Nakazawa T, Ohara K, Sawa Y, Edakubo T, Matsui H, Sawa J, Kawaguchi K, Hattori S, Nakajima M
J Int Med Res. 1983;11(5):247-58. doi: 10.1177/030006058301100501.
The clinical efficacy and safety of timiperone, a new butyrophenone derivative, on chronic schizophrenia was compared with clocapramine by the double-blind method using a total of eighty-eight patients, consisting of forty-four patients in each group. In the final global improvement rating, the global improvement rating in each week and the general usefulness rating, there were no statistically significant differences between the two groups. However, in the global improvement rating in each symptom, timiperone was significantly superior to clocapramine in delusion and showed a superior tendency to clocapramine in contact. Timiperone showed a higher improvement rate than clocapramine in hallucination and disturbance of self-consciousness. In the over-all safety rating, there were no significant differences between the two groups, but in accompanying symptoms and side-effects, timiperone showed significantly less tendency than clocapramine in dyskinesia, insomnia, constipation and nausea. From these results, including the analysis by stratification, it was considered that timiperone was a superior or equivalent neuroleptic in comparison with clocapramine against the negative symptoms as well as the positive ones of chronic schizophrenia, and was equally safe or safer than clocapramine.
采用双盲法，将一种新型丁酰苯衍生物替米哌隆与氯氮平对88例慢性精神分裂症患者的临床疗效和安全性进行比较，每组各44例。在最终总体改善评分、每周总体改善评分和总体有用性评分方面，两组之间无统计学显著差异。然而，在各症状的总体改善评分中，替米哌隆在妄想方面显著优于氯氮平，在接触方面显示出优于氯氮平的趋势。替米哌隆在幻觉和自我意识障碍方面的改善率高于氯氮平。在总体安全性评分方面，两组之间无显著差异，但在伴随症状和副作用方面，替米哌隆在运动障碍、失眠、便秘和恶心方面的倾向明显低于氯氮平。从这些结果，包括分层分析来看，认为替米哌隆与氯氮平相比，在治疗慢性精神分裂症的阴性症状和阳性症状方面是一种更优或等效的抗精神病药物，并且与氯氮平同样安全或更安全。
