利培酮与氟哌啶醇治疗精神分裂症双盲对照试验

Double-blind Comparison between Rispendone and Haloperidol in the Treatment of Schizophrenic Patients

目的:对比利培酮与氟哌啶醇治疗精神分裂症的疗效和安全性。方法:101例精神分裂症患者随机分为两组,采用平行双盲随机对照方法分别口服利培酮2～6mg·d-1（51例）或氟哌啶醇6～18mg·d-1（50例）治疗,疗程6周。采用阳性和阴性症状量表（PANSS）和临床疗效四级评定标准评定疗效。用Simpson—Angus量表（SAS）和治疗中出现的药物不良反应量表（TESS）评定不良反应。结果:利培酮和氟哌啶醇的临床总有效率分别是68.6％和60.0％（P>0.05）。两药对精神分裂症阳性,阴性症状及一般精神病理学症状均有良好疗效,但两组间各种疗效指标无显著差异。利培酮的锥体外系症状（EPS）严重度显著低于氟哌啶醇。在肌紧张,震颤,静坐不能三种药物不良反应的严重度,TESS总严重度,药物不良反应所致痛苦程度诸方面,利培酮也显著低于氟哌啶醇（P<0.01）。结论:利培酮与氟哌啶醇总体疗效相当;临床治疗剂量的利培酮所致的EPS显著低于氟哌啶醇。

OBJECTIVE: To compare the efficacy and safety of risperidone and haloperidol in the treatment of schizophrenic. METHODS:A hundred and one schizophrenic patients were randomly assigned to two groups given oral doses of risperidone (2 to 6mg·d-1, 51 cases) or haloperidol (6 to 18 mg·d-1, 50 cases) in a double-blind parallel way for 6 weeks. PANSS and a 4-score clinical impression of efficacy were used to measure the efficacy. Simpson-Angus Scale (SAS) and Treatment Emergent Side-Effect Scale (TESS) were used to measure adverse effects. RESULTS: The response rates were 68.6% and 60.0% for risperidone and haloperidol, respectively (P>0.05). Both of the drugs were effective in the positive, negative and general psychopathological symptoms while no significant differences were detected between groups. The SAS total scores were significantly lower in risperidone than in haloperidol group. Less muscular tension, tremor, akathesia were seen in risperidone than in haloperidol group (P<0.01). CONCLUSIONS: The efficacy of risperidone is comparable to that of haloperidol. The prevalence of EPS of risperidone in recommended dose range is significantly lower than that of haloperidol.