in the Lareb database, based on patients' reports.
Patient reports about statins, before and after the broadcast of a consumer programme about statins, were compared. In order to calculate the correlation between the ROR for patient-statin reports between the period before and after the broadcast a Pearson correlation-coefficient (r) was calculated. The type of reported ADRs associated with statins before and after the broadcast was compared both on the level of system organ class (SOC) and preferred terms (PT).
Pearson's Correlation-coefficient for the comparison of RORs before and after the broadcast was 0.83. In respect to specific ADRs, no differences were found in reporting on SOC level before and after the broadcast, except for the SOC Musculoskeletal and connective tissue disorders. For ADRs that were specifically mentioned during the broadcast, no differences were found except for an increased number of myalgia and arthralgia reports.
Our study demonstrates that media attention does not necessarily influence the relative reporting by patients expressed as RORs in the national ADR database. On SOC level only in Musculoskeletal and connective tissue disorders the relative reporting increased. For myalgia and arthralgia, there was a proportional increase of reporting within the statin class but not for the other ADRs that were explicitly mentioned in the TV programme about statins.
研究媒体对他汀类药物和不良反应的关注对基于患者报告的莱比锡不良反应数据库中他汀类药物不均衡程度（表示为报告比值比[ROR]）的影响。
比较了他汀类药物患者报告在广播前后的数据。为了计算广播前后患者他汀类药物报告的 ROR 之间的相关性，计算了 Pearson 相关系数（r）。比较了广播前后与他汀类药物相关的报告不良反应的类型，包括系统器官分类（SOC）和首选术语（PT）。
广播前后 ROR 比较的 Pearson 相关系数为 0.83。就特定的不良反应而言，在广播前后的 SOC 水平上报告没有差异，除了 SOC 肌肉骨骼和结缔组织疾病。对于在广播中特别提到的不良反应，除了肌痛和关节痛报告数量增加外，没有发现差异。
我们的研究表明，媒体关注不一定会影响患者在国家不良反应数据库中表达的相对报告率，以 ROR 表示。仅在肌肉骨骼和结缔组织疾病的 SOC 水平上，相对报告有所增加。对于肌痛和关节痛，他汀类药物类别的报告呈比例增加，但对于电视节目中明确提到的其他不良反应则不然。
