A Retrospective Analysis on 1330 Adverse Event Reports of Qingkailing in China: Further Perception of Its Risks and Rational Use.

ABSTRACT

Qingkailing (QKL) is a modern preparation exploited according to the traditional Chinese medicine theory. It becomes the second leading cause of adverse drug events (ADEs) in all traditional Chinese medicine injections. The safety evaluation and rational use of QKL are of special importance. This retrospective study used data from Adverse Drug Reaction Monitoring Center of Hubei Province in China from January 2012 to December 2014. ADE cases induced by QKL were collected and analyzed according to patients' demographics, characteristics of drugs involved, characteristics of ADEs, causality, and outcomes. A total of 1330 qualified ADEs were included. Most ADEs occurred within 30 min after administration and the 0-10 years old age group had the highest number of ADEs. The common ADEs included anaphylactic reaction, dyspnea and nausea. Serious reactions accounted for 5.19%. Combination with cephalosporin (74/146, 50.69%) caused more ADEs than other drugs did. Serious attention should be paid when QKL is used for children, and combination with cephalosporin should be avoided.