丹参酮ⅡA磺酸钠注射液治疗急性冠脉综合征临床疗效的Meta分析与试验序贯分析  

Meta-analysis and Trial Sequential Analysis of the Clinical Efficacy of Sodium TanshinoneⅡA Sulfonate Injection in the Treatment of Acute Coronary Syndrome

作　　者：罗派格 王沛[1,2] 林珑[1,2] Paige Luo;Pei Wang;Long Lin(Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing,Jiangsu 210029;Nanjing University of Chinese Medicine First Clinical Medical School,Nanjing,Jiangsu 210023)

机构地区：[1]南京中医药大学附属医院,江苏省中医院,江苏南京210029 [2]南京中医药大学第一临床医学院,江苏南京210023

出　　处：《医学研究前沿》2025年第3期26-34,共9页Frontiers of Medical Research

基　　金：2023年度国家中医临床研究基地开放课题(JD2023SZ14)。

摘　　要：目的系统评价丹参酮ⅡA磺酸钠注射液治疗急性冠脉综合征(ACS)的临床疗效。方法通过计算机检索,筛选出建库至2024年3月20日发表在万方数据库、维普、知网、CBM、PubMed等数据库中的相关文献。纳入的研究为丹参酮ⅡA磺酸钠注射液治疗ACS的随机对照试验(RCTs),并根据Cochrane评估标准评价文献质量。采用RevMan 5.4软件进行Meta分析,以及TSA 0.9.5.10 Beta软件进行试验序贯分析。结果共纳入37项RCTs,涉及3066例患者。与对照组相比,试验组(STS联合西医常规治疗)在临床疗效上表现出显著优势,具体指标包括:临床总有效率:[OR=4.68,95%CI(3.61,6.06),P<0.00001]、心电图疗效:[OR=3.62,95%CI(2.74,4.78),P<0.00001]、血液流变学:(全血高切粘度:[MD=-0.56,95%CI(-0.65,-0.48),P=0.11]、全血低切粘度:[MD=-1.43,95%CI(-1.85,-1.00),P<0.00001]、血浆粘度:[MD=-0.11,95%CI(-0.21,-0.00),P=0.05])、血脂(TC:[MD=-0.82 mmol/L,95%CI(-1.39,-0.25),P=0.005]、TG:[MD=-0.30 mmol/L,95%CI(-0.48,-0.13),P=0.0008]、HDL-C:[MD=0.17 mmol/L,95%CI(-0.04,0.38),P<0.00001]、LDL-C:[MD=-0.42 mmol/L,95%CI(-0.60,-0.25),P<0.00001])IL-6:[MD=-3.19 pg/ml,95%CI(-3.99,-2.40),P<0.00001]TNF-α:[MD=-1.90 ng/ml,95%CI(-2.54,-1.25),P<0.00001]、CRP:[MD=-2.21 mg/L,95%CI(-2.84,-1.59),P<0.00001]。此外,联合使用STS进行治疗不会给患者带来额外的治疗风险[OR=0.29,95%CI(0.15-0.56),P=0.0002]。进一步采用试验序贯分析验证了Meta分析结果的可靠性。结论丹参酮ⅡA磺酸钠注射液联合西医常规治疗ACS的临床疗效优于单纯西医常规治疗,且不带来额外治疗风险。Objective To systematically review the clinical efficacy of sodium tanshinoneⅡA sulfonate injection in the treatment of Acute Coronary Syndrome(ACS).Method Relevant literature was identified through computer searches of databases including Wanfang,VIP,CNKI,CBM,and PubMed up to March 20,2024.Included studies were randomized controlled trials(RCTs)using sodium tanshinoneⅡA sulfonate injection for ACS,assessed by the Cochrane criteria for quality of evidence.Meta-analysis was conducted using RevMan 5.4,and trial sequential analysis was performed with TSA 0.9.5.10 Beta.Result A total of 37 RCTs involving 3066 patients were included.Compared with the control group,the trial group(STS combined with conventional Western medicine treatment)showed significant superiority in clinical efficacy.Specific indicators included:Overall clinical efficacy rate:[OR=4.68,95%CI(3.61,6.06),P<0.00001]ECG efficacy:[OR=3.62,95%CI(2.74,4.78),P<0.00001]Hemorheology:(whole blood high shear viscosity:[MD=-0.56,95%CI(-0.65,-0.48),P=0.11],whole blood low shear viscosity:[MD=-1.43,95%CI(-1.85,-1.00),P<0.00001],plasma viscosity:[MD=-0.11,95%CI(-0.21,-0.00),P=0.05])Lipid profile(TC:[MD=-0.82 mmol/L,95%CI(-1.39,-0.25),P=0.005],TG:[MD=-0.30 mmol/L,95%CI(-0.48,-0.13),P=0.0008],HDLC:[MD=0.17 mmol/L,95%CI(-0.04,0.38),P<0.00001],LDL-C:[MD=-0.42 mmol/L,95%CI(-0.60,-0.25),P<0.00001])Inflammatory markers(IL-6:[MD=-3.19 pg/ml,95%CI(-3.99,-2.40),P<0.00001],TNF-α:[MD=-1.90 ng/ml,95%CI(-2.54,-1.25),P<0.00001],CRP:[MD=-2.21 mg/L,95%CI(-2.84,-1.59),P<0.00001]).Additionally,combined treatment with STS did not introduce additional treatment risks[OR=0.29,95%CI(0.15,0.56),P=0.0002].Trial sequential analysis confirmed the meta-analysis results.Conclusion Sodium tanshinoneⅡA sulfonate injection combined with conventional Western medicine treatment for ACS is more effective than conventional treatment alone,without additional treatment risks.

关 键 词：丹参酮ⅡA磺酸钠注射液 急性冠脉综合征 序贯分析 Meta分析 

分 类 号：R542.2[医药卫生—心血管疾病]