Adverse drug reactions linked to Ciwujia injection: a systematic review of 521 cases

Abstract

Objective: To analyze adverse drug reactions (ADRs) associated with Ciwujia injection and possible contributing factors.

Methods: We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. Relevant information such as disease treated; menstruum and compatibility of the Ciwujia injection; age, gender, and allergic history of ADR cases; and the types, occurrence time and severity of the ADRs were collected and analyzed.

Results: In the 800 clinical studies of Ciwujia injection's efficacy and safety, 97 (12.1%) reported 285 ADR cases. There were 144 ADR reports for the drug describing a total of 236 ADR cases. Most of the ADR reports described cases of anaphylactic shock, while the most common ADR reported in clinical studies was local pain; 27.7% of ADR cases were I to II class in all 521 cases, and four anaphylactic shock cases died.

Conclusion: The relevant information of ADRs for Ciwujia injection was insufficiently reported in included studies. The ADR type distribution between clinical studies and ADR reports was inconsistency. Most of the reported ADRs were mild, and were treated successfully by slowing down the drip velocity or by withdrawing the drug and treating the symptoms. As Ciwujia injection was one of the highest numbers of ADR reports of traditional Chinese medicine injections, high quality ADR monitoring, standardized ADR reporting, and timely analysis risk factors of ADRs are extremely urgent.