他莫昔芬与帕金森症风险：一项病例/非病例研究
Tamoxifen and the risk of Parkinsonism: a case/non-case study.
作者信息
Montastruc François, Khosrow-Khavar Farzin, de Germay Sibylle, Renoux Christel, Rousseau Vanessa, Durrieu Geneviève, Montastruc Marion, Rascol Olivier, Sommet Agnès, Lapeyre-Mestre Maryse, Benevent Justine, Montastruc Jean-Louis
机构信息
Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, Université de Toulouse, 37 allées Jules-Guesde, 31000, Toulouse, France.
Service de Pharmacologie Médicale et Clinique, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
出版信息
Eur J Clin Pharmacol. 2018 Sep;74(9):1181-1184. doi: 10.1007/s00228-018-2496-3. Epub 2018 Jun 3.
BACKGROUND
Three studies have suggested a potential positive association between the use of tamoxifen in breast cancer and Parkinsonism, mainly after long-term exposure.
OBJECTIVES
To explore this potential signal, we performed a case/non-case study using the World Health Organization Global Individual Case Safety Reports (ICSRs) database, VigiBase® between 1979 and 2018.
METHODS
Among women ≥ 55 years, we measured the risk of reporting "Parkinsonism" compared with all other adverse drug reactions [as a reporting odds ratio (ROR 95% CI)] for tamoxifen compared to all other drugs or aromatase inhibitors.
RESULTS
During the study period, 356 ICSRs of Parkinsonism reported with tamoxifen were identified. We failed to find a positive association between tamoxifen exposure and Parkinsonism in comparison with exposure to other drugs (ROR = 0.79; 95% CI 0.71-0.88) or aromatase inhibitors (ROR = 0.39; 95% CI 0.33-0.46).
CONCLUSION
This study did not find evidence for Parkinsonism associated with tamoxifen.
背景
三项研究表明，乳腺癌患者使用他莫昔芬与帕金森症之间可能存在正相关，主要发生在长期用药之后。
目的
为探究这一潜在信号，我们使用世界卫生组织全球个体病例安全报告（ICSR）数据库VigiBase®，于1979年至2018年间开展了一项病例/非病例研究。
方法
在年龄≥55岁的女性中，我们测量了他莫昔芬与所有其他药物或芳香化酶抑制剂相比，报告“帕金森症”的风险与所有其他药物不良反应的风险之比（作为报告比值比，ROR 95% CI）。
结果
在研究期间，共识别出356份使用他莫昔芬后报告帕金森症的ICSR。与使用其他药物（ROR = 0.79；95% CI 0.71 - 0.88）或芳香化酶抑制剂（ROR = 0.39；95% CI 0.33 - 0.46）相比，我们未发现他莫昔芬暴露与帕金森症之间存在正相关。
结论
本研究未发现他莫昔芬与帕金森症相关的证据。
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