Wagner W, Zaborny B A, Gray T E
Solvay Human Health Division, Hannover, Germany.
Int Clin Psychopharmacol. 1994 Winter;9(4):223-7. doi: 10.1097/00004850-199400940-00001.
Fluvoxamine, a selective serotonin reuptake inhibitor, was studied extensively in 34,587 predominantly depressed patients in 66 studies conducted world-wide. These studies were largely uncontrolled trials representing the use of fluvoxamine by psychiatric and general practice physicians in everyday conditions. The safety data were analyzed according to standardized medical review and data management policies. Approximately 70% of the fluvoxamine population were female and 44% were aged 31-51 years. The modal total daily dose was 100 mg. Safety findings revealed a pharmacological adverse event profile similar to that seen with other serotonin reuptake inhibitors. Nausea was found to be the only common symptom, with an incidence rate of 16%. Approximately 2% of the fluvoxamine population reported at least one serious adverse event (per FDA criteria). Overall suicidality rates of fluvoxamine were found to be low (0.7%). No cases of zimelidine syndrome, bleeding syndrome or Guillain-Barré syndrome were identified. Overall, fluvoxamine was found to be safe and well tolerated suggesting a favorable alternative in the treatment of depression.
氟伏沙明是一种选择性5-羟色胺再摄取抑制剂，在全球开展的66项研究中，对34587名主要为抑郁症患者进行了广泛研究。这些研究大多为非对照试验，代表了精神科医生和全科医生在日常情况下使用氟伏沙明的情况。根据标准化的医学审查和数据管理政策对安全性数据进行了分析。使用氟伏沙明的人群中约70%为女性，44%年龄在31至51岁之间。每日总剂量的众数为100毫克。安全性研究结果显示，其药理学不良事件谱与其他5-羟色胺再摄取抑制剂相似。发现恶心是唯一常见症状，发生率为16%。使用氟伏沙明的人群中约2%报告了至少一项严重不良事件（按照美国食品药品监督管理局标准）。发现氟伏沙明的总体自杀率较低（0.7%）。未发现齐美利定综合征、出血综合征或吉兰-巴雷综合征病例。总体而言，氟伏沙明被发现是安全且耐受性良好的，提示其是治疗抑郁症的一个有利选择。
