系统评价丹参酮ⅡA磺酸钠注射液联合依那普利治疗肺心病急性加重期患者的临床疗效和安全性。从EMbase筛选丹参酮Ⅱ_A磺酸钠注射液联合依那普利治疗肺心病急性加重期的随机对照试验(RCT),PubMed,WebofScience,科克伦图书馆,VIP,CNKI,和万方自成立至2022年3月20日。在RevMan5.3和TSA0.9中对各指标进行Meta分析。最后,纳入41个RCTs,涉及3865例患者。Meta分析显示,观察组总有效率较高(RR=1.21,95CI[1.18,1.24],P<0.00001),较低的血浆粘度(MD=-0.25,95CI[-0.34,-0.16],P<0.00001),降低全血黏度(MD=-0.99,95CI[-1.14,-0.85],P<0.00001),和较低的血细胞比容(MD=-9.03,95CI[-10.57,-7.50],P&lt;0.00001)比对照组。两组不良反应发生率无显著差异(RR=1.42,95CI[0.82,2.45],P=0.21)。序贯分析显示丹参酮Ⅱ_A磺酸钠注射液联合依那普利治疗肺心病急性加重期疗效确切,并排除了假阳性的可能性。根据现有证据,丹参酮Ⅱ_A磺酸钠注射液联合依那普利可提高总有效率,降低血浆粘度,全血黏度,和血细胞比容,证明肺心病急性加重患者具有良好的安全性。在未来,更多的RCT与大样本量,严谨的设计,并根据国际规范需要进一步验证结果。
To systematically evaluate the clinical efficacy and safety of Tanshinone Ⅱ_A Sodium Sulfonate Injection combined with
enalapril in the treatment of patients with acute exacerbation of pulmonary heart disease. The randomized controlled trial(RCT) on Tanshinone Ⅱ_A Sodium Sulfonate Injection combined with
enalapril for acute exacerbation of pulmonary heart disease was screened from EMbase, PubMed, Web of Science, Cochrane Library, VIP, CNKI, and Wanfang from inception to March 20, 2022. Meta-analysis of each index was performed in RevMan 5.3 and TSA 0.9. Finally, 41 RCTs involving 3 865 patients were included. Meta-analysis showed that the observation group had higher total response rate(RR=1.21, 95%CI[1.18, 1.24], P<0.000 01), lower plasma viscosity(MD=-0.25, 95%CI[-0.34,-0.16], P<0.000 01), lower whole blood viscosity(MD=-0.99, 95%CI[-1.14,-0.85], P<0.000 01), and lower hematokrit(MD=-9.03, 95%CI[-10.57,-7.50], P<0.000 01) than the control group. The incidence of adverse effects showed no significant difference between groups(RR=1.42, 95%CI[0.82, 2.45], P=0.21). Sequential analysis showed that Tanshinone Ⅱ_A Sodium Sulfonate Injection combined with
enalapril exerted definite efficacy in the treatment of acute exacerbation of pulmonary heart disease, and the possibility of false positives was excluded. Based on the existing evidence, Tanshinone Ⅱ_A Sodium Sulfonate Injection combined with
enalapril can improve the total response rate and reduce plasma viscosity, whole blood viscosity, and hematocrit, demonstrating good safety in patients with acute exacerbation of pulmonary heart disease. In the future, more RCT with large sample size, rigorous design, and in accordance with international norms are needed to further validate the results.