Objective To analyze the characteristics of clinical application of Fufang Kushen Injection（ 复方苦参注射液） in the real world. Methods The electronic medical data from 49 597 patients using Fufang Kushen Injection from 22 large-scale hospitals nationwide based on the hospital information system（ HIS） established by Institute of Basic Research in Clinical Medicine

China Academy of Chinese Medical Sciences were extracted. A descriptive analysis was performed in admission information

clinical diagnosis and medication status

combination medication

discharge outcomes

etc. Results In the real world of the HIS database

the age of the patients was mainly 46 to65 years old（ 50. 84%）

with 15 to 28 d（ 27. 93%） hospitalization. The top 3 departments of medication were department of oncology

gastroenterology and cardiovascular. It was widely applied in clinical treatment of lung malignancies（ 24. 29%）

hepatic malignancy（ 11. 66%）

gastric malignancy（ 9. 23%）; the single dose and daily dose were 10 to 20 ml and 20 to 30 ml

with medication course of 4 to 14 d. It is often used in combination with dexamethasone

tropisetron injection

and thymosin injection. The number of combined drugs was about 10 in the most common. A total of 1994 patients were discharged to death. The top three causes of death were pulmonary infections

electrolyte metabolism disorders

and lung malignancies. Conclusion The main indication of Fufang Kushen Injection is malignant tumors. The majority of patients in the real world are middle-aged and old patients

which conforms to the general rule of diseases of indications（ malignant tumors）; the dose and course of treatment basically meet the specifications of package insert

and the clinical combination is widely used with exact curative effect.