Department of Clinical Sciences and Administration, University of Houston Texas Medical Center, Houston, TX 77030, USA.
Psychiatr Serv. 2010 Feb;61(2):130-6. doi: 10.1176/ps.2010.61.2.130.
This study examined off-label and evidence-based use of second-generation antipsychotic agents among elderly nursing home residents and factors associated with off-label use.
This study involved a retrospective, cross-sectional analysis of data from the 2004 National Nursing Home Survey (NNHS). The sample included nursing home residents 65 years and older who received second-generation antipsychotic agents. This study used an indication-based definition of off-label use established by the U.S. Food and Drug Administration (FDA). Evidence-based use included FDA-approved indications and indications for which the Agency of Healthcare Research and Quality found at least moderate strength of evidence of effectiveness. Descriptive statistics were used to examine the prevalence of off-label and evidence-based use. Multiple logistic regression was used to examine the patient and facility factors associated with off-label use of second-generation antipsychotics.
According to the 2004 NNHS, 308,990 (23.5%) elderly nursing home residents received at least one second-generation antipsychotic agent. Of those using second-generation antipsychotics, 86.3% received them for off-label indications and 56.9% received them for an evidence-based use. Multivariate analysis found that age (> or =75 years), self-pay for nursing home care, diagnosis of dementia, and residing in a nonprofit nursing home were positively associated with off-label use, whereas receiving Medicaid benefits was negatively associated with such use.
Although second-generation antipsychotics were frequently used for off-label indications, most of the usage was evidence based among elderly nursing home residents. However, the high level of non-evidence-based use combined with recent safety and efficacy data suggests an urgent need to address the evidence base for this vulnerable population.
本研究旨在调查第二代抗精神病药物在老年疗养院居民中的非适应证使用和基于证据的使用情况，以及与非适应证使用相关的因素。
本研究涉及对 2004 年全国疗养院调查（NNHS）数据的回顾性、横断面分析。样本包括年龄在 65 岁及以上、接受第二代抗精神病药物治疗的疗养院居民。本研究使用了美国食品和药物管理局（FDA）建立的基于适应证的非适应证使用定义。基于证据的使用包括 FDA 批准的适应证以及医疗保健研究和质量局（Agency of Healthcare Research and Quality）发现至少有中度有效性证据的适应证。使用描述性统计来检查非适应证和基于证据的使用的流行率。使用多变量逻辑回归来检查与第二代抗精神病药物非适应证使用相关的患者和机构因素。
根据 2004 年的 NNHS，有 308990 名（23.5%）老年疗养院居民至少接受了一种第二代抗精神病药物。在使用第二代抗精神病药物的患者中，86.3%的患者使用它们的适应证为非适应证，56.9%的患者使用它们的适应证为基于证据的适应证。多变量分析发现，年龄（≥75 岁）、自付疗养院护理费用、痴呆诊断以及居住在非营利性疗养院与非适应证使用呈正相关，而接受医疗补助福利与这种使用呈负相关。
尽管第二代抗精神病药物经常被用于非适应证，但在老年疗养院居民中，大多数使用都是基于证据的。然而，高比例的非基于证据的使用，加上最近的安全性和有效性数据，表明迫切需要为这一脆弱人群解决证据基础问题。
