Analysis of 2 575 cases of adverse drug reactions of traditional Chinese medicine injections / 中国基层医药

ABSTRACT

Objective:To analyze the occurrence characteristics, rules and causes of adverse drug reactions (ADR) of traditional Chinese medicine injections, and to provide a basis for guiding clinical safe and reasonable medication.Methods:From February 2011 to February 2020, the 2 575 cases of ADR of traditional Chinese medicine injections which were collected and reported by Adverse Drug Reaction Monitoring Center of Huainan were statistically analyzed by using the functions such as EXCEL pivot table and automatic Σ.Results:The high incidence of Chinese medicine injection ADR was >40-80 years old, accounting for 78.2% (2014/2 575). The remaining age group accounted for 21.8% (561/2 575). ADR types 2.0% (52/2 575) of severe types, 98.0% (2523/2 575) of general types, and 26.5% (683/2 575) of new ones.ADR involved 68 varieties of traditional Chinese medicine injections, and the top 10 ADR reports accounted for 53.5% (1378/2 575). Among them, Shenmai injection caused the most ADR, accounting for 14.5% (372/2 575). The clinical manifestations of skin and its appendages ranked first, accounting for 31.8% (995/3 127), followed by systemic damage, accounting for 24.6% (769/3 127).Conclusion:The occurrence of ADR of traditional Chinese medicine injection may be related to factors such as the patients’ age, medication variety, unreasonable medication, complex Chinese medicine composition, impurities, related substances, solubilizing excipients, and incomplete safety information in the drug manual.ADR monitoring of traditional Chinese medicine injections should be strengthened, in particular, severe ADR monitoring and early warning should be strengthened, strictly follow the principle of reasonable medication, and implement treatment based on syndrome differentiation, reduce the occurrence of ADR, and ensure the safety of medication.