目的 挖掘和評(píng)價(jià)真實(shí)世界中使用地諾孕素發(fā)生藥物不良事件的相關(guān)情況。方法 收集美國(guó)食品藥品監(jiān)督管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）中使用地諾孕素的不良事件報(bào)告，采用描述性分析、比例報(bào)告比（PRR）和報(bào)告比值比（ROR）對(duì)地諾孕素進(jìn)行不良反應(yīng)信號(hào)挖掘分析。結(jié)果 地諾孕素上報(bào)的為首要懷疑藥物的不良事件個(gè)案報(bào)告69例，為次要懷疑的報(bào)告180例。首要懷疑藥物報(bào)告從2010年開始，地諾孕素不良事件報(bào)告數(shù)逐年升高，主要來自德國(guó)（14例）和意大利（13例），女性占97.1%，年齡主要分布在18～42歲（46.4%），給藥劑量主要為1片/次，1次/d。信號(hào)檢測(cè)結(jié)果顯示，地諾孕素不良事件（首要懷疑、次要懷疑、合并用藥及相互作用）篩選出87個(gè)陽性信號(hào)，累及系統(tǒng)器官共20個(gè)。首要懷疑的不良事件信號(hào)檢測(cè)結(jié)果有肺栓塞、深靜脈血栓形成和視覺損害。地諾孕素相關(guān)的不良事件也包括多個(gè)與靜脈血栓相關(guān)的陽性信號(hào)，此外還有蒂爾病、局灶性結(jié)節(jié)性增生、牙髓炎等較強(qiáng)信號(hào)；“各種肌肉骨骼及結(jié)締組織疾病”“血管與淋巴管類疾病”“呼吸系統(tǒng)、胸及縱隔疾病”這3個(gè)系統(tǒng)器官分類未在說明書中引起充分重視，其中“血管及淋巴管類疾病”未在說明書中提及。結(jié)論 臨床使用地諾孕素時(shí)，應(yīng)注意其藥品不良反應(yīng)。

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