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Effects of heart failure with reduced ejection fraction with Shenfu Injection: a Meta-analysis and GRADE evaluation
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DOI   10.11656/j.issn.1672-1519.2022.06.16
Key Words   Shenfu Injection;HFrEF;Meta-analysis;GRADE evaluation
Author NameAffiliationE-mail
ZHAO Ting Cardiology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China 
 
CAO Yawen Cardiology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China 
 
YANG Ying Cardiology Department, Tianjin Nankai District Traditional Chinese Medicine Hospital, Tianjin 300102, China  
WANG Xianliang Cardiology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China  
BI Yingfei Cardiology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China  
WANG Shuai Cardiology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China  
MAO Jingyuan Cardiology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China jymao@126.com 
Abstract
    Objective To analyze the clinical efficacy and safety of Shenfu Injection on heart failure with reduced ejection fraction (HFrEF), evaluate the evidence level and to provide reference for the rational clinical application of Shenfu Injection in clinical practice.Methods Collected randomized controlled trials (RCT) of the combined Western medicine routine of the Shenfu Injections (treatment group) compared to the Western medical routine (control group) for the treatment of HFrEF in the databases of CBM, CNKI, VIP, WANFANG DATA, PubMed, Embase, the Cochrane Library. Two researchers independently carried out literature screening and extracted the relevant data, and the quality evaluation were carried out by ROB scale. Meta-analysis were carried out by RevMan 5.3 software, and the quality of evidence was graded using the GRADE system.Results The 21 RCT literature were included, with 1 791 patients. Meta-analysis result showed that Shenfu injection combined with Western medicine routine treatment can improve cardiac function (NYHA) [RR=1.17, 95%CI(1.12, 1.23), P < 0.01], and improve quality of life [MD=-4.92, 95%CI(-6.60, -3.24), P < 0.01], improve LVEF [MD=4.71, 95%CI(3.16, 6.27), P < 0.01], and increase 6-minute walk distance (6 MWD) [MD=44.17, 95%CI(19.07, 69.26), P < 0.01], decrease type B Natriuretic peptide (BNP) [MD=-76.42, 95%CI(-92.66, -60.18), P < 0.01]/N-terminal B-type natriuretic peptide (NT-proBNP) [MD=-182.23, 95%CI(-274.07, -90.38), P < 0.01], and the curative effect was better than the Western medicine routine. As to adverse events [RR=1.06, 95%CI(0.41, 2.76), P=0.90], and the curative effect was equivalent to Western medicine routine. According the GRADE, NYHA cardiac function, 6 MWD were low quality evidence, LVEF, Minnesota Living with Heart Failure Questionnaire (MLHFQ) score, BNP, NT-proBNP, safety were very low quality evidence.Conclusion The curative efficacy of treatment of HFrEF in the combination of Shenfu Injections and Western medicine was better than Western medicine routine, and the safety is good, and due to the low quality of the included research. The exact conclusion needs more high-quality research to be further verified.

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