Möller H J, van Praag H M, Aufdembrinke B, Bailey P, Barnes T R, Beck J, Bentsen H, Eich F X, Farrow L, Fleischhacker W W
Psychopharmacology (Berl). 1994 Jun;115(1-2):221-8. doi: 10.1007/BF02244775.
There is little agreement about the methodology of clinical trials of antipsychotic drugs in patients with negative symptoms. A literature review revealed wide variation in experimental design, rating scales and study duration. This reflects differing views as to the definition and response to treatment of negative symptoms. Some degree of standardization would improve comparability of studies and aid the development of new compounds. Patients included in such studies should have displayed negative symptoms for at least 6 months. Depressive symptoms, positive schizophrenic symptoms and extrapyramidal signs may all influence or be confused with negative symptoms and may respond to treatment; they should be at a low level at baseline and should be measured during the study period. Studies should last at least 8 weeks. Several scales are available for measuring negative symptoms and are reviewed; a global impression score should be used additionally.
关于抗精神病药物治疗阴性症状患者的临床试验方法,目前几乎没有共识。一项文献综述显示,实验设计、评定量表和研究持续时间存在很大差异。这反映出对于阴性症状的定义和治疗反应存在不同观点。一定程度的标准化将提高研究的可比性,并有助于新化合物的研发。纳入此类研究的患者应至少6个月表现出阴性症状。抑郁症状、精神分裂症阳性症状和锥体外系体征可能都会影响阴性症状或与之混淆,并且可能对治疗有反应;它们在基线时应处于低水平,并应在研究期间进行测量。研究应至少持续8周。有几种量表可用于测量阴性症状,本文对其进行了综述;此外还应使用整体印象评分。