Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial

Background: Shenfu injection is a traditional Chinese medicine formulation that alleviates ischemia-reperfusion injury through multiple pharmacologic effects. However, no data are available regarding its efficacy in patients with myocardial infarction. We aimed to examine the effects of Shenfu injec...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Xiao Wang, Huangtai Miao, Yan Yan, Ruifeng Guo, Wei Gong, Yi He, Hui Wang, Xinliang Ma, Shaoping Nie
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	myocardial infarction primary percutaneous coronary intervention reperfusion injury Shenfu injection cardiac magnetic resonance imaging Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/0439b2c85e6a4969b210d86362bfe49f
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:0439b2c85e6a4969b210d86362bfe49f
record_format	dspace
spelling	oai:doaj.org-article:0439b2c85e6a4969b210d86362bfe49f2021-12-03T06:23:45ZEffect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial2297-055X10.3389/fcvm.2021.736526https://doaj.org/article/0439b2c85e6a4969b210d86362bfe49f2021-12-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fcvm.2021.736526/fullhttps://doaj.org/toc/2297-055XBackground: Shenfu injection is a traditional Chinese medicine formulation that alleviates ischemia-reperfusion injury through multiple pharmacologic effects. However, no data are available regarding its efficacy in patients with myocardial infarction. We aimed to examine the effects of Shenfu injection on infarct size in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).Methods: From April 2016 to February 2018, 40 patients with first-time anterior STEMI undergoing primary PCI within 6 h of symptom onset were randomized 1:1 to intravenous Shenfu injection (80 ml Shenfu injection + 70 ml 5% glucose injection) or placebo (150 ml 5% glucose injection) before reperfusion. Treatment started before PCI and maintained for 5 days after PCI. The primary end point was infarct size assessed by CK-MB area under the curve (AUC) over 72 h and cardiac magnetic resonance (CMR) imaging 4 ± 1 days after PCI.Results: Infarct size by area under the curve for CK-MB over 72 h did not differ between the Shenfu injection and placebo groups (5602.5 [3539.4–7526.4] vs. 6403.2 [2234.4–8340.6] ng·h/ml, P = 0.82). Among 32 patients who underwent CMR Imaging, a nominal reduction in infarct size was observed in the Shenfu injection group compared with the placebo group (23.9 [15.2–28.5] % vs. 27 [21.9–31.9] %, P = 0.42). After excluding patients with no or minimal infarct, there was a trend toward reduction in infarct size in the Shenfu injection group (24.1 [20.3–29.3] % vs. 29.1 [24.5–32] %, P = 0.18). Incidence of adverse events was similar between the groups.Conclusions: This pilot study showed that the use of Shenfu injection was safe but did not reduce infarct size by CMR Imaging and CK-MB release kinetics in reperfused patients with STEMI. Larger studies (confining to patients with extensive infarct size) to evaluate the efficacy of Shenfu injection on reperfusion injury are warranted.Clinical Trail Registration:clinicaltrials.gov, identifier: NCT02709798.Xiao WangHuangtai MiaoYan YanRuifeng GuoWei GongYi HeYi HeHui WangXinliang MaShaoping NieFrontiers Media S.A.articlemyocardial infarctionprimary percutaneous coronary interventionreperfusion injuryShenfu injectioncardiac magnetic resonance imagingDiseases of the circulatory (Cardiovascular) systemRC666-701ENFrontiers in Cardiovascular Medicine, Vol 8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	myocardial infarction primary percutaneous coronary intervention reperfusion injury Shenfu injection cardiac magnetic resonance imaging Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	myocardial infarction primary percutaneous coronary intervention reperfusion injury Shenfu injection cardiac magnetic resonance imaging Diseases of the circulatory (Cardiovascular) system RC666-701 Xiao Wang Huangtai Miao Yan Yan Ruifeng Guo Wei Gong Yi He Yi He Hui Wang Xinliang Ma Shaoping Nie Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial
description	Background: Shenfu injection is a traditional Chinese medicine formulation that alleviates ischemia-reperfusion injury through multiple pharmacologic effects. However, no data are available regarding its efficacy in patients with myocardial infarction. We aimed to examine the effects of Shenfu injection on infarct size in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).Methods: From April 2016 to February 2018, 40 patients with first-time anterior STEMI undergoing primary PCI within 6 h of symptom onset were randomized 1:1 to intravenous Shenfu injection (80 ml Shenfu injection + 70 ml 5% glucose injection) or placebo (150 ml 5% glucose injection) before reperfusion. Treatment started before PCI and maintained for 5 days after PCI. The primary end point was infarct size assessed by CK-MB area under the curve (AUC) over 72 h and cardiac magnetic resonance (CMR) imaging 4 ± 1 days after PCI.Results: Infarct size by area under the curve for CK-MB over 72 h did not differ between the Shenfu injection and placebo groups (5602.5 [3539.4–7526.4] vs. 6403.2 [2234.4–8340.6] ng·h/ml, P = 0.82). Among 32 patients who underwent CMR Imaging, a nominal reduction in infarct size was observed in the Shenfu injection group compared with the placebo group (23.9 [15.2–28.5] % vs. 27 [21.9–31.9] %, P = 0.42). After excluding patients with no or minimal infarct, there was a trend toward reduction in infarct size in the Shenfu injection group (24.1 [20.3–29.3] % vs. 29.1 [24.5–32] %, P = 0.18). Incidence of adverse events was similar between the groups.Conclusions: This pilot study showed that the use of Shenfu injection was safe but did not reduce infarct size by CMR Imaging and CK-MB release kinetics in reperfused patients with STEMI. Larger studies (confining to patients with extensive infarct size) to evaluate the efficacy of Shenfu injection on reperfusion injury are warranted.Clinical Trail Registration:clinicaltrials.gov, identifier: NCT02709798.
format	article
author	Xiao Wang Huangtai Miao Yan Yan Ruifeng Guo Wei Gong Yi He Yi He Hui Wang Xinliang Ma Shaoping Nie
author_facet	Xiao Wang Huangtai Miao Yan Yan Ruifeng Guo Wei Gong Yi He Yi He Hui Wang Xinliang Ma Shaoping Nie
author_sort	Xiao Wang
title	Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial
title_short	Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial
title_full	Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial
title_fullStr	Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial
title_full_unstemmed	Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial
title_sort	effect of shenfu injection on reperfusion injury in patients undergoing primary percutaneous coronary intervention for st segment elevation myocardial infarction: a pilot randomized clinical trial
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/0439b2c85e6a4969b210d86362bfe49f
work_keys_str_mv	AT xiaowang effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT huangtaimiao effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT yanyan effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT ruifengguo effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT weigong effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT yihe effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT yihe effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT huiwang effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT xinliangma effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial AT shaopingnie effectofshenfuinjectiononreperfusioninjuryinpatientsundergoingprimarypercutaneouscoronaryinterventionforstsegmentelevationmyocardialinfarctionapilotrandomizedclinicaltrial
_version_	1718373851858993152

Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial

Ejemplares similares