Safety and Tolerability Associated With Second-Generation Antipsychotic Polytherapy in Bipolar Disorder: Findings From the Systematic Treatment Enhancement Program for Bipolar Disorder
Safety and Tolerability Associated With Second-Generation Antipsychotic Polytherapy in Bipolar Disorder: Findings From the Systematic Treatment Enhancement Program for Bipolar Disorder
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DOI：
10.4088/jcp.09m05214yel
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发表时间：
2011-02-01
影响因子：
5.3
通讯作者：
Thase, Michael E.
中科院分区：
文献类型：
--
作者：
Brooks, John O., III;Goldberg, Joseph F.;Thase, Michael E.
背景：尽管缺乏数据支持双相情感障碍患者的安全性、耐受性或有效性，但从业者经常联合使用 2 种或多种第二代抗精神病药物 (SGA)。 目的：本研究旨在评估在 22 点双相情感障碍系统治疗强化计划 (STEP-BD) 中接受开放式自然治疗的双相情感障碍患者中，SGA 联合疗法与 SGA 单药疗法的安全性和耐受性。 1,958 名至少服用 1 SGA 的患者是从 1999 年 11 月至 2005 年 7 月期间招募的 STEP-BD 中的 4,035 名双相情感障碍患者中抽取的，至少每季度进行一次评估，平均持续时间为 21 个月。主要结果指标是不良事件的平均季度发生率、医疗和精神科服务的使用情况、总体功能评估评级以及良好度过的天数百分比。结果：服用 SGA 的患者中几乎 10% 接受了 SGA 综合治疗。在控制发病、年龄、基线疾病严重程度和用药量后，与单一疗法相比，接受 SGA 多药治疗的患者表现出更多的口干（造成伤害所需的数量 [NNH] = 4）、震颤（NNH = 6）、镇静（NNH = 8）、性功能障碍（NNH = 8）和便秘（NNH = 11），并且接受更多精神和医疗护理的可能性几乎是其 3 倍；结论：虽然 SGA 综合疗法在双相情感障碍中相当常见，但它与副作用和医疗服务使用增加有关，但与临床状态或功能的改善无关。因此，双相情感障碍的 SGA 综合疗法可能会带来重要的缺点，而没有明显的益处，因此在采取此类干预措施之前需要仔细考虑。 J Clin Psychiatry 2011；72(2):240-247 (C) 版权所有 2010 Physicians Postgraduate Press, Inc.
Context: Practitioners often combine 2 or more second-generation antipsychotics (SGAs) in patients with bipolar disorder, despite an absence of data to support their safety, tolerability, or efficacy.Objective: This study sought to evaluate the safety and tolerability of SGA polytherapy compared to SGA monotherapy in bipolar disorder patients receiving open naturalistic treatment in the 22-site Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD).Method: A longitudinal cohort of 1,958 patients who were prescribed at least 1 SGA was drawn from 4,035 bipolar patients in STEP-BD recruited between November 1999 and July 2005 and assessed at least quarterly for a mean duration of 21 months. Main outcome measures were the mean quarterly prevalence of adverse events, medical and psychiatric service usage, Global Assessment of Functioning ratings, and percentage of days spent well.Results: Almost 10% of patients taking SGAs were prescribed SGA polytherapy. After controlling for illness onset, age, baseline illness severity, and medication load, patients prescribed SGA polytherapy, compared to monotherapy, exhibited more dry mouth (number needed to harm [NNH] = 4), tremor (NNH = 6), sedation (NNH = 8), sexual dysfunction (NNH = 8), and constipation (NNH = 11) and were almost 3 times as likely to incur more psychiatric and medical care; there was no association with greater global functioning scores or percentage of days spent well.Conclusions: Although SGA polytherapy was fairly common in bipolar disorder, it was associated with increased side effects and health service use but not with improved clinical status or function. Thus, SGA polytherapy in bipolar disorder may incur important disadvantages without clear benefit, warranting careful consideration before undertaking such interventions. J Clin Psychiatry 2011;72(2):240-247 (C) Copyright 2010 Physicians Postgraduate Press, Inc.