Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase II, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial

Hu, Mingzhe; Zhou, Zhongyu; Lu, Hui; Gao, Min; Long-min, Liu; Song, Haiqing; Lin, Ang; Wu, Qingming; Zhou, Hongfei; Li, Lei; Wang, Xia; Cai, Yefeng

doi:10.1007/s11655-020-3094-7

Cited by 27 publications

(13 citation statements)

References 23 publications

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“…HSYA showed excellent neuroprotective effect. HSYA injection (50 mg/d and 75 mg/d) in patients with acute ischemic stroke of blood stasis syndrome might be to undergo for a phase III clinical trial (Zhu et al, 2020). HSYA (2 mg/kg, tail vein injection) protected the C57BL/6J mice against middle cerebral artery occlusion (MCAO) by decreasing the expression of inflammatory genes factors, including TNF-α, IL-1β, and NO (Lv et al, 2015).…”

Section: Neuroprotective Effectmentioning

confidence: 99%

Hydroxysafflor Yellow A: A Systematical Review on Botanical Resources, Physicochemical Properties, Drug Delivery System, Pharmacokinetics, and Pharmacological Effects

et al. 2020

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Hydroxysafflower yellow A (HSYA), as a principal natural ingredient extracted from safflower (Carthamus tinctorius L.), has significant pharmacological activities, such as antioxidant, anti-inflammatory, anticoagulant, and anticancer effects. However, chemical instability and low bioavailability have been severely hampering the clinical applications of HSYA during the treatment of cardiovascular and cerebrovascular disease. Therefore, this present review systematically summarized the materials about HSYA, including acquisition methods, extraction and detection methods, pharmacokinetics, pharmacological effects and molecular mechanism, especially focus on the possible causes and resolutions about the chemical instability and low bioavailability of HSYA, in order to provide relatively comprehensive basic data for the related research of HSYA.

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Section: Neuroprotective Effectmentioning

confidence: 99%

Hydroxysafflor Yellow A: A Systematical Review on Botanical Resources, Physicochemical Properties, Drug Delivery System, Pharmacokinetics, and Pharmacological Effects

et al. 2020

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“…Hydroxysafflor yellow A (HSYA) is the dominant watersoluble component of C. tinctorius L., which is used for treating cardiovascular diseases [10]. Notably, HSYA injection has been clinically used in China to treat stable fatigue angina caused by blood stasis [11]. Our team proved that HSYA plays a protective role against MI/RI and cardiomyocyte hypoxia-reoxygenation (HR) injury [12,13].…”

Section: Introductionmentioning

confidence: 89%

Hydroxysafflor Yellow A Ameliorates Myocardial Ischemia/Reperfusion Injury by Suppressing Calcium Overload and Apoptosis

Wang

et al. 2021

Oxidative Medicine and Cellular Longevity

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Myocardial ischemia/reperfusion injury (MI/RI) is an urgent problem with a great impact on health globally. However, its pathological mechanisms have not been fully elucidated. Hydroxysafflor yellow A (HSYA) has a protective effect against MI/RI. This study is aimed at further clarifying the relationship between HSYA cardioprotection and calcium overload as well as the underlying mechanisms. We verified the protective effect of HSYA on neonatal rat primary cardiomyocytes (NPCMs) and human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) from hypoxia-reoxygenation (HR) injury. To explore the cardioprotective mechanism of HSYA, we employed calcium fluorescence, TUNEL assay, JC-1 staining, and western blotting. Finally, cardio-ECR and patch-clamp experiments were used to explain the regulation of L-type calcium channels (LTCC) in cardioprotection mediated by HSYA. The results showed that HSYA reduced the levels of myocardial enzymes and protected NPCMs from HR injury. HSYA also restored the contractile function of hiPSC-CMs and field potential signal abnormalities caused by HR and exerted a protective effect on cardiac function. Further, we demonstrated that HSYA protects cardiomyocytes from HR injury by decreasing mitochondrial membrane potential and inhibiting apoptosis and calcium overload. Patch-clamp results revealed that MI/RI caused a sharp increase in calcium currents, which was inhibited by pretreatment with HSYA. Furthermore, we found that HSYA restored contraction amplitude, beat rate, and field potential duration of hiPSC-CMs, which were disrupted by the LTCC agonist Bay-K8644. Patch-clamp experiments also showed that HSYA inhibits Bay-K8644-induced calcium current, with an effect similar to that of the LTCC inhibitor nisoldipine. Therefore, our data suggest that HSYA targets LTCC to inhibit calcium overload and apoptosis of cardiomyocytes, thereby exerting a cardioprotective effect and reducing MI/RI injury.

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“…The randomized controlled clinical trial (RCT) is an essential step in confirming the efficacy and safety of drugs. In contrast with the large numbers of preclinical experiments, only a few completed RCTs of HSYA were reported, which were mainly reflected in evaluating the efficacy and safety of HSYA injection in the treatment of acute ischemic stroke with blood stasis syndrome ( Qin et al., 2016 ; Hu et al., 2020 ), followed by a currently ongoing phase III RCT (No. CTR20150839, ).…”

Section: Conclusion and Prospectsmentioning

confidence: 99%

Therapeutic Potential of Hydroxysafflor Yellow A on Cardio-Cerebrovascular Diseases

Bai

Wang

et al. 2020

Front. Pharmacol.

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The incidence rate of cardio-cerebrovascular diseases (CCVDs) is increasing worldwide, causing an increasingly serious public health burden. The pursuit of new promising treatment options is thus becoming a pressing issue. Hydroxysafflor yellow A (HSYA) is one of the main active quinochalcone C-glycosides in the florets of Carthamus tinctorius L., a medical and edible dual-purpose plant. HSYA has attracted much interest for its pharmacological actions in treating and/or managing CCVDs, such as myocardial and cerebral ischemia, hypertension, atherosclerosis, vascular dementia, and traumatic brain injury, in massive preclinical studies. In this review, we briefly summarized the mode and mechanism of action of HSYA on CCVDs based on these preclinical studies. The therapeutic effects of HSYA against CCVDs were presumed to reside mostly in its antioxidant, anti-inflammatory, and neuroprotective roles by acting on complex signaling pathways.

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Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase II, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial

Cited by 27 publications

References 23 publications

Hydroxysafflor Yellow A: A Systematical Review on Botanical Resources, Physicochemical Properties, Drug Delivery System, Pharmacokinetics, and Pharmacological Effects

Hydroxysafflor Yellow A: A Systematical Review on Botanical Resources, Physicochemical Properties, Drug Delivery System, Pharmacokinetics, and Pharmacological Effects

Hydroxysafflor Yellow A Ameliorates Myocardial Ischemia/Reperfusion Injury by Suppressing Calcium Overload and Apoptosis

Therapeutic Potential of Hydroxysafflor Yellow A on Cardio-Cerebrovascular Diseases

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