Rationality analysis of clinical application of Danhong injection in affiliated hospital of Nanjing university of Chinese medicine from 2013 to 2014

It is necessary to investigate the influence of the rationality of clinical drug use on the benefit and risk factors of traditional Chinese medicine injections. The retrospective survey was based on the medical records and information of 4 950 patients who used Danhong injection in the HIS database of the first affiliated hospital of Nanjing University of Chinese Medicine from 2013 to 2014. The basic statistical methods and associated rules analysis were utilized to analyze the HIS information of these patients, including the basic information, the diagnosis, the department, the dosage, the usage of medication, the drug combination and the adverse reactions. And the rationality analysis of the clinical application of Danhong injection was carried out to investigate relevant factors of the adverse reactions. The results showed that most cases came from the department of cardiology (51.95%) and encephalopathy center (20.67%). In the statistical period, the patients aged above 40 years old accounted for 96.65%. And the two western medicine diagnosis items with the highest confidence level were coronary heart disease and angina pectoris (97.15%), while the three items were coronary heart disease, angina pectoris and hypertension (97.02%). The irrational indications were mainly hypertension (12.93%) and diabetes (4.55%). All of them were diagnosed as blood stasis syndrome by the traditional Chinese medicine. About 98.93% of the single dosage was within the range stipulated on package insert, the duration mainly ranged between 1 and 21 days, and 97.64% of the menstrua contained 0.9% NS and 5% GS. According to the medication records,99.26% were the use of combined drugs, with 8.41 drugs on average. Antiplatelet drugs (72.04%) were the most frequently combined with western medicine, followed by the cholesterol-regulating drugs (64.86%) and the cerebrovascular drugs (60.26%). When used in the combination with antibiotics for the infection, cephalosporin antibiotics were the most frequently applied (8.81%). When used with traditional Chinese medicines, traditional Chinese medicines for activating blood circulation and removing blood stasis or monomer traditional Chinese medicine injections (28.93%) were the dominance, in which Gastrodin injection was the most frequently applied (16.23%). And 12 cases of adverse reactions were reported, with the ADR rate of 0.24%. The indications, solvent compatibility and irrational drug combination may be the potential risk factors for ADRs induced by Danhong injection. Further experiments are required to evaluate the benefits and risks in these three aspects.