2018－2020年山东省瑞舒伐他汀所致严重不良反应报告的回顾分析

目的: 分析瑞舒伐他汀致药品不良反应(adverse drug reaction, ADR)的发生特征和规律,为临床合理使用调脂药物提供参考。方法: 从2018年1月1日至2020年12月31日山东省ADR数据库上报的3 840份他汀类药物报告中筛选出瑞舒伐他汀所致严重类型的ADR报表,对患者的年龄、ADR发生时间分布、ADR累及系统/器官及临床表现等统计分析。结果: 瑞舒伐他汀所致严重ADR报告共计254例,多发生在用药2~14 d(75.99%)内,年龄分布以60~69岁(35.43%)患者占比最多;累及系统/器官及临床表现多样化,以肝胆损害(75.48%)多见,多发生在2~14 d(79.48%);ADR转归结果方面,痊愈或好转209例(82.28%);ADR对原患疾病影响方面,不明显205例(80.71%),病程延长44例(17.32%),病情加重5例(1.97%)。结论: 患者在开始使用瑞舒伐汀的14 d内,临床应密切观察患者是否出现ADR,特别是肝胆损害,及时鉴别和干预,避免严重ADR的发生。

Retrospective analysis of severe adverse drug reactions induced by rosuvastatin in Shandong Province from 2018 to 2020

OBJECTIVE To study the general pattern and characteristics of the adverse drug reaction induced by rosuvastatin calcium in order to provide reference for monitoring adverse drug reactions (ADR) and clinical rational drug use.METHODS Totally 3 840 ADR cases caused by rosuvastatin were screened and analyzed statistically from ADR cases reported in Shandong Province from January 1, 2018 to December 31, 2020, and the reports of severe ADRs caused by rosuvastatin were screened, and the age, time distribution of ADR occurrence, ADR-involved systems/organs and clinical manifestations were analyzed.RESULTS A total of 254 cases of severe ADR reports caused by rosuvastatin were screened, most of which occurred within 2-14 days (75.99%), with patients aged from 60 to 69 years old (35.43%); ADR-involved systems/organs and clinical manifestations were diversified, and liver and gallbladder damage (75.48%) was common, which mostly occurred in 2-14 days (79.48%). In terms of ADR outcomes, 209 cases were cured or improved (82.28%). The effect of ADRs on the original disease was not obvious in 205 cases (80.71%), the course of disease was extended in 44 cases (17.32%), and the disease was aggravated in 5 cases (1.97%).CONCLUSION Within 14 days of the use of rosuvastine, patients should be closely observed for adverse reactions, especially for hepatobiliary damage, and timely identification and intervention should be performed to avoid the occurrence of severe ADRs.