更新于：2024-05-01

Malaria, Falciparum

恶性疟

更新于：2024-05-01

基本信息

别名

Falciparum Malaria、Falciparum malaria、Falciparum malaria (disorder)

+ [47]

简介

Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.

关联

101

项与恶性疟相关的药物

Tafenoquine Succinate

琥珀酸他非诺喹

靶点-

作用机制

病毒复制抑制剂

在研机构

GSK Plc [+3]

原研机构

Walter Reed Army Institute of Research

在研适应症

疟疾 [+2]

非在研适应症

新型冠状病毒感染 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2018-07-20

Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

靶点-

作用机制

免疫刺激剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

比利时

首次获批日期2015-01-10

Arterolane maleate/Piperaquine Phosphate

靶点

CYP3A4

作用机制

CYP3A4抑制剂

在研机构

Sun Pharmaceutical Industries Ltd. [+1]

原研机构

Ranbaxy Laboratories Ltd.

在研适应症

间日疟原虫感染 [+2]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

印度

首次获批日期2012-01-01

612

项与恶性疟相关的临床试验

NCT06083688 / Not yet recruiting临床4期IIT

Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

This is an individually randomized, controlled, single blind four arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ).Arm 4: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.

开始日期2024-10-01

申办/合作机构

Liverpool School of Tropical Medicine

[+1]

NCT06293339 / Not yet recruiting临床1期

Durability of Protection After Single Immunisation With Genetically Attenuated Plasmodium Falciparum ∆mei2 (GA2) Sporozoites - a Follow-up, Controlled Human Malaria Rechallenge Study

This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606)

开始日期2024-06-01

申办/合作机构

Leids Universitair Medisch Centrum

NCT06068530 / Not yet recruiting临床4期IIT

A Cluster-randomised, Open-label Trial to Compare the Impact of Combined Mass Vaccine and Drug Administrations, Mass Drug Administration, Mass Vaccinations, or no Intervention on Plasmodium Falciparum Malaria Transmission

This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.

开始日期2024-05-01

申办/合作机构

University of Oxford

100 项与恶性疟相关的临床结果

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100 项与恶性疟相关的转化医学

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0 项与恶性疟相关的专利（医药）

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14,854

项与恶性疟相关的文献（医药）

2024-04-01·Life science alliance

Targeting circulating labile heme as a defense strategy against malaria.

Article

作者: Susana Ramos ; Viktoria Jeney ; Ana Figueiredo ; Tiago Paixão ; Maria Rosário Sambo ; Vatúsia Quinhentos ; Rui Martins ; Zélia Gouveia ; Ana Rita Carlos ; Ana Ferreira ; Teresa F Pais ; Hugo Lainé ; Pedro Faísca ; Sofia Rebelo ; Silvia Cardoso ; Emanuela Tolosano ; Carlos Penha-Gonçalves ; Miguel P Soares

Severe presentations of malaria emerge as Plasmodium (P.) spp. parasites invade and lyse red blood cells (RBC), producing extracellular hemoglobin (HB), from which labile heme is released. Here, we tested whether scavenging of extracellular HB and/or labile heme, by haptoglobin (HP) and/or hemopexin (HPX), respectively, counter the pathogenesis of severe presentations of malaria. We found that circulating labile heme is an independent risk factor for cerebral and non-cerebral presentations of severe P. falciparum malaria in children. Labile heme was negatively correlated with circulating HP and HPX, which were, however, not risk factors for severe P. falciparum malaria. Genetic Hp and/or Hpx deletion in mice led to labile heme accumulation in plasma and kidneys, upon Plasmodium infection This was associated with higher incidence of mortality and acute kidney injury (AKI) in ageing but not adult Plasmodium-infected mice, and was corroborated by an inverse correlation between heme and HPX with serological markers of AKI in P. falciparum malaria. In conclusion, HP and HPX act in an age-dependent manner to prevent the pathogenesis of severe presentation of malaria in mice and presumably in humans.

2024-03-01·The Pediatric infectious disease journal

Complicated Falciparum Malarial ARDS Requiring Noninvasive Support.

Article

作者: Marco Piastra ; Enzo Picconi ; Orazio Genovese ; Vittoria Ferrari ; Tony Christian Morena ; Piero Valentini ; Gennaro De Pascale ; Massimo Antonelli ; Giorgio Conti

Severe plasmodium falciparum infection can induce respiratory distress and clinical ARDS in children, requiring intensive care admission and respiratory support. We present 3 cases of imported malarial acute respiratory distress syndrome requiring noninvasive ventilation in the pediatric intensive care unit, in the absence of any cerebral involvement. Radiological features and their relationship with severe hematological complications are also illustrated.

2024-02-23·eLife

Noncanonical usage of stop codons in ciliates expands proteins with structurally flexible Q-rich motifs.

Article

作者: Chi-Ning Chuang ; Hou-Cheng Liu ; Tai-Ting Woo ; Ju-Lan Chao ; Chiung-Ya Chen ; Hisao-Tang Hu ; Yi-Ping Hsueh ; Ting-Fang Wang

Serine(S)/threonine(T)-glutamine(Q) cluster domains (SCDs), polyglutamine (polyQ) tracts and polyglutamine/asparagine (polyQ/N) tracts are Q-rich motifs found in many proteins. SCDs often are intrinsically disordered regions that mediate protein phosphorylation and protein-protein interactions. PolyQ and polyQ/N tracts are structurally flexible sequences that trigger protein aggregation. We report that due to their high percentages of STQ or STQN amino acid content, four SCDs and three prion-causing Q/N-rich motifs of yeast proteins possess autonomous protein expression-enhancing activities. Since these Q-rich motifs can endow proteins with structural and functional plasticity, we suggest that they represent useful toolkits for evolutionary novelty. Comparative Gene Ontology (GO) analyses of the near-complete proteomes of 26 representative model eukaryotes reveal that Q-rich motifs prevail in proteins involved in specialized biological processes, including Saccharomyces cerevisiae RNA-mediated transposition and pseudohyphal growth, Candida albicans filamentous growth, ciliate peptidyl-glutamic acid modification and microtubule-based movement, Tetrahymena thermophila xylan catabolism and meiosis, Dictyostelium discoideum development and sexual cycles, Plasmodium falciparum infection, and the nervous systems of Drosophila melanogaster, Mus musculus and Homo sapiens. We also show that Q-rich-motif proteins are expanded massively in 10 ciliates with reassigned TAA^Q and TAG^Q codons. Notably, the usage frequency of CAG^Q is much lower in ciliates with reassigned TAA^Q and TAG^Q codons than in organisms with expanded and unstable Q runs (e.g. D. melanogaster and H. sapiens), indicating that the use of noncanonical stop codons in ciliates may have coevolved with codon usage biases to avoid triplet repeat disorders mediated by CAG/GTC replication slippage.

项与恶性疟相关的新闻（医药）

2024-02-12

·PRNewswire

On-Device AI Healthcare Company Noul Becomes First Korean Diagnostic Company to Join Swiss Malaria Group

Join global network led by international organizations and global pharmaceutical companies Obtain a membership in recognition of innovation in malaria diagnostic solution Strengthen global leadership in malaria diagnosis based on European subsidiary YONGIN, South Korea, Feb. 12, 2024 /PRNewswire/ -- Noul Co., Ltd., (376930.KR), an On-Device AI healthcare company, announced that its European subsidiary (noul GmbH) has become an official member of the Swiss Malaria Group, a Swiss public, private, academic & civil society leadership network for a malaria-free world. Continue Reading Noul and SMG Logo The recognition of innovation in the malaria diagnostic solution, miLab™ MAL played a major role in Noul becoming an official member of the Swiss Malaria Group. Through this membership, Noul will have a voice in the decision-making process towards developing healthcare policies to eradicate global malaria and will strengthen its global cooperation with other group members (Global Fund, FIND, MMV, Swiss TPH, Terre des Hommes, global pharmaceutical companies, and other civil society organizations) to consolidate its leadership in the field of malaria diagnosis. As Noul's malaria diagnostic solution, miLab™ MAL was introduced as 'an innovative product that will enter scale-up level' in Unitaid's 2022 Annual Report, it is getting attention from the international community as an innovative malaria diagnostic solution that overcomes the limitation of rapid diagnostic testing and manual microscopic diagnosis. According to the results of a clinical study of a total of 1,649 patients in Ethiopia and Ghana, unveiled in October 2023 at the American Academy of Tropical Medicine and Hygiene (ASTMH), miLab™ MAL showed significantly higher sensitivity and specificity in diagnosis of P. falciparum and P. vivax malaria compared to field microscopy test. It also showed high applicability in diagnosing parasites with the pfhrp2/3 deletions. Dr. Taehwan Kim, Managing Director of noul GmbH said, "noul GmbH will play a pivotal role in global malaria diagnosis through its activities as a member of the Swiss Malaria Group. By utilizing Noul's innovative malaria diagnostic solution, we are going to further expand our presence in the market by leading strategies to eliminate global malaria and strengthening global cooperation with other group members." Swiss Malaria Group said, "Noul's innovative diagnostic tools align perfectly with the Swiss Malaria Group's emphasis on innovative solutions in the fight against malaria. Noul, which focuses on diagnostic solutions in blood and tissue diagnostics, has developed a cutting-edge digital microscopy-based malaria diagnostic tool, miLab™ MAL." Noul Website: Swiss Malaria Group Website: #SwissMalariaGroup #SMG #Noul #malaria #miLab #AI #innovation Photo - Logo -

临床研究

2023-11-27

·生物探索

青蒿素+香豆素=对抗疟疾耐药性的新方法

疟疾是世界上最广泛、最致命的传染病之一。由于疟原虫可能对目前使用的药物产生抗药性，因此不断需要新的化合物。来自埃尔兰根-纽伦堡弗里德里希亚历山大大学（FAU）由Svetlana B. Tsogoeva博士教授领导的研究小组现已将抗疟疾药物青蒿素与香豆素结合起来（与青蒿素一样，香豆素也存在于植物中），并从这两种生物活性物质中开发出了一种自发荧光化合物。这种自发荧光化合物可以用于活细胞成像，并显示药物如何在精确的时间序列中发挥作用。该工作组还发现，自发荧光青蒿素-香豆素杂交体能够消灭一种特定的耐药疟疾病原体。近期，他们在《化学科学》杂志上发表了他们的发现。青蒿素是从一种叫做青蒿（Artemisia annua L.）的植物中提取出的成分，常用于制作治疗疟疾的药物，而香豆素则是在多种植物中可以发现的次生植物化合物。在开发抗疟疾药物时，研究人员使用荧光剂标记活性物质，以便在成像技术的辅助下，按精确的时间顺序研究活性物质是如何对抗疟疾病原体的。复合物质实现自发荧光使用荧光物质标记的显著缺点是会改变药物的作用方式。这意味着在荧光标记后，感染疟疾的细胞吸收青蒿素等药物的方式会与以前不同，例如药物的溶解度会发生变化。通过开发自发荧光化合物可以避免这种情况，该化合物由两种或多种自发荧光化合物合成，可以在成像技术的辅助下精确观察其作用模式。对抗药菌株具备疗效由有机化学主席Tsogoeva教授领导的团队决定将青蒿素与生物活性香豆素进行合成，因为香豆素衍生物也具有抗疟疾特性，两者可以很容易地进行化学改变以获得很强的荧光性。在研究过程中，科学家们不仅观察到了自发荧光青蒿素-香豆素混合物在感染恶性疟原虫的活红细胞中的作用模式，还在与Barbara Kappes（FAU化学与生物工程系）和Diogo R. M. Moreira（巴西Gonçalo Moniz研究所）的合作中，发现该活性剂在体外对恶性疟原虫菌株非常有效，而该菌株对氯喹和其他疟疾药物具有抗药性。最重要的是在小鼠模型中，该全新的混合物也被证明对疟疾病原体非常有效。第一款自发荧光青蒿素-香豆素混合物的成功研制，为FAU的研究团队开发更多用于治疗疟疾的自发荧光药物奠定了基础，并在克服疟疾治疗中的多重耐药性方面取得了重大进展。参考文献：Lars Herrmann, Maria Leidenberger, Adrielle Sacramento de Morais, et al. Autofluorescent antimalarials by hybridization of artemisinin and coumarin: in vitro/in vivo studies and live-cell imaging. Chemical Science, 2023; DOI: 10.1039/D3SC03661H责编|探索君排版|探索君End往期精选围观科学家称，每25人中就有1人携带“短寿”基因热文维生素B12在细胞重编程与组织再生中发挥关键作用！热文肝癌概率与种族相关？研究发现墨西哥裔美国人后代肝癌患病风险更高热文1型糖尿病潜在新疗法：抑制β细胞的Atf6基因激活热文一项最新发现或可用于阿尔茨海默病药物开发点击“阅读原文”，了解更多~

临床研究微生物疗法

2023-11-19

·蒲公英Ouryao

【出海新进展】3药品分别出口FDA、WHO和以色列

来源：企业公告整理：wangxinglai2004近日，三药企分别发布了产品海外上市进展公告，具体为亿帆生物创新药艾贝格司亭α注射液获得FDA上市批准、普利药业制剂依替巴肽注射液获得以色列上市许可、华润三九下属公司昆药集团抗疟疾药品双氢青蒿素磷酸哌喹片通过WHO预认证。亿帆生物制剂获FDA上市批准一、药物基本情况药品通用名：艾贝格司亭α注射液中文商品名：亿立舒® 英文商品名：Ryzneuta® 申请事项：生物制品许可申请美国获批适应症：RYZNEUTA®是一种白细胞生长因子，用于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染发生率。二、药物其他相情况 Ryzneuta®是基于控股子公司Evive Biotech Ltd.具有自主知识产权 Di-KineTM双分子技术平台开发的治疗用一类生物制品新药，是基于Fc融合蛋白技术，由CHO细胞表达的rhG-CSF二聚体，具有长效和强效的生物学特点。目前 Ryzneuta®主要应用于预防及治疗肿瘤患者在接受抗癌药物出现嗜中性粒细胞减少症，可使肿瘤化疗患者嗜中性粒细胞迅速增殖和恢复，从而增强了免疫系统抵抗感染的能力，以防止患者在化疗期间死于感染或者其他相关并发症，也使得患者能完成完整的化疗周期，取得更好的抗肿瘤治疗效果。 2018年1月，亿一生物完成了Ryzneuta®首个在美国及欧洲开展的 III 期临床试验（以下简称“04 试验”），并达到预设主要疗效终点，受试者耐受情况良好，安全性达到预期。2020年1月5日，亿一生物收到在中国开展的 Ryzneuta® 的 III 期临床试验《统计数据图表合集》，统计结果表明，Ryzneuta®中国 III 期临床试验的有效性结果已全面达到临床试验预设评价标准，疗效与对照药品（原研进口药品重组人粒细胞集落刺激因子）相当；2020 年 6 月，亿一生物收到在美国及欧洲开展的第二个国际 III 期临床试验（以下简称“05 试验”）《统计数据图表合集》，结果显示，第二个国际 III 期临床试验成功达到预设主要疗效终点和次要疗效终点，药物疗效与对照药品（美国安进公司原研产品Neulasta）相当；2020年7月，公司完成了05试验有关免疫原性的中和抗体检测，结果为阴性，标志着无药物相关的抗体产生；自此，Ryzneuta®国内外开展的 I 期、II 期及 III 期临床试验，均圆满达到临床试验预设目标。2021年3月30日，亿一生物就 Ryzneuta®向FDA提交了 Ryzneuta®的生物制品许可申请，并于2021年5月27日收到 FDA的受理函，正式接受 Ryzneuta®的上市申请。 2021年8月26日，公司、亿一生物与中国生物制药有限公司附属公司正大天晴药业集团股份有限公司及其全资子公司正大天晴药业集团南京顺欣制药有限公司签订了《商业化合作协议》，约定将Ryzneuta®相关的在中国境内的商业化权益独家许可给天晴南京顺欣，天晴南京顺欣需向亿一生物支付最高额不超过21,000万元的许可费，以及分级的净销售额提成费。 2021年9月30日，亿一生物收到欧洲药品管理局（以下简称：“EMA”）签发的关于 Ryzneuta®上市许可申请受理函，并进入审评程序。 2022年2月23日，公司收到国家药品监督管理局签发的 Ryzneuta®境内生产药品注册上市许可申请《受理通知书》。 2022年3月31日，公司收到FDA的邮件通知，因旅行限制FDA将推迟 Ryzneuta®上市申请批复，直到现场检查完成。普利制药制剂获以色列上市许可一、药物基本情况（一）药物名称：依替巴肽注射液（二）适应症：1、用于急性冠状动脉综合征（不稳定型心绞痛/非ST段抬高型心肌梗死）患者，包括接受药物治疗的患者和进行经皮冠状动脉介入术（PCI ）的患者，以降低死亡或新发生心肌梗死的联合终点发生率。2、用于进行经皮冠状动脉介入术（PCI）的患者，包括进行冠状动脉内支架置入术的患者，以降低死亡、新发生心肌梗死或需要紧急介入治疗的联合终点发生率。（三）剂型：注射剂（四）规格：20mg/10mL（2mg/mL）、75mg/100mL（0.75mg/mL）。（五）生产商：海南普利制药股份有限公司二、药物其他相情况依替巴肽是血小板糖蛋白IIb/IIIa受体拮抗剂。通过选择性、可逆性抑制血小板聚集的最终共同通路，可逆转因血栓形成而导致的缺血状态。适用于急性冠状动脉综合症患者的治疗。依替巴肽注射液于1998年5月在美获准上市，现由默克公司负责销售，1999年7月在欧洲获准上市，现由葛兰素史克公司负责销售；商品名均为INTEGRILIN，目前已在全球广泛上市销售。普利制药的依替巴肽注射液成功研发后进行了多国注册申报，已于2018年2 月获得荷兰上市许可，于2018年7月获得德国上市许可，于2019年1月获得美国上市许可，于2019年8月获得英国上市许可，于2021年7月获得国家药品监督管理局颁发的药品注册批件，于2023年3月获得泰国上市许可，于2023年8月获得加拿大上市许可。近日，公司收到以色列卫生部的上市许可，标志着普利制药具备了在以色列销售依替巴肽注射液的资格，将对公司拓展以色列市场带来积极影响。华润三九制剂通过WHO预认证一、药物基本情况药物名称：双氢青蒿素磷酸哌喹片 40mg/320mg Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 40mg/320mg持证人:北京华方科泰医药有限公司（昆药集团下属全资子公司）制剂生产厂家:贝克诺顿（浙江）制药有限公司（昆药集团下属全资孙公司）二、药物其他相情况据 WHO《世界疟疾报告2022》统计，全球2021年疟疾感染病例为2.47亿例，疟疾死亡病例为62.5万例。目前，以青蒿素为基础的复方疗法依然是恶性疟疾最有效的治疗方法；2021年，全球通过国际公立市场采购共分发2.42亿份青蒿素类药物。目前，全球有三个双氢青蒿素磷酸哌喹片 40mg/320mg供应商（含昆药集团）通过PQ认证。昆药集团借助青蒿素产品的销售，已形成覆盖50多个国家的国际销售网络；其中双氢青蒿素磷酸哌喹片40mg/320mg在24个国家注册并进行商业市场销售。2022年，该产品销售收入2,366.34万元人民币。WHO的PQ认证是国际组织采购药品的重要门槛。本次昆药集团的抗疟药产品通过 PQ 认证，昆药集团成为国际公立采购市场的合格供应商，为昆药集团扩展国际公立市场提供了有力的支撑和保证；同时，通过本次PQ认证进一步提升了昆药集团质量管理体系及质量文化，为昆药集团其他产品的国际化认证积累了经验，有利于加速昆药集团产品的国际化进程。

上市批准临床3期