Assessment of the safety of Qin Kai Ling injection: a systematic review.

Objective Qin Kai Ling (QKL) injection, which is based upon the traditional Chinese medicine formulation 'An Gong Niu Huang Wan', is widely used in treatment of many diseases. This review aims to assess the safety of QKL. Methods We searched Chinese databases CNKI and VIP for articles published between January 1987 and April 2009. Results A total of 1486 cases were included in this review. We were unable to determine the frequency of ADR/AE induced by QKL due to the lack of complete production and market information. We estimate, based on the limited data, that the risk of ADR/AE from QKL use should be low. We found some ADR/AE may have been induced by incorrect use of QKL, such as use in infants, or use with incompatible drugs, and some places may not suite for use of QKL, for example, four of seven patients died in private clinics or patient's home. We unable to distinguish whether incidents were ADRs or AEs because the poor reports. Conclusion Current evidence, while weak, indicates that QKL carries a low risk of ADR/AE, and some adverse events that do occur may be ascribed to improper use of the drug. Reporting of ADR/AEs needs to be greatly improved, and should follow the 'Recommendations for reporting traditional Chinese medicine adverse drug reaction'. [ABSTRACT FROM AUTHOR]