目的 通過系統(tǒng)評價(jià)和藥品說明書形成藥物治療房顫不良事件/反應(yīng)清單，為房顫不良事件/反應(yīng)評價(jià)標(biāo)準(zhǔn)的構(gòu)建奠定基礎(chǔ)。方法 檢索中國知網(wǎng)、萬方、SinoMed、EMBASE、PubMed、Cochrane等數(shù)據(jù)庫中明確診斷為房顫的臨床研究，檢索時(shí)限為2015年1月—2022年6月，提取臨床研究中報(bào)告的不良事件/反應(yīng)；從《國家醫(yī)療保險(xiǎn)目錄》《國家基本藥物目錄》和《世界衛(wèi)生組織基本藥物清單》中選取治療房顫的中成藥、化學(xué)藥，從藥品說明書提取中藥、化學(xué)藥治療房顫報(bào)告的不良事件/反應(yīng)。經(jīng)過規(guī)范及合并，形成藥物治療房顫的不良事件/反應(yīng)清單。結(jié)果 共納入411項(xiàng)臨床研究，提取47種藥物藥品說明書，經(jīng)過規(guī)范及合并，形成了包含106個(gè)不良事件/反應(yīng)的清單。其中神經(jīng)系統(tǒng)和胃腸道疾病不良事件/反應(yīng)報(bào)告頻次最高，缺血性腦卒中、死亡、惡心、顱內(nèi)出血、血栓栓塞事件是藥物治療房顫最常見的不良事件/反應(yīng)。結(jié)論 藥物治療房顫的不良事件/反應(yīng)涉及多個(gè)系統(tǒng)，在相關(guān)臨床研究報(bào)告中應(yīng)重點(diǎn)關(guān)注神經(jīng)系統(tǒng)及胃腸道疾病不良事件/反應(yīng)；應(yīng)進(jìn)一步構(gòu)建心血管病不良事件/反應(yīng)報(bào)告標(biāo)準(zhǔn)，為臨床研究者選擇和報(bào)告危害指標(biāo)提供依據(jù)。

Objective To lay a foundation for the construction of evaluation criteria for adverse events/reactions of atrial fibrillation, to form a list of adverse events/reactions of drug treatment of atrial fibrillation through systematic review and package insert. Methods Clinical studies with a diagnosis of atrial fibrillation were searched from CNKI, Wanfang, SinoMed, EMBASE, PubMed and Cochrane, and the search time was from January 2015 to June 2022. Adverse events/reaction reported in clinical studies were extracted. Chinese patent medicines and western medicines for the treatment of atrial fibrillation were selected from the National Medical Insurance Catalogue, the National Essential Medicines Catalogue and the World Health Organization Essential Medicines List, and the adverse events/reactions reported were extracted through the package insert. After specification and merger, a list of adverse events/reactions were formed. Results A total of 411 clinical studies were included, 47 kinds of package insert of Chinese patent medicines and western medicines were extracted, and 106 adverse events/reactions were included in the final list of adverse events/reactions after standardization and consolidation. The top two most frequently reported systems were nervous system and gastrointestinal disease, and the top five most frequently reported indicators were ischemic stroke, death, nausea, intracranial hemorrhage, and thromboembolic events. Conclusion Adverse events/reactions to drug therapy for atrial fibrillation involves multiple systems, the adverse events/reactions of nervous system and gastrointestinal disease should be paid attention to report in atrial fibrillation clinical study. Reporting standards for adverse events/reactions of cardiovascular diseases should be further established to provide a basis for clinical investigators to select and report hazard indicators.

R973

北京中醫(yī)藥大學(xué)東直門醫(yī)院2024年度科技創(chuàng)新專項(xiàng)（DZMKJCX-2024-004）;岐黃學(xué)者（RS086）