Systematic review on safety of Salvianolate injection / 中国中药杂志

ABSTRACT

To systematically evaluate the safety of salvianolate injection in clinical medication. A systematic literature search was performed in the databases of Cochrane Library, Medline, Embase, the Web of Science, Clinical Trials, CNKI, VIP, WanFang Data and CBM. Literature screening was done according to inclusion and exclusion criteria, and quality was assessed according to internationally recognized quality evaluation criteria. Then the data were reviewed for analysis. 148 papers were included, consisting of 122 randomized controlled trials(RCTs), 10 non-randomized controlled trials(NRCTs), 4 case series studies, and 12 case reports. In the analysis of 135 studies, totally 7 300 patients used salvianolate injection. There were a total of 419 adverse drug reactions(ADRs), and 12 cases of serious adverse drug reactions. In the patients with Salvianolate injection, there were 176 cases of adverse drug reactions(ADRs) and 1 case of adverse cardiac event. The ADRs included 17 cases of rash, 9 cases of gastrointestinal reaction, 38 cases of headache, dizziness, heaviness in head, 1 case each of drug fever, hypotension, bleeding gums, chills, lip numbness, body jitter, slightly elevated ALT, 3 cases of palpitation, 4 cases of breath shortness, and 25 cases of other unkonwn ADRs. In the present study, a large number of rare, serious adverse events were not seen in clinical application of Salvianolate injection, but future long-term monitoring is needed to obtain evidence for the safety of the drug. In addition, the clinical application of Salvianolate injection is seriously beyond the instruction, so relevant departments shall urgently develop the medication specifications for salvianolate injection to provide better guidance for its clinical medication.