Cassano G B, Conti L, Massimetti G, Fornaro P, Levine J
Pharmacopsychiatria. 1982 May;15(3):84-9. doi: 10.1055/s-2007-1019514.
This article describes a controlled clinical trial comparing nomifensine and amitriptyline in endogenously depressed inpatients. It is also the first trial of the ICPP-BLIPS, a computer based clinical trial data documentation system. Using strict methodological criteria, careful quality control and comprehensive and systematic data display and data analysis, we have been able to show clearcut efficacy differences between nomifensine and amitriptyline (favouring the later) and clearcut differences in the profile of side effects between these drugs. Future studies utilizing this methodology are recommended were definitive and documented results of clinical trials are desired.
本文描述了一项针对内因性抑郁症住院患者比较诺米芬辛和阿米替林的对照临床试验。这也是首次使用基于计算机的临床试验数据记录系统ICPP - BLIPS进行的试验。通过严格的方法学标准、细致的质量控制以及全面系统的数据展示和数据分析,我们得以明确显示出诺米芬辛和阿米替林之间存在显著的疗效差异(更有利于后者),以及这两种药物在副作用方面存在明显差异。若希望获得临床试验的确切且有记录的结果,建议未来采用此方法进行研究。