The Efficacy and Safety of Blonanserin Compared with Haloperidol in Acute-Phase Schizophrenia A Randomized, Double-Blind, Placebo-Controlled, Multicentre Study
The Efficacy and Safety of Blonanserin Compared with Haloperidol in Acute-Phase Schizophrenia A Randomized, Double-Blind, Placebo-Controlled, Multicentre Study
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DOI：
10.2165/00023210-200923070-00006
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发表时间：
2009-01-01
期刊：
影响因子：
6
通讯作者：
Terazawa, Yoshikatsu
中科院分区：
文献类型：
--
作者：
Garcia, Esther;Robert, Marta;Terazawa, Yoshikatsu
背景：布南色林是一种新型的非典型抗精神病药物，具有强效多巴胺D-2和5-羟色胺5-HT 2拮抗剂特性。它可能有一个潜在的不良事件发生率较低比其他antipsychotic agents.Objective：要确定三个剂量的布南色林与安慰剂和氟哌啶醇在急性期schizophrenia.Methods患者的疗效和安全性：这是一个为期6周，随机，双盲，安慰剂和氟哌啶醇对照导致，国际，多中心研究。精神分裂症急性加重患者，阳性和阴性症状量表（PANSS）评分≥ 70，临床总体印象疾病严重程度（CGI-S）评分≥ 4（“中度疾病”）[在洗脱期内分别没有下降>= 20%或>= 1分]被随机分配到5个治疗组之一（布南色林2.5、5或10 mg，氟哌啶醇10 mg或安慰剂，每日一次）。每周对患者的临床疗效、不良事件、锥体外系症状（EPS）和药物依从性进行评估，并每两周对其他安全性变量进行评估。结果：所有307例随机化患者均接受至少一次研究药物给药，228例（74.3%）完成了研究。与安慰剂组相比，所有活性药物治疗组第6周PANSS总评分的平均下降幅度显著更大（-12.58; p
Background: Blonanserin is a novel atypical antipsychotic agent with potent dopamine D-2 and serotonin 5-HT2 antagonist properties. It may potentially have a lower incidence of adverse events than other antipsychotic agents.Objective: To determine the efficacy and safety of three doses of blonanserin compared with placebo and haloperidol in patients with acute-phase schizophrenia.Methods: This was a 6-week, randomized, double-blind, placebo- and haloperidol-control led, international, multicentre study. Patients with an acute exacerbation of their schizophrenia, with a Positive and Negative Syndrome Scale (PANSS) score >= 70 and a Clinical Global Impression Severity of Illness (CGI-S) score >= 4 ('moderately ill') [with no decrease >= 20% or >= 1 point, respectively, during the wash-out period] were randomized into one of five treatment groups (blonanserin 2.5, 5 or 10 mg, haloperidol 10 mg or placebo once daily). Patients were assessed weekly for clinical efficacy, adverse events, extrapyramidal symptoms (EPS) and drug compliance, and were assessed biweekly for other safety variables.Results: All 307 randomized patients received at least one dose of study medication and 228 (74.3%) completed the study. The mean reduction in PANSS total score at week 6 was significantly greater with all active treatments compared with placebo (-12.58; p