Kheloufi Farid, Default Anne, Blin Olivier, Micallef Joelle
Regional pharmacovigilance center of Marseille Provence Corse, department of clinical pharmacology and pharmacovigilance, Assistance publique-Hôpitaux de Marseille, 13009 Marseille, France; Aix-Marseille university, Neurosciences institut Timone, CNRS 7289, 13385 Marseille, France.
Regional pharmacovigilance center of Marseille Provence Corse, department of clinical pharmacology and pharmacovigilance, Assistance publique-Hôpitaux de Marseille, 13009 Marseille, France; Aix-Marseille university, Neurosciences institut Timone, CNRS 7289, 13385 Marseille, France.
Therapie. 2017 Sep;72(4):483-490. doi: 10.1016/j.therap.2016.10.004. Epub 2016 Dec 9.
Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins.
A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines. One day of December 2012, postings about simvastatin, rosuvastatin and atorvastatin publicly available on the website were collected. Their informativeness according to 16 key elements of information (including drug start and stop date, duration of treatment, time to onset and duration of the ADR, outcome, medical history, concomitant medication) was assessed. General information about reported ADRs was also investigated.
Among the 96 postings related to statins, 72 (40 women, 32 men; mean age: 59 [40-78]) mentioned at least one ADR accounting for a total of 176 ADRs. Musculoskeletal and connective tissue disorders (42.6%) and nervous system disorders (15.3%) were the main represented ADRs. Only 2 patients mentioned ADRs that could be considered as serious but 24 patients mentioned they stopped or switched their treatment toward another lipid modifying agent because of the ADR. Mean number of available key elements of information per narrative was 6/16. Time to onset and duration of the ADR were respectively available in only 31% and 3% of the narratives. Medical history and concomitant medication were respectively lacking in 87% and 86% of the narratives. Outcome was found only in 39% of the narratives.
Patient narratives posted on Internet include mainly non-serious expected ADR. However, their informativeness level is very incomplete and makes difficult their assessment and use for pharmacovigilance purpose.
患者健康论坛等与健康相关的网络可被视为早期发现药物警戒问题或获取药物安全性完整数据的潜在信息来源。然而，此类信息来源的临床和药理学相关性尚未得到明确探讨。我们旨在描述患者发布的、提及与他汀类药物相关的药物不良反应（ADR）的网络叙述的特征和信息丰富程度。
在一个专门用于分享用药经验的互联网网站上进行了一项回顾性横断面研究。收集了2012年12月某一天该网站上公开的关于辛伐他汀、瑞舒伐他汀和阿托伐他汀的帖子。根据16个关键信息要素（包括用药开始和停药日期、治疗持续时间、ADR的发生时间和持续时间、结局、病史、合并用药）评估其信息丰富程度。还对报告的ADR的一般信息进行了调查。
在96篇与他汀类药物相关的帖子中，72篇（40名女性，32名男性；平均年龄：59岁[40 - 78岁]）提到了至少一种ADR，共计176例ADR。肌肉骨骼和结缔组织疾病（42.6%）和神经系统疾病（15.3%）是主要出现的ADR。只有2名患者提到的ADR可被视为严重，但有24名患者提到他们因ADR而停止用药或改用另一种调脂药物。每篇叙述中可用关键信息要素的平均数量为6/16。ADR的发生时间和持续时间分别仅在31%和3%的叙述中提及。87%和86%的叙述中分别缺少病史和合并用药信息。仅在39%的叙述中发现了结局信息。
互联网上发布的患者叙述主要包括非严重的预期ADR。然而，其信息丰富程度非常不完整，难以用于药物警戒目的的评估和使用。
