A real-world study on adverse drug reactions to Xuebijing injection: hospital intensive monitoring based on 93 hospitals (31,913 cases).

Background: Although we have made tremendous medical advances in recent decades in modern antibiotics and supportive therapies, the treatment of sepsis has not experienced such rapid advancement. Xuebijing injection (XBJ) is a Chinese prescription consisting of rubra, and . Clinical experience suggests that XBJ may provide a solution in the management of sepsis. However, the safety of this treatment is still controversial. This study aims to detect the occurrence of XBJ-related adverse drug reactions (ADRs) among individuals in clinical practice.

Methods: From the clinical application of XBJ in a real-world setting, patients in 93 hospitals using XBJ were monitored between August 2013 and August 2016. There was no limit on the treatment course and dosage. From data obtained in interviews or telephone follow-ups with hospitalized patients, the circumstances of patients' adverse events (AEs) during the course of drug treatment and during the 7 days after drug withdrawal were recorded and encoded by MedDRA18.0. The likelihood of ADRs was determined by the criteria of the Uppsala Monitoring Centre. Statistical analyses were performed by SAS9.2 software.

Results: In total, 31,913 participants enrolled, and none were lost to follow-up. AEs (suspected ADRs) occurred in 234 participants. ADRs occurred in 96 participants, and the incidence was 0.3%. The ADRs with the top three frequencies were skin pruritus (0.116%), erythra (0.066%) and chest tightness (0.044%). There was no significant relationship between ADRs and solvents (P=0.149), route of administration (P=0.640), unhealthy addiction (P=0.069), allergy (P=0.535), first use of XBJ (P=0.161) or dosage (P=0.743). There was a significant relationship between ADRs and irrigating syringe (P<0.0001) and fluid dripping too quickly (P=0.019).

Conclusions: This large-scale survey of hospitalized patients found that the incidence of ADRs was occasional (0.3%), while most of the ADRs were relatively mild or non-serious. XBJ should be administered rationally and according to its instructions to prevent the occurrence of ADRs.