长期利培酮暴露后骨折风险与其他非典型抗精神病药相比并未增加：一项回顾性队列研究。
The risk of bone fracture after long-term risperidone exposure is not increased compared to other atypical antipsychotics: A retrospective cohort study.
机构信息
Department of Public Health, China Medical University, Taichung City, Taiwan.
Janssen Research & Development, LLC, Global Epidemiology, Titusville, New Jersey, United States of America.
出版信息
PLoS One. 2019 Sep 5;14(9):e0221948. doi: 10.1371/journal.pone.0221948. eCollection 2019.
OBJECTIVE
Antipsychotic agents can increase circulating serum prolactin levels, potentially leading to osteoporosis and increased risk of bone fracture. The risk appears to be lower for atypical antipsychotics. We investigated whether risperidone was associated with an increased fracture risk by estimating the incidence of hip/femur and non-hip/femur fractures in users of risperidone, other atypical, and typical antipsychotics.
METHODS
This retrospective cohort study with a nested case-control study used claims data from the Taiwan National Healthcare Insurance database. All new users of antipsychotics between 2000-2012 were included. Incident fractures were identified using ICD-9 codes from inpatient records. Cox proportional hazards models compared fracture incidence among exposure groups. Conditional logistic regression models compared antipsychotic exposure among fracture cases versus matched controls.
RESULTS
340,948 patients were included in the analysis. There were 2832 hip/femur fractures and 2693 non-hip/femur fractures: Hip/femur fracture incidence 636.8/100,000 person-years (Risperidone), 885.7/100,000 person-years (Other Atypical), 519.4/100,000 person-years (Typical). The adjusted hazard ratio of hip/femur fracture was 0.92 (95%CI 0.84-1.01) comparing Other Atypical with Risperidone, and 1.00 (95%CI 0.89-1.11) comparing Typical with Risperidone. The adjusted hazard ratio of non-hip/femur fracture was 1.08 (95%CI 0.98-1.20) for Other Atypical versus Risperidone, and 1.10 (95%CI 0.99-1.22) for Typical versus Risperidone. The adjusted odds ratio for hip/femur fractures was 0.92 (95% CI 0.83-1.01) in cases and controls exposed to other atypical antipsychotics compared with risperidone for 1 year prior to fracture date, 0.97 (95% CI 0.87-1.07) during 1-3 years, and 0.92 (95% CI 0.81-1.06) during 3-5 years prior to fracture date. The adjusted odds ratio for non-hip/femur fractures were 1.11 (95% CI 0.99-1.24), 1.02 (95% CI 0.0.91-1.14), and 0.95 (95% CI 0.82-1.09), respectively.
CONCLUSION
There was no increased risk of bone fracture in long-term users of risperidone compared to users of other atypical antipsychotics.
目的
抗精神病药物可增加循环血清催乳素水平，从而可能导致骨质疏松症和骨折风险增加。这种风险在非典型抗精神病药物中似乎较低。我们通过估计利培酮、其他非典型和典型抗精神病药物使用者的髋部/股骨和非髋部/股骨骨折的发生率，来研究利培酮是否与骨折风险增加有关。
方法
本回顾性队列研究嵌套病例对照研究使用了来自台湾全民健康保险数据库的索赔数据。纳入了 2000 年至 2012 年间所有新使用抗精神病药物的患者。使用 ICD-9 代码从住院记录中确定骨折事件。Cox 比例风险模型比较了暴露组的骨折发生率。条件逻辑回归模型比较了骨折病例与匹配对照之间的抗精神病药物暴露情况。
结果
共纳入了 340948 名患者。发生了 2832 例髋部/股骨骨折和 2693 例非髋部/股骨骨折：髋部/股骨骨折发生率为 636.8/100000 人年（利培酮）、885.7/100000 人年（其他非典型）、519.4/100000 人年（典型）。与利培酮相比，其他非典型与利培酮相比，髋部/股骨骨折的调整后危险比为 0.92（95%CI 0.84-1.01），与利培酮相比，典型与利培酮相比，髋部/股骨骨折的调整后危险比为 1.00（95%CI 0.89-1.11）。与利培酮相比，其他非典型与利培酮相比，非髋部/股骨骨折的调整后比值比为 1.08（95%CI 0.98-1.20），与利培酮相比，典型与利培酮相比，非髋部/股骨骨折的调整后比值比为 1.10（95%CI 0.99-1.22）。与利培酮相比，在骨折日期前 1 年、1-3 年和 3-5 年内暴露于其他非典型抗精神病药物的病例和对照组中，髋部/股骨骨折的调整后比值比分别为 0.92（95%CI 0.83-1.01）、0.97（95%CI 0.87-1.07）和 0.92（95%CI 0.81-1.06）。非髋部/股骨骨折的调整后比值比分别为 1.11（95%CI 0.99-1.24）、1.02（95%CI 0.91-1.14）和 0.95（95%CI 0.82-1.09）。
结论
与使用其他非典型抗精神病药物的患者相比，长期使用利培酮的患者骨折风险没有增加。
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