Loudon J B, Tiplady B, Ashcroft G W, Waddell J L
Acta Psychiatr Scand Suppl. 1981;290:454-63. doi: 10.1111/j.1600-0447.1981.tb00752.x.
Depressive patients seen at hospital clinics are likely to be unrepresentative in terms of treatment response. In this study patients were always seen at their general practitioners' surgeries for assessment by specialists after selection as being in need of antidepressant treatment. The Research Diagnostic Criteria for major or minor depressive illness and a Hamilton Depression (Ham-D) score of at least 10 were required for inclusion, using the Present State Examination as a basis for interview. Patients were seen at weekly intervals, alternatively by practitioner and assessor for further Ham-D ratings, completion of the Kellner Sheffield Self-Rating test (KSSRT), event record and side effect checklist. Patients were randomly and blindly allocated to either zimelidine or amitriptyline dispensed identically at dosages of 100 mg and 75 mg at night, rising to 200 mg and 150 mg after two weeks. At four weeks there was no significant difference between the improvement found with zimelidine and amitriptyline or either the Ham-D or the KSSRT. Amitriptyline patients tended to gain and zimelidine patients to lose weight; difference significant. Other amitriptyline side effects were not found in those taking zimelidine, the latter tending to suffer diarrhoea. Preliminary analysis shows no relationship between clinical response and plasma level of either compound.
在医院诊所就诊的抑郁症患者在治疗反应方面可能不具有代表性。在本研究中,患者总是先在其全科医生诊所接受检查,被选定需要抗抑郁治疗后再由专家进行评估。纳入标准为符合严重或轻度抑郁疾病的研究诊断标准,且汉密尔顿抑郁量表(Ham-D)评分至少为10分,以目前状态检查作为访谈依据。患者每周接受一次检查,由医生和评估人员交替进行,以进一步评定Ham-D评分、完成凯尔纳谢菲尔德自评测试(KSSRT)、记录事件及填写副作用清单。患者被随机、盲法分配至齐美利定组或阿米替林组,二者均在每晚分别给予100mg和75mg的剂量,两周后增至200mg和150mg。四周时,齐美利定和阿米替林在Ham-D评分或KSSRT评分方面的改善无显著差异。服用阿米替林的患者体重有增加趋势,而服用齐美利定的患者体重有减轻趋势,差异显著。服用齐美利定的患者未出现服用阿米替林时出现的其他副作用,前者倾向于出现腹泻。初步分析显示,临床反应与两种药物的血浆水平之间均无关联。