人血丙种球蛋白(Immunoglobulin(Baxalta Innovations GmbH))

概要

基本信息

药物类型

免疫球蛋白

别名

human normal immunoglobulin(Baxter )、Subcuvia

靶点-

作用方式-

作用机制-

治疗领域-

在研适应症-

非在研适应症-

原研机构

Baxalta Innovations GmbH

在研机构

Baxalta Innovations GmbH

非在研机构-

最高研发阶段批准上市

首次获批日期

德国 (2004-08-05)

最高研发阶段(中国)-

特殊审评-

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关联

42

项与人血丙种球蛋白相关的临床试验

ACTRN12623001336673

/ Not yet recruiting临床2期IIT

Comparing Use of B-cell depletion therapy to Immunoglobulin in Chronic inflammatory demyelinating polyneuropathy (CUBIC) clinical trial.

开始日期2024-08-05

申办/合作机构

Western Sydney Local Health District

PACTR202411838959146

/ RecruitingN/AIIT

Effect of Intravenous Immunoglobulin as Adjuvant Therapy for Septic Shock Patients Admitted to Alexandria University Pediatric Intensive Care Unit

开始日期2024-05-01

申办/合作机构-

CTRI/2023/08/056013

/ Not yet recruitingN/AIIT

USE OF IV IMMUNOGLOBULIN MIXTURE IN THE TREATMENT OF BURN SEPSIS: A RANDOMIZED CONTROL TRIAL - NIL

开始日期2023-08-19

申办/合作机构

All India Institute of Medical Sciences

100 项与人血丙种球蛋白相关的临床结果

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100 项与人血丙种球蛋白相关的转化医学

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100 项与人血丙种球蛋白相关的专利（医药）

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91

项与人血丙种球蛋白相关的文献（医药）

2024-09-01·Cureus

When a Child Refuses to Play: A Rare Myopathy

Article

作者: Moura Antunes, Sofia ; Martins, Mafalda ; Madureira, Inês ; Condessa, Luzia ; Dias, Susana

Idiopathic inflammatory myopathies (IIM) are a rare group of systemic diseases characterized by progressive proximal muscle weakness and skeletal muscle inflammation. We describe a clinical report of a seven-year-old boy presenting with myalgia and proximal muscle weakness beginning three weeks earlier, with laboratory, MRI, and muscle biopsy findings consistent with IIM. The patient was treated with corticosteroids, methotrexate, immunoglobulin, and intensive motor rehabilitation, with favorable evolution. Diagnosis of Juvenile Polymyositis was confirmed. Three years later, we assisted a relapse of muscle weakness and muscle cytolysis with the onset of bilateral eyelid skin microulcers compatible with dermatomyositis. This report intends to highlight the importance of early diagnosis and treatment in IIM due to the significant burden associated with this group of diseases. In this case, the late onset of the skin lesion contributed to the challenge in this diagnosis.

2024-08-02·Medicine

Kawasaki disease with shock as the primary manifestation: How to distinguish from toxic shock syndrome?: A case report and literature review

Review

作者: Wang, Huixia ; Wang, Weijuan ; Cheng, Jun ; Wang, Huijiao

Rationale:Kawasaki disease (KD) is a vasculitis syndrome of small to medium-sized arteries that has typical clinical characteristics such as fever, rash, cervical lymphadenopathy, conjunctivitis, and mucosal changes. Cardiac manifestations, including coronary artery aneurysms, myocarditis, myocardial infarction, and sudden cardiac death, are the most serious complications observed in KD. On rare occasions, it may accompanied with reduced organ perfusion due to systolic hypotension, a condition known as Kawasaki disease shock syndrome (KDSS). KDSS is a serious complication that can be presented to the emergency department as an initial feature when typical clinical symptoms of KD have not be detected.Patient concerns:We report the case of a 12-year-old boy admitted with prolonged fever, bilateral non-purulent conjunctivitis, and signs of shock such as hypotension and tachycardia. Laboratory findings showed elevated inflammatory markers, hypoalbuminemia, and sterile pyuria. He was initially treated with intravenous cefotaxime and vancomycin considering the possible diagnosis of toxic shock syndrome, while the treatment was not effective. Subsequent chest computerized tomography and ultrasound identified pulmonary consolidation and polyserous effusion. Echocardiography revealed mild biatrial dilatation and mild valvular regurgitation with preserved left ventricular function.Diagnosis:After a multidisciplinary consultation, a diagnosis of KDSS was made.Interventions:To prevent coronary artery lesions and other severe complications, the patient immediately received immunoglobulin, corticoid, and acetylsalicylic acid.Outcomes:Soon afterwards, he showed significant improvement, with the temperature dropped to normal and hypotension corrected about 24 hours post-intravenous immunoglobulin therapy. Polyserous effusions also disappeared before discharge. Follow-up echocardiography revealed normal results.Lessons:Clinicians should maintain a high index of suspicion for KD and consider pulmonary involvement and polyserous effusions as potential complications. For children with KD, any symptoms pointing to infection should be carefully considered. When there is no etiologic evidence, antibiotics should be used with caution. Our case also highlights the importance of considering KDSS as a differential diagnosis in children presenting with prolonged fever and shock. Early recognition, timely treatment, and close monitoring are key to preventing severe complications and ensuring favorable outcomes in patients with KDSS.

2024-07-01·American Heart Journal

Different dose aspirin plus immunoglobulin (DAPI) for prevention of coronary artery abnormalities in Kawasaki disease: Study protocol for a multi-center, prospective, randomized, open-label, blinded end-point, non-inferiority trial

Article

作者: Li, Ming ; Zhang, Xu ; Li, Wei ; Xie, Xiaofei ; Yuan, Jia ; Zhang, Li ; Li, Jianbin ; Wang, Yanfei ; Li, Fengxiang ; Wu, Yujian ; Hu, Lin ; Huang, Ping ; Xia, Shuliang ; Wang, Zhouping

BACKGROUNDKawasaki disease is a pediatric acute systemic vasculitis that specifically involves the coronary arteries. Timely initiation of immunoglobulin plus aspirin is necessary for diminishing the incidence of coronary artery abnormalities (CAAs). The optimal dose of aspirin, however, remains controversial. The trial aims to evaluate if low-dose aspirin is noninferior to moderate-dose in reducing the risk of CAAs during the initial treatment of Kawasaki disease.METHODSThis is a multi-center, prospective, randomized, open-label, blinded endpoint, noninferiority trial to be conducted in China. The planned study duration is from 2023 to 2026. Data will be analyzed according to intention-to-treat principles. Participants are children and adolescents under the age of 18 with Kawasaki disease, recruited from the inpatient units. A sample size of 1,346 participants will provide 80% power with a one-sided significance level of 0.025. Qualifying children will be randomized (1:1) to receive either intravenous immunoglobulin (2 g/kg) plus oral moderate-dose aspirin (30-50 mg·kg^-1·d^-1) until the patient is afebrile for at least 48 hours, or immunoglobulin plus low-dose aspirin (3-5 mg·kg^-1·d^-1) as initial treatment. The primary outcome will be the occurrence of CAAs at 8 weeks after immunoglobulin infusion. Independent blinded pediatric cardiologists will assess the primary endpoint using echocardiography.CONCLUSIONSThere is a shortage of consensus on the dose of aspirin therapy for Kawasaki disease due to the lack of evidence. The results of our randomized trial will provide more concrete evidence for the efficacy and adverse events of low- or moderate-dose aspirin in the acute phase of Kawasaki disease.TRIAL REGISTRATIONwww.chictr.org.cn: ChiCTR2300072686.

1

项与人血丙种球蛋白相关的新闻（医药）

2024-07-31

·药研网

和黄医药：呋喹替尼Q2海外销售额达7800万美元，环比增长56%!

刚刚，武田公布了2024 财年第一季度（4 月-6 月）财务业绩：截至 2024 年 6 月 30 日, 武田 Q1 总收入约 12080 亿日元（按最新汇率，约80亿美元）。按实际汇率（AER）计算，收入增长14.1% ; 按固定汇率（CER）计算, +2.1%。武田的增长和上市产品组合表现强劲，产品销售额增长17.8%（按 CER 计算)，占总收入的46%，体现其在短期内恢复可持续收入和利润增长的前景良好。其中，消化道肿瘤领域收入3485 亿日元（+6.0% ，CER)。ENTYVIO（治疗克罗恩病和溃疡性结肠炎）的销售额为2,344亿日元（+7.6% CER）；罕见病领域收入1995亿日元（+4.4% ，CER）。TAKHZYRO(用于遗传性血管性水肿)的销售额为560亿日元(+19.8% ，CER) PDT领域收入2714亿日元（+14.7% ，CER)， Immunoglobulin产品的总销售额为2,015亿日元(+21.9%，CER)。肿瘤板块收入1421亿日元（+17.2% ，CER)，2023年11月在美国上市用于结直肠癌的呋喹替尼FRUZAQLA的销售额为119亿日元（约0.78亿美元）！疫苗板块收入为125亿日元(+9.7%，CER)。新推出的QDENGA(用于登革热)销售额为95亿日元(+1,098.6%，CER)。主要受益于QDENGA在流行国家的可用性扩大，现在包括非流行国家在内的20多个国家。神经科学板块收入为1691亿日元(-15.0%，CER) FRUZAQLA Fruzaqla(fruquintinib,呋喹替尼)最初由和黄医药子公司和记黄埔研发，是一种高选择性的VEGFR-1/2/3激酶抑制剂,于 2018 年 9 月在中国获批用于结直肠癌的治疗。该产品是与礼来公司合作开发的，并以ELUNATE™品牌进行销售。 2023年1月，武田与和记黄埔签订独家授权协议，获得在中国大陆、香港和澳门以外进一步开发、商业化和制造呋喹替尼Fruzaqla的独家权利。 2023年11月，呋喹替尼于美国获批上市，用于治疗经治转移性结直肠癌，成为美国首个且唯一获批用于治疗经治转移性结直肠癌的针对全部三种 VEGF 受体激酶的高选择性抑制剂，无论患者的生物标志物状态如何。如今，呋喹替尼海外业绩傲人。根据武田公布的数据显示，自美国上市以来，呋喹替尼在美国市场第一季度的销售额已超5000万美元。如今武田财报2024年4月-6月卖出7800万美元，环比增长56%! 上市半年总销售额已近1.4亿美元，这凸显了该药物的前景及未来实现强劲收入增长的潜力。展望2024，武田与之前5月份宣布的2024全年展望相比不变。武田首席财务官Milano Furuta评论道：“预计未来几个季度仿制药侵蚀的影响将加速，由于计划启动多个第三阶段项目，我们的研发投资将集中在下半年。外汇一直是第一季度收入表现的利好因素，我们认为，如果目前的汇率继续下去，我们的收入预测可能会上行。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信 wfj_GM 商务合作稿件征集点击了解详情往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

财报疫苗上市批准

100 项与人血丙种球蛋白相关的药物交易

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研发状态

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EHA2022	N/A	多发性骨髓瘤	2,445	IMMUNOGLOBULIN (Patients who received Ig)	糧艱餘選觸蓋廠夢鹽範(鹹壓觸範蓋窪繭築範餘) = 夢鑰餘網鬱簾齋製衊餘糧鹹範遞網膚膚遞窪窪 (鏇遞網鑰遞積選遞廠鏇 )	-	2022-05-12
				IMMUNOGLOBULIN (Patients who did not receive Ig)	糧艱餘選觸蓋廠夢鹽範(鹹壓觸範蓋窪繭築範餘) = 膚襯糧觸遞蓋夢鑰艱鹽糧鹹範遞網膚膚遞窪窪 (鏇遞網鑰遞積選遞廠鏇 )
P5.044 (AAN2016)	N/A	慢性炎症性脱髓鞘性多发性神经病 \| 多发性骨髓瘤	-	IVIG	(網糧獵鬱構願簾鑰鹽繭) = 蓋遞鹹齋鑰蓋廠網鏇窪積齋製淵壓膚鏇願蓋獵 (餘選鬱壓夢餘鏇願夢襯 ) 更多	-	2016-04-05
				Immunoglobulin	(網糧獵鬱構願簾鑰鹽繭) = 範鑰淵夢淵鑰糧鬱醖鬱積齋製淵壓膚鏇願蓋獵 (餘選鬱壓夢餘鏇願夢襯 ) 更多
SP153 (ERA2015)	N/A	膜性肾小球肾炎 IgG \| IgM \| IgA	61	IMMUNOGLOBULIN (rich form LMN)	(獵憲糧鹹願範範鑰壓積) = 艱簾壓觸淵淵獵願範齋襯齋醖糧鏇衊簾鬱觸窪 (繭憲選構憲繭憲衊齋顧 )	不佳	2015-05-21
				IMMUNOGLOBULIN (poor form LMN)	(積獵築衊憲觸繭齋選窪) = 簾淵淵願積窪蓋鏇鹹簾襯淵築鬱窪築鏇廠窪選 (構遞願醖糧蓋衊襯願廠 ) 更多