评估利培酮长效治疗起始的精神分裂症患者的有效性测量指标：SOURCE 研究结果。

BACKGROUND

To evaluate effectiveness outcomes in a real-world setting in patients with schizophrenia initiating risperidone long-acting therapy (RLAT).

METHODS

This was a 24-month, multicenter, prospective, longitudinal, observational study in patients with schizophrenia who were initiated on RLAT. Physicians could change treatment during the study as clinically warranted. Data were collected at baseline and subsequently every 3 months up to 24 months. Effectiveness outcomes included changes in illness severity as measured by Clinical Global Impression-Severity (CGI-S) scale; functional scores as measured by Personal and Social Performance (PSP) scale, Global Assessment of Functioning (GAF), and Strauss-Carpenter Levels of Functioning (LOF); and health status (Medical Outcomes Survey Short Form-36 [SF-36]). Life-table methodology was used to estimate the cumulative probability of relapse over time. Adverse events were evaluated for safety.

RESULTS

532 patients were enrolled in the study; 209 (39.3%) completed the 24-month study and 305 (57.3%) had at least 12 months of follow-up data. The mean (SD) age of patients was 42.3 (12.8) years. Most patients were male (66.4%) and either Caucasian (60.3%) or African American (23.7%). All changes in CGI-S from baseline at each subsequent 3-month follow-up visit were statistically significant (p < .0001), indicating improvement in disease severity. Improvements were also noted for the PSP, GAF, and total LOF, indicating improvement in daily functioning and health outcome.

CONCLUSIONS

Patients with schizophrenia who were initiated on RLAT demonstrated improvements in measures of effectiveness within 3 months, which persisted over 24 months.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00246194.

背景

评估精神分裂症患者起始利培酮长效治疗（RLAT）的真实世界环境中的有效性结局。

方法

这是一项为期 24 个月、多中心、前瞻性、纵向、观察性研究，纳入起始 RLAT 的精神分裂症患者。医生可根据临床需要在研究期间更改治疗方案。数据在基线时收集，并随后在 24 个月内每 3 个月收集一次。有效性结局包括用临床总体印象严重度量表（CGI-S）衡量的疾病严重度变化；用个人和社会功能量表（PSP）、总体功能评估（GAF）和施特劳斯-卡彭特功能水平（LOF）衡量的功能评分；以及健康状况（医疗结局研究 36 项简短量表 [SF-36]）。生命表法用于估计随时间推移的复发累积概率。评估不良事件以确定安全性。

结果

共纳入 532 例患者；209 例（39.3%）完成了 24 个月的研究，305 例（57.3%）有至少 12 个月的随访数据。患者的平均（SD）年龄为 42.3（12.8）岁。大多数患者为男性（66.4%），且为白种人（60.3%）或非裔美国人（23.7%）。与基线相比，CGI-S 在每个后续的 3 个月随访时的所有变化均具有统计学意义（p <.0001），表明疾病严重度的改善。PSP、GAF 和总 LOF 也有改善，表明日常功能和健康结局的改善。