Ischemic Stroke

רופא/ה נכבדים,

לפניכם תקציר מאמרים המסכמים ניסויים קליניים רלבנטיים לשבץ מוחי איסכמי ולתרומתו של NurAid לשיקום לאחר אירוע מוחי (Ischemic CVA).

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CHInese Medicine NeuroAiD Efficacy on Stroke Recovery – Extension Study
CHIMES-E: A Multicenter Study of Long-Term Efficacy

Narayanaswamy Venketasubramanian et al. Cerebrovasc Dis 2015;39:

CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85–1.37, p = 0.543) and mRS dichotomy ≤ 1 was 1.29 (95% CI 0.96–1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤ 1 at 6 months (OR 1.49, 95% CI 1.11–2.01, p =0.008), 12 months (OR 1.41, 95% CI 1.05– 1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01–1.83, p = 0.045), and for BI dichotomy ≥ 95 at 6 months (OR 1.55, 95% CI 1.14–2.10, p =0.005) but not at other time points. While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤ 1 was significantly increased at 6 months and persisted up to 18 months after a stroke. 



Prognostic Factors and Treatment Effect in the CHIMES Study
Siwaporn Chankrachang, MD. Et al. Journal of Stroke and Cerebrovascular Diseases 2015.

Analyses were performed using data from the CHIMES study, an international, randomized, placebo-controlled, double-blind trial comparing MLC601 with placebo in patients with ischemic stroke of intermediate severity in the preceding 7hours. All subjects with baseline data and the modified Rankin Scale (mRS) score at 3 months were included. Data from 1006 subjects were analyzed. The predictive variables formRS score greater than 1 atmonth 3 were age older than 60 years )P ,.001), baseline National Institutes of Health Stroke Scale score 10-14 (P ,.001,(stroke onset to initiation of study treatment of more than 48 hours (P ,.001), and female sex (P 5.026). A higher number of predictors was associated with poorer



NeuroAiD: Properties for Neuroprotection and Neurorepair.
Heurteaux C, et al. Cerebrovasc Dis 2013.

This paper reviews the pharmacological effects of NeuroAiD on the normal and ischemic brain and neurons. In vivo and in vitro experiments using mouse model of stroke (focal ischemia), rat model of cardiac arrest (global ischemia) and cortical neurons in culture were reviewed and summarized. In conclusion NeuroAID demonstrated both neuroprotective and neuroregenerative properties in rodent models of focal and global ischemia and in cortical cell cultures.



Activation of ATP-sensitive potassium channels as an element of the neuroprotective effects of the Traditional Chinese Medicine MLC901 against oxygen glucose deprivation.
Moha Ou Maati H, et al. Neuropharmacology 2012.

This paper highlights the potency of NeuroAid in neuroprotection with the discovery of a key underlying mechanism of action. The activation by NeuroAid of the ATPsensitive potassium channel located in the suffering neurons of the brain protects them from death. Indeed, the opening of the channel decreases the excitability of neurons (by hyperpolarization) preventing an overload of calcium and release of excitotoxic glutamate. Besides the beneficial effects in neuroplasticity already published, these results strengthen the interest of NeuroAid in stroke recovery.



MLC901, a traditional Chinese medicine protects the brain against global ischemia.
Quintard H, et al. Neuropharmacology 2011.

The paper describes the results of a series of in vivo experiments demonstrating neuroprotective and neurogenesis effects of MLC901 on hippocampal CA1 region against global ischemia in rodent models of global ischemia. It shows how neuronal protection by MLC901 is likely mediated by the Akt protein (a central mediator in the
signal transduction pathway involved in cell survival) and reduction of oxidative stress. MLC901 prevents necrosis and apoptotic cell death induced byglobal ischemia, enhances neurogenesis, and enhances functional recovery. This makes MLC901a potential novel therapeutic strategy in treating cognitive and neurological deficits caused byglobal ischemia from conditions that deprive the brain of oxygen and glucose, such as cardiacarrest. stroke.



Chinese Medicine Neuroaid Efficacy on Stroke Recovery : A Double-Blind, Placebo-Controlled,Randomized Study.
Chen C, et al. Stroke 2013.

The CHIMES study is an academic international double-blind placebo-controlled clinical trial which treated and monitored 1100 patients from several countries who had suffered an ischemic stroke of intermediate severity within 72 hours, for 3 months. The research concluded that NeuroAiD is statistically no better than placebo in improving outcomes at 3 months when used among patients with acute ischemic stroke of intermediate severity. However the results of the study confirmed
the overall benefit of NeuroAiD in stroke recovery and showed that treatment effect for achieving functional independence was greater among non-acute strokes, consistent with previous studies. In addition the study showed that NeuroAiD had an excellent safety profile.



Efficacy and Safety of MLC601 (NeuroAiD), a Traditional Chinese Medicine, in Poststroke Recovery: A Systematic Review.
Siddiqui FJ, et al. Cerebrovasc Dis 2013.

This publication updates the 2-study meta-analysis published in Stroke journal in 2009 with all clinical data available since on NeuroAiD and provides an overall assessment of the effects of NeuroAiD in improving functional and motor outcomes by the end of treatment. In a systematic review this paper shows that previous studies on NeuroAiD in ischemic stroke in general were of low risk of bias. The meta-analysis showed a statistically significant beneficial effect in favor of NeuroAiD on functional outcome when assessed at the end of study treatment. Although the results did not reach statistical significance, the overall effects on motor recovery were also in favor ofNeuroAiD.



NeuroAiD (Danqi Piantang Jiaonang), a Traditional Chinese Medicine, in Poststroke Recovery.
Chen C, et al. Stroke 2009.

The paper reports the pooled analysis of two randomized controlled clinical trials (initial stroke trials in China) that included 605 patients recruited between 2 weeks and 6 months after their stroke. The results show that patients on NeuroAiD have 2.4 times more chances of achieving independence after 1 month of treatment, and have a 25% better recovery in motor impairments. No seriousadverse event was reported.\



NeuroAiD (MLC601) versus piracetam in the recovery of post-infarct homonymous hemianopsia.
Ghandehari K, et al. Neural Regen Res 2011.

In the clinic, the natural recovery rate of homonymous hemianopsia caused by occipital lobe infarction is low. This prospective study compared the effects of NeuroAiD (MLC601) versus piracetam in improving visual field defects in 40 patients
matched for age and sex within 1 week of PCA infarction with pure homonymous hemianopsia. After 3 months of treatment, the findings suggest that MLC601 is superior to piracetam for reducing quantitative visual field defects in homonymous hemianopsia patients.



The Use of NeuroAiD (MLC601) in Post ischemic Stroke Patients.
Navarro JC, et al. Rehabil Res Pract 2012.

This paper aimed to assess the efficacy of MLC601 on functional recovery in patients given MLC601 after an ischemic stroke. This was a retrospective cohort study comparing 30 post-stroke patients given open-label MLC601 for three months
and 30 matching patients who did not receive MLC601 from the Stroke Data Bank. There were positive results from this study: NeuroAiD has been shown to improve functional recovery at 3 months post-ischemic stroke.



NeuroAiD in Stroke Recovery.
Siow C, Eur Neurol 2008.

This case series report deals with 10 patients who received NeuroAiD after an ischemic stroke as confirmed on brain imaging (MRI). Conducted in an outpatient private clinic in Mount Alvernia Hospital in Singapore, the report suggests that
NeuroAiD can be considered as an add-on treatment to other medications including anti-platelet, warfarin, lipid-lowering, anti-hypertensive, anti-diabetic,and antidepressant medications.

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