325例屈螺酮炔雌醇(Ⅱ)不良反应报告分析

325 Cases of Adverse Drug Reactions Induced by Drospirenone and Ethinylestradiol Tablets(Ⅱ)

目的通过屈螺酮炔雌醇(Ⅱ)的药品不良反应数据分析,了解不良反应发生特点,提示临床用药可能存在的安全性风险,为临床合理应用屈螺酮炔雌醇(Ⅱ)提供依据。方法对2015年1月1日至2018年12月31日期间北京市药品不良反应监测中心收集到的屈螺酮炔雌醇(Ⅱ)不良反应/事件报告进行回顾性分析。结果屈螺酮炔雌醇(Ⅱ)临床表现以生殖系统疾病、胃肠疾病和神经系统疾病多见。结论屈螺酮炔雌醇引起的一般不良反应通常可以耐受,虽然低剂量屈螺酮炔雌醇不良反应更少,但仍存在发生静脉血栓栓塞的风险;在用药前仔细评估用药风险,并为用药患者建立长期、系统的随访关系;鼓励不良反应的报告并及时更新循证证据,将新的不良反应修订到药品说明书中,以降低患者的用药风险、更好地促进屈螺酮炔雌醇(Ⅱ)的长期合理使用。

Objective To analyze the data on adverse drug reactions caused by of drospirenone and ethinylestradiol tablets(Ⅱ) in order to contribute to clinical rational application of this drug and to make recommendations for clinical application. Methods Case reports on adverse reactions associated with drospirenone and ethinylestradiol tablets(Ⅱ) in Beijing between 2015 and 2018 were analyzed retrospectively. Results The adverse reactions caused by drospironone and ethinylestradiol tablets(Ⅱ) were mainly manifested as reproductive system diseases, gastrointestinal diseases and nervous system diseases. Conclusion The adverse reactions induced by drospirenone and ethinylestradiol tablets are generally tolerable. Although low-dose drospironone and ethinylestradiol tablets cause fewer adverse reactions, the risk of venous thromboembolism remains. It is recommended that the risk of medication be assessed before use, a long-term, systematic follow-up be maintained with the patients, and high-quality reporting of adverse reactions be encouraged. In order to reduce the risk of drug use and promote the longterm rational use of drospirenone and ethinylestradiol(Ⅱ), evidence should be updated and new adverse reactions should be added to the drug instructions.