THE REAL-WORLD STUDY OF SHENMAI INJECTION AND ITS ADVERSE REACTIONS ASSOCIATED TO PATIENTS IN CHINESE HOSPITALS: A PROSPECTIVE RESEARCHAbstract
Shenmai injection (SMI) is the Traditional Chinese Medicine Injection (TCMI) prepared by Red Ginseng and Radix Ophiopogonis extract. The aim of this study is to reveal the real-word of SMI, to evaluate its use and its adverse reactions associated to patients.A prospective, observational combined nested case-control clinical research carried out in two tertiary care teaching hospitals and two secondary hospitals in China. During the study period, 7632 cases were enrolled and 8 cases of ADR / ADE were reported. It was found that 1.05‰ (95% CI: 0.45-2.06‰) of the patients treated with SMI had some of ADEs classically induced by the use of this drug from the data collected and 6 cases were also in accordance with the instructions, the incidence of ADR to SMI was 1.60‰ (95% CI: 0.58-3.44‰). A total of 121 different diagnoses were stated, most of them were off-label use. 3257 cases (42.68%) in the usage of solvent does not meet the requirements of the specification in accordance with the instructions. 65 cases (0.86%) mixed insulin injection and 13 cases (0.17%) mixed vitamin K1 injection and dexamethasone injection.In conclusion, SMI have excessive use and its clinical application need to further strengthen the supervision, but the safety of SMI is more reliable.
Qing-ping Shi, Xiao-dong Jiang*, Jinxiu Zhu, Yan Liu , Rang Sang , Feng Ding , Mu-hua Wang , Dao-hua Guo, Pei-lan Shi , Mei-ling Yu , Shengtong Wei , Zhiming Xin , Ru Song , Shu-qiang Zhang
Department of Pharmacy, the first Affiliated Hospital of Bengbu Medical College, 287 Changhuai Road, Bengbu, 233004, China
29 May, 2013
11 July, 2013
26 September, 2013
01 October, 2013