Non-interventional prospective centralized monitoring on post-marketing safety evaluation of Dazhuhongjingtian injection(大株红景天注射液)

Abstract

Objective To re-evaluate the post-marketing safety of Dazhuhongjingtian injection and to explore the safety re-evaluation method of traditional Chinese medicine injection. Methods To observe and analyze inpatients admitted to the department of cardiovascular medicine in the second hospital of Jilin University from November 2013 to February 2016 by using the non-interventional centralized monitoring method with participation of pharmacists and nurses. All the patients enrolled were treated with Dazhuhongjingtian injection. We further analyzed the clinical application of this injection as well as the adverse event. Results A total of 3 000 patients (1 560 male and 1 440 female) were enrolled in this study. Of them, the average age was (61±11) years (17-97 years), 29 patients had allergic history, 388 patients (12.93%) were medication beyond the indications of Dazhuhongjingtian injection due to their primary diagnosis of non-coronary heart disease. The solvent dosage and/or types of 2 975 patients (99.17%) did not conform to the instructions. The treatment duration of 917 patients (30.57%) was over 10 days. Of 2 999 patients receiving drug combination with 1-30 kinds, the average kinds was (9±4). Adverse events occurred in 19 patients (0.63%). Of them, 10 male and 9 female with the average age of (60±11) years (35-82 years), 4 patients had the allergic history. The incidence of adverse event with allergic history was higher than that without allergic history [13.79% (4/29) vs. 0.50% (15/2 971), P 0.05). All adverse events occurred within one week, 8 cases (42.11%) happened in the first day of the medicine. The symptoms were generally mild, mainly for skin rashes, itching, dizziness and palpitation. These symptoms can be improved or disappear after medication withdrawal and symptomatic treatment. Conclusions The Dazhuhongjingtian injection is comparatively safe. It was proved to be a good mode for post-marketing safety re-evaluation of traditional Chinese medicine injection by non-interventional prospective monitoring with pharmacists and nurses participating in. Off-label drug use of Dazhuhongjingtian injection existed in clinical practice. We sincerely recommend the manufacturer to carry out research according to its clinical application and to provide the clinic convenience. Key words: RHODIOLA SACRA; Adverse drug reaction report system; Drug evaluation