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用于治疗精神分裂症和严重精神疾病的吗啉酮。

Molindone for schizophrenia and severe mental illness.

作者信息

Bagnall A, Fenton M, Lewis R, Leitner M L, Kleijnen J

机构信息

NHS Centre for Reviews and Dissemination, University of York, York, North Yorkshire, UK, YO10 5DD.

出版信息

Cochrane Database Syst Rev. 2000(2):CD002083. doi: 10.1002/14651858.CD002083.

Abstract

BACKGROUND

Typical antipsychotic drugs are widely used as the first line treatment for people with schizophrenia. However, the atypical class of antipsychotic drugs is making important inroads into this approach. 'Atypical' is a term widely used to describe some antipsychotics which have a low propensity to produce movement disorders, sedation and raised serum prolactin. There is some suggestion that the different adverse effect profiles of the atypical antipsychotic group make them more acceptable to people with schizophrenia. Molindone has a similar profile to quetiapine (a novel atypical antipsychotic), with very low binding to all receptors. Some authors have suggested that molindone is safer than other 'typical' antipsychotics in that extrapyramidal adverse effects are not usually seen at clinically effective antipsychotic doses and that it should therefore be classed as an atypical antipsychotic.

OBJECTIVES

To determine the effects of molindone compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and related psychoses.

SEARCH STRATEGY

Electronic searches of Biological Abstracts (1980-1999), The Cochrane Library CENTRAL (Issue 1, 1999), The Cochrane Schizophrenia Group's Register (January 1999), CINAHL (1982-1999), EMBASE (1980-1999), MEDLINE (1966-1999), LILACS (1982-1999), PSYNDEX (1977-1999), and PsycLIT (1974-1999) were undertaken. In addition, pharmaceutical databases on the Dialog Corporation Datastar and Dialog services were searched. References of all identified studies were searched for further trials. The manufacturer of molindone and authors of trials were contacted.

SELECTION CRITERIA

All randomised controlled trials that compared molindone to other treatments for schizophrenia and schizophrenia-like psychoses were included by independent assessment.

DATA COLLECTION AND ANALYSIS

Citations and, where possible, abstracts were independently inspected by reviewers, papers ordered, re-inspected and quality assessed. Data were independently extracted. Data were excluded if loss to follow up was greater than 50%. For homogeneous dichotomous data the risk ratio (RR), 95% confidence interval (CI) and, where appropriate, the number needed to treat (NNT) were calculated on an intention-to-treat basis. For continuous data, weighted mean differences (WMD) were calculated. All data were inspected for heterogeneity.

MAIN RESULTS

Thirteen studies were included in the review. Data for this compound range from very short (10 day) studies of the intramuscular preparation to trials lasting over three months. For measures of global state available data do not justify any conclusions on the comparative efficacy of molindone and placebo. When compared to other typical antipsychotics no difference in effectiveness was evidenced (doctors' RR 1.13, CI 0.69 to 1.86; nurses' RR 1.23, CI 0.82 to 1.86). It is no more or less likely than typical drugs to cause movement disorders, but causes significantly more weight loss (RR 2.78, CI 1.10 to 6.99).

REVIEWER'S CONCLUSIONS: The strength of the evidence relating to this compound is limited, owing to small sample size, poor study design, limited outcomes and incomplete reporting. Molindone may be an effective antipsychotic; however, its adverse effect profile does not differ significantly from that of typical antipsychotics, apart from the event of weight loss. At present there is no evidence to suggest that it may have an atypical profile.

摘要

背景

典型抗精神病药物被广泛用作精神分裂症患者的一线治疗药物。然而,非典型抗精神病药物类别正在对这种治疗方法产生重大影响。“非典型”是一个广泛用于描述某些抗精神病药物的术语,这些药物产生运动障碍、镇静作用和血清催乳素升高的倾向较低。有迹象表明,非典型抗精神病药物组不同的不良反应特征使它们更容易被精神分裂症患者接受。吗茚酮与喹硫平(一种新型非典型抗精神病药物)具有相似的特征,对所有受体的结合力都非常低。一些作者认为吗茚酮比其他“典型”抗精神病药物更安全,因为在临床有效抗精神病剂量下通常不会出现锥体外系不良反应,因此它应被归类为非典型抗精神病药物。

目的

确定吗茚酮与安慰剂、典型和其他非典型抗精神病药物相比,对精神分裂症及相关精神病的疗效。

检索策略

对《生物学文摘》(1980 - 1999年)、《考克兰图书馆CENTRAL》(1999年第1期)、《考克兰精神分裂症研究组注册库》(1999年1月)、《护理学与健康领域数据库》(1982 - 1999年)、《荷兰医学文摘数据库》(1980 - 1999年)、《医学索引》(1966 - 1999年)、《拉丁美洲及加勒比地区卫生科学数据库》(1982 - 1999年)、《德国心理学文摘数据库》(1977 - 1999年)和《心理学文摘数据库》(1974 - 1999年)进行了电子检索。此外,还检索了Dialog公司Datastar和Dialog服务上的制药数据库。对所有已识别研究的参考文献进行检索以寻找进一步的试验。与吗茚酮的制造商和试验作者进行了联系。

选择标准

所有将吗茚酮与其他治疗精神分裂症及精神分裂症样精神病的药物进行比较的随机对照试验均通过独立评估纳入。

数据收集与分析

由评审人员独立检查引文,并在可能的情况下检查摘要,订购论文,重新检查并进行质量评估。独立提取数据。如果失访率大于50%,则排除数据。对于同质二分数据,基于意向性分析计算风险比(RR)、95%置信区间(CI),并在适当情况下计算治疗所需人数(NNT)。对于连续数据,计算加权平均差(WMD)。检查所有数据的异质性。

主要结果

该综述纳入了13项研究。该化合物的数据范围从肌肉注射制剂的非常短(10天)的研究到持续超过三个月的试验。对于整体状态的测量,现有数据无法就吗茚酮与安慰剂的比较疗效得出任何结论。与其他典型抗精神病药物相比,未发现有效性有差异(医生的RR为1.13,CI为0.6至1.86;护士的RR为1.23,CI为0.82至1.86)。它引起运动障碍的可能性与典型药物相同,但导致体重减轻的情况明显更多(RR为2.78, CI为1.10至6.99)。

评审结论

由于样本量小、研究设计差、结果有限和报告不完整,与该化合物相关的证据力度有限。吗茚酮可能是一种有效的抗精神病药物;然而,除了体重减轻这一情况外,其不良反应特征与典型抗精神病药物没有显著差异。目前没有证据表明它可能具有非典型特征。

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