Abstract: Objective To improve the safety of clinical application of Xianlinggubao oral dosage forms, a Chinese patent medicine commonly used for orthopedics by detecting early warning signals of adverse reactions (ADR) in clinical practice. Methods SRS data of Xianlinggubao oral dosage forms provided by Guizhou Tongjitang Pharmaceutical Co., Ltd. were used as the subjects of this study. The data was collected between January 1, 2004 and July 21, 2016. Early warning signals of adverse drug reactions related to Xianlinggubao oral dosage forms were analyzed. PRR and Bayesian confidence propagation neural network (BCPNN) were used to analyze the top ten frequent ADR manifestations (rash, itching, nausea, vomiting, chills, gastric dysfunction, dizziness, fever, allergic reaction and pneumothorax) in SRS data reports and background data, while the propensity score method (PS) was used to control the confounding factors. Results The early warning signals of ADR manifestations confirmed by both methods were nausea, vomiting, gastric dysfunction and dizziness. The warning signals disappeared after the tendency score brought the confounding factors under control. Conclusion Nausea, vomiting and gastric dysfunction are the early warning signals of ADRs caused by Xianlinggubao oral dosage forms. Due to the limitation of SRS data, whether this result is directly related to Xianlinggubao oral dosage forms needs to be confirmed by multiple studies to find comprehensive evidence and provide more reliable and effective guidance for rational clinical use and risk reduction.

Key words: Xianlinggubao oral dosage forms, pharmacovigilance, adverse drug reactions, proportion reporting ratio, Bayesian onfidence propagation neural network