目的 分析江西省天麻制劑不良反應(yīng)（ADR）報(bào)告，為臨床合理用藥和藥物基礎(chǔ)研究提供參考。方法 以天麻制劑為例，以患者一般情況、用藥情況、藥品ADR臨床表現(xiàn)等作為考查項(xiàng)，對(duì)江西省藥品不良反應(yīng)監(jiān)測(cè)中心上報(bào)數(shù)據(jù)庫(kù)中近20年共1 777例天麻制劑致ADR報(bào)告進(jìn)行回顧性統(tǒng)計(jì)分析，并結(jié)合中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)（CNKI）、Web of Science數(shù)據(jù)庫(kù)開展文獻(xiàn)計(jì)量可視化研究，分析ADR產(chǎn)生的原因和特點(diǎn)。結(jié)果 天麻制劑ADR報(bào)告例數(shù)逐年增加；女性患者略多于男性，主要發(fā)生在60歲以上；注射劑型所發(fā)生ADR例數(shù)遠(yuǎn)遠(yuǎn)超過其他劑型；無論是iv還是im所致ADR大部分都在24 h內(nèi)發(fā)生，口服給藥藥效略慢，所致ADR多發(fā)于48 h內(nèi)。共發(fā)生ADR 2 286例次，累及系統(tǒng)/器官以胃腸系統(tǒng)、神經(jīng)系統(tǒng)、皮膚及其附件為主，ADR臨床表現(xiàn)有惡心、頭暈、嘔吐、瘙癢、口干、胃部不適等。文獻(xiàn)計(jì)量所呈現(xiàn)的關(guān)鍵詞共現(xiàn)圖譜、時(shí)間突現(xiàn)圖譜，顯示了我國(guó)學(xué)者對(duì)天麻制劑的研究主要是在其功效，缺少ADR的研究。結(jié)論 天麻制劑總體ADR發(fā)生率較低，主要發(fā)生在注射劑劑型，其臨床使用的安全性與有效性不容忽視，建議豐富理論研究，對(duì)于部分天麻中藥制劑可補(bǔ)充修改用藥說明書，明確用藥指導(dǎo)。

Objective To analyze the adverse reaction reports of Tianma preparations in Jiangxi Province, and provide reference for clinical rational drug use and drug basic research. Methods Taking Tianma preparations as an example, a retrospective statistical analysis was conducted on 1 777 ADR reports caused by Tianma preparations in the database reported by the Jiangxi Provincial Drug ADR Monitoring Center in the past 20 years, with patient general information, medication use, and clinical manifestations of drug ADRs as examination items. A bibliometric visualization study was conducted in combination with CNKI and WOS databases to analyze the causes and characteristics of ADR. Results The number of ADR reports for Tianma preparations has been increasing year by year; There are slightly more female patients than male patients, mainly occurring in the age group of 60 and above; The number of adverse drug reactions (ADRs) occurring in injectable formulations far exceeds that of other dosage forms; Most ADRs caused by intravenous or intramuscular injection occur within 24 h, while oral administration may have slower efficacy, resulting in ADRs occurring more frequently within 48 h. A total of 2 282 cases of ADR occurred, involving mainly the gastrointestinal system, nervous system, skin, and their attachments. The clinical manifestations of ADR include nausea, dizziness, vomiting, itching, dry mouth, and stomach discomfort. The co-occurrence and temporal saliency maps of keywords presented in bibliometrics show that Chinese scholars' research on Tianma preparations mainly focuses on their efficacy, lacking research on ADR. Conclusions The overall incidence of ADRs in Tianma preparations is not high, but the safety and effectiveness of their clinical use cannot be ignored. It is recommended to enrich theoretical research and supplement and modify medication instructions for some Tianma traditional Chinese medicine preparations to clarify medication guidance.

R971

江西省高水平本科教學(xué)團(tuán)隊(duì)（225201011）；江西省教育科學(xué)“十四五”規(guī)劃課題（24GJZX010）；江西省藥監(jiān)局科研項(xiàng)目（ 2024GL23）