According to the drug-related risk factors indicated in the latest product monograph, we made this research to analyze and discuss the risk factors associated with rosiglitazone in clinical application in China-Japan Friendship Hospital. We collected and reviewed all cases involving inpatients who had used rosiglitazone in the hospital over the past two years. The focus of our study is on the identification and discussion of the incidence of adverse reactions, contraindications and drug induced problems associ- ated with monotherapy or combined therapy of rosiglitazone. Three hundred and ninety eight cases were reviewed in the study including 3 patients with type 1 DM （0.75%） and 395 patients with type 2 diabetes mellitus （99.25%）. Peripheral edema developed in 9 patients （2.26%） in the course of rosiglitazone therapy; one patient （0.25%） was found to have macula edema before rosiglitazone therapy; Cardiac abnormalities were identified in 6 patients （1.51%） in the course of treatment, of which 2 patients were NYHA class 1, 3 patients were NYHA class Ⅱ and 1 patient was NYHA class IV. Abnormal hepatic function （elevated ALT） was found in 79 patients （19.85%） during their stay in hospital. In these patients, ALT levels of 1 - 2.5 times, 2.5 - 3 times over the upper limit were identified in 70 patients, 3 patients and 6 patients, respectively. Of the 398 patients on rosiglitazone, 123 patients （30.90%）, 165 patients （41.46%）, 104 patients （26.13%）, 3 patients （0.75%） and 1 patient （0.25%） were found to use concurrently insulin, metformin, organic nitrate, gemfibrozil and rifampin, respectively. We analyzed the risk factors associated with the clinical use of rosiglitazone, and identified the potential risks, and put forward suggestions to improve the effectiveness and safety of rosiglitazone therapy.
