d'Elia G, Borg S, Hermann L, Lundin G, Perris C, Raotma H, Román G, Siwers B
Acta Psychiatr Scand. 1977 Jan;55(1):10-20. doi: 10.1111/j.1600-0447.1977.tb00136.x.
Lofepramine, an imipramine analogue, was compared with imipramine in a multicentre, double-blind clinical trial. The 62 patients (31 in each of two treatment groups) had a depressive syndrome that normally would have been treated with a tricyclic antidepressant. These patients had not received any adequate treatment for this present depressive episode. After a wash-out period and once a week during treatment (up to 5 weeks), routine laboratory tests and electrocardiograms was done. The dosage was 50 mg t.i.d. for imipramine and 70 mg t.i.d. for lofepramine. Depression ratings with the Cronholm-Ottosson depression rating scale were performed before treatment and once weekly for 3 weeks and then in the 5th week. The last four ratings were combined with rating of side-effects. In the 5th week of treatment 15 out of 31 in the lofepramine group and 18 out of 31 in the imipramine group had recovered. This difference was not significant, nor did the median values of individual symptoms differ between the groups. The side-effects were moderate and the two groups only differed significantly in the items "dry mouth" and accommodation disturbances in favour of lofepramine. The drug compliance was checked by plasma levels of desmethylimipramine in the imipramine group, parent compound, and "apparent" desmethylimipramine in the lofepramine group. The relationship between plasma drug levels, the effect on noradrenaline uptake in vitro and amelioration discussed in Siwers et al. (1977) in this issue. The clinical outcome in the two groups did not differ significantly; interpretation of this result is discussed in relation to the reliability and selection of patients.
洛非帕明是一种丙咪嗪类似物，在一项多中心双盲临床试验中与丙咪嗪进行了比较。62名患者（两个治疗组各31名）患有通常会用三环类抗抑郁药治疗的抑郁综合征。这些患者目前的抑郁发作未接受过任何充分治疗。在洗脱期后以及治疗期间每周一次（长达5周），进行了常规实验室检查和心电图检查。丙咪嗪的剂量为每日3次，每次50毫克；洛非帕明的剂量为每日3次，每次70毫克。使用克伦霍尔姆 - 奥托森抑郁评定量表在治疗前、每周一次共3周然后在第5周进行抑郁评定。最后四次评定与副作用评定相结合。在治疗的第5周，洛非帕明组31名患者中有15名康复，丙咪嗪组31名患者中有18名康复。这种差异不显著，两组之间各个症状的中位数也没有差异。副作用为中度，两组仅在“口干”和调节障碍项目上有显著差异，洛非帕明组情况较好。通过丙咪嗪组去甲丙咪嗪的血浆水平、母体化合物以及洛非帕明组“表观”去甲丙咪嗪来检查药物依从性。西韦斯等人（1977年，本期）讨论了血浆药物水平、体外对去甲肾上腺素摄取的影响和病情改善之间的关系。两组的临床结果没有显著差异；结合患者的可靠性和选择对这一结果进行了讨论。
