Jansen W, Brückner G W, Henauer S, Omer L M
Pharmacopsychiatria. 1982 Nov;15(6):205-9. doi: 10.1055/s-2007-1019539.
The objective of this double-blind trial was to assess the effect of diclofensine on geriatric patients with depressive syndromes in comparison to placebo. 40 patients (age 60-75 years) were treated for 3 weeks with a mean daily dose of 57.5 mg diclofensine or placebo. Diclofensine was found effective in 18 (= 90%) cases (placebo 60%) after 2.9 days on an average (placebo, 4.2 days), mostly having a mood elevating effect and in only 2 cases (placebo 1) having a stimulatory effect. The results of the global assessments, the Hamilton depression scale, the d2-test, the block design test and the mood scale (Befindlichkeitsskala) demonstrated a statistically significant superiority of diclofensine over placebo. The critical flicker frequency, on the other hand, was not able to differentiate significantly between the two drugs. The tolerance was considered as very good in all cases. Unwanted effects were observed in 13 patients (= 65%) of the diclofensine group and in 9 patients (= 45%) of the placebo group. They disappeared in most cases within one week after their appearance. According to this trial diclofensine can be described as a well tolerated drug without pronounced anticholinergic side effects, capable of improving depressive states faster and more effectively than placebo.
这项双盲试验的目的是评估双氯芬辛与安慰剂相比,对患有抑郁综合征的老年患者的疗效。40名年龄在60至75岁之间的患者接受了为期3周的治疗,双氯芬辛的平均日剂量为57.5毫克,或服用安慰剂。平均2.9天后(安慰剂组为4.2天),发现双氯芬辛在18例(90%)患者中有效(安慰剂组为60%),多数具有情绪提升作用,仅有2例(安慰剂组1例)有刺激作用。整体评估、汉密尔顿抑郁量表、d2测试、区组设计测试和情绪量表(Befindlichkeitsskala)的结果显示,双氯芬辛在统计学上显著优于安慰剂。另一方面,临界闪烁频率无法显著区分这两种药物。在所有病例中,耐受性均被认为非常好。双氯芬辛组有13名患者(65%)出现了不良反应,安慰剂组有9名患者(45%)出现了不良反应。大多数情况下,这些不良反应在出现后一周内消失。根据该试验,双氯芬辛可被描述为一种耐受性良好的药物,无明显抗胆碱能副作用,能够比安慰剂更快、更有效地改善抑郁状态。