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氟桂利嗪或桂利嗪所致帕金森综合征的风险:一项基于人群的研究。

Risk of parkinsonism induced by flunarizine or cinnarizine: a population-based study.

作者信息

Lin Hsiu-Li, Lin Hsiu-Chen, Tseng Yuan-Fu, Chen Shih-Chang, Hsu Chien-Yeh

机构信息

Department of Neurology, Sijhih Cathay General Hospital, No. 2, Ln. 59, Jiancheng Rd., Sijhih Dist, New Taipei City, 221, Taiwan.

Graduate Institute of Biomedical Informatics, Taipei Medical University, No. 252, Wu-Xing Street, Taipei, 110, Taiwan.

出版信息

Eur J Clin Pharmacol. 2017 Mar;73(3):365-371. doi: 10.1007/s00228-016-2181-3. Epub 2016 Dec 16.

Abstract

PURPOSE

This retrospective cohort study used a population-based dataset to test the risk for parkinsonism in patients receiving flunarizine and cinnarizine, compared with matched controls.

METHODS

Data were obtained from the National Health Insurance Research Dataset of Taiwan. Patients receiving flunarizine or cinnarizine for more than 1 month between 2000 and 2005 were enrolled. Exclusion criteria included receiving flunarizine, cinnarizine, or antipsychotics for more than 1 month during 1997-1999, a history of neurodegenerative diseases, and an age of less than 30 years. One matched control for each patient was selected. Each participant was followed for diagnosis of parkinsonism within a 3-year observation period. Stroke, diabetes mellitus, total prescription days, and doses of flunarizine or cinnarizine were recorded.

RESULTS

The study and control groups consisted of 9830 subjects. In the study group, 280 patients (2.9 %) were diagnosed with parkinsonism with a median observation period of 1.2 years, and 49 participants (0.5 %) were diagnosed in the control group with a median observation period of 1.9 years. The adjusted hazard ratio for parkinsonism among patients receiving flunarizine and cinnarizine was 5.117 (95 % CI = 3.758-6.967). Age, stroke, and diabetes mellitus were significant risk factors, but female sex and total doses of the study drugs were not.

CONCLUSIONS

This study demonstrates that flunarizine and cinnarizine significantly increase the risk for parkinsonism. The treatment benefits of these two agents should be balanced with this adverse effect. Physicians must look carefully for early signs of parkinsonism in patients treated with flunarizine and cinnarizine.

摘要

目的

这项回顾性队列研究使用基于人群的数据集,来测试接受氟桂利嗪和桂利嗪的患者相较于匹配对照发生帕金森综合征的风险。

方法

数据取自台湾国民健康保险研究数据库。纳入2000年至2005年间接受氟桂利嗪或桂利嗪治疗超过1个月的患者。排除标准包括在1997 - 1999年间接受氟桂利嗪、桂利嗪或抗精神病药物治疗超过1个月、有神经退行性疾病病史以及年龄小于30岁。为每位患者选择一名匹配对照。在3年观察期内对每位参与者进行帕金森综合征诊断随访。记录中风、糖尿病、总处方天数以及氟桂利嗪或桂利嗪的剂量。

结果

研究组和对照组由9830名受试者组成。研究组中,280例患者(2.9%)被诊断为帕金森综合征,中位观察期为1.2年;对照组中有49例参与者(0.5%)被诊断为帕金森综合征,中位观察期为1.9年。接受氟桂利嗪和桂利嗪治疗的患者发生帕金森综合征的校正风险比为5.117(95%可信区间 = 3.758 - 6.967)。年龄、中风和糖尿病是显著的风险因素,但女性性别和研究药物的总剂量不是。

结论

本研究表明氟桂利嗪和桂利嗪显著增加帕金森综合征风险。这两种药物的治疗益处应与这种不良反应相权衡。医生必须仔细观察接受氟桂利嗪和桂利嗪治疗患者的帕金森综合征早期迹象。

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