Xiang Qian, Wang Mengxi, Ding Yuhan, Fan Manlu, Tong Huaqin, Chen Jiandong, Yu Peng, Shen Le, Chen Xiaohu
Department of Cardiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Department of Cardiology, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
Front Pharmacol. 2022 Apr 4;13:832782. doi: 10.3389/fphar.2022.832782. eCollection 2022.
Heart failure with reduced ejection fraction (HFrEF) is a complex, chronic disease and is among the top causes of morbidity and mortality. Angiotensin receptor-neprilysin inhibitor drugs represented by sacubitril/valsartan are the key drugs for the treatment of HFrEF in western medicine, and Qili Qiangxin Capsule (QQC) is a vital drug for the treatment of HFrEF in Chinese medicine. In recent years, there have been many relevant clinical studies on the combination of the two in the treatment of HFrEF. There are no systematic reviews or meta-analyses specific to sacubitril/valsartan combined with QQC for the treatment of HFrEF, so there is an urgent need to evaluate the effectiveness and safety of these two drugs. To systematically assess the safety and effectiveness of QQC combined with sacubitril/valsartan in the treatment of HFrEF through a meta-analysis. Searching studies on the combination of QQC and sacubitril/valsartan in the treatment of HFrEF, from databases such as PubMed, Cochrane Library, Web of Science, Wanfang Databases, Chinese Biomedical Literature Database, China Science and Technology Journal Database, and China National Knowledge Infrastructure, prior to 31 October 2021. Two reviewers regulated research selection, data extraction, and risk of bias assessment. Review Manager Software 5.4 was used for meta-analysis. There were 26 studies with 2,427 patients included in total. The meta-analysis showed the combination therapy has significant advantages in improving the clinical efficacy, 6-MWT (RR = 1.18, 95% CI: 1.11-1.26, MD = 70.65, 95% CI: 23.92-117.39), superior in ameliorating LVEF, LVEDD, LVESD, and SV (LVEF: MD = 5.41, 95% CI: 4.74-6.08; LVEDD: MD = -4.41, 95% CI: -6.19 to -2.64; LVESD: MD = -3.56, 95% CI: -4.58 to -2.54; and SV: MD = 5.04, 95% CI: 3.67-6.40), and in improving BNP, NT-proBNP, AngII, and ALD (BNP: MD = -97.55, 95% CI: -112.79 to -82.31; NT-proBNP: MD = -277.22, 95% CI: -348.44 to -206.01; AngII: MD = -11.48, 95% CI: -15.21 to -7.76; and ALD: MD = -26.03, 95% CI: -38.91 to -13.15), and all the differences have statistical advantages (p < 0.05). There are no advantages in improving CO and adverse events (MD = 0.66, 95% CI: -0.12 to 1.43 and RR = 0.62, 95% CI: 0.37-1.04, respectively), and the differences have no statistical advantages. Compared with the control group, QQC combined with sacubitril/valsartan may be effective in the treatment of HFrEF. However, the conclusion of this study must be interpreted carefully due to the high risk and ambiguity of bias in the included trials.
射血分数降低的心力衰竭（HFrEF）是一种复杂的慢性疾病，是发病率和死亡率的主要原因之一。以沙库巴曲缬沙坦为代表的血管紧张素受体脑啡肽酶抑制剂药物是西医治疗HFrEF的关键药物，而芪苈强心胶囊（QQC）是中医治疗HFrEF的重要药物。近年来，关于两者联合治疗HFrEF有许多相关临床研究。目前尚无关于沙库巴曲缬沙坦联合QQC治疗HFrEF的系统评价或Meta分析，因此迫切需要评估这两种药物的有效性和安全性。通过Meta分析系统评价QQC联合沙库巴曲缬沙坦治疗HFrEF的安全性和有效性。检索截至2021年10月31日PubMed、Cochrane图书馆、Web of Science、万方数据库、中国生物医学文献数据库、中国科技期刊数据库和中国知网等数据库中关于QQC与沙库巴曲缬沙坦联合治疗HFrEF的研究。两名评价员负责研究筛选、数据提取和偏倚风险评估。使用Review Manager软件5.4进行Meta分析。共纳入26项研究，2427例患者。Meta分析显示，联合治疗在提高临床疗效方面具有显著优势，6分钟步行试验（RR = 1.18，95%CI：1.11 - 1.26，MD = 70.65，95%CI：23.92 - 117.39），在改善左心室射血分数（LVEF）、左心室舒张末期内径（LVEDD）、左心室收缩末期内径（LVESD）和每搏输出量（SV）方面更优（LVEF：MD = 5.41，95%CI：4.74 - 6.08；LVEDD：MD = -4.41，95%CI：-6.19至-2.64；LVESD：MD = -3.56，95%CI：-4.58至-2.54；SV：MD = 5.04，95%CI：3.67 - 6.40），在改善脑钠肽（BNP）、N末端脑钠肽前体（NT-proBNP）、血管紧张素II（AngII）和醛固酮（ALD）方面也更优（BNP：MD = -97.55，95%CI：-112.79至-82.31；NT-proBNP：MD = -277.22，95%CI：-348.44至-206.01；AngII：MD = -11.48，95%CI：-15.21至-7.76；ALD：MD = -26.03，95%CI：-38.91至-13.15），且所有差异均具有统计学优势（p < 0.05）。在改善心输出量（CO）和不良事件方面无优势（MD = 0.66，95%CI：-0.12至1.43；RR = 0.62，95%CI：0.37 - 1.04），差异无统计学意义。与对照组相比，QQC联合沙库巴曲缬沙坦可能对治疗HFrEF有效。然而，由于纳入试验存在高风险和偏倚的模糊性，本研究的结论必须谨慎解读。
