目的 分析江西省天麻制剂不良反应（ADR）报告，为临床合理用药和药物基础研究提供参考。方法 以天麻制剂为例，以患者一般情况、用药情况、药品ADR临床表现等作为考查项，对江西省药品不良反应监测中心上报数据库中近20年共1 777例天麻制剂致ADR报告进行回顾性统计分析，并结合中国学术期刊全文数据库（CNKI）、Web of Science数据库开展文献计量可视化研究，分析ADR产生的原因和特点。结果 天麻制剂ADR报告例数逐年增加；女性患者略多于男性，主要发生在60岁以上；注射剂型所发生ADR例数远远超过其他剂型；无论是iv还是im所致ADR大部分都在24 h内发生，口服给药药效略慢，所致ADR多发于48 h内。共发生ADR 2 286例次，累及系统/器官以胃肠系统、神经系统、皮肤及其附件为主，ADR临床表现有恶心、头晕、呕吐、瘙痒、口干、胃部不适等。文献计量所呈现的关键词共现图谱、时间突现图谱，显示了我国学者对天麻制剂的研究主要是在其功效，缺少ADR的研究。结论 天麻制剂总体ADR发生率较低，主要发生在注射剂剂型，其临床使用的安全性与有效性不容忽视，建议丰富理论研究，对于部分天麻中药制剂可补充修改用药说明书，明确用药指导。

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学团队（225201011）；江西省教育科学“十四五”规划课题（24GJZX010）；江西省药监局科研项目（ 2024GL23）