The 10th Academic Annual Conference of the 2024 Chinese Stroke Society and the Temple of Heaven Cerebrovascular Disease Conference (Temple of Heaven Conference) was held in Beijing from June 14th to 16th. News will be uploaded that the international authoritative medical journal New England Journal of Medicine (NEJM) will simultaneously publish two heavyweight articles on the treatment of ischemic stroke with domestically produced thrombolytic drugs, riteplase and teneplase, from Professor Wang Yongjun's team at Beijing Temple of Heaven Hospital affiliated with Capital Medical University on June 15th. At the same time, the "Emergency Stroke Unit" with fully independent intellectual property rights, created by Beijing Temple of Heaven Hospital, has officially made its debut. By applying these new breakthroughs, the treatment of patients with acute ischemic stroke (commonly known as cerebral infarction) will be more convenient and efficient, and more patients will benefit from it. Meanwhile, these breakthroughs are expected to change the treatment guidelines for acute ischemic stroke and leverage the global thrombolytic industry landscape. This is also the first time that the New England Journal of Medicine has simultaneously published two clinical studies on different drugs conducted by the same Chinese team, and it is also the first time that this top medical journal has simultaneously published research results with Chinese academic conferences. 18 milligrams of "Made in China" have shown good efficacy and low cost. Over the past 30 years, the global dominance of thrombolytic drugs for acute ischemic stroke has always been dominated by a drug called ateplase. In 1995, clinical trials abroad confirmed that reperfusion therapy with ateplase intravenous thrombolysis as the core can greatly reduce the disability rate of ischemic stroke and improve patient survival treatment, marking the beginning of the era of reperfusion therapy for ischemic stroke. However, due to complex production processes and limited production capacity, these drugs that are monopolized by Western pharmaceutical companies have experienced supply shortages in multiple countries around the world. At the same time, as a country with a high incidence rate of ischemic stroke, the intravenous thrombolysis rate of the population with indications in China is only 40%. Compared with advanced countries, there is a significant difference in the treatment proportion and quality. To reduce the disability and mortality rates caused by ischemic stroke, further promotion of intravenous thrombolytic reperfusion therapy is needed, and the shortage of thrombolytic drugs undoubtedly becomes a huge obstacle to promoting reperfusion therapy in China. Since the launch of ateplase, the evidence for stroke thrombolytic drug research has mostly come from the West, with little data from Asians. There are differences between different races, and Asians directly apply Western data, resulting in uncertainty in drug safety and efficacy Wang Yongjun, the director of Beijing Temple of Heaven Hospital, believes that it is necessary to find a path for the Chinese people themselves, where "drugs need to be self-sufficient and evidence needs to be self-sufficient.". Reteplase is a genetically engineered modified drug approved for the treatment of acute myocardial infarction overseas in 1996. From the perspective of drug principles, this drug should have good effects on acute ischemic stroke, but for many years, due to the halo of ateplase, few people have associated reteplase with stroke. In 2017, Wang Yongjun's team hit it off with a Beijing state-owned enterprise and decided to awaken this drug that had been dormant for over 20 years. Li Shuya, Director of the Clinical Trial Center at Beijing Temple of Heaven Hospital, is the leader of the research project called "RAISE". "This is the world's first and largest phase III clinical trial comparing the role of reteplase and ateplase in acute ischemic cerebrovascular events, jointly completed by 62 hospitals nationwide, with a total of 1412 patients enrolled. Li Shuya introduced that the trial results showed that for acute ischemic stroke patients who were suitable for intravenous thrombolysis treatment after 4.5 hours of onset, the proportion of patients with good functional prognosis after 90 days in the reteplase treatment group was better than that in the ateplase group. There was no significant difference in the proportion of symptomatic intracranial hemorrhage and death patients compared to the ateplase treatment group." Simply put, the effect of reteplase is better than that of ateplase ".". Compared to ateplase, reteplase does not require estimating the patient's weight or intravenous infusion, and only requires two intravenous injections of 18 milligrams of medication every half hour. More importantly, in order to better adapt to stroke treatment, the research team optimized the production process of this drug, significantly reducing costs and greatly reducing the economic burden on patients. "Next, we need to conduct international multicenter trials of riteplase to enable this' Beijing made 'drug to' go global 'as soon as possible." Wang Yongjun said. In fact, Wang Yongjun's team has found more than just one way to broaden the 24-hour window for intravenous thrombolysis. A year ago, a team study called "TRACE II" was published in the Lancet journal. This study shows that a genetically engineered and improved next-generation specific thrombolytic drug, Teneplase (TNK), independently developed in China, is not inferior to Ateplase in terms of safety. "This is just the starting point." Wang Yongjun said that there are many and complex factors that affect the proportion of reperfusion treatment in China, and finding drugs cannot solve all the problems. "For example, many patients are not aware of ischemic stroke, do not seek timely treatment in hospitals after onset, or cannot determine the time of onset; some grassroots medical institutions do not have the conditions and ability for intravenous thrombolysis, and patients need to be transferred to hospitals that can thrombolysis, wasting time on the road..." Data shows that about 67% to 75% of acute ischemic stroke patients arrive at the hospital for more than 4.5 hours or the onset time is unknown. Saving patient lives and avoiding disability as much as possible is crucial, and even with the continuous efforts of researchers, the time window for intravenous thrombolysis in acute ischemic stroke is only 4.5 hours. Can we break through? Wang Yongjun and his team members set their sights on this "4.5 hours". "We selected patients with acute ischemic stroke onset of 4.5 to 24 hours, who have large vessel occlusion but imaging shows the presence of 'penumbra' in the brain, and treated with Teneplase." Xiong Yunyun, the project execution leader and deputy director of the Department of Vascular Neurology at the Neurology Center of Beijing Temple of Heaven Hospital, said that the "semi dark zone" means that this part of the brain tissue is between normal and infarcted, and after restoring normal blood flow, its function may still be restored, which can help patients avoid disability or reduce the degree of disability. This study called "TRACE III" introduces artificial intelligence technology. In order to make imaging judgments more timely and accurate, the team independently developed the iStroke Intelligent Imaging Decision Platform for Acute Stroke. As an "assistant", this system can quickly analyze and evaluate head images, identifying key "semi dark areas". This trial included 516 patients from 58 research centers nationwide, and the final conclusion was encouraging: "For acute ischemic stroke patients with anterior circulation artery occlusion and imaging penumbra within 4.5-24 hours after onset, intravenous thrombolysis with Teneplase can reduce disability rates without increasing mortality or symptomatic intracranial hemorrhage." "This is the first time in the world that the time window for intravenous thrombolysis has been expanded to within 24 hours, which is safe and effective." Xiong Yunyun introduced that a large proportion of stroke patients worldwide have large artery occlusion within 24 hours of onset and there is salvageable brain tissue, but cannot receive endovascular treatment for various reasons. The "TRACE III" trial provides a late treatment for such patients. A new time window intravenous thrombolysis treatment plan. Meanwhile, the convenient administration method of intravenous injection of Teneplase is expected to reduce the risk of stroke progression during inter hospital transportation. In traditional medical models, stroke patients need to undergo clinical evaluation, CT, MRI, and other imaging assessments after arriving at the emergency department. From entering the hospital to receiving thrombolytic treatment, it often takes about an hour to maximize the protection of the brain by 32 square meters. For patients, the simpler the process and smoother the waiting time, the better it can protect brain function Wang Yongjun said that it is precisely for this goal that this 32 square meter "emergency stroke unit" has emerged. This "emergency stroke unit" highly concentrates the key links of traditional acute stroke clinical evaluation, imaging evaluation, and treatment into one space, and incorporates innovative solutions, making it a "hidden dragon crouching tiger". Quick physical examination. Intelligent wearable devices are equipped here, which can collect key information such as blood pressure and blood sugar of patients in real time, and monitor their vital signs. The little elf. This fully self-developed low field magnetic resonance scanner has a field strength of only 0.23 Tesla (conventional magnetic resonance is 1.5 or 3.0 Tesla) and can be easily moved using a 220V household power supply. More importantly, patients do not need to remove personal or implanted metal objects, and can directly undergo examinations, greatly saving time. Through the self-developed artificial intelligence image recognition system, it is possible to quickly distinguish between cerebral hemorrhage and cerebral ischemia within 1.5 minutes, ensuring that patients receive effective treatment in the shortest possible time. Information technology assisted diagnosis. Here, it is possible to achieve rapid entry of fully structured data. Based on patient signs and imaging findings, AI can assist healthcare professionals in making decisions. Innovative drug therapy. Using new generation thrombolytic drugs such as Teneplase and Reteplase, intravenous injection replaces the previous 1-hour intravenous drip, resulting in faster drug action. Through the "Emergency Stroke Unit", the time for patients to come to the hospital and receive reperfusion treatment can be compressed to within 20 minutes, without the need to rush to the diagnosis room, imaging examination room, laboratory, treatment room, etc., in order to maximize the protection of the patient's brain function and buy time. At present, the "Emergency Stroke Unit" has been put into use in nearly 20 hospitals in China. The key word for these projects is' self-reliance and self-improvement '. China is a major country in the incidence of ischemic stroke. We need to develop drugs, instruments, and equipment suitable for the Chinese people, rewrite guidelines more, make the treatment of ischemic stroke faster and more convenient, and enable more ischemic stroke patients to receive timely and effective treatment Wang Yongjun said. (Lai Xin She)