Effects of Safflower Yellow on the Treatment of Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial

Abstract

Objective. To evaluate the clinical effect of safflower yellow on the treatment of severe sepsis and septic shock. Methods. 85 patients with severe sepsis and septic shock were randomly selected to receive either therapy according to the international guidelines for management of severe sepsis and septic shock (Surviving Sepsis Campaign 2012) (control group, n = 45) or conventional therapy plus safflower yellow (study group, n = 40). The 28-day mortality and 28-day Kaplan-Meier survival curves were compared as primary outcomes. Results. The 28-day mortality from all causes and in-hospital mortality were significantly lower in the study group (50%, 17.5%) as compared to the control group (78.58%, 54.76%) (P = 0.007, all causes, P < 0.001, in-hospital), and the 28-day Kaplan-Meier survival curve was higher in the study group than in the control group (P = 0.008, all causes, P < 0.001, in-hospital, Log Rank). 72 hours after treatment, secondary outcomes including heart rate, leukocyte counts, lactate levels, and platelet counts of patients in the study group were ameliorated significantly as compared with the control group. Conclusion. This study offers a potential new strategy employing safflower yellow to more effectively treat patients with severe sepsis and septic shock. This trial is registered with identifier ChiCTR-TRC-14005196.

The Repression of the HMGB1-TLR4-NF-κB Signaling Pathway by Safflower Yellow May Improve Spinal Cord Injury

“…Hydroxysafflor yellow A-4 -O-b-D-glucopyranoside and 3 -hydroxyhydroxysafflor yellow A are separated from the SY (Zhang et al, 2020). SY has anti-infection and anti-inflammatory properties, and has been used for the clinical treatment of patients who suffer from severe sepsis and septic shock (Li et al, 2016). Furthermore, SY has anti-fibrotic (Wang et al, 2011), anti-oxidative (Wang et al, 2020), anti-coagulative (Sun et al, 2010), anti-obesity (Yan et al, 2020), anti-calcium-antagonist (Du et al, 2019), and neuroprotective effects (Pang et al, 2020).…”

Hydroxysafflor Yellow A Attenuates the Apoptosis of Peripheral Blood CD4+ T Lymphocytes in a Murine Model of Sepsis

“…Our results indicate that HSYA can reduce the release of inflammatory cytokines under septic conditions. Previously, Li et al (2016) have also shown that safflower yellow significantly reduces 28-day mortality and increases survival in patients with severe sepsis and septic shock, and decreasing inflammatory reaction accounts for this protection.…”

The Effects of Safflower Yellow on Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized, Controlled Clinical Trial

“…Hydroxysafflor yellow A (CAS number is 78281-02-4) is a major ingredient in safflower yellow, and hydroxysafflor yellow A represents the most abundant and active components in safflower yellow. The main pharmacological effects of safflor yellow A are that it is an antagonist for platelet-activating factor receptor, and platelet-activating factor receptor in the lung tissue of patients with COPD was obviously upregulated [11], which increased airway inflammation, so we used hydroxysafflor yellow A to block upregulated platelet-activating factor receptor in AECOPD, which reduced pathogen adhesion and airway response. Furthermore, T lymphocyte apoptosis was inhibited by safflower yellow [26].…”

“…PAF acts not only on platelets but also on leukocytes, endothelial cells, lymphocytes, macrophages, and other cells and participates in the pathophysiological process of allergic asthma, acute inflammation, and other diseases. As a PAF inhibitor, safflower yellow has anticoagulant, anti-inflammatory, vasodilator, and antioxidant effects [8–11]. The recent research literature has shown that PAF receptor is a specific adhesion point of bacteria on cells, especially common haemophilus influenzae (NTHi) and streptococcus pneumoniae in the respiratory tract, which are prone to adhesion to small airway epithelial cells, the reticular basement membrane, and the alveolar space of COPD patients [12].…”

“…As such, the PAF receptor was the potential target for the treatment of patients with AECOPD, so we selected safflower yellow as a therapy to treat AECOPD. In our previous clinic trial, we also attempted to treat patients with severe sepsis and septic shock using safflower yellow and achieved good clinical anti-infection and anti-inflammation effects [11]. Clinical data on the use of safflower yellow in the treatment of AECOPD are sparse; furthermore, the existing studies often have ambiguous research designs and are not strictly prospective randomized controlled trials [14, 15].…”