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美国食品药品监督管理局(FDA)的警告对临床实践中抗精神病药物使用的影响:一项调查。

The impact of FDA's warning on the use of antipsychotics in clinical practice: a survey.

作者信息

Saad Maha, Cassagnol Manouchkathe, Ahmed Ebtesam

机构信息

Clinical Pharmacy Department, St. John's University School of Pharmacy and Allied Health Professions, Queens, New York 11439, USA.

出版信息

Consult Pharm. 2010 Nov;25(11):739-44. doi: 10.4140/TCP.n.2010.739.

DOI:10.4140/TCP.n.2010.739
PMID:21138822
Abstract

OBJECTIVES

Determine the influence of warnings from the Food and Drug Administration (FDA) regarding antipsychotic use for the management of dementia-related psychosis on clinical practice.

DESIGN/SETTINGS/PARTICIPANTS: A survey of health care professionals specializing in geriatrics was conducted with the use of a Web-based software program. The questions focused on practitioners' familiarity with recent FDA warnings, perceptions of their validity, and changes in antipsychotic use patterns. Sixty-five geriatric practitioners belonging to major national geriatric organizations completed the survey.

INTERVENTION

Responses were reviewed once the survey was closed, six weeks after Web posting.

MAIN OUTCOME MEASURE(S): Changes in prescribing practices for the management of dementia-related psychosis in light of the antipsychotic FDA warnings.

RESULTS

The majority of participants responded that they were "very familiar" with the FDA warnings. The results indicated that 68% of participants reported using antipsychotic medications in elderly patients with known cerebral/cardiovascular diseases. Forty-nine percent of participants reported that they changed the way they managed elderly patients with dementia-related psychosis based on this notification. The most commonly reported barriers for not taking into consideration the FDA warnings were: no alternative treatment available, lack of guidance, lack of evidence, and poor availability of data. The majority of participants reported the use of atypical antipsychotics more frequently than the typical antipsychotics.

CONCLUSIONS

Despite FDA warnings, antipsychotics are still being used for the management of dementia-related psychosis; management of behaviors associated with dementia either through drug therapy or nonpharmacologic interventions remains a challenge.

摘要

目的

确定美国食品药品监督管理局(FDA)关于使用抗精神病药物治疗痴呆相关精神病的警告对临床实践的影响。

设计/地点/参与者:使用基于网络的软件程序对老年医学专业的医疗保健专业人员进行了一项调查。问题集中在从业者对FDA近期警告的熟悉程度、对其有效性的看法以及抗精神病药物使用模式的变化。65名隶属于主要全国性老年医学组织的老年医学从业者完成了该调查。

干预措施

在网络发布六周后,调查结束时对回复进行了审查。

主要观察指标

鉴于FDA对抗精神病药物的警告,痴呆相关精神病管理处方实践的变化。

结果

大多数参与者表示他们“非常熟悉”FDA的警告。结果表明,68%的参与者报告在患有已知脑/心血管疾病的老年患者中使用抗精神病药物。49%的参与者报告说,基于这一通知,他们改变了管理患有痴呆相关精神病老年患者的方式。最常报告的未考虑FDA警告的障碍是:没有其他可用治疗方法、缺乏指导、缺乏证据以及数据获取困难。大多数参与者报告使用非典型抗精神病药物的频率高于典型抗精神病药物。

结论

尽管有FDA的警告,抗精神病药物仍被用于治疗痴呆相关精神病;通过药物治疗或非药物干预来管理与痴呆相关的行为仍然是一项挑战。

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