| BackgroundElevated serum inflammatory markers, such as high sensitivity C-reactive protein (hs-CRP), were regarded as independent risk factors for cardiovascular events. Sodium tanshinone IIA sulfate (STS) has been proved to have anti-inflammatory effects in basic researches, but the evidence supporting such efficacy in Coronary Heart Disease (CHD) patients remains unclear, especially in a real-world setting with statin treatment.ObjectivesAccording to system review, to investigate the clinical effects of STS on CHD.By conducting a randomized control trial (RCT), to access the effects of STS on elevated serum hs-CRP and other inflammatory markers in patients with CHD.MethodsFirst, we used RevMan5.1.6statistical software in the system review.Furthermore, we conducted a prospective randomized open-label blinded end point (PROBE) designed method in the study.72confirmed CHD inpatient of unstable angina (UA) or acute non-ST segment elevation myocardial infarction (NSTEMI) with elevated serum hs-CRP without any infection were enrolled and randomized1:1into the control or treatment group. Informed consent was obtained from each patient before the study. The control group received standard medication for treatment of CHD including20mg atorvastatin while the treatment group additionally received intravenously a daily80mg dose of STS for14days. The primary outcome was serum hs-CRP level. The secondary outcome were other serum inflammatory factors, including interleukin-6(IL-6), tumor necrosis factor alpha (TNF-a), soluble vascular cell adhesion molecule-1(sVCAM-1), soluble CD40ligand (sCD40L), monocyte chemotactic protein-1(MCP-1), matrix metalloproteinase-9(MMP-9), and improvement in symptoms of angina as well as side effects. Outcome parameters were assessed blindly to treatment allocation at baseline, immediately after the14-day treatment period and at30days after the treatment stopped.Results The result of system review shows the treatment of combined with standard western therapy with STS on patient with CHD, superior to standard western treatment alone in the improvement of clinical symptoms and electrocardiogram. It also shows less adverse reactions at the same time.In the RCT, after14-day treatment, the level of hs-CRP were significantly reduced (6.36±3.42mg/l to2.83±5.94mg/l and5.75±2.39mg/l to1.02±4.31mg/l) in both the treatment and control groups. The reduction of the treatment group was more significant than that of the control group (p=0.0485, IQR:2.9(1.3,6.05) vs1.54(-1.45,3.51) mg/dL), so as the percent change (p=0.0114, media:71.75%vs30%). The reduction in MCP-1and sCD40L of the treatment group was more significant than those of the control group (p=0.013and p=0.0454, respectively). At30days after the treatment stopped, the level of MCP-1had greater reduction in the treatment group compared with that of the control group (p=0.0253,54.64±47.38vs30.72±39.82pg/dL), so as the percent change (P=0.039,13.55%vs.7.59%). Other inflammatory markers had no significant reduction between groups. In addition, treatment with STS also demonstrated greater improvement of angina symptom at the two time-points after treatment when assessed by quantification with scores. There were no serious adverse reactions occurred.ConclusionThe result of System review indicates that combined treatment with STS on CHD has better therapeutic effect in the clinical symptoms and electrocardiogram improvement.On the background of statin therapy, a daily80mg dose of STS intravenously for14days further reduced levels of circulating inflammatory markers of hs-CRP, sCD40L and MCP-1in UA/NSTEMI patients. Together, our study suggested that STS could be used as a complementary treatment in CHD patients with increased inflammatory reaction. |
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