Li Nan, Feng Yu, Lu Huafei, Cai Shang Li, Zhuo Jianmin, Si Tianmei, Zhang Lili
Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, People's Republic of China.
Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore.
Neuropsychiatr Dis Treat. 2018 Mar 22;14:825-837. doi: 10.2147/NDT.S158353. eCollection 2018.
Paliperidone palmitate once-monthly (PP1M) demonstrated symptomatic and functional remission in patients with schizophrenia. This post hoc analysis aimed to identify factors associated with improved clinical outcomes in patients switching to PP1M (75-150 mg eq.).
The improved patient outcomes were observed as Positive and Negative Symptom Scale (PANSS, symptoms) score <70:66.7% (407/610), Personal and Social Performance (PSP, function) score >70:34.3% (199/581), and Involvement Evaluation Questionnaire (IEQ, caregiver burden) reduction ≥6:50.2% (270/538). Independent variables including demographics, disease duration, employment status, and clinical scores were screened individually using a univariate analysis and subsequently, variables (cutoff <0.15) were analyzed using a multivariate regression analysis for association with better clinical outcomes at week 13.
The factors significantly associated with favorable clinical outcomes were reduction in PANSS at week 5 (odds ratio [OR]=1.14, 95% CI=1.11-1.17) with symptom reduction; baseline PSP total score (OR=1.07, 95% CI=1.05-1.10), PSP change at week 5 (OR=1.07, 95% CI=1.05-1.10), PANSS reduction at week 5 (OR=1.06, 95% CI=1.03-1.08) with functional improvement, reduction in PANSS at week 5 (OR=1.02, 95% CI=1.01-1.03), and total IEQ score at baseline (OR=1.09, 95% CI=1.07-1.11) with caregiver burden reduction.
Thus, symptom and functional improvements with caregiver burden reduction were observed in patients, and PANSS reduction at week 5 was commonly associated with favorable outcomes.
棕榈酸帕利哌酮每月一次(PP1M)在精神分裂症患者中显示出症状缓解和功能改善。这项事后分析旨在确定转用PP1M(75 - 150毫克当量)的患者中与临床结局改善相关的因素。
观察到患者结局改善的情况为阳性和阴性症状量表(PANSS,症状)评分<70:66.7%(407/610),个人和社会功能量表(PSP,功能)评分>70:34.3%(199/581),以及参与度评估问卷(IEQ,照顾者负担)降低≥6:50.2%(270/538)。使用单因素分析分别筛选包括人口统计学、病程、就业状况和临床评分在内的自变量,随后,对变量(截断值<0.15)进行多因素回归分析,以确定其与第13周更好的临床结局的关联。
与良好临床结局显著相关的因素包括第5周时PANSS降低(比值比[OR]=1.14,95%置信区间[CI]=1.11 - 1.17)且症状减轻;基线PSP总分(OR=1.07,95% CI=1.05 - 1.10)、第5周时PSP变化(OR=1.07,95% CI=1.05 - 1.10)、第5周时PANSS降低(OR=1.06,95% CI=1.03 - 1.08)且功能改善,第5周时PANSS降低(OR=1.02,95% CI=1.01 - 1.03),以及基线时IEQ总分(OR=1.09,95% CI=1.07 - 1.11)且照顾者负担减轻。
因此,观察到患者症状和功能改善且照顾者负担减轻,第5周时PANSS降低通常与良好结局相关。