University of Sydney, Sydney, Australia.
Hospital Meixoeiro, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
Ann Gen Psychiatry. 2011 Apr 4;10:10. doi: 10.1186/1744-859X-10-10.
Because wide variations in mental health care utilization exist throughout the world, determining long-term effectiveness of psychotropic medications in a real-world setting would be beneficial to physicians and patients. The purpose of this analysis was to describe the effectiveness of injectable risperidone long-acting therapy (RLAT) for schizophrenia across countries.
This was a pragmatic analysis of data from two prospective observational studies conducted in the US (Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation [SOURCE]; ClinicalTrials.gov registration number for the SOURCE study: NCT00246194) and Spain, Australia, and Belgium (electronic Schizophrenia Treatment Adherence Registry [eSTAR]). Two separate analyses were performed to assess clinical improvement during the study and estimate psychiatric hospitalization rates before and after RLAT initiation. Clinical improvement was evaluated using the Clinical Global Impressions-Severity (CGI-S) and Global Assessment of Functioning (GAF) scales, and change from baseline was evaluated using paired t tests. Psychiatric hospitalization rates were analyzed using incidence densities, and the bootstrap resampling method was used to examine differences between the pre-baseline and post-baseline periods.
The initial sample comprised 3,069 patients (US, n = 532; Spain, n = 1,345; Australia, n = 784; and Belgium, n = 408). In all, 24 months of study participation, completed by 39.3% (n = 209), 62.7% (n = 843), 45.8% (n = 359), and 64.2% (n = 262) of patients from the US, Spain, Australia, and Belgium, respectively, were included in the clinical analysis. Improvements compared with baseline were observed on both clinical assessments across countries (P < 0.001 at all post-baseline visits). The mean improvement was approximately 1 point on the CGI-S and 15 points on the GAF. A total of 435 (81.8%), 1,339 (99.6%), 734 (93.6%), and 393 (96.3%) patients from the US, Spain, Australia, and Belgium, respectively, had ≥1 post-baseline visit and were included in the analysis of psychiatric hospitalization rates. Hospitalization rates decreased significantly in all countries regardless of hospitalization status at RLAT initiation (P < 0.0001) and decreased significantly in the US and Spain (P < 0.0001) when the analysis was limited to outpatients only.
RLAT in patients with schizophrenia was associated with improvements in clinical and functional outcomes and decreased hospitalization rates in the US, Spain, Australia, and Belgium, despite differences in health care delivery systems.
由于精神卫生保健的利用在世界各地存在很大差异，因此在真实环境中确定精神药物的长期疗效对医生和患者都将是有益的。本分析的目的是描述在不同国家中，注射用利培酮长效治疗（RLAT）治疗精神分裂症的效果。
这是在美国（精神分裂症结局利用、复发和临床评估[SOURCE]；ClinicalTrials.gov 登记号为 SOURCE 研究：NCT00246194）和西班牙、澳大利亚和比利时（电子精神分裂症治疗依从性登记[estar]）进行的两项前瞻性观察性研究数据的务实分析。进行了两项独立分析，以评估研究期间的临床改善情况，并估计 RLAT 开始前后的精神病住院率。使用临床总体印象严重程度（CGI-S）和总体功能评估（GAF）量表评估临床改善情况，使用配对 t 检验评估与基线相比的变化。使用发病率密度分析精神病住院率，并使用引导重采样方法检查基线前后期间的差异。
初始样本包括 3069 名患者（美国，n=532；西班牙，n=1345；澳大利亚，n=784；比利时，n=408）。共有 39.3%（n=209）、62.7%（n=843）、45.8%（n=359）和 64.2%（n=262）的患者完成了 24 个月的研究，分别来自美国、西班牙、澳大利亚和比利时，被纳入临床分析。与基线相比，所有国家的临床评估均有改善（所有随访时 P<0.001）。CGI-S 平均改善约 1 分，GAF 平均改善约 15 分。美国、西班牙、澳大利亚和比利时分别有 435（81.8%）、1339（99.6%）、734（93.6%）和 393（96.3%）名患者至少有 1 次随访，被纳入精神病住院率分析。无论 RLAT 开始时的住院状态如何，所有国家的住院率均显著下降（P<0.0001），在美国和西班牙，当分析仅限于门诊患者时，住院率也显著下降（P<0.0001）。
在精神分裂症患者中使用 RLAT 与临床和功能结局的改善以及美国、西班牙、澳大利亚和比利时的住院率降低有关，尽管卫生保健提供系统存在差异。
