图片由尼科公司提供埃默里大学医学院的研究人员领导的一项为期六年的出血性中风治疗临床试验的开创性结果表明，所研究的微创方法是安全的，并且优于目前的护理标准，这标志着脑出血（ich）这一最致命的中风形式的治疗取得了重大进展。 这项研究结果于4月10日由《新英格兰医学杂志》在线发表。 这项名为rich（早期微创清除ich）的研究是一项随机、多中心、适应性的临床试验，于2017年至2023年在美国37家医院进行。 rich招募了300名自发性出血性卒中患者，其中92名患者基底节前部出血，208名患者脑叶出血。 这项研究将早期（出血后24小时内）微创束旁手术（mips）与当前的医疗管理标准（mm）进行了比较。 在手术过程中，神经外科医生使用脑路径设备穿过大脑复杂的褶皱和纤维到达出血区域。 它巧妙地移动脑组织，建立通往出血点的通道。 一旦到达目标，无数的装置，一种用于抽吸和切除的自动化工具，就可以排出凝块。 rich的联合首席研究员、埃默里大学医学院神经外科副教授、格拉迪纪念医院神经外科主任古斯塔沃·普拉迪拉医学博士说：“rich试验的结果不仅证明了mips的有效性和安全性，而且预示着整个脑卒中社区将迎来一个变革性的里程碑，通过标准化的方法和先进的技术改变ich的治疗模式。”。 rich的关键发现表明mips显著改善了ich患者的预后。 mips不仅在180天时显著提高了效用加权改良rankin量表（uwmrs）评分，而且在30天时降低了死亡率，缩短了icu和住院时间。 具体来说，mips显示效用加权uwmrs为0。 180天时为458，相比之下为0。 374毫米，带98。 1%的优势后验概率（95%ci，0。 005到0。 163)。 9岁时mips的死亡率较低。 3%对18%。 1%（mm）。 此外，mips使icu住院时间缩短了2天。 8天，住院3天。 1天。 先前的研究将手术干预与药物治疗进行了比较，表明存活率有所提高，但没有证明神经功能有所改善。 然而，rich试验首次表明，除了降低进一步脑损伤和死亡的风险外，它还改善了大叶性脑出血患者的神经功能。 这种方法减少了不良事件，减少了紧急脑减压手术的必要性。 “这些发现标志着我们这一领域的一个历史性进展，”帕梅拉牧场的丹巴罗说。 rollins董事长、埃默里大学神经外科教授兼联合首席研究员。 “我们非常感谢37个参与试验的地点出色地执行了试验，也非常感谢我们勇敢的患者及其家人对我们的信任，并参与了这项重要的试验，以进一步增进科学理解，造福他人。 “每年，超过200万美国人和3。 全球有400万人经历出血性中风，这是公认的最致命、最昂贵、最使人衰弱的中风类型。 当虚弱的血管破裂并渗入周围的脑组织，导致有害血液在大脑内积聚时，就会发生出血性中风。 令人遗憾的是，高达50%的美国出血性中风患者将在30天内死亡，而在幸存者中，只有25%的人将恢复功能独立。 除了死亡人数外，出血性中风还需要花费u。 s。 医疗保健系统约170亿美元，其中估计每年120亿美元的护理成本和幸存者的生产力损失。 “以最安全的方式最大限度地排出血栓的能力是一个关键的进步。 普拉迪拉说：“我们坚定地致力于与医学界合作，对这些跨学科的实践进行教育，并促进它们在各个机构和专业中的广泛采用。”。 “我们共同致力于显著改善脑出血患者、护理人员和亲人的预后和生活。 其他参与试验的地点包括：马约诊所、约翰霍普金斯大学、华盛顿大学、克利夫兰诊所基金会、南加州大学、布莱根妇女医院、范德比尔特大学、北卡罗来纳大学和宾夕法尼亚州立大学。 在埃默里大学，丰富的研究团队由神经科学和急诊医学的跨学科团队组成。 除了barrow和pradilla之外，支持emory进行这项研究的教员还包括：联合首席研究员jonathan ratcliff，医学博士；迈克尔·弗兰克尔，医学博士；杰森w。 allen，医学博士，博士；david wright，医学博士；还有alex hall，dhsc，ms，rn。 rich试验由尼科公司赞助，该公司是一家致力于推进微创神经外科治疗的医疗技术公司。 阅读nejm的研究。
image courtesy of nico corporationgroundbreaking results from a six-year clinical trial investigating treatment for hemorrhagic strokes, led by researchers at emory university school of medicine, show the minimally invasive approach under study is safe and superior to the current standard of care, marking a major advancement in the treatment of intracerebral hemorrhage (ich), the deadliest form of stroke.the findings were published online april 10 by the new england journal of medicine (nejm). the study, named enrich (early minimally-invasive removal of ich), was a randomized, multi-center, adaptive clinical trial conducted across 37 hospitals in the united states from 2017 to 2023. enrich enrolled 300 patients with spontaneous hemorrhagic stroke – 92 patients with a hemorrhage in the anterior basal ganglia location and 208 in the lobar location.the study compared early (within 24 hours of a bleed) minimally invasive parafascicular surgery (mips), using the nico corporation’s brainpath and myriad technology, to the current standard of medical management (mm).during the procedure, neurosurgeons use the brainpath device to navigate through the intricate folds and fibers of the brain to reach the area of bleeding. it delicately displaces brain tissue to establish a passage to the bleeding spot. upon reaching the target, the myriad device, an automated tool for suction and resection, can then evacuate the clot.“the results of the enrich trial not only demonstrate the efficacy and safety of mips, but they also herald a transformative milestone for the entire stroke community, changing the ich treatment paradigm through a standardized approach and advanced technology,” says gustavo pradilla, md, co-lead investigator for enrich, associate professor of neurosurgery at emory university school of medicine and chief of neurosurgery for grady memorial hospital. key findings from enrich demonstrate mips offers significant improvements in outcomes for patients ich. mips not only led to a statistically significant enhancement in utility-weighted modified rankin scale (uwmrs) scores at 180 days, but also reduced mortality rates at 30 days and shortened both icu and hospital stays.specifically, mips showed a utility-weighted uwmrs of 0.458 at 180 days compared to 0.374 for mm, with a 98.1 percent posterior probability of superiority (95 percent ci, 0.005 to 0.163). mortality rates were lower with mips at 9.3 percent versus 18.1 percent for mm. additionally, mips reduced icu length of stay by 2.8 days and hospital stay by 3.1 days. previous studies that compared surgical interventions with medical management indicated an increase in survival rates but did not demonstrate improvement in neurological function. however, for the first time, the enrich trial shows that in addition to reducing the risk of further brain damage and death, it also improves neurological function in patients with lobar ich. this approach results in fewer adverse events and diminishes the necessity for emergency brain decompression surgeries."these findings mark a historic advancement in our field,” says dan barrow, the pamela r. rollins chairman and professor of neurosurgery at emory university and co-principal investigator. “we are immensely grateful to the 37 participating sites for their excellent execution of the trial and for our courageous patients and their families for placing their trust in us and participating in this important trial to further scientific understanding for the good of others.”every year, more than 2 million americans and 3.4 million people globally experience hemorrhagic strokes, recognized as the most deadly, costly and debilitating type of stroke. hemorrhagic stroke occurs when a weakened blood vessel ruptures and bleeds into the surrounding brain tissue, resulting in the accumulation of harmful blood within the brain. regrettably, up 50 percent of americans who suffer from hemorrhagic strokes will die within 30 days, and among survivors, only 25 percent will return to functional independence. in addition to the human toll, hemorrhagic stroke costs the u.s. healthcare system approximately $17 billion, with $12 billion in estimated annual costs of care and productivity losses for survivors.“the ability to maximize the amount of clot evacuated in the safest manner is a pivotal advancement. we are steadfast in our commitment to collaborate with the medical community to educate on these interdisciplinary practices and foster their widespread adoption across institutions and specialties,” says pradilla. “together, we aspire to significantly improve the outcomes and lives of ich patients, caregivers and loved ones.”other participating trial sites included: mayo clinic, johns hopkins university, washington university, cleveland clinic foundation, university of southern california, brigham and womens hospital, vanderbilt university, university of north carolina and penn state university. at emory, the enrich research team was comprised of a cross-disciplinary team from neurosciences and emergency medicine. in addition to barrow and pradilla, supporting emory faculty members on this research include: co-principal investigator jonathan ratcliff, md; michael frankel, md; jason w. allen, md, phd; david wright, md; and alex hall, dhsc, ms, rn.the enrich trial was sponsored by nico corporation, a medical technology company working to advance minimally invasive neurosurgical care. read the nejm study.
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