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精神分裂症中认知功能与利培酮长效注射剂对比棕榈酸帕利哌酮:一项为期6个月的开放标签随机试点试验

Cognitive function and risperidone long-acting injection vs. paliperidone palmitate in schizophrenia: a 6-month, open-label, randomized, pilot trial.

作者信息

Takekita Yoshiteru, Koshikawa Yosuke, Fabbri Chiara, Sakai Shiho, Sunada Naotaka, Onohara Ai, Nishida Keiichiro, Yoshimura Masafumi, Kato Masaki, Serretti Alessandro, Kinoshita Toshihiko

机构信息

Department of Biomedical and NeuroMotor Sciences, University of Bologna, Viale Carlo Pepoli 5, Bologna, 40123, Italy.

Department of Neuropsychiatry, Kansai Medical University, 10-15 fumizono-cho, Moriguchi-shi, Osaka, 570-8507, Japan.

出版信息

BMC Psychiatry. 2016 May 29;16:172. doi: 10.1186/s12888-016-0883-9.

Abstract

BACKGROUND

Recently, long-acting injection (LAI) of second-generation antipsychotics has become a valuable strategy for the treatment of schizophrenia. However, few studies have compared the effects of different LAI antipsychotics on cognitive functions so far. The present study aimed to compare the influence of risperidone LAIs (RLAI) and paliperidone palmitate LAIs (PP) on cognitive function in outpatients with schizophrenia.

METHODS

In this 6-month, open-label, randomized, and controlled study, 30 patients with schizophrenia who were treated with RLAIs were randomly allocated to the RLAI-continued group or the PP group. At baseline and 6 months, the patients were evaluated using the Brief Assessment of Cognition in Schizophrenia (BACS) that was the primary outcome of the study. The Subjective Well-being under Neuroleptic drug treatment-Short form (SWNS), the Positive and Negative Syndrome Scale (PANSS), and the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) scores were secondary outcome variables and they were tested at the same time points.

RESULTS

The two groups did not differ in terms of PANSS, DIEPSS, or SWNS total score changes. However, the BACS score for the attention and processing speed item showed higher improvement in the PP group than the RLAI group (p = 0.039).

CONCLUSIONS

The results of this preliminary study suggest that PPs may improve attention and processing speed more than RLAIs. Anyway, a replication in a larger and double-blind study is needed.

TRIAL REGISTRATION

UMIN000014470 . Registered 10 July 2014.

摘要

背景

近年来,第二代抗精神病药物长效注射剂(LAI)已成为治疗精神分裂症的一项重要策略。然而,目前很少有研究比较不同的LAI抗精神病药物对认知功能的影响。本研究旨在比较利培酮长效注射剂(RLAI)和棕榈酸帕利哌酮长效注射剂(PP)对精神分裂症门诊患者认知功能的影响。

方法

在这项为期6个月的开放标签、随机对照研究中,30例接受RLAI治疗的精神分裂症患者被随机分配到RLAI持续治疗组或PP组。在基线和6个月时,使用精神分裂症认知功能简短评估量表(BACS)对患者进行评估,这是本研究的主要结局指标。使用抗精神病药物治疗下的主观幸福感简表(SWNS)、阳性和阴性症状量表(PANSS)以及药物所致锥体外系症状量表(DIEPSS)评分作为次要结局变量,并在相同时间点进行检测。

结果

两组在PANSS、DIEPSS或SWNS总分变化方面无差异。然而,PP组在注意力和处理速度项目上的BACS评分改善程度高于RLAI组(p = 0.039)。

结论

这项初步研究结果表明,与RLAI相比,PP可能对注意力和处理速度有更好的改善作用。无论如何,需要在更大规模的双盲研究中进行重复验证。

试验注册

UMIN000014470。2014年7月10日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/614b/4884618/41ca09559d30/12888_2016_883_Fig1_HTML.jpg

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