Efficacy and Safety of Panax Notoginseng Saponins (Xueshuantong) in Patients With Acute Ischemic Stroke (EXPECT) Trial: Rationale and Design

Abstract

Background: Although revascularization treatment is recommended as the first-line therapy for patients with non-minor acute ischemic stroke (AIS), it only benefits a minority of patients. Previous studies have reported the positive effects of Panax notoginseng saponins (PNS) (Xueshuantong lyophilized powder) on AIS, however, there have been no rigorous trials. This study aims to assess the efficacy and safety of PNS therapy for patients with AIS.Methods: The Evaluation of Xueshuantong in Patients with acutE ischemiC sTroke (EXPECT) trial is a multicenter, randomized, placebo-controlled, double-blind study aiming to enroll 480 patients in China. Eligible patients with AIS within 72 h of symptom onset will randomly receive either PNS or PNS placebo for 10 days and subsequently be followed up to 90 days. The primary outcome will be a change in the National Institute of Health Stroke Scale (NIHSS) score from baseline to 10 post-randomization days. The secondary outcomes include early neurological improvement (proportion of patients with NIHSS score 0–1), and Patient-Reported Outcomes Scale for Stroke score at 10 post-randomization days, the proportion of patients with life independence (modified Rankin Scale score of 0–1), the proportion of patients with a favorable outcome (Barthel Index ≥90), and Stroke-Specific Quality of Life score at 90 days. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of PNS.Conclusions: To our knowledge, this study is the first double-blind trial to assess the efficacy and safety of PNS in patients with AIS. Findings of the EXPECT trial will be valuable in improving evidence regarding the clinical application of PNS therapy in patients with AIS ineligible for revascularization treatment in the reperfusion era.

Molecular mechanisms underlying the therapeutic effects of Linggui Zhugan decoction in stroke: Insights from network pharmacology and single-cell transcriptomics analysis

“…These effects may be attributed to its ability to inhibit oxidative stress and endoplasmic reticulum stress, consequently playing a role in maintaining BBB integrity. [32] The efficacy of TCM in stroke treatment has been demonstrated through the identification of active ingredients such as Panax notoginseng saponins [33] and salvianolic acid IIA. [34] Network pharmacology analysis has further revealed 144 potential active components in LZD, among which quercetin, kaempferol, and oleic acid, exhibited the most targeted effects.…”

Traditional Chinese medicines treat ischemic stroke and their main bioactive constituents and mechanisms

“…Xueshuantong for injection (XSTI) is produced from extracts from the roots and rhizomes of Notoginseng Radix . XSTI is a clinically used Chinese patent medicine for activating blood and resolving stasis, which is widely used in cerebral infarction, coronary heart disease, and venous thrombosis (Feng et al, 2021). Notoginsenoside R1, Ginsenoside Rg1, and Ginsenoside Rb1 are the main components (Pintusophon et al, 2019).…”

Research progress on metabolomics in the quality evaluation and clinical study ofPanax ginseng

“…The major reason for this is that different preparation techniques are applied by different manufacturers. With the increased clinical application of injection of total saponins from P. notoginseng (ISPN), a modern preparation derived from TCM, adverse drug reactions and related safety issues have attracted much attention (Feng et al, 2021). A recent report was the first to demonstrate that Rg5, Rk1, and 20(S)‐ginsenoside Rh2 were potential compounds of clinical adverse drug reactions in the clinical practice of ISPN (Wang et al, 2022).…”