布雷哌嗪对精神分裂症患者各症状领域的影响：短期和长期研究分析。
Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Analysis of Short- and Long-Term Studies.
作者信息
Marder Stephen R, Meehan Stine R, Weiss Catherine, Chen Dalei, Hobart Mary, Hefting Nanco
机构信息
Department of Psychiatry, Semel Institute for Neuroscience at UCLA and the VA VISN 22 Mental Illness Research, Education, and Clinical Center, Los Angeles, CA.
H. Lundbeck A/S, Valby, Copenhagen, Denmark.
出版信息
Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan.
The successful treatment of schizophrenia entails improvement across a spectrum of symptoms. The aim of this analysis was to characterize the short- and long-term effects of brexpiprazole on Positive and Negative Syndrome Scale (PANSS) 'Marder factors.' Data were included from three 6-week, randomized, double-blind, placebo-controlled studies; a 52-week, randomized, double-blind, placebo-controlled maintenance treatment study; and two 52-week open-label extension (OLEx) studies-all in schizophrenia (DSM-IV-TR criteria). Patients receiving oral brexpiprazole were dosed at 2-4 mg/day (short-term studies) or 1-4 mg/day (long-term studies). At Week 6, least squares mean differences (LSMDs, with 95% confidence limits [CLs]) for brexpiprazole ( = 868) vs placebo ( = 517) were: Positive symptoms: -1.55 (-2.30, -0.80), < .0001, Cohen's effect size (ES) = 0.27; Negative symptoms: -1.12 (-1.63, -0.61), < .0001, ES = 0.29; Disorganized thought: -1.26 (-1.78, -0.74), < .0001, ES = 0.32; Uncontrolled hostility/excitement: -0.76 (-1.15, -0.37), = .0002, ES = 0.26; Anxiety/ depression: -0.56 (-0.91, -0.22), = .0014, ES = 0.22. At last visit of the maintenance study, LSMDs (95% CLs) for brexpiprazole ( = 96) vs placebo ( = 104) were: Positive symptoms: -3.44 (-4.99, -1.89), < .0001, ES = 0.62; Negative symptoms: -1.23 (-2.52, 0.07), = .063, ES = 0.27; Disorganized thought: -1.69 (-2.81, -0.56), = .0035, ES = 0.42; Uncontrolled hostility/excitement: -1.26 (-2.12, -0.39), = .0046, ES = 0.41; Anxiety/depression: -0.72 (-1.47, 0.03), = .061, ES = 0.27. In the OLEx studies, improvements were maintained over 58 (6 + 52) weeks of brexpiprazole treatment. In conclusion, these data suggest that brexpiprazole treats the continuum of schizophrenia symptoms, in the short- and long-term. Trial Registration: Data used in this analysis came from ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01668797, NCT01397786, NCT01810783.
精神分裂症的成功治疗需要一系列症状得到改善。本分析的目的是描述布雷哌唑对阳性和阴性症状量表（PANSS）“马德因子”的短期和长期影响。数据来自三项为期6周的随机、双盲、安慰剂对照研究；一项为期52周的随机、双盲、安慰剂对照维持治疗研究；以及两项为期52周的开放标签扩展（OLEx）研究——所有研究均针对精神分裂症患者（符合DSM-IV-TR标准）。接受口服布雷哌唑治疗的患者剂量为2 - 4毫克/天（短期研究）或1 - 4毫克/天（长期研究）。在第6周时，布雷哌唑组（n = 868）与安慰剂组（n = 517）的最小二乘均值差异（LSMDs，95%置信区间[CLs]）如下：阳性症状：-1.55（-2.30，-0.80），p <.0001，科恩效应量（ES） = 0.27；阴性症状：-1.12（-1.63，-0.61），p <.0001，ES = 0.29；思维紊乱：-1.26（-1.78，-0.74），p <.0001，ES = 0.32；失控的敌意/兴奋：-0.76（-1.15，-0.37），p =.0002，ES = 0.26；焦虑/抑郁：-0.56（-0.91，-0.22），p =.0014，ES = 0.22。在维持治疗研究的最后一次访视时，布雷哌唑组（n = 96）与安慰剂组（n = 104）的LSMDs（95% CLs）如下：阳性症状：-3.44（-4.99，-1.89），p <.0001，ES = 0.62；阴性症状：-1.23（-2.52，0.07），p =.063，ES = 0.27；思维紊乱：-1.69（-2.81，-0.56），p =.0035，ES = 0.42；失控的敌意/兴奋：-1.26（-2.12，-0.39），p =.0046，ES = 0.41；焦虑/抑郁：-0.72（-1.47，0.03），p =.061，ES = 0.27。在开放标签扩展研究中，布雷哌唑治疗58周（6 + 52周）期间症状持续改善。总之，这些数据表明布雷哌唑在短期和长期均能治疗精神分裂症的一系列症状。试验注册：本分析中使用的数据来自ClinicalTrials.gov标识符：NCT01396421、NCT01393613、NCT01810380、NCT01668797、NCT01397786、NCT01810783。
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