Sandmann J, Lörch B, Bandelow B, Härtter S, Winter P, Hiemke C, Benkert O
Department of Psychiatry, University of Mainz, Germany.
Pharmacopsychiatry. 1998 Jul;31(4):117-21. doi: 10.1055/s-2007-979311.
A six-week double-blind placebo-controlled trial of fluvoxamine was undertaken in 46 patients suffering from panic disorder with or without agoraphobia diagnosed by DSM-III-R guidelines. Average daily dosage of fluvoxamine was 160 mg, with a highest permitted dose of 300 mg/day. Weekly evaluation included a diary in which the number, severity, and duration of full-blown and limited panic attacks and the duration and severity of anticipating fear, CAS, GAS, CGI, HAM-D, adverse effects and the number of capsules not taken were noted. Fluvoxamine was not significantly superior to placebo with regard to the main outcome criterion, i.e., the reduction in the number of panic attacks, but it was significantly more effective with regard to the diminution in the number of limited panic attacks and showed a tendency to significance in respect of GAS and CGI. Plasma levels of fluvoxamine were measured at the end of week one and at the end of the study. Most patients with complete remission at the end of the study were found in the verum group with plasma fluvoxamine levels ranging from 10 to 100ng/ml. It is suggested that therapeutic response might be maximized by monitoring fluvoxamine concentrations in blood.
对46例根据《精神疾病诊断与统计手册》第三版修订本（DSM-III-R）指南诊断为伴有或不伴有广场恐怖症的惊恐障碍患者进行了一项为期六周的氟伏沙明双盲安慰剂对照试验。氟伏沙明的平均日剂量为160毫克，最高允许剂量为300毫克/天。每周评估包括一份日记，记录全面发作和有限惊恐发作的次数、严重程度和持续时间，以及预期恐惧、临床总体印象量表（CAS）、大体评定量表（GAS）、临床疗效总评量表（CGI）、汉密尔顿抑郁量表（HAM-D）、不良反应以及未服用胶囊的数量。在主要结局标准方面，即惊恐发作次数的减少，氟伏沙明并不显著优于安慰剂，但在减少有限惊恐发作次数方面显著更有效，并且在GAS和CGI方面有显著趋势。在第一周结束时和研究结束时测量了氟伏沙明的血浆水平。在研究结束时完全缓解的大多数患者在试验组中被发现，其血浆氟伏沙明水平在10至100纳克/毫升之间。建议通过监测血液中氟伏沙明浓度来使治疗反应最大化。
