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控释瑞莫必利、速释瑞莫必利与氟哌啶醇治疗精神分裂症的双盲对照多中心研究

A double-blind comparative multicentre study of controlled-release remoxipride, immediate-release remoxipride and haloperidol in schizophrenia.

作者信息

Hebenstreit G F, Laux G, Schubert H, Beckmann H, Amman J, Bunse J, Eikmeier G, Geretsegger C, Kanitz R D, Kanzow W T

机构信息

Psychiatric State Hospital Mauer, Austria.

出版信息

Pharmacopsychiatry. 1991 Sep;24(5):153-8. doi: 10.1055/s-2007-1014460.

Abstract

A double-blind multicentre study comparing the efficacy and safety of remoxipride in controlled-release formulation (REM-CR), given once a day, and immediate-release formulation (REM-IR) and haloperidol, given twice daily, was conducted in patients with schizophrenic illness. In total, 150 inpatients were randomized: 49, 51 and 50 in the REM-CR, REM-IR, and haloperidol groups, respectively. The mean daily dose of REM-CR during the last week of treatment was 361 mg, that of REM-IR 332 mg. In the haloperidol group the corresponding dose was 12.5mg per day. The study treatment period was four weeks. The median BPRS total score was 37.5 in the REM-CR group at start of treatment, and 14.5 at last rating (n = 38). For the REM-IR group and the haloperidol group the corresponding figures were 36.0 and 38.0 at start of treatment and 18.0 (n = 43) and 16.5 (n = 40) at last rating. No statistically significant differences were found between the treatments. Therapy-emergent extrapyramidal symptoms (Simpson & Angus rating scale) were significantly (p less than 0.05) more frequent and more severe during haloperidol than during REM-CR and REM-IR treatment, despite significantly higher concurrent use of anticholinergic drugs in the haloperidol group.--REM-CR was comparable in efficacy and tolerability to REM-IR. The tolerability profile favoured both remoxipride formulations over haloperidol. Evaluation of the clinical chemistry, haematology, and cardiovascular data showed no clinically significant deleterious effects on any organ system for either drug.

摘要

一项双盲多中心研究在精神分裂症患者中开展,比较了每日给药一次的控释型瑞莫必利(REM-CR)、速释型瑞莫必利(REM-IR)以及每日给药两次的氟哌啶醇的疗效和安全性。总共150名住院患者被随机分组:REM-CR组49例、REM-IR组51例、氟哌啶醇组50例。治疗最后一周REM-CR的平均日剂量为361mg,REM-IR为332mg。氟哌啶醇组的相应剂量为每日12.5mg。研究治疗期为四周。治疗开始时REM-CR组BPRS总分中位数为37.5,末次评估时为14.5(n = 38)。REM-IR组和氟哌啶醇组治疗开始时的相应数字分别为36.0和38.0,末次评估时分别为18.0(n = 43)和16.5(n = 40)。各治疗组之间未发现统计学显著差异。尽管氟哌啶醇组同时使用抗胆碱能药物的比例显著更高,但治疗中出现的锥体外系症状(辛普森&安格斯评定量表)在氟哌啶醇治疗期间比在REM-CR和REM-IR治疗期间显著更频繁且更严重(p小于0.05)。——REM-CR在疗效和耐受性方面与REM-IR相当。两种瑞莫必利制剂的耐受性均优于氟哌啶醇。临床化学、血液学和心血管数据评估显示,两种药物对任何器官系统均无临床显著的有害影响。

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