Lehmann E, Kretschmar J H, Brauer H, Reinhardt B
Pharmacopsychiatria. 1982 Mar;15(2):57-60. doi: 10.1055/s-2007-1019509.
Chronic psychiatric patients (N = 42) predominantly diagnosed as schizophrenics, who had been hospitalized for the mean of 9 years were treated in a double-blind study with a neurotropic drug (tamitinol dihydrochloride coated tablets of 300 mg t.i.d.) and placebo. Test drugs were administered concomitantly to the existing drug therapy during two treatment periods of 6 weeks each with an interval of two months free of test medication. In the second treatment period patients moved to a new building. It was expected that neurotropic drug effects can be made clearer after the transfer requiring patient's reorientation in a new environment than before the transfer. Assessment of efficacy was made using observer ratings (Psychic and Somatic Findings of the A.M.P. System, WING Behaviour Rating Scale) and patient's self ratings (Adjective Check List. List of Somatic Symptoms) and clinical laboratory parameters. Results show that neurotropic co-medication reduced the "neurological syndrome" and the "psychoorganic syndrome" (A.M.P. System). An amelioration of the "neurological syndrome" was observed at the end of the first and at the end of the second medication phase (p less than or equal to 0.10) whilst the improvement of the "psychoorganic syndrome" was particularly evident as expected after the transfer to the new building (p less than or equal to 0.001) Patients receiving placebo described themselves as more active than patients receiving the test drug. (Adjective Check List: p less than or equal to 0.10). No subjective or objective side effects (List of somatic symptoms and laboratory parameters) were evident due to the test medication which was tolerated by all patients.
42名主要被诊断为精神分裂症的慢性精神病患者,平均住院9年,在一项双盲研究中接受了一种神经营养药物(300毫克盐酸他米诺醇包衣片,每日三次)和安慰剂治疗。在两个为期6周的治疗期内,将试验药物与现有的药物治疗同时给药,两个治疗期之间有两个月的无试验药物间隔期。在第二个治疗期,患者搬到了一栋新楼。预计在转移后,由于患者需要在新环境中重新适应,神经营养药物的效果会比转移前更明显。使用观察者评分(AMP系统的精神和躯体检查结果、WING行为评分量表)、患者自评(形容词检查表、躯体症状清单)和临床实验室参数对疗效进行评估。结果表明,神经营养药物联合用药减少了“神经综合征”和“精神器质性综合征”(AMP系统)。在第一个用药阶段结束时和第二个用药阶段结束时观察到“神经综合征”有所改善(p≤0.10),而“精神器质性综合征”的改善在转移到新楼后正如预期的那样特别明显(p≤0.001)。接受安慰剂的患者称自己比接受试验药物的患者更活跃。(形容词检查表:p≤0.10)。试验药物未出现明显的主观或客观副作用(躯体症状清单和实验室参数),所有患者均能耐受。