Sodium Tanshinone Ⅱ A Sulfonate for Coronary Heart Disease: A Systematic Review of Randomized Controlled Trials

Objective: To assess whether an adjunctive therapy of Sodium Tanshinone ⅡA Sulfonate Injection(STS) is effective and safe in improving clinical outcomes in patients with coronary heart disease(CHD). Methods: A literature search was conducted through PubMed, the Cochrane Library, Knowledge Infrastructure Databases(CNKI), Chinese Biomedical Literature Database(SinoMed), Chinese Science and Technology Periodical Database(VIP) and Wanfang Database up to August 2017. Randomized controlled trials(RCTs) comparing STS with placebo or no additional treatments on the basis of standard conventional medicine therapies were included. The outcomes were all-cause mortality, major acute cardiovascular events(MACEs), cardiac function and inflammatory factors. The risk of bias assessment according to the Cochrane Handbook was used to evaluate the methodological quality of the included trials. Revman 5.3 software was used for data analyses. Results: A total of 22 RCTs involving 1,873 participants were included. All of the trials used STS as adjunctive treatment to standard conventional medicine therapy. Due to the poor quality of methodologies of most trials, only limited evidence showed that a combination of STS with percutaneous coronary intervention(PCI) or thrombolytic therapy(TT) might be more effective on reduction of all cause death rate than TT alone [risk ratio(RR) 0.25, 95% confidence interval(CI) 0.07 to 0.87] or PCI alone(RR 0.42, 95% CI 0.04 to 4.36). The results of 6 trials comparing STS plus TT with TT alone showed that the addition of STS significantly reduced the incidence of cardiac shock(RR 0.35, 95% CI 0.14 to 0.86), heart failure(RR 0.41, 95% CI 0.20 to 0.83) and arrhythmia(RR 0.21, 95% CI 0.12 to 0.46). STS combined with TT also showed a superior effect on cardiac function and inflammatory factor. No severe adverse event was reported related to STS. Conclusions: As an adjunctive therapy, STS combined with standard conventional medicine seems to be more effective on all-cause mortality or MACEs than conventional medicine treatment alone with less side effects. However, we cannot make a firm conclusion due to low quality of inclusion trials. Well-designed trials with high methodological quality are needed to validate the effect of STS for CHD patients.