Mackay F J, Dunn N R, Wilton L V, Pearce G L, Freemantle S N, Mann R D
Drug Safety Research Unit, Bursledon Hall, Southampton, UK.
Pharmacoepidemiol Drug Saf. 1997 Jul;6(4):235-46. doi: 10.1002/(SICI)1099-1557(199707)6:4<235::AID-PDS293>3.0.CO;2-3.
To compare the safety and side-effect profiles of the four selective serotonin reuptake inhibitor antidepressants (SSRIs), fluvoxamine, fluoxetine, sertraline and paroxetine.
The results from four observational cohort studies of the four SSRIs were compared. Each of these studies was conducted by Prescription-Event Monitoring (PEM). The exposure data were derived from general practitioner (GP) prescriptions confidentially supplied by the Prescription Pricing Authority (PPA) in England. Outcome data were obtained from questionnaires (green forms) on which the prescribing doctor recorded event data. The main findings comprised demographic information, including patients' date of birth and sex; the indication for prescribing the monitored drug; the effectiveness of the drug as perceived by the GP; the reasons for stopping treatment and all events recorded during and after treatment.
The final cohort for each of the four SSRIs exceeded 10,000 patients. The sex, age distributions and indications for prescribing the four SSRIs were very similar. Only 36% of the GPs expressing an opinion reported fluvoxamine as effective, compared with approximately 60% for fluoxetine, sertraline and paroxetine. Fluvoxamine was associated with a higher incidence of adverse events than the other three SSRIs. Nausea/vomiting was both the most frequent clinical reason for stopping all four SSRIs and the most frequently reported clinical event. Adverse events reported in patients aged 70 years and over were comparable with the events reported for the total cohorts. Differences were identified between the four SSRIs for less frequently reported adverse events. Withdrawal symptoms were significantly more frequent with paroxetine than the other three SSRIs.
The data from the four studies were comparable in terms of age distribution, sex of patients and indication for prescribing the drugs. Fluvoxamine had a considerably higher incidence of side-effects associated with its use than the other three SSRIs. The side-effect profiles of the four SSRIs were comparable for frequently reported events. Important differences were identified between the four SSRIs in respect of less frequently reported events. This study suggests that fluvoxamine compares unfavourably with fluoxetine, sertraline and paroxetine, both in terms of reported effectiveness and the incidence of adverse events. Biases possibly affecting the comparisons involved in this study are unlikely to account for the observed differences between fluvoxamine and the other three SSRIs.
比较四种选择性5-羟色胺再摄取抑制剂抗抑郁药（氟伏沙明、氟西汀、舍曲林和帕罗西汀）的安全性和副作用情况。
比较了四项关于这四种选择性5-羟色胺再摄取抑制剂的观察性队列研究结果。这些研究均通过处方事件监测（PEM）开展。暴露数据源自英国处方定价管理局（PPA）保密提供的全科医生（GP）处方。结局数据通过问卷（绿色表格）获取，开处方的医生在问卷上记录事件数据。主要研究结果包括人口统计学信息，包括患者出生日期和性别；所监测药物的处方指征；全科医生所感知到的药物疗效；停药原因以及治疗期间和治疗后的所有记录事件。
四种选择性5-羟色胺再摄取抑制剂各自的最终队列均超过10000例患者。四种选择性5-羟色胺再摄取抑制剂的性别、年龄分布及处方指征非常相似。表达意见的全科医生中只有36%报告氟伏沙明有效，而氟西汀、舍曲林和帕罗西汀的这一比例约为60%。与其他三种选择性5-羟色胺再摄取抑制剂相比，氟伏沙明的不良事件发生率更高。恶心/呕吐既是停用所有四种选择性5-羟色胺再摄取抑制剂最常见的临床原因，也是报告最多的临床事件。70岁及以上患者报告的不良事件与整个队列报告的事件相当。在报告频率较低的不良事件方面，四种选择性5-羟色胺再摄取抑制剂之间存在差异。帕罗西汀的撤药症状比其他三种选择性5-羟色胺再摄取抑制剂明显更常见。
四项研究的数据在年龄分布、患者性别及药物处方指征方面具有可比性。与其他三种选择性5-羟色胺再摄取抑制剂相比，氟伏沙明使用相关的副作用发生率要高得多。四种选择性5-羟色胺再摄取抑制剂在常见报告事件方面的副作用情况具有可比性。在报告频率较低的事件方面，四种选择性5-羟色胺再摄取抑制剂之间存在重要差异。本研究表明，无论是在报告的疗效还是不良事件发生率方面，氟伏沙明与氟西汀、舍曲林和帕罗西汀相比都处于劣势。本研究中可能影响比较结果的偏倚不太可能解释氟伏沙明与其他三种选择性5-羟色胺再摄取抑制剂之间观察到的差异。
