BACKGROUND:Naoxueshu oral liquid is the only approved drug for acute treatment of cerebral hemorrhage in China. It has been used widely for the treatment of acute ischemic stroke and acute hemorrhagic stroke. However, safety and efficacy data on the early use of Naoxueshu oral liquid are lacking. The main purpose of this study is to observe the benefit and safety of early use of Naoxueshu oral liquid (< 72 h of cerebral hemorrhage) and offer evidence into the potential superiority of Naoxueshu oral liquid in patients with hemorrhagic stroke, and its healthcare costs.METHODS:This registration study for the prevention and treatment of cerebral hemorrhage using Naoxueshu oral liquid will be a quantitative, prospective, multicenter, observational clinical registry study. We aim to register 2000 patients with cerebral hemorrhage within 7 days of disease onset. This study will be an observational study and not interfere with the medication regimen of participants. Hence, we will not allocate patients. The main observation indicators will be the hematoma volume and the proportion of reduction 14 days post-cerebral hemorrhage (or at hospital discharge), onset of new stroke (ischemic stroke, hemorrhagic stroke) within 12 months of disease onset, independence in everyday life activities (modified Rankin Scale score ≤ 2), total cost during hospitalization, and treatment costs.CONCLUSION:This registration study will offer strong evidence for the efficacy and safety of Naoxueshu oral liquid for the prevention and treatment of cerebral hemorrhage, particularly with regard to early use (72 h after onset). It will offer evidence into the potential advantages of Naoxueshu oral liquid in patients with hemorrhagic stroke, including healthcare costs.

目的 运用文献计量法分析中医药数据库的研究现状与发展趋势,为中医药数据库的相关研究提供参考.方法 计算机检索中国知识资源总库(CNKI)、中文科技期刊数据库(VIP)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)2002年1月1日-2021年12月31日收录的中医药数据库相关研究文献,运用CiteSpace5.8.R3软件对年度发文量、来源期刊、作者、单位、基金项目及关键词进行分析,并形成可视化图谱.结果 经筛选,共纳入372篇文献,2002-2014年发文量缓慢增加,2015-2021年发文量有所下降,主要来源于医药卫生科技、信息科技领域期刊.主要研究者有李敬华、于琦、于彤等,主要研究机构为中国中医科学院中医药信息研究所及各大中医药院校.关键词共现涉及372个关键词,形成12个有效聚类,主要聚类为中医古籍、特异性症状、中医文献、软件开发.结论 2002-2021年中医药数据库研究领域有一定发展,主要集中在中医古籍、中医文献方面,但该领域核心研究团队与其他机构合作较少,有待进一步研究与发展.

Vascular dementia(VD) is a condition of cognitive impairment due to acute and chronic cerebral hypoperfusion. The available therapies for VD mainly focus on mitigating cerebral ischemia, improving cognitive function, and controlling mental behavior. Achievements have been made in the basic and clinical research on the treatment of VD with traditional Chinese medicine(TCM) active components, including Ginkgo leaf extract, puerarin, epimedium, tanshinone, and ginsenoside. Most of these components have anti-inflammatory, anti-apoptotic, anti-oxidant, and neuroprotective effects, and puerarin demonstrates excellent performance in mitigating cholinergic nervous system disorders and improving synaptic plasticity. Puerarin, ginkgetin, and epimedium are all flavonoids, while tanshinone is a diterpenoid. Puerariae Lobatae Radix, pungent in nature, can induce clear Yang to reach the cerebral orifices and has the wind medicine functions of ascending, dispersing, moving, and scurrying. Puerariae Lobatae Radix entering collaterals will dredge blood vessels to promote blood flow, and that entering the sweat pore will open the mind, which is in line with the TCM pathogenesis characteristics of VD. This study reviews the progress in the mechanism of puerarin, the main active component of Puerariae Lobatae Radix, in treating VD. Puerarin can ameliorate cholinergic nervous system disorders, reduce excitotoxicity, anti-inflammation, inhibit apoptosis, alleviate oxidative stress injury, enhance synaptic plasticity, up-regulate neuroprotective factor expression, promote cerebral circulation metabolism, and mitigate Aβ injury. The pathways of action include activating nuclear factor erythroid 2-related factor 2(Nrf2)/antioxidant response element(ARE), vascular endothelial growth factor(VEGF), extracellular regulated protein kinases(ERK), phosphatidylinositol-3-kinase(PI3K)/protein kinase B(Akt), Janus-activating kinase 2(JAK2)/signal transducer and activator of transcription 3(STAT3), AMP-activated protein kinase(AMPK), as well as inhibiting the tumor necrosis factor α(TNF-α), transient receptor potential melastatin 2(TRPM2)/N-methyl-D-aspartate receptor(NMDAR), p38 mitogen-activated protein kinase(p38 MAPK), Toll-like receptor 4(TLR4)/nuclear factor-kappaB(NF-κB), early growth response 1(Egr-1), and matrix metalloproteinase 9(MMP-9). By reviewing the papers about the treatment of VD by puerarin published by CNKI, Wanfang, VIP, PubMed, and Web of Science in the last 10 years, this study aims to support the treatment and drug development for VD.

Stroke is caused by gradual disequilibrium of Qi collaterals and then the blood collaterals get injured, which leads to Qi and blood stagnation and stasis.It was proposed in the theory of collateral disease that "Qi is stagnating in the meridian at the beginning and blood is injured in collateral gradually".After thrombolysis, the main problem of hemorrhage transformation is deficiency syndrome, which is manifested as "not solid" due to brain Qi collateral damage.Phlegm and blood stasis and other evil factors in meridian cause toxic pathogens, which will inevitably damage the collateral.After thrombolytic therapy, the visible Phlegm and blood stasis toxic pathogens can be quickly removed, but the collateral injury still exists.In addition, the effect of thrombolytic drugs is relatively aggressive, which makes the deficiency syndrome is increasingly prominent.Therefore, the use of drugs in supplementing and reinforcing Qi can help to restore the steadying function of Qi collateral, replenish the deficiency of brain Qi, promote the circulation of brain Qi and restore the nerve function.At the same time, it is combined with astringent Chinese medicine to strengthen blood vessels and prevent bleeding of blood collateral.

中医药在脑缺血再灌注损伤(cerebral ischemia reperfusion injury,CIRI)的治疗中发挥着重要作用,取得了显著的临床效果.中医药干预CIRI的相关通路主要有核转录因子-κB(nuclear factor-κB,NF-κB)信号通路、磷脂酰肌醇 3-激酶/蛋白激酶B(phosphatidylinositol 3 kinase/kinase B,PI3K/Akt)信号通路、丝裂原活化蛋白激酶(mitogen-activated protein kinase,MAPK)信号通路、Wnt经典通路、Janus激酶/信号转导与转录激活子(the Janus kinase/signal transducer and activator of tran-i-ons,JAK/STAT)信号通路等,通过调控这些信号通路可发挥抗炎、抑制细胞凋亡等作用.但目前研究仍存在一定局限性,如中医药作用机制尚未明确,相关研究以动物实验为主,且多为单成分、单通路研究,针对此,今后需加强中药常用药对、复方对多通路的作用研究,探索中医药治疗疾病的多通路、多靶点机制,为治疗CIRI提供有效的药物及靶点信息.