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米诺环素补充治疗早期精神分裂症阴性症状:一项双盲、随机、对照试验。

Minocycline supplementation for treatment of negative symptoms in early-phase schizophrenia: a double blind, randomized, controlled trial.

作者信息

Liu Fang, Guo Xiaofeng, Wu Rengrong, Ou Jianjun, Zheng Yingjun, Zhang Bingkui, Xie Liqin, Zhang Limei, Yang Li, Yang Shuyun, Yang Junwei, Ruan Ye, Zeng Yong, Xu Xiufeng, Zhao Jingping

机构信息

Mental Health Institute of The Second Xiangya Hospital, Key Laboratory of Psychiatry and Mental Health of Hunan Province, Central South University, 139 Renmin Middle Road, Changsha, Hunan 410011, China; First Affiliated Hospital of Kunming Medical University, 295 Xican Rd., Kunming, Yunnan, China.

Mental Health Institute of The Second Xiangya Hospital, Key Laboratory of Psychiatry and Mental Health of Hunan Province, Central South University, 139 Renmin Middle Road, Changsha, Hunan 410011, China.

出版信息

Schizophr Res. 2014 Mar;153(1-3):169-76. doi: 10.1016/j.schres.2014.01.011. Epub 2014 Feb 3.

Abstract

BACKGROUND

It is difficult to improve negative symptoms and cognitive impairments in schizophrenia. A previous pilot study has shown that minocycline, a semi-synthetic second-generation tetracycline, is effective in treating for negative and/or cognitive symptoms in schizophrenia.

OBJECTIVES

The present study was designed to examine the efficacy and safety of minocycline for the treatment of negative symptoms and cognitive impairments in patients with schizophrenia.

METHODS

Ninety-two patients with early stage schizophrenia treated with risperidone entered this 16-week, double blind, randomized, placebo-controlled clinical trial. Subjects were randomly assigned to receive minocycline (200mg per day) or the placebo. The primary outcome was evaluated using the Scale for the Assessment of Negative Symptoms (SANS). Secondary outcomes included the response rate of SANS, the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression Scale (CGI), and cognitive tests.

RESULTS

Subjects receiving minocycline had greater improvements on SANS total scores and PANSS negative subscale scores (P<0.001) when compared with those receiving the placebo. Rates of treatment response (43.6%) in the minocycline group were significantly higher than those in the placebo group (10.0%) after 16weeks of treatment. There was no significant difference between the seven cognitive domains (P>0.05), except for the attention domain (P=0.044).

CONCLUSIONS

The addition of minocycline to atypical antipsychotic drugs in early schizophrenia had significant efficacy on negative symptoms but had a slight effect on the attention domains of patients with schizophrenia. It may be considered as a new adjunct treatment for negative symptoms of schizophrenia. Clinical trials.gov identifier: NCT01493622.

摘要

背景

改善精神分裂症的阴性症状和认知障碍具有挑战性。先前的一项试点研究表明,米诺环素,一种半合成的第二代四环素,在治疗精神分裂症的阴性和/或认知症状方面有效。

目的

本研究旨在检验米诺环素治疗精神分裂症患者阴性症状和认知障碍的疗效及安全性。

方法

92例接受利培酮治疗的早期精神分裂症患者进入这项为期16周的双盲、随机、安慰剂对照临床试验。受试者被随机分配接受米诺环素(每日200mg)或安慰剂。主要结局采用阴性症状评定量表(SANS)进行评估。次要结局包括SANS的缓解率、阳性和阴性症状量表(PANSS)、临床总体印象量表(CGI)以及认知测试。

结果

与接受安慰剂的受试者相比,接受米诺环素的受试者在SANS总分和PANSS阴性分量表得分上有更大改善(P<0.001)。治疗16周后,米诺环素组的治疗缓解率(43.6%)显著高于安慰剂组(10.0%)。除注意力领域外(P=0.044),七个认知领域之间无显著差异(P>0.05)。

结论

在早期精神分裂症患者中,在非典型抗精神病药物基础上加用米诺环素对阴性症状有显著疗效,但对精神分裂症患者的注意力领域有轻微影响。它可被视为精神分裂症阴性症状的一种新的辅助治疗方法。ClinicalTrials.gov标识符:NCT01493622。

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