Ohnishi Takashi, Wakamatsu Akihide, Kobayashi Hisanori
Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
Research and Development Clinical Science Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
Neuropsychiatr Dis Treat. 2021 Apr 16;17:1095-1104. doi: 10.2147/NDT.S294503. eCollection 2021.
The aim of this study was to clarify whether early symptomatic improvement in response to a long-acting injectable antipsychotic (LAI) contributes to subsequent social functional remission in patients with schizophrenia using the previous clinical trial data (EudraCT registration number: 2011-004889-15). Associations between other factors and social functional remission were also explored.
We analyzed 428 patients with schizophrenia in which the personal and social performance scale (PSP) and the involvement evaluation questionnaire (IEQ) at the time of the base line were recorded. Social functional remission was defined as participants who scored PSP >70 at the end of 65 weeks. Logistic regression analyses were done to examine associations between social functional remission and clinical and demographic characteristics including early symptomatic response evaluated by Positive and Negative Syndrome Scale (PANSS) at week one.
One hundred out of 428 patients showed social functional remission at the end of the observation period. Shorter duration of illness, higher baseline score of supervision evaluated by IEQ and higher baseline PSP were significantly associated with the social functional remission. Improvement of positive subscale of PANSS at one week was significantly associated with later social functional remission when baseline PSP scores were excluded from predictive variables.
Shorter duration of illness, residual type of schizophrenia, higher baseline score of supervision and higher baseline social functioning were predictors of subsequent social functional remission. Although its effect seems to be limited, early symptomatic improvement could be also was a predictor of social functional remission.
本研究旨在利用先前的临床试验数据（欧盟临床试验注册号：2011 - 004889 - 15），阐明长效注射用抗精神病药物（LAI）治疗后早期症状改善是否有助于精神分裂症患者随后的社会功能缓解。还探讨了其他因素与社会功能缓解之间的关联。
我们分析了428例精神分裂症患者，记录了其基线时的个人和社会表现量表（PSP）及参与度评估问卷（IEQ）。社会功能缓解定义为在65周结束时PSP得分>70的参与者。进行逻辑回归分析，以检验社会功能缓解与临床及人口统计学特征之间的关联，包括第1周时用阳性和阴性症状量表（PANSS）评估的早期症状反应。
428例患者中有100例在观察期结束时出现社会功能缓解。病程较短、IEQ评估的基线监督得分较高以及基线PSP较高与社会功能缓解显著相关。当预测变量中排除基线PSP得分时，第1周PANSS阳性分量表的改善与后期社会功能缓解显著相关。
病程较短、残留型精神分裂症、较高的基线监督得分和较高的基线社会功能是随后社会功能缓解的预测因素。尽管其作用似乎有限，但早期症状改善也可能是社会功能缓解的一个预测因素。
