Shi-Guang Sun1, Zi-Feng Li2, Yan-Ming Xie3, Jian Liu2, Yan Lu2, Yi-Fei Song2, Ying-Hua Han2, Li-Da Liu2, Ting-Ting Peng2. 1. Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Department of Pharmacy, Shandong Provincial Hospital of Integrated Medicine, Jinan 250001, China. S.G.SUN@hotmail.com 2. Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Department of Pharmacy, Shandong Provincial Hospital of Integrated Medicine, Jinan 250001, China. 3. Institute of Basic Research in Clinical Basis Medicine, China Academy of Chinese Medical Science, Beijing 100700, China.
Abstract
OBJECTIVE: To rationalize the clinical use and safety are some of the key issues in the surveillance of traditional Chinese medicine injections (TCMIs). METHOD: In this 2011 study, 240 medical records of patients who had been discharged following treatment with TCMIs between 1 and 12 month previously were randomly selected from hospital records. Consistency between clinical use and the description of TCMIs was evaluated. Research on drug use and adverse drug reactions/events using logistic regression analysis was carried out. RESULT: There was poor consistency between clinical use and best practice advised in manuals on TCMIs. Over-dosage and overly concentrated administration of TCMIs occurred, with the outcome of modifying properties of the blood. Logistic regression analysis showed that, drug concentration was a valid predictor for both adverse drug reactions/events and benefits associated with TCMIs. CONCLUSION: Surveillance of rational clinical use and safety of TCMIs finds that clinical use should be consistent with technical drug manual specifications, and drug use should draw on multi-layered logistic regression analysis research to help avoid adverse drug reactions/events.
OBJECTIVE: To rationalize the clinical use and safety are some of the key issues in the surveillance of traditional Chinese medicine injections (TCMIs). METHOD: In this 2011 study, 240 medical records of patients who had been discharged following treatment with TCMIs between 1 and 12 month previously were randomly selected from hospital records. Consistency between clinical use and the description of TCMIs was evaluated. Research on drug use and adverse drug reactions/events using logistic regression analysis was carried out. RESULT: There was poor consistency between clinical use and best practice advised in manuals on TCMIs. Over-dosage and overly concentrated administration of TCMIs occurred, with the outcome of modifying properties of the blood. Logistic regression analysis showed that, drug concentration was a valid predictor for both adverse drug reactions/events and benefits associated with TCMIs. CONCLUSION: Surveillance of rational clinical use and safety of TCMIs finds that clinical use should be consistent with technical drug manual specifications, and drug use should draw on multi-layered logistic regression analysis research to help avoid adverse drug reactions/events.