氟哌啶醇与利培酮治疗痴呆患者精神行为症状的随机双盲对照研究

A randomized double-blind trial of haloperidol and risperidone for behavioral and psychological symptoms of dementia

目的 比较氟哌啶醇与利培酮治疗痴呆患者精神行为症状(BPSD)的疗效及安全性。方法 116例伴精神行为症状的痴呆患者随机入组,双盲对照治疗8周,评定疗效和不良反应并记录用药量。结果 氟哌啶醇组和利培酮组的最高平均治疗剂量分别为(2.5±1.0)mg/d和(1.2±0.6)mg/d;治疗后痴呆病理行为评定表减分率>30％者分别为84％和85％;不良反应发生率分别为31％和21％,合并应用安坦频度分别为19％和6％;两组不良反应的差异以第4周最为明显,利培酮组无严重不良反应发生。结论 较低剂量氟哌啶醇或利培酮可以显著改善BPSD,利培酮的安全性和耐受性优于氟哌啶醇。

Objective To compare the efficacy and safety of haloperidol and risperidone in treating behavioral and psychological symptoms of dementia(BPSD). Methods Patients with a DSM-Ⅳ diagnosis of dementia and BPSD were randomized to receive a flexible dose of either haloperidol and risperidone for a period of 8 weeks. Behavioral and psychological symptoms were assessed with Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) and Cohen-Mansfield Agitation Inventory (CMAI). Measurements of tolerability and cognitive level included Extrapyramidal Symptom Rating Scale (ESRS) , Treatment Emergent Symptom Scale ( TESS ) , Mini-Mental State Examination ( MMSE ) , Global Deteriorating Scale ( GDS) and Activity of Daily Life ( ADL) . Scales were rated at baseline and 2 ,4,6 and 8 week during treatment. The dosage of haloperidol and risperidone were recorded every week. Results The maximumeffective dosage of haloperidol and risperidone were ( 2. 5 ± 1. 0 ) mg/d and ( 1. 2 ±0. 6 ) mg/d respectively. After the 2nd week of treatment, the reduction of the BEHAVE-AD, CMAI, scores were statistically significant different from baseline in both of the groups, but there was no significant difference between them. The proportion of patients who showed clinical improvement ( > 30% reduction rate from baseline to endpoint in BEHAVE-AD total score) were 84% in haloperidol and 85% in risperidone group, respectively. A similar improvement was also seen for the CMAI score, which clinical improvement were 71% in haloperidol and 80% in risperidone group. Overall, 31% of haloperidol group and 21% of risperidone group reported adverse events. Artane were used in 19% and 6% of patients in haloperidol and risperidone groups, respectively. The frequency or the severity of side-effects showed significant difference between two groups at 4th week. There were no severe side-effects appeared with risperidone therapy especially. Conclusions Both haloperidol and risperidone could improve BPSD. The effective dose of haloperidol and risperidone for the treatment of BPSD were pretty low. The tolerability and safety of risperidone was better than haloperidol.