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

2021 ◽  
Vol 12 ◽  
Author(s):  
Luda Feng ◽  
Fang Han ◽  
Li Zhou ◽  
Shengxian Wu ◽  
Yawei Du ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Panax Notoginseng ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Panax Notoginseng Saponins ◽  
Double Blind ◽  
Nihss Score ◽  
Positive Effects ◽  
Patient Reported

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.

scholarly journals Systematic Review and Meta-Analysis on Randomized Controlled Trials on Efficacy and Safety of Panax Notoginseng Saponins in Treatment of Acute Ischemic Stroke

2021 ◽  
Vol 2021 ◽  
pp. 1-17
Author(s):  
Liu-ding Wang ◽  
Zhen-min Xu ◽  
Xiao Liang ◽  
Wen-ran Qiu ◽  
Shao-jiao Liu ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Activities Of Daily Living ◽  
Acute Ischemic Stroke ◽  
Daily Living ◽  
Adverse Reactions ◽  
Meta Analysis ◽  
Panax Notoginseng ◽  
Efficacy And Safety ◽  
Panax Notoginseng Saponins ◽  
Randomized Controlled

Importance. Panax Notoginseng Saponins (PNS) are proven to have antiplatelet effects in patients with acute ischemic stroke (AIS). Objective. To assess the efficacy and safety of PNS on antiplatelet therapy in the treatment of AIS. Methods. We searched 7 literature databases and 2 clinical studies databases for randomized controlled studies (RCTs) evaluating PNS as an adjuvant therapy for AIS. Relevant studies were retrieved and screened, and data were extracted independently by two reviewers. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool. Meta-analysis was carried out with the Rev Man 5.4 software. Results. Of 8267 records identified, 43 RCTs met our inclusion criteria (n = 4170 patients). Patients assigned to PNS with conventional treatments (CTs) had improved functional independence at 90 days compared with those assigned to CTs alone (RR = 1.87, 95% CI = 1.37, to 2.55, P < 0.0001 ). Patients who received PNS combined with CTs showed significantly high improvements in neurological function among individuals with AIS on the neurologic deficit score (NDS) (MDCSS = −5.71, 95% CI = −9.55 to −1.87, P = 0.004 ; MDNIHSS = −3.94, 95% CI = −5.65 to −2.23, P < 0.00001 ). The results also showed PNS contributed to a betterment in activities of daily living (ADL) on the Barthel index (MDday10 BI = 4.86, 95% CI = 2.18, to 7.54, P < 0.00001 ; MDday 14 BI = 13.92, 95% CI = 11.46 to 16.38, P < 0.00001 ; MDday 28 BI = 7.16, 95% CI = 0.60, to 13.72, P < 0.00001 ). In addition, PNS, compared with CTs alone, could significantly improve overall response rate (ORR) (RRNIHSS = 1.20, 95% CI = 1.16, to 1.24, P < 0.00001 ; RRCSS = 1.15, 95% CI = 1.08, to 1.24, P < 0.0001 ), hemorheological parameters, maximum platelet aggregation rate (MPAR) (MD = −6.82, 95% CI = −9.62 to −4.02, P < 0.00001 ), platelet parameters (MDPLT = 4.85, 95% CI = 1.82 to 7.84, P = 0.002 ; MDMPV = −0.79, 95% CI = −1.09 to −0.48, P < 0.00001 ), and serum CD62P (MD = −0.21, 95% CI = −0.29 to −0.13, P < 0.00001 ). The incidence of adverse reactions in PNS was lower than that in the control group (RR = 0.62, 95% CI = 0.39 to 0.97, P = 0.04 ). Adverse reactions in the PNS were mild adverse reactions. Conclusion. PNS may be effective and safe in treating AIS on ameliorating neurological deficit, improving activities of daily living function, and enhancing antiplatelet effects. However, more high-quality evidence is needed before it can be recommended for routine antiplatelet therapy in patients with AIS.

Efficacy and Safety of Timely Urgent Superficial Temporal Artery-to-Middle Cerebral Artery Bypass Surgery in Patients with Acute Ischemic Stroke: A Single-Institutional Prospective Study and a Pooled Analysis

2021 ◽  
pp. 1-12
Author(s):  
Jang Hun Kim ◽  
Wonki Yoon ◽  
Chi Kyung Kim ◽  
Haewon Roh ◽  
Hee Jin Bae ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Middle Cerebral Artery ◽  
Acute Ischemic Stroke ◽  
Cerebral Artery ◽  
Bypass Surgery ◽  
Superficial Temporal Artery ◽  
Pooled Analysis ◽  
Published Data ◽  
Efficacy And Safety ◽  
Nihss Score

<b><i>Background:</i></b> Clinical outcome in patients with acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) is not satisfactory if reperfusion treatment fails or is not tried. <b><i>Aims:</i></b> We aimed to assess the efficacy and safety of urgent superficial temporal-to-middle cerebral artery (STA-MCA) bypass surgery in selected patients. <b><i>Methods:</i></b> Patients who were diagnosed with LVO-induced AIS in the anterior circulation but had a failed intra-arterial thrombectomy (IAT) or were not tried due to IAT contraindications were prospectively enrolled. Timely urgent STA-MCA bypass surgery was performed if they showed perfusion-diffusion mismatch or symptom-diffusion mismatch in the acute phase of disease. Clinical and radiological data of these patients were assessed to demonstrate the safety and efficacy of urgent bypass procedures. A pooled analysis of published data on urgent bypass surgery in acute stroke patients was conducted and analyzed. <b><i>Results:</i></b> In 18 patients who underwent timely bypass, the National Institutes of Health Stroke Scale (NIHSS) score improved from 12.11 ± 4.84 to 9.89 ± 6.52, 1 week after surgery. Three-month and long-term (9.72 ± 5.00 months) favorable outcomes (modified Rankin Scale [mRS] scores 0–2) were achieved in 50 and 75% of the patients, respectively. The pooled analysis (117 patients from 10 articles, including ours) identified favorable mRS scores in 71.79% patients at 3 months. A significant NIHSS score improvement from 11.51 ± 4.89 to 7.59 ± 5.50 was observed after surgery with significance. Major complications occurred in 3 patients (2.6%, 3/117) without mortality. <b><i>Conclusions:</i></b> Urgent STA-MCA bypass surgery can be regarded as a safe optional treatment to prevent cerebral infarct expansion and to improve clinical and radiological outcomes in highly selected patients.

scholarly journals Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Barthel Index ◽  
Controlled Trial ◽  
Survival Rates ◽  
Control Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

A double-blind study of neurotropin in patients with acute ischemic stroke

2009 ◽  
Vol 89 (5) ◽  
pp. 329-335 ◽  
Author(s):  
J. Reuck ◽  
D. Decoo ◽  
P. Vanderdonckt ◽  
A. Dallenga ◽  
W. Ceusters ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind

scholarly journals The Alteration of Plasma Matrix Metalloproteinase-9 Level after the Addition of Bromelin 500 mg to Standard Therapy of Acute Ischemic Stroke and Its Correlation with Outcome

2018 ◽  
Vol 6 (4) ◽  
pp. 624-628
Author(s):  
Puji Pinta Sinurat ◽  
Hasan Sjahrir ◽  
Aldy S. Rambe ◽  
Ratna Akbari Ganie
Keyword(s):  
Ischemic Stroke ◽  
Matrix Metalloproteinase ◽  
Acute Ischemic Stroke ◽  
Standard Therapy ◽  
Statistical Correlation ◽  
Matrix Metalloproteinase 9 ◽  
Standard Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Metalloproteinase 9

BACKGROUND: Matrix metalloproteinase-9 (MMP9) expression due to ischemic cause spreading of brain damage. Previous studies have reported that Bromelin was beneficial as anti-inflammation and prevent brain tissue damage.AIM: This study aimed to determine the alteration of plasma MMP9 level after addition of Bromelin 500 mg to Standard therapy and its correlation with outcome in acute ischemic stroke.METHODS: This was a preliminary report of a prospective randomised, double-blind study with pre and post-test design, forty-six acute ischemic stroke patients were randomly allocated with Bromelin and Standard groups. Measurement of MMP9 and outcome were performed before and after 14-days treatment.RESULT: The Bromelin group showed a significant decrement of MMP9 level, from 6.02 ± 0.32 ng/ml before treatment to 5.50 ± 0.94 ng/ml after treatment (p = 0.028). There was a negative correlation between MMP9 level and mRS (r= -0.03; p = 0.905) and a positive correlation toward BI (r = 0.039; p = 0.859), while the Standard group showed increased MMP9 level from 5.82 ± 0.71 ng/ml to 5.91 ± 0.83 ng/ml (p = 0.616) which was correlated insignificantly to outcome.CONCLUSION: We concluded that the addition of 500 mg Bromelin to standard ischemic stroke therapy reduced MMP9 level significantly and correlated to outcome improvement. However, there is a tight statistical correlation.

Efficacy and Safety of Mildronate for Acute Ischemic Stroke: A Randomized, Double-Blind, Active-Controlled Phase II Multicenter Trial

2013 ◽  
Vol 33 (10) ◽  
pp. 755-760 ◽  
Author(s):  
Yi Zhu ◽  
Guangyun Zhang ◽  
Jun Zhao ◽  
Deshuai Li ◽  
Xiaodong Yan ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Phase Ii ◽  
Multicenter Trial ◽  
Efficacy And Safety ◽  
Double Blind
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