Abstract: Objective To explore the clinical safety of Qizhitongluo capsule in the real world after its launch. Methods The safety of Qizhitongluo capsule was evaluated in all patients using the capsules from November 24, 2020 to November 25, 2022 at 19 institutions in 6 provinces (Henan, Shanxi, Guangxi, Liaoning, Shandong, and Heilongjiang) by means of drug-derived prospective centralised surveillance and nested case-control methods. Results A total of 3010 patients were included, and 21 cases of adverse reactions occurred, accounting for 0.7%, including 15 cases of gastrointestinal diseases, 2 cases of various neurological disorders, 2 cases of psychiatric disorders, and 2 cases of various musculoskeletal and connective tissue disorders, which were mainly manifested as abdominal discomfort, diarrhoea, oral ulcers, headache, and insomnia, etc., and no serious adverse reactions occurred. The results of multifactorial analysis showed that the occurrence of adverse reactions was related to the dosage frequency of Qizhitongluo capsules, and the frequency of dosage exceeding the dosage frequency recommended by the instruction manual would increase the incidence of adverse reactions. Conclusion The incidence of adverse reactions of Qizhitongluo capsules was 0.70%, mostly in gastrointestinal diseases, and also in psychiatric diseases and musculoskeletal and connective tissue disease.

Key words: Qizhitongluo capsules, proprietary Chinese medicines, nested case-control, frequency of dosage, safety, real world, adverse drug reaction