Drug Use Evaluation of Shenmai Injection in the First Affiliated Hospital of Bengbu Medical College: a Prospective Analysis

Introduction: To investigate the evaluation pattern of Traditional Chinese medicine injection, establish the drug use evaluation(DUE) standards of shenmai injection, and implement of DUE programs of shenmai injection in the First Affiliated Hospital of Bengbu Medical College. Methods: Three hundred and thirty four patients were included in this retrospective analysis. The study duration was divided into two periods: cycle A: from November 2011 to December 2011; cycle B: from January 2012 to March 2012. A series of indices including indications, administration frequency, dosage, administration period, drug-drug interactions, adverse reactions and treatment efficiency were evaluated. Results: The number of patients showed the indications of shenmai injection were 119 (77.27%) and 168 (93.33%) in cycle A and cycle B, respectively. The number of patients showed the contraindications of shenmai injection were 18 (11.69%) and 12 (6.67%) in cycle A and cycle B, respectively. Satisfactory outcomes were reported among all the patients with no serious adverse reactions reported. Conclusions: The establishing of the standards of Traditional Chinese medicine injection should integrate the guidelines approved by drug use evaluation system. There are some shortcomings for the evaluation of Traditional Chinese medicine injections. The drug use evaluation of shenmai injection could promote the reasonable application of the injection in clinical practices. INTRODUCTION: According to the Chinese State Food and Drug Administration, modern Chinese hospitals used as many as 147 kinds of herbal injections in China between 2004 and 2007 1, . Shenmai injection (SMI), a Chinese traditional prescription mainly consisted of two herbal components (Radix ginseng Rubra and Radix ophiopogonis) , is widely used for the treatment of coronary atherosclerotic cardiopathy and viral myocarditis 4, . Although several trials have reported that shenmai injection might show a therapeutic effect on the cardiac function with pulmonary heart diseases 6, , the quality of these trials has not been evaluated systematically. Additionally, Traditional Chinese medicine (TCM) injection showed characteristics of large dosage, high concentration and long term administration, which may induce severe adverse