Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
Eur J Clin Pharmacol. 2013 Feb;69(2):209-15. doi: 10.1007/s00228-012-1313-7. Epub 2012 Jun 12.
Duloxetine (Cymbalta(®)) is a serotonin (5-HT) and norepinephrine (NE) re-uptake inhibitor indicated for the treatment of depression, diabetic peripheral neuropathic pain and general anxiety disorder. The aim of this study is to gain insight in the user and safety profile of duloxetine in daily practice, reported by patients via a web-based intensive monitoring system during their first 6 months of use.
First-time users of duloxetine were identified through the first dispensing signal in the pharmacy. Patient demographics and information about drug use and adverse drug reactions, ADRs, were collected through electronic questionnaires sent 2 and 6 weeks, 3 and 6 months after the start of duloxetine administration. ADRs were quantified and signal detection was performed on a case by case basis.
Three hundred and ninety-eight patients registered for the study; 69.1 % were female. Depression was the main indication. Three hundred and three patients (76.1 %) filled in at least one questionnaire and 78.9 % of these reported an ADR. Serious ADRs were reported by 4 patients. Three new signals were identified, amenorrhea, shock-like paraesthesias and micturition problems.
Web-based intensive monitoring is an observational prospective cohort study mirroring the use and ADRs of duloxetine in daily practice. This study indicates that duloxetine is a relatively safe drug as used by patients for six months in daily practice, but the aforementioned signals need to be evaluated in more detail.
度洛西汀（欣百达）是一种 5-羟色胺（5-HT）和去甲肾上腺素（NE）再摄取抑制剂，用于治疗抑郁症、糖尿病周围神经病理性疼痛和广泛性焦虑障碍。本研究旨在通过患者在使用度洛西汀的前 6 个月通过基于网络的强化监测系统报告，深入了解度洛西汀在日常实践中的使用情况和安全性概况。
通过药房的首次配药信号识别度洛西汀的首次使用者。通过电子问卷收集患者人口统计学信息和药物使用信息以及不良反应（ADR），这些问卷在开始使用度洛西汀后的第 2、6 周，第 3、6 个月发送。对 ADR 进行定量并逐个病例进行信号检测。
398 名患者注册参加了该研究；69.1%为女性。抑郁症是主要适应症。303 名患者（76.1%）填写了至少一份问卷，其中 78.9%报告了 ADR。有 4 名患者报告了严重的 ADR。确定了 3 个新的信号，分别是闭经、休克样感觉异常和排尿问题。
基于网络的强化监测是一种观察性前瞻性队列研究，反映了度洛西汀在日常实践中的使用情况和 ADR。本研究表明，度洛西汀在日常实践中被患者使用六个月是一种相对安全的药物，但需要更详细地评估上述信号。
