目的 探讨仙灵骨葆胶囊引起不良反应尤其是药物性肝损伤的人群特点与药物不良反应（ADR）发生与转归特点，以期为临床合理用药提供参考，为中药上市后安全性再评价提供思路。方法 采用真实世界研究方法，选取某三甲医院788例患者，观察仙灵骨葆的临床应用安全性。结果 仙灵骨葆组与常规治疗组相比，总ADR发生率差异不显著（P>0.05），仙灵骨葆组消化道ADR发生率最高（占总ADR 83.0%）；与常规治疗组相比，仙灵骨葆组腹胀发生率更高（P<0.01），与仙灵骨葆用药时间、住院时间相关；仙灵骨葆组肝功能异常（≥ 2倍正常上限）、严重肝功能异常（≥ 3倍正常上限）发生率均高于常规治疗组，但无统计学意义（P>0.05），用药前存在肝功能异常或伴有基础肝脏疾病者更易发生肝功能异常（30.4%）。结论 临床应加强对仙灵骨葆制剂ADR的监测，促进合理用药，保障用药安全。

Objective To explore the characteristics of Xianling Gubao Capsule (XGC) induced adverse reactions, especially drug-induced liver injury, and the occurrence and prognosis of ADR, aiming to provide a reference for clinical rational drug use, and ideas for after-marketing re-evaluation of Chinese materia medica. Methods A total of 788 patients were enrolled in one tertiary hospital to observe the clinical application safety of XGC based on real-word study. Results Compared with the conventional treatment group, the incidence of ADR in the treatment group showed no significant difference (P > 0.05) in XGC group. XGC group had the highest incidence of adverse gastrointestinal reactions (83.0%), and a higher incidence of abdominal distension (P < 0.01). Incidence of liver function abnormalities (≥ 2 ULN) and abnormal liver function abnormalities (≥ 3 ULN) was both higher in XGC group, but there was no statistical significance (P > 0.05). Pre-drug liver abnormalities or patients with underlying liver disease were more likely to have drug induced liver injury (30.4%). Conclusion Monitoring adverse reactions of XGC should be enhanced in order to promote the rational use and ensure the safety in clinic.