目的： 出血為bevacizumab 引起的不良反應之一，可能造成危及生命之後果，本研究之目的為分析臺灣不良反應通報案例中bevacizumab 相關出血之風險性。
方法: 本研究針對全國藥物不良反應通報系統中疑似與bevacizumab 相關之案例進行評估，在去除國外與重複通報案例後，餘留的案例再進一步針對出血案件利用描述性統計進行分析。

結果： 國內八年八個月期間467 件通報案例中，出血為最常被通報之bevacizumab 相關不良反應 (n = 81)，尤其是胃腸道出血 (n = 29) 及穿孔(n = 17)，其他常見出血部位還有鼻出血 (n = 12)、肺出血／咳血 (n = 6)、顱內出血(n = 5) 等。出血案件中共有15 例病人死亡，其餘案件以導致病人住院 (n = 29) 和非嚴重不良反應 (n = 25) 為主。出血案例大多來自大腸直腸癌病患 (n = 38)，其次為非小細胞肺癌 (n = 9) 及腎細胞癌(n = 9)。另外，未觀察到bevacizumab 之使用劑量與發生出血嚴重不良反應存在正相關。
結論： 本研究顯示出血確實是使用bevacizumab 的風險，建議各職類醫療人員應謹慎評估與衛教患者，以保障病人用藥安全。
 

Objectives: Hemorrhage is a serious ADR of bevacizumab which may lead to life-threatening consequences.The aim of this study was to evaluate the risk of hemorrhage in reported patients treated with bevacizumab.

Methods: The study evaluated the cases with bevacizumab therapy reported in the National Adverse Drug Reactions (ADRs) Reporting System. After excluding the foreign and duplicated cases,remaining cases were reviewed and further analyzed by descriptive statistics.
Results: Hemorrhage was the most commonly reported adverse reaction (n = 81) of the domestic reports (n = 467), especially gastrointestinal hemorrhage (n = 29) and perforation (n = 17) in the past 8 years. Other common bleeding sites were epistaxis (n = 12), pulmonary hemorrhage/hemoptysis (n = 6) and intracranial hemorrhage (n = 5). There were 15 death reports, but most cases resulted in hospitalization (n = 29) or non-serious adverse reaction (n = 25). Reports were mostly received from patients with colorectal cancer (n = 38), non-small-cell lung cancer (n = 9), and renal cell carcinoma (n = 9). Moreover, we did not observe a positive correlation between the dose of bevacizumab and the outcome of hemorrhage events.
Conclusions: Hemorrhage is indeed a common risk of bevacizumab, which cannot be ignored. Thus patients should be monitored for signs and symptoms of bleeding in order to ensure safe use of medications.