Said Qayyim, Gutterman Elane M, Kim Myoung S, Firth Sean D, Whitehead Richard, Brixner Diana
Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.
Pharmacoepidemiol Drug Saf. 2008 Apr;17(4):354-64. doi: 10.1002/pds.1559.
This study examined the relationship between antipsychotic medications, categorized by published somnolence effects, and unintentional injury (UI).
The study population included patients of 18-64 years of age in a healthcare insurance database with claims from 2001 to 2004 and diagnoses of schizophrenia or affective disorder. A nested case-control design was used with cases defined by an E-code claim (a specified external cause of injury) for selected UIs. For cases, the index date referred to the first injury. For controls, the "control index date" was the date of claim if there was only a single medical claim; for patients with > or =2 claims, one was selected at random as the "control index date." Both groups had a prescription for a first-generation antipsychotic (FGA) or second-generation antipsychotic (SGA) overlapping the index date. Potential somnolence effects were defined as: low (referent)--aripiprazole/ziprasidone; medium--risperidone; high--olanzapine/quetiapine: or any single FGA. Logistic regression models were used to estimate odds ratio (OR) and 95% confidence interval (CI) for UI, adjusted for gender, age, concomitant drug, and psychiatric diagnosis.
Among 648 cases and 5214 controls, high-somnolence SGAs were associated with an OR of 1.41 95%CI (1.03-1.93) for risk of UI, while medium-somnolence SGAs, and FGAs had ORs of 1.17 95%CI (0.83-1.64) and 1.17 95%CI (0.79-1.74), respectively. When quetiapine and olanzapine were disaggregated, ORs were 1.61 95%CI (1.15-2.25) and 1.25 95%CI (0.89-1.74), respectively.
High-somnolence SGAs may lead to UI among patients. When prescribing antipsychotics, clinicians should consider potential somnolence.
本研究探讨了根据已发表的嗜睡效应分类的抗精神病药物与意外伤害（UI）之间的关系。
研究人群包括2001年至2004年医疗保险数据库中年龄在18 - 64岁之间、患有精神分裂症或情感障碍且有理赔记录的患者。采用嵌套病例对照设计，病例由选定意外伤害的E编码理赔记录（特定外部伤害原因）定义。对于病例，索引日期指首次受伤日期。对于对照，“对照索引日期”如果只有一份医疗理赔记录则为理赔日期；对于有≥2份理赔记录的患者，随机选择一份作为“对照索引日期”。两组在索引日期均有第一代抗精神病药物（FGA）或第二代抗精神病药物（SGA）的处方。潜在嗜睡效应定义为：低（参照）——阿立哌唑/齐拉西酮；中——利培酮；高——奥氮平/喹硫平：或任何一种单一FGA。采用逻辑回归模型估计意外伤害的比值比（OR）和95%置信区间（CI），并对性别、年龄、伴随用药和精神疾病诊断进行调整。
在648例病例和5214例对照中，高嗜睡性SGA与意外伤害风险的OR为1.41，95%CI（1.03 - 1.93），而中嗜睡性SGA和FGA的OR分别为1.17，95%CI（0.83 - 1.64）和1.17，95%CI（0.79 - 1.74）。当将喹硫平和奥氮平分开分析时，OR分别为1.61，95%CI（1.15 - 2.25）和1.25，95%CI（0.89 - 1.74）。
高嗜睡性SGA可能导致患者发生意外伤害。在开具抗精神病药物处方时，临床医生应考虑潜在的嗜睡作用。
