目的 挖掘和评价真实世界中使用地诺孕素发生药物不良事件的相关情况。方法 收集美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中使用地诺孕素的不良事件报告，采用描述性分析、比例报告比（PRR）和报告比值比（ROR）对地诺孕素进行不良反应信号挖掘分析。结果 地诺孕素上报的为首要怀疑药物的不良事件个案报告69例，为次要怀疑的报告180例。首要怀疑药物报告从2010年开始，地诺孕素不良事件报告数逐年升高，主要来自德国（14例）和意大利（13例），女性占97.1%，年龄主要分布在18～42岁（46.4%），给药剂量主要为1片/次，1次/d。信号检测结果显示，地诺孕素不良事件（首要怀疑、次要怀疑、合并用药及相互作用）筛选出87个阳性信号，累及系统器官共20个。首要怀疑的不良事件信号检测结果有肺栓塞、深静脉血栓形成和视觉损害。地诺孕素相关的不良事件也包括多个与静脉血栓相关的阳性信号，此外还有蒂尔病、局灶性结节性增生、牙髓炎等较强信号；“各种肌肉骨骼及结缔组织疾病”“血管与淋巴管类疾病”“呼吸系统、胸及纵隔疾病”这3个系统器官分类未在说明书中引起充分重视，其中“血管及淋巴管类疾病”未在说明书中提及。结论 临床使用地诺孕素时，应注意其药品不良反应。

Objective To detect and evaluate the adverse drug events related to the use of dienogest in the real world. Methods Adverse event reports of dienogest used in the FAERS were collected. Descriptive analysis, proportional reporting ratio (PRR) and reported odds ratio (ROR) were used to mine the adverse event signal of dienogest. Results Sixty-nine cases of adverse events with dienogest as primary suspect and 180 cases as secondary suspect were reported. Since 2010, the number of adverse events reported by dienogest increased year by year, mainly from Germany (14 cases) and Italy (13 cases), accounting for 97.1% of females, and mainly distributed in the age range from 18 to 42 years old (46.4%). The main dose was 1 tablet/time, once daily. The results of signal detection showed that 87 positive signals of dienogest adverse events (primary suspicion, secondary suspicion, drug combination and interaction) were screened out, involving a total of 20 organs. The first suspected adverse event signal results were pulmonary embolism deep vein thrombosis and visual impairment. Dienogest-related adverse events also included multiple positive signals associated with venous thrombosis, in addition to stronger signals such as Teal's disease, focal nodular hyperplasia, and pulpitis. "Various musculoskeletal and connective tissue diseases" "vascular and lymphatic diseases" and "respiratory, thoracic and mediastinal diseases" were not given sufficient attention in the instructions, among which "vascular and lymphatic diseases" were not mentioned in the instructions. Conclusions When using dienogest, attention should be paid to the adverse reactions of this drug.

R977.1