Aripiprazole Versus Haloperidol in Combination With Clozapine for Treatment-Resistant Schizophrenia A 12-Month, Randomized, Naturalistic Trial

Aripiprazole Versus Haloperidol in Combination With Clozapine for Treatment-Resistant Schizophrenia A 12-Month, Randomized, Naturalistic Trial
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DOI:
10.1097/jcp.0b013e318296884f
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发表时间:
2013-08-01
影响因子:
2.9
通讯作者:
Barbui, Corrado
Barbui, Corrado
中科院分区:
医学4区
文献类型:
--
作者:
Cipriani, Andrea;Accordini, Simone;Barbui, Corrado

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背景资料:对难治性精神分裂症患者的长期研究是必要的,以评估联合策略对持续阳性症状的有效性。(ClinicalTrials.gov标识符:NCT 00395915)旨在比较氟哌啶醇与阿立哌唑作为与氯氮平联合治疗难治性精神分裂症患者的临床疗效和耐受性。106例患者随访12个月。12个月后,阿立哌唑和氟哌啶醇之间停止治疗的患者比例无显著差异(分别为37%和28%; P = 0.431)。阿立哌唑组和氟哌啶醇组简明精神病评定量表评分的变化相似(分别为-7.0 vs-7.9; P = 0.389),而阿立哌唑组的耐受性总评分下降幅度更大(-7.2 vs -2.3; P = 0.008)。虽然第二种抗精神病药物加强氯氮平的有效性尚未得到明确证明,该研究的结果表明,阿立哌唑的增强在功效上没有提供超过氟哌啶醇的实质性益处。阿立哌唑被认为比氟哌啶醇更耐受,但尚不确定这一发现如何转化为真实的临床实践。
Background: Long-term studies for patients with resistant schizophrenia are necessary to assess the effectiveness of combination strategies on persisting positive symptoms.Aims and Methods: This multicenter, naturalistic, randomized, superiority study (ClinicalTrials.gov identifier: NCT00395915) aimed to compare clinical efficacy and tolerability of haloperidol versus aripiprazole as combination treatment with clozapine in patients with resistant schizophrenia.Results: One hundred six patients were followed up for 12 months. After 12 months, the proportion of patients who discontinued treatment was not significantly different between aripiprazole and haloperidol (37% vs 28%, respectively; P = 0.431). The change in the Brief Psychiatric Rating Scale score was similar in the aripiprazole and haloperidol groups (-7.0 vs -7.9, respectively; P = 0.389), whereas the tolerability total score decreased significantly more in the aripiprazole group (-7.2 vs -2.3; P = 0.008).Conclusions: While the effectiveness of clozapine augmentation with a second antipsychotic agent is not clearly demonstrated yet, results from this study suggest that augmentation with aripiprazole offers no substantial benefit over haloperidol in efficacy. Aripiprazole was perceived more tolerable than haloperidol, but it is uncertain how this finding may translate into the real world of clinical practice.