Adverse Drug Reaction Caused By Traditional Chinese Medicine Injections:Status And Related Factors

Objective:(1) To explore the incidence, types and severity of adverse drug reaction caused by Traditional Chinese Medicine Injections;(2) To assess the reasons and related factors of adverse drug reaction caused by Traditional Chinese Medicine Injections;(3) To estimate irrational use and put forward countermeasures and suggestions;(4) To provide scientific evidences for further improving the rational drug use and medication safety.Methods:A self-designed traditional Chinese medicine injections usage inventory, which involves medical cause, medications, adverse drug reaction and rational drug use, were applied to evaluate all the qualified patients. All the qualified patients used traditional Chinese medicine injections of a grade three A hospital during Jan.2009-Dec.2011were taken as theoretical sample.Results:2650inpatients were included in the study.125(4.72%) had adverse drug reactions related to Traditional Chinese Medicine Injections. The rate of adverse drug reaction related to TCM Injections in females (5.22%) was higher than that in males (4.53%). Inpatients of all ages had adverse drug reaction. Patients older than60had the highest rate, while patients less than10years old had the lowest rate. Patients with higher education or above had the highest rate. The top three injections with high incidence rate were Traditional Shuanghuanglian Injection(12.43%,23/185), Tanreqing injection(10.29%,18/175) and Acanthopanax Senticosus injection(9.71%,17/175). The adverse drug reactions caused by TCM injections of this group were Mild-to-moderate. The major clinic signs included:Infusion site discomfort, nausea and vomiting, rash, pruritus, palpitation, chest distress, allergic shock, etc. All the signs became normal after withdrawal and symptomatic treatment.85(68.00%) patients with adverse drug reactions were judged as "possible" or above in the causality assessment, which was more than the rates of adverse drug reactions caused by other reasons. Non-conditional Logistic Stepwise Regression show:irrational drug use, individual difference(gender, age and educational level), food and drug allergy were statistically significant factors of adverse drug reactions related to Traditional Chinese Medicine Injections.Conclusion:The incidence of adverse drug reactions related to M Injections is4.72%in the hospital. The adverse drug reactions are Mild-to-moderate.Irrational drug use, individual difference (gender, age and educational level), food and drug allergy are statistically significant factors of adverse drug reactions related to TCM injections.There are many influencing factors related to adverse drug reactions. It is necessary to synthetically evaluate the safety of traditional Chinese medicine injections. Irrational drug use controllable factor. And the potential risk of TCM injections cannot be ignored. Medical staffs and patients should regulate the use of TCM injections.