Zhou Hufang, Zhao Ying, Peng Wenhua, Han Wenbo, Wang Zichen, Ren Xiaoxia, Wang Dayang, Pan Guozhong, Lin Qian, Wang Xian
Cardiovascular Diseases Center, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.
Front Cardiovasc Med. 2021 Nov 24;8:770746. doi: 10.3389/fcvm.2021.770746. eCollection 2021.
Lipid-lowering therapy is very important in secondary prevention of coronary heart disease (CHD). In many clinical trials, it has been found that Sodium Tanshinone IIA Sulfonate Injection (STS) have a lipid-lowering effect while reducing major cardiovascular events in patients with CHD. However, up to now, there is no system review on the effectiveness and safety of STS affecting blood lipids. The aim of this review is to systematically assess the effects of STS on blood lipid levels in patients with CHD. Until Mar 2021, five databases (PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and Wanfang Database) were searched for randomized controlled trials (RCTs) about STS treating patients with CHD. Risk bias was assessed for included studies according to Cochrane handbook. The primary outcome was total cholesterol (TC). The secondary outcomes were triglycerides (TG), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), and adverse events (AEs). A total of 27 trials including 2,445 CHD patients met the eligibility criteria. Most trials had high risks in random sequence generation, allocation concealment, blinding of patients and personal, blinding of outcome assessment. Meta-analysis showed that STS significantly reduced plasma TC levels [MD = -1.34 mmol/l 95% CI (-1.59, -1.09), < 0.00001, = 98%], TG levels [MD = -0.49 mmol/l 95% CI (-0.62, -0.35), < 0.00001, = 97%], LDL-c levels [MD = -0.68 mmol/l (-0.80, -0.57), < 0.00001, = 96%], increased HDL-c levels [MD = 0.26 mmol/l (0.15, 0.37), < 0.00001, = 97%], without increasing the incidence of AEs [RR = 1.27 95% CI (0.72, 2.27), = 0.94, = 0%] in patients with CHD. STS can safely and effectively reduce plasma TC, TG and LDL-c levels in patients with CHD, and improve plasma HDL-c levels. However, these findings require careful recommendation due to the low overall quality of RCTs at present. More multi-center, randomized, double-blind, placebo-controlled trials which are designed follow the CONSORT 2010 guideline are needed.
降脂治疗在冠心病（CHD）的二级预防中非常重要。在许多临床试验中，已发现丹参酮ⅡA磺酸钠注射液（STS）具有降脂作用，同时可减少冠心病患者的主要心血管事件。然而，截至目前，尚无关于STS影响血脂的有效性和安全性的系统评价。本综述的目的是系统评估STS对冠心病患者血脂水平的影响。截至2021年3月，检索了五个数据库（PubMed、EMBASE、Cochrane图书馆、中国知网和万方数据库），以查找关于STS治疗冠心病患者的随机对照试验（RCT）。根据Cochrane手册对纳入研究进行风险偏倚评估。主要结局指标是总胆固醇（TC）。次要结局指标是甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-c）、高密度脂蛋白胆固醇（HDL-c）和不良事件（AE）。共有27项试验，包括2445例冠心病患者符合纳入标准。大多数试验在随机序列产生、分配隐藏、患者和研究者设盲、结局评估设盲方面存在高风险。荟萃分析表明，STS可显著降低冠心病患者的血浆TC水平[MD = -1.34 mmol/l，95%CI（-1.59，-1.09），P < 0.00001，I² = 98%]、TG水平[MD = -0.49 mmol/l，95%CI（-0.62，-0.35），P < 0.00001，I² = 97%]、LDL-c水平[MD = -0.68 mmol/l（-0.80，-0.57），P < 0.00001，I² = 96%]，升高HDL-c水平[MD = 0.26 mmol/l（0.15，0.37），P < 0.00001，I² = 97%]，且不增加不良事件的发生率[RR = 1.27，95%CI（0.72，2.27），P = 0.94，I² = 0%]。STS可安全有效地降低冠心病患者的血浆TC、TG和LDL-c水平，并提高血浆HDL-c水平。然而，由于目前RCT的总体质量较低，这些研究结果需要谨慎推荐。需要更多遵循CONSORT 2010指南设计的多中心、随机、双盲、安慰剂对照试验。
