To investigate the occurrence of adverse reactions of traditional Chinese medicine injection and its influencing factors.

A total of 200 cases were treated with Shuanghuanglian injection at our hospital from January, 2015 to December, 2017 and were retrospectively analyzed. The incidence of adverse reactions of Shuanghuanglian injection and its influencing factors were analyzed.

A total of 25 cases of adverse reactions occurred in 200 patients who received double-linked injection. The incidence was 12.5%. Univariate analysis showed that the adverse reactions of Shuanghuanglian injection occurred because of age, BMI index, history of drug allergy, history of allergy, abnormal liver and kidney function, cardiovascular disease, pregnancy or lactation, TCM differentiation of medication, dispensing time, dosage, hourly dose, drip rate, vehicle, route of administration, drug concentration, contraindications, and combination therapy (all P<0.05). The results of multivariate analysis showed that age, history of drug allergy, abnormal liver and kidney function, TCM syndrome differentiation medication, dispensing time, drip rate, and combination therapy were independent influencing factors of adverse reactions of Shuanghuanglian injection (all P<0.05).

Shuanghuanglian injection has a high incidence of adverse reactions, which is mainly related to age, drug allergy history, abnormal liver and kidney function, TCM syndrome differentiation, drug dispensing time, drip rate, and combination therapy. Clinical intervention for these factors should be taken to reduce the incidence of adverse reactions.

Shuanghuanglian injection; Adverse reactions; Occurrence; Influencing factors