目的 分析肺力咳合剂在成人真实世界应用中不良反应（ADR）发生情况及其影响因素，明确用药风险，为临床用药提供参考。方法 采用前瞻性、多中心、大样本、注册登记式医院集中监测研究方法，对全国25家研究中心于2020年12月24日—2021年12月20日服用肺力咳合剂的门诊和住院成人患者进行监测，分析发生ADR患者的基本情况及用药特征，通过单因素及多因素Logistic回归，分析发生ADR的影响因素。结果 全国25家研究中心，3 189例服用肺力咳合剂的患者中有93例发生121例次ADR，发生率为2.92%。ADR累及7个系统-器官损害，均为轻中度ADR。单因素及多因素Logistic回归显示，合并用药和超说明书剂量用药是导致ADR出现的主要原因。结论 肺力咳合剂ADR发生率较低，安全性良好，无严重ADR，且提示当有合并用药时需特别注意用药风险和避免超说明书剂量用药情况。

Objective To analyze the occurrence and influencing factors of adverse drug reactions（ADRs） in real-world application of Feilike Mixture in adult population, clarify the risks of medication, and provide reference for clinical medication. Methods A prospective, multi-center, large-sample, registered hospital centralized monitoring study method was used to monitor outpatient and inpatient adult patients who used Feilike Mixture from December 24 th, 2020 to December 20 th, 2021. The basic conditions and medication characteristics of patients with ADR were analyzed, and the influencing factors of ADR were analyzed through single factor and multivariate Logistic regression. Results In 25 research centers across the country, 93 of the 3 189 patients who used Feilike Mixture had 121 ADRs, with an incidence rate of 2.92%.The ADRs involved seven system-organ damages, all of which were mild to moderate ADRs. Univariate and multivariate Logistic regression analysis showed that concomitant medication and off-label medication were the main causes of ADRs. Conclusion Feilike Mixture has a low incidence of ADR, has good safety, and has no serious ADRs, which suggests that special attention should be paid to medication risks and avoid taking drugs beyond the label when combined medication is used.

R969.4;R285.1;R974

国家自然科学基金资助项目(82074584); 中国中医科学院中药监管科学研究项目(ZYJGKX202409);中国中医科学院科技创新工程项目(CI2021A04702)