STROKE magazine: TASTE study finds that Ida La 莰 can have...

On February 16, THES, the official journal of the American Heart/Stroke Association (AHA/ASA), officially published the results of a clinical study in the third phase of the treatment of acute ischemic stroke (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol, TASTE).
compared to Idala, Idala's right-handsignificantly increased the proportion of AIS patients with 90 days of functional independence.
large-scale clinical research from China has been published in the International Authoritative Journal of Cerebrovascular Clinical Research, representing a major breakthrough in this field of Innovative Drugs in China! TASTE is a multi-center, random double-blind, positive control phase III clinical study, led by the National Clinical Research Center for Neurological Diseases, The Capital Medical University affiliated with Beijing Tiantan Hospital Professor Wang Congjun led by 48 medical centers in the country.
based on the good results of Phase III clinical studies,has been approved for listing in China on July 30, 2020.
twists and turns, stroke nerve protection path ahead According to the global disease burden study estimates, China has become the stroke life-long risk and the highest burden of disease in the country, as high as 39.3 percent.
perfusion therapy and neuroseptic therapy are important means of ischemic stroke therapy.
recent years, refill therapy has made rapid progress, but neuro-protective agents in the stroke treatment exploration has been facing the dilemma of basic-clinical transformation.
to break through this dilemma, the U.S. Stroke Treatment Development Roundtable (STAIR) has made a number of standardized recommendations for neuropulant research since 1999 to improve the success rate of potential therapies.
of the research concept of neuroseptic protection has provided confidence, and the theory of ischemic ischemic waterfall (cascade) theory of ischemic stroke has laid a theoretical foundation for multi-target nerve protection agents.
Ischemia cascading reactions are the culprits of brain nerve cell damage, including a number of different path pathfours: energy metabolic disorders, hypoxia depolarization around infarction, calcium overload, excitable amino acid toxicity, oxidative stress damage, inflammatory response, etc.
paths can occur at different points in time, overlapping and interconnecting, causing and causing each other, creating a vicious circle.
STAIR's recommendations point out that single-mechanism drugs are difficult to regulate complex cascading reactions effectively and may require drug federations with multiple effects.
STAIR strategy to help restart the nerve protection gate, dual-target nerve protection agent highlights the therapeutic advantages of Idara fon right ol for Idalafon and rightol two active ingredients composed of a compound preparation, Ida Rafe is an antioxidant and free-form sculster, can remove a variety of free fundamentals. Right ol is a bicyclycular monothyl compound that inhibits the expression of inflammatory cytokines TNF-α, IL-1 beta and the expression of inflammatory proteins COX-2 and iNOS, which may reduce apoptosis and necrosis.
is designed and implemented in accordancestAIR principle in the study of the right-hand alcohol.
In the preclinical stage, through the study of different ratios and doses of the two groups of drugs, it was found that the nerve damage of the animal model was significantly alleviated when Idalafon and right ol were applied in a 4:1 ratio.
In Phase II clinical trials involving 400 patients with ischemic stroke, the mid-dose group of Idarafeng rightol (37.5 mg) showed a trend of efficacy and better safety, and successfully completed dose exploration and preliminary validation of efficacy for Phase III. clinical studies.
Phase III. Phase III clinical trial, launched in 2015, included 1,200 patients with acute ischemic stroke with a duration of 48h to assess the efficacy of Idalafeng rightol pydaravon for acute ischemic stroke A total of 1,165 patients were entered into improved intent (mITT) analysis and were continuously treated for 14 days on the basis of routine clinical treatment with Idalafeng rightol (585 cases) and Ida Raven (580 cases).
endpoint indicator of the study was the proportion of patients with an improved Rankin Scale (mRS) score of ≤ 90 days.
secondary efficacy endpoints included the ms score on the 90th day of treatment, the change in the baseline on the National Institutes of Health Stroke Scale (NIHSS) score on the 14th day of treatment, and the ratio of NIHSS score 0-1 on the 14th, 30th, and 90th days of treatment.
results showed that for the main end of efficacy, the proportion of subjects with a 0-1 ms score on the 90th day of the rightol group was significantly higher than that of the Idalafeng group, at 67.18 percent and 58.8 percent, respectively. 97% (advantage ratio OR s 1.42, 95% CI: 1.12 to 1.81, P s 0.004), the main efficacy end results are basically consistent among subgroups.
the 90th day mrRS score of the two treatment groups was similar in the proportion of patients with a score of 0 to 1, and the two groups were similar in terms of overall occurrence of adverse reactions, occurrence of serious adverse reactions, and death toll.
Idara feng right alcohol group and Idala feng group adverse event rate lit up the life of the "semi-dark belt", for stroke patients to seize time AIS treatment is in a race against time, whether neuro protective agents, venous thrombosis or intravascular treatment, the goal is ischemic semi-dark belt, that is, with continuous ischemic, there is a great risk of developing into infarction or death of brain tissue.
AIS patients from the onset to arrival of the hospital, isoemia core is still evolving, if the use of drugs to slow the expansion of isoemia core, when patients arrive at the central hospital will have more brain tissue can be saved, especially in the limited level of medical care, the incidence of longer areas of the hospital is significant.
the clinical results ofalcohol III have undoubtedly brought hope to global neurosafness research and added an alternative and effective drug to patients with acute stroke in China. Professor Marc Fisher, a former editor-in-chief of
STROKE and president of the World Stroke Association (WSO), believes that the combination of Ida Lafeng and rightol may have the dual effect of neuro-protection and functional recovery, and hopes that further research will be made in the future on the separate effects of these two.
is a very attractive strategy to combine drugs with neuropythr protection or promote functional recovery, and the development of drugs with similar functions will be a future trend.
attached: Original summary Edaravone Dexborneol Versus Edaravone Alone for The Treatment of Acute Ischemic Stroke - A Phase III, Randomized, Double-Blind, Comparative Trial Idala Fonse rightol biydala single drug to treat acute ischemic stroke: a Phase III, randomized, double-blind, controlled trial background and purpose: Idala Fon right ol consists of Idalafon and rightol, is a new nerve protection agent, in animal models with antioxidant and anti-inflammatory synergy.
clinical trials were conducted to test the effects of idarahand idalaphospon on 90-day functional outcomes in patients with acute ischemic stroke (AIS).
: From May 2015 to December 2016, a multi-center randomized double-blind control Phase III clinical trial was conducted at 48 hospitals in China.
criteria include: diagnosis of AIS, age 35 to 80 years old, National Institutes of Health Stroke Scale (NIHSS) score 4 to 24, AIS attack time of no more than 48 hours.
randomly divided AIS patients into two treatment groups on a 1:1 scale: infusion of idalaol for 14 days or injection of idalatol.
the proportion of patients with an improved Rankin Scale (mRS) score of 1 on the 90th day after the ≤ was randomly grouped.
results: 1,165 AIS patients were randomly assigned to the Idala fon rightol group (n=585) or the Idala Fon group (n=580).
the proportion of patients in the ol group who had good functional outcomes on the 90th day after the random grouping was significantly higher than in the Idalafeng group (mRS score≤1:67.18% vs 5 8.97%; Ratio ratio: 1.42; 95% confidence interval: 1.12-1.81; P. 0.004).
preset subgroup analysis showed that female patients benefited more than male patients (2.26, 1.49-3.43) vs. (1.14, 0.85-1.52).
conclusion: When Idala was given right ol and Idala within 48 hours of an AIS attack, the 90-day good function of the Idala rightol group was better, especially in female patients.
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