Morozova M A, Beniashvili A G, Rupchev G E, Lepilkina T A, Starostin D S, Brusov O S
Zh Nevrol Psikhiatr Im S S Korsakova. 2008;108(11):28-35.
An objective of the study was to investigate the effectiveness of neuromidin in stable schizophrenic patients with predominance of symptoms of pseudoorganic deficits. Fifty-five patients stable after a transition from routine medication to monotherapy with risperidone were randomized into two groups with add-on placebo or neuromidin treatment. Patients were studied during 24 weeks. The PANSS and a battery of neurocognitive tests were used for assessment of treatment. In the end of the trial, positive changes on the following PANSS items - N1, N2, N6, N7, G4, G7 and G13 were observed in the neuromidin group. In the placebo group, the changes were found only on one PANSS item - N2. The decrease of scores on this item (emotional withdrawal) during the study was more significant only in the patients receiving neuromidin (p=0,037). The results of assessment of cognitive functioning showed the positive changes in visual-spatial memory, attention, retention and retrieval of data, planning in the group treated with neuromidin. In the placebo group, the positive changes were observed only in one index - one type of mistakes (omissions) in visual-spatial memory test. In the end of the trial, between-group differences were significant for planning - number of tasks with time-limit violation and rule violations. All differences were beneficial for patients treated with neuromidin. Not all tests were sensitive to changes in cognitive status of patients: indices of working memory, psychomotor speed, flexibility of attention were not changed significantly in both groups, nor they changed between groups. The authors conclude that the problem of rationality of add-on anticholinergic treatment in schizophrenia is not solved yet due to the difficulties in selection of patients and tests for cognitive assessment. The need of further studies is emphasized.
该研究的一个目标是调查神经介质素对以假性器质性缺陷症状为主的稳定型精神分裂症患者的有效性。55名从常规药物治疗过渡到利培酮单一疗法后病情稳定的患者被随机分为两组，分别接受附加安慰剂或神经介质素治疗。对患者进行了24周的研究。使用阳性和阴性症状量表（PANSS）以及一系列神经认知测试来评估治疗效果。在试验结束时，神经介质素组在以下PANSS项目上观察到了积极变化——N1、N2、N6、N7、G4、G7和G13。在安慰剂组中，仅在一个PANSS项目——N2上发现了变化。在研究期间，仅在接受神经介质素治疗的患者中，该项目（情感退缩）得分的下降更为显著（p = 0.037）。认知功能评估结果显示，接受神经介质素治疗的组在视觉空间记忆、注意力、数据保留和检索、规划方面有积极变化。在安慰剂组中，仅在一个指标上观察到了积极变化——视觉空间记忆测试中的一种错误类型（遗漏）。在试验结束时，在规划方面——违反时间限制和规则的任务数量，两组之间的差异具有显著性。所有差异对接受神经介质素治疗的患者都是有益的。并非所有测试都对患者认知状态的变化敏感：两组的工作记忆指标、精神运动速度、注意力灵活性均无显著变化，两组之间也没有变化。作者得出结论，由于在患者选择和认知评估测试方面存在困难，精神分裂症附加抗胆碱能治疗的合理性问题尚未得到解决。强调了进一步研究的必要性。
