This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.

开始日期2014-09-01

申办/合作机构

高端疫苗生物制剂股份有限公司

RPCEC00000101 / Completed临床2期

Reactogenicity and immunogenicity of a new formulation of the cuban conjugated vaccine against Haemophilus influenzae type b (QuimiHib®) adjuvated in aluminium phosphate in healthy infants. A controlled, randomized, doubled blinded clinical trial.”

开始日期2008-02-15

申办/合作机构-

NCT00347555 / Completed临床1期IIT

Phase I, Double-Blinded, Placebo-Controlled Dosage-Escalation Study of the Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly

Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host) that enters the human body through the bite of an infected mosquito. The purpose of this study is to find out about the safety of an experimental malaria vaccine and whether the vaccine causes humans to produce antibodies (proteins made by the body's immune system to help control or prevent infection). Four strengths of the vaccine will be tested. The lowest strength of the vaccine will be tested before the next higher strength is tested. Each dosage (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6 months. Two people in each dosage group will receive injections of a placebo (contains no medication). Participants will include 80 healthy adults between 18 and 40 years of age. Multiple blood draws will occur over the duration of the study. Participants will be involved in study related procedures for approximately 13 months.

开始日期2006-05-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与磷酸铝相关的临床结果

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100 项与磷酸铝相关的转化医学

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100 项与磷酸铝相关的专利（医药）

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246

项与磷酸铝相关的文献（医药）

2024-09-17·Environmental Science & Technology

2-Ethylhexyl Diphenyl Phosphate Induces Autism Spectrum Disorder-Like Behaviors in Offspring Mice by Disrupting Postsynaptic Development

Article

作者: Xu, Cheng ; Liu, Yanan ; Xu, Chenke ; Jiang, Xianlei ; Li, Linwan ; Hu, Jianying ; Li, Qiang ; Huang, Chong

As organophosphorus flame retardants (OPFRs) are constantly detected in human samples, the neurotoxicity of OPFRs is of concern. In this study, pregnant ICR mice were exposed to 2-ethylhexyl diphenyl phosphate (EHDPP) in drinking water from gestation to lactation to investigate its effects on autism spectrum disorder-like (ASD-like) behaviors in offspring. Serum EHDPP concentrations in dams in the 0.4, 2, and 10 mg/kg groups were 0.282 ± 0.051, 0.713 ± 0.115, and 0.974 ± 0.048 ng/mL, respectively, within the concentration range in humans. At the highest dose, EHDPP exposure induced ASD-like behaviors in both female and male offspring. Significant reductions in mature dendritic spines and structural damage to the postsynaptic density zone were noted in all but the lowest exposure groups, indicating postsynaptic membrane impairment. Mechanistically, EHDPP significantly downregulated disc large MAGUK scaffold protein 4 expression by inhibiting protein kinase B and type 1 insulin-like growth factor receptor phosphorylation. In the heterologous synapse formation assay in vivo, EHDPP significantly reduced the levels of postsynaptic density protein 95 expression in neurons at 1 μM. Overall, the study utilized in vitro and in vivo experiments to confirm that EHDPP damaged postsynaptic membrane formation and might increase the incidence of ASD in offspring.

2024-09-01·Ecotoxicology and Environmental Safety

2-ethylhexyl diphenyl phosphate exposure induces duodenal inflammatory injury through oxidative stress in chickens

Article

作者: Zhang, Haolin ; Wang, Haibin ; Sun, Yiming ; Zhang, Ruili ; Luo, Linghuan ; Hu, Yihan ; Ge, Ming

2-ethylhexyl diphenyl phosphate (EHDPHP) is a widely used organophosphorus flame retardant and plasticizer, which is commonly found in the environment. EHDPHP not only potentially harms the environment but also causes different degrees of damage to the organism. In this study, the duodenum of chicks was selected as the potential toxic target organ to explore the mechanism of duodenal injury induced by EHDPHP exposure. Ninety one-day-old healthy male chicks were selected and randomly divided into C1(control group), C2(solvent control group), L(800 mg/kg), M(1600 mg/kg), H(3200 mg/kg) according to different doses of EHDPHP after one week of environmental adaptation. The chicks were given continuous gavage for 14 d, 28 d, and 42 d. It was found that constant exposure to EHDPHP caused an increase in duodenal MDA content, a decrease in P-gp, SOD, GSH-Px activities, and a decrease in duodenal mucosal immune factor (sIgA, GSH-Px). The expression of sIgM and mucosal link proteins (CLDN, OCLN, ZO-1, JAM) decreased, and the expression of the inflammatory protein (NF-κB, COX2) in duodenal tissues was up-regulated. The results showed that continuous exposure to EHDPHP could cause duodenal oxidative stress, inflammation, and mucosal barrier damage in chicks, which provided a basis for studying the mechanism of toxic damage caused by EHDPHP in poultry.

2024-06-29·JBMR Plus

Iron and bones: effects of iron overload, deficiency and anemia treatments on bone

Review

作者: von Brackel, Felix N ; Oheim, Ralf

AbstractIron is a vital trace element and exerts opposing effects on bone in both iron overload and iron deficiency situations. Remarkably, iron supplementation through intravenous infusion in patients with iron deficiency can also have detrimental effects on bone in special cases. The diverse mechanisms underlying these effects and their manifestations contribute to the complexity of this relationship. Iron overload impacts both bone resorption and formation, accelerating bone resorption while reducing bone formation. These effects primarily result from the direct action of reactive oxygen species (ROS), which influence the proliferation, differentiation, and activity of both osteoclasts and osteoblasts differently. This imbalance favors osteoclasts and inhibits the osteoblasts. Simultaneously, multiple pathways, including bone morphogenic proteins, RANK ligand, and others, contribute to these actions, leading to a reduction in bone mass and an increased susceptibility to fractures. In contrast, iron deficiency induces low bone turnover due to energy and co-factor deficiency, both of which require iron. Anemia increases the risk of fractures in both men and women. This effect occurs at various levels, reducing muscular performance and, on the bone-specific level, decreasing bone mineral density. Crucially, anemia increases the synthesis of the phosphaturic hormone iFGF23, which is subsequently inactivated by cleavage under physiological conditions. Thus, iFGF23 levels and phosphate excretion are not increased. However, in specific cases where anemia has to be managed with intravenous iron treatment, constituents—particularly maltoses—of the iron infusion suppress the cleavage of iFGF23. As a result, patients can experience severe phosphate wasting and, consequently, hypophosphatemic osteomalacia. This condition is often overlooked in clinical practice and is often caused by ferric carboxymaltose. Ending iron infusions or changing the agent, along with phosphate and vitamin D supplementation, can be effective in addressing this issue.

项与磷酸铝相关的新闻（医药）

2024-02-21

·医药地理

春节吃多消化不良？为您送上节后消食用药指南以及药物院端销售分析

春节期间走亲访友，聚餐频繁，不少人开启了大吃大喝模式，一不小心就导致消化不良，市场上治疗消化不良的药物品种繁多，胃痛、胃胀、胃酸...该如何对症下药呢？在此为大家送上一份节后消食用药指南，为胃肠道减轻负担，更好的投入日常工作生活轨道吧！消化不良是指位于上腹部的胃部及十二指肠一种或一组症状，主要表现为上腹痛、上腹部灼感、餐后饱胀和早饱感或恶心、呕吐及嗳气等。按病因可分为器质性消化不良和功能性消化不良。如果是由某些疾病引起的器质性消化不良，会直接按原发病去诊治。因此，通常提及的“消化不良”为功能性消化不良(functional dyspepsia，FD)。根据《2022中国功能性消化不良诊治专家共识》，FD分为上腹痛综合征（EPS）和餐后不适综合征（PDS）。常用的治疗消化不良的药物可以分为以下几类：1. 抑酸药：这类药物主要用于治疗胃酸过多引起的消化不良，如胃炎、胃溃疡等。常见的抑酸药有质子泵抑制剂(如奥美拉唑、雷贝拉唑等)、H2受体阻滞剂(如雷尼替丁、法莫替丁等)。2. 保护胃黏膜药：这类药物主要用于保护胃黏膜，防止胃酸对胃黏膜的损伤。常见的保护胃黏膜药有铋剂(如胶体铋、枸橼酸铋钾等)、磷酸铝、硫糖铝等。3. 抗胃酸返流药物：减少胃酸返流到食道的药物，主要包括质子泵抑制剂、H2受体拮抗剂以及利福平等。4. 促胃肠动力药：这类药物主要用于增强胃肠蠕动，加快食物的消化和吸收。常见的促胃肠动力药有多潘立酮、莫沙必利等。5. 消化酶制剂：这类药物主要用于帮助食物的消化，尤其是对于消化酶缺乏引起的消化不良。常见的消化酶制剂有胰酶、糖酶、脂肪酶等。6. 益生菌和益生元：调节肠道菌群平衡，改善消化功能，常用的包括乳酸菌、双歧杆菌、菊粉等。7. 中药：中医认为消化不良与脾胃虚弱、湿热内阻等因素有关，因此常用的中药有健脾胃的药物(如六君子汤、香砂六君子汤等)、清热化湿的药物(如黄连温胆汤、三黄片等)等。《2022中国功能性消化不良诊治专家共识》中提到，抑酸药物质子泵抑制剂PPI和H2受体拮抗剂可作为上腹痛综合征（EPS）的首选治疗；胃肠促动药可作为餐后不适综合征（PDS）的首选治疗；中成药治疗对改善功能性消化不良症状有较好的疗效；消化酶可改善功能性消化不良患者的部分症状。此外，我国为上消化道恶性肿瘤高发国家，推荐初诊消化不良患者及时进行胃镜检查。了解了基本的药物分类，消化不良类药物在院端的销售表现如何呢?让我们一探究竟。以下数据来自中国医药工业信息中心的PDB药物综合数据库，欢迎扫描文末二维码试用。据PDB药物综合数据库统计，近3年来，治疗消化不良类药物在院端的销售趋势趋于平稳，2021年全国医院市场销售额为38.51亿元，2022年为37.68亿元，2023年Q1-Q3销售额达到30.27亿元。图1: 2021-2023治疗消化不良药销售额统计数据来源：PDB药物综合数据库-国内院端放大，中国医药工业信息中心按照ATC四级分类统计，中药类、止泻药中的止泻微生物类、酶抑制剂类助消化药稳居TOP3榜单。以2023年前三季度销售额为例统计，其中，中药类销售额达到12.3亿元，占比40.65%；止泻微生物销售额为9.77亿元，占比32.28%；酶抑制剂类助消化药销售额为5.44亿元，占比17.97%。图2: 2021-2023治疗消化不良药不同类别药物销售额数据来源：PDB药物综合数据库-国内院端放大，中国医药工业信息中心统计前三季度每季度的TOP 10销售产品发现，销售冠军来自杭州远大生物制药有限公司的双歧杆菌四联活菌片（商品名：思连康），每季度销售额均突破1亿元，销售额占比＞10%。该产品属于止泻微生物类，用于治疗与肠道菌群失调相关的腹泻、便秘、功能性消化不良，于2020年进入国家医保目录。此外，10款产品中近一半都属于中成药，神曲消食口服液、小儿消积止咳口服液、健胃消食口服液、枳术宽中胶囊均有亮眼的销售表现。图3: 2023 Q1-Q3治疗消化不良药销售额TOP 10产品数据来源：PDB药物综合数据库-国内院端放大，中国医药工业信息中心以上药物的使用需要根据患者的具体病情和医生的建议，不同的人可能需要不同的治疗方案。同时，药物治疗只是治疗消化不良的一部分，患者还需要调整饮食习惯，避免过度饮食，保持良好的生活习惯，多多运动。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

2023-07-21

·drugs

Maternal Vaccine Can Prevent Group B Strep in Young Infants

FRIDAY, July 21, 2023 -- A hexavalent capsular polysaccharide (CPS)-cross-reactive material 197 glycoconjugate vaccine (GBS6) can prevent invasive group B streptococcus in young infants, according to a study published in the July 20 issue of the New England Journal of Medicine . Shabir A. Madhi, M.D., Ph.D., from the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit in Johannesburg, and colleagues conducted an ongoing phase 2, placebo-controlled trial involving pregnant women to assess the safety and immunogenicity of a single dose of various GBS6 formulations and analyzed maternally transferred anti-CPS antibodies. In a parallel seroepidemiologic study, serotype-specific anti-CPS immunoglobulin G (IgG) concentrations that were associated with a reduced risk for invasive disease among newborns were assessed to define putative protective thresholds. The researchers found that among infants in the seroepidemiologic study, naturally acquired anti-CPS IgG concentrations were associated with a reduced risk for disease. IgG thresholds of 0.184 to 0.827 µg/mL were determined to be associated with 75 to 95 percent reductions in the risk for disease. There were no GBS6-associated safety signals among mothers or infants. Across the trial groups, the incidence rates of adverse events and serious adverse events were similar for mothers and infants; the groups that received GBS6 containing aluminum phosphate had more local reactions. GBS6 induced maternal antibody responses to all serotypes; depending on the dose, maternal-to-infant antibody ratios were approximately 0.4 to 1.3. "The potential protective concentrations that are reported herein are based on a single seroepidemiologic study," the authors write. "Future studies are needed to better define these immunologic relationships." The study was funded by Pfizer. Abstract/Full Text Editorial (subscription or payment may be required) Posted July 2023

临床2期疫苗临床结果免疫疗法

2023-02-07

·赛柏蓝

罗素医药独家品种，全渠道招商

企业简介罗素医药自2006年于中国深圳成立以来，已经快速发展成为一家专注于药品进口公司，并保持了35%以上的年成长率。自成立以来已与多家知名海外药厂合作并不断取得成功，是中国大陆为数不多专注于进口药营销与引进的医药公司，不断建立并且完善专业临床推广队伍，实现完成全国市场布局与整合。医疗产品招商01开刻立®西吡氯铵含片点击图片，一键申请代理1.产品信息【成份】化学名称：1-氯化十六烷基砒啶一水合物。【适应症】口咽局部抗菌剂，可用于口腔感染性疾病的辅助治疗。【规格】每片2mg【包装】铝箔袋装。12片/盒，24片/盒。【用法用量】每次1片，每日3~4次，含于口中使其徐徐溶化。2.产品优势●国际最高药品标准PIC/S GMP出品●相较于地喹氯铵西吡氯铵有更强的抗菌活性且口感更好、性价比更高●新冠疫情防控4省市（甘肃、山西、河南、芜湖）推荐用药●对新型冠状病毒具有抑制作用——《新型冠状病毒肺炎疫情期间口腔溃疡等黏膜病的防治及护理专家建议》、《新型冠状病毒感染防控时期口腔外科门诊诊疗的专家建议》、《口腔院感防控要点问答》、《新冠居家用药与安全》、中华全科医师杂志发布《新型冠状病毒感染基层诊疗和服务指南（第一版）》●北京协和医院新冠感染基层诊疗方案建议用药●日本大正制药联合熊本大学经体外试验证实，同属季铵型阳离子表面活性剂-西吡氯铵，对新冠病毒灭活同样有效，即当CPC浓度为0.0125%时，可灭活99%的新冠病毒●中华口腔医学会口腔粘膜病专业委员会及中国口腔颌面外科杂志专家建议推荐3.招商目标等级医院、基层医疗销售团队。（省代、地代）联系人：练经理 13775541727 李经理 1351067541602明通®治伤风颗粒点击图片，一键申请代理点击图片，一键申请代理1.产品信息【成份】葛根、麻黄、桂枝、白芍、大枣、生姜、甘草、人参、对乙酰氨基酚、无水咖啡因、盐酸那可汀、马来酸氯苯那敏。辅料为：乳糖、焦糖、羧甲纤维素钠、糖精钠。【适应症】缓解感冒引起的鼻塞、流鼻水、打喷嚏、咳嗽、喉咙痛、发烧、头痛、关节痛、肌肉痛等症状【规格】每袋装2克【包装】铝箔包装。每盒6袋。【用法用量】饭后服用，一次1袋，一日3次。2.产品优势●含240mg对乙酰氨基酚的中西复方抗感冒药，对乙酰氨基酚含量低，有利于有基础疾病的老人和儿童●唯一含人参的抗感冒药，人参可助力解表发汗，补益元气，扶正祛邪，有效缩短感冒病程。●中药组方源自《伤寒论》经方——葛根汤，具有解肌退热、升津舒筋的作用。中西合璧，退热迅速不易反弹。●原装进口，组方独特，独家产品，无集采带量风险。国际PICS-GMP出品，属高品质药物。●操作空间大，可多科室覆盖（主要推广科室包括呼吸科、发热门诊、急诊科、儿科、老年科、普内科、全科、中医科），财务处理高效、便捷、贴心，具有强大的学术支持保障。●50年无事故，安全性高●适应症均为新冠感染症状，《江苏省新冠病毒感染者居家中医药（中成药）干预专家共识》、《江苏省药学会关于新冠病毒患者居家治疗常用药的有关建议》中成人发热推荐用药。《安徽省新型冠状病毒感染中医药防治推荐方案》推荐用药。3.招商目标临床团队联系人：孙总 13971054911 刘经理 13871309854第三终端联系人：杨经理 1738064527703甘美达®复方甘菊利多卡因凝胶点击图片，一键申请代理1.产品信息【成分】本品为复方制剂，其组分为每克凝胶中含：盐酸利多卡因 20毫克麝香草酚 1毫克洋甘菊花酊（1:5.5） 200毫克其他成分为：苯扎氯铵、聚丙烯酸、糖精钠、氨基丁三醇、桂皮油。【适应症】1、用于牙龈、唇以及口腔黏膜的炎症性疼痛。2、可以缓解乳牙和智齿萌出过程中所出现的局部症状及由于配戴正畸矫治器所致的局部症状等。3、可作为配戴义齿后所出现的疼痛不适及刺激性和/或过敏性反应的辅助性治疗。【包装】铝管包装，10 克/支，1 支/盒。【用法用量】1、牙龈或口腔黏膜炎症性疼痛：每日 3 次，每次涂约 0.5 厘米凝胶于疼痛或发生炎症的牙龈区，稍加按摩。2、治疗与配戴义齿有关的症状或病损可用约豌豆大小的凝胶，按摩患处。2.产品优势●口腔科：术前表麻及各类口腔治疗术后止痛、抗炎、促愈。（贴合口腔全程舒式化无痛治疗观念）●麻醉科：全麻下喉罩及气管插管应用，减轻咽反射，拔管后局部抗炎消肿。●头颈放疗科、肿瘤科、血液科：口腔溃疡及放射性口腔粘膜炎；●泌尿外科：早泄、包皮环切术前表麻、术后止痛促愈。●2021年《EAU性与生殖健康指南》推荐早泄用药，2021年《发育医学电子杂志》5月刊复方甘菊利多卡因凝胶应用于小儿包皮环切术的疗效评估。《儿童阴茎修复手术后疼痛管理专家共识（2022版）》：甘美达用于儿童阴茎修复术后疼痛管理。3.招商目标等级医院、基层医疗销售团队。（省代、地代）联系人：田总 15281009726 谭经理 1391391056804吉福士®磷酸铝凝胶点击图片，一键申请代理1.产品信息【成份】化学名称：磷酸铝【适应症】缓解胃及十二指肠溃疡、胃炎、食道炎所伴胃酸过多引起的胃部不适或灼热症状。【规格】130mg/g【包装】铝箔袋包装，16克/袋×10袋/盒。【用法用量】用法：本品为口服用药，确诊为胃溃疡时，于餐前半小时服用一袋。确诊为十二指肠溃疡时，于餐后两小时服用一袋。急性疼痛时可即刻服用一袋。用量：每次一袋，每日三次。2.产品优势●优秀的消化系统黏膜保护剂，兼具抗酸作用●止痛、止吐、抗酸、止泻、多重功效，吸附能力强●无铝剂副作用原型排出lPIC/S GMP标准●《咽喉反流性疾病诊断与治疗专家共识（2022年，修订版）》、《中国胃食管反流病多学科诊疗共识（2019年）》、《中国急性胃粘膜病变急诊专家共识（2015年）》、《慢性非萎缩性胃炎中西医结合诊疗共识意见（2017年）》上述专家共识推荐用药。●口感好低龄儿童易顺服不含蔗糖●2020年11月《中国现代医生》发表由广州妇女儿童医疗中心消化科专家撰写的“磷酸铝凝胶联合注射用奥美拉唑钠治疗小儿消化性溃疡的临床效果观察”，证实吉福士（磷酸铝凝胶）联合注射用奥美拉唑治疗患儿消化性溃疡疗效显著、不良反应少，值得临床借鉴。3.招商目标等级医院、基层医疗销售团队。（省代、地代）联系人：许总 18602866447业务支持1. 省代+地代模式，严格市场保护；2. 学术宣传支持，专业商务支持；3. 统一价格体系，各级代理合理分润；4. 签订年度合作协议，保证代理商权益。END声明：此篇文章受众仅为医药、医疗等健康产业专业伙伴，仅供医学药学专业人士使用，不针对普通消费大众。

诊断试剂临床研究

100 项与磷酸铝相关的药物交易

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