OBJECTIVE: To analyze adverse drug reactions (ADRs) associated with Shenmai injection and possible contributing factors. METHODS: We searched all clinical studies and ADR reports of Shenmai injection from the China National Knowledge Infrastructure (CNKI) database, the Data Bank of Chinese Scientific Journals (VIP), and Chinese Biomedical (CBM) database. We collected relevant information such as gender, age, allergic history, and diseases treated in ADR cases; types, occurrence times, and severity of ADRs; and menstruum and compatibility of Shenmai injection. RESULTS: Of the 1828 clinical studies of Shenmai injection, 146 (7.99%) mentioned 576 ADR cases; 181 ADR reports mentioned 246 ADR cases. The most commonly affected age group was 40 to 69 (57.32%). In 36 (14.63%) cases, patients were described as having an allergic history. The diseases treated in ADR cases were principally heart failure and coronary artery heart disease. Thirty-eight (15.45%) of the 246 ADR cases in ADR reports described anaphylactic shock, while the most common ADR reported in clinical studies was headache/dizziness. Of the 822 total reported ADR cases, 99 (12.04%) were class III, and 637 (77.50%) were class IV, and there were no fatalities. The menstruum of most Shenmai injections was 5% glucose. Incompatible drugs were given in 68 ADR cases. In ADR cases, the most common dosage of Shenmai injection was 40 to 60 ml; 215 (80.90%) ADR cases occurred in first time medication, mainly in the first 30 minutes after injection. CONCLUSIONS: Current evidence shows that Shenmai injection had lower ADR occurrence, but some potential factors such as irrational compatibility, dosages may lead to a high risk of ADR. In future, clinicians should follow indications or functions to promote rational use of Chinese Medicine Injections .
OBJECTIVE: To analyze adverse drug reactions (ADRs) associated with Shenmai injection and possible contributing factors. METHODS: We searched all clinical studies and ADR reports of Shenmai injection from the China National Knowledge Infrastructure (CNKI) database, the Data Bank of Chinese Scientific Journals (VIP), and Chinese Biomedical (CBM) database. We collected relevant information such as gender, age, allergic history, and diseases treated in ADR cases; types, occurrence times, and severity of ADRs; and menstruum and compatibility of Shenmai injection. RESULTS: Of the 1828 clinical studies of Shenmai injection, 146 (7.99%) mentioned 576 ADR cases; 181 ADR reports mentioned 246 ADR cases. The most commonly affected age group was 40 to 69 (57.32%). In 36 (14.63%) cases, patients were described as having an allergic history. The diseases treated in ADR cases were principally heart failure and coronary artery heart disease. Thirty-eight (15.45%) of the 246 ADR cases in ADR reports described anaphylactic shock, while the most common ADR reported in clinical studies was headache/dizziness. Of the 822 total reported ADR cases, 99 (12.04%) were class III, and 637 (77.50%) were class IV, and there were no fatalities. The menstruum of most Shenmai injections was 5% glucose. Incompatible drugs were given in 68 ADR cases. In ADR cases, the most common dosage of Shenmai injection was 40 to 60 ml; 215 (80.90%) ADR cases occurred in first time medication, mainly in the first 30 minutes after injection. CONCLUSIONS: Current evidence shows that Shenmai injection had lower ADR occurrence, but some potential factors such as irrational compatibility, dosages may lead to a high risk of ADR. In future, clinicians should follow indications or functions to promote rational use of Chinese Medicine Injections .