[A Systematic Review on Safety Evaluation of Treating Cardiovascular Diseases by Shuxuening In- jection].

Objective To systematically evaluate the safety of Shuxuening Injection ( SI) for treating cardiovascular disease in line with indications. Methods Ten databases such as Cochrane Li- brary, Medline, EMBase, Web of Science, Clinical Trials, CBM, CNKI, VIP, Wangfang Data, and Chinese Clinical Trial Registry Database were retrieved in October 2015 for collecting literatures on use of SI. Data were screened by inclusion and exclusion criteria. Literatures retrieved included randomized controlled trials, non-randomized controlled trials, observational research (case control, cohort studies, case series, case reports, and so on) , and were methodologically evaluated by Cochrane Systematic Risk of Bias Manual, TREND, and SUMARI. Results A total of 185 literatures were retrieved in this systematic review. Of them, 155 randomized controlled trials( RCT) , 6 non-randomized controlled trials, 11 case series, and 13 case reports were finally identified. Among the 13 case reports, adverse drug reactions (ADRs) occurred in 15 cases. Of the 155 RCT studies, XI was used in 8 553 patients, with ADRs in 162 cases and adverse events (AEs) in 4 cases. The outcomes of ADRs mainly covered the gastrointestinal system damage, central/peripheral nervous system damage, skin and appendages injury, and so on. The degree of damage was mostly mild. It is difficult to get a clear judgment on the relationship be- tween the occurrence of these ADRs and drug dosage, drug administration, drug solvents, and combina- tion medications. Conclusions The general safety of using XI for treating cardiovascular diseases was acceptable in this systematic review. Although Xl was systematically analyzed to be safely used in case reports, mechanism studies or large sample observational studies are lack.