A Multicenter, Prospective Study to Evaluate the Risk of Hypothyroidism in Pediatric Patients Administered Intravascular Iohexol, Iodixanol, Iopromide, or Ioversol. THYROPED.

This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.

开始日期2022-03-01

申办/合作机构

GE Healthcare Holdings, Inc.

[+2]

NCT04605471

/ CompletedN/A

Safety Profile of Ultravist in Children and Elderly (UV Age)

Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Even after a treatment or substance has been approved for use, researchers continue to study it to learn more about its safety.
Researchers have done studies on the safety of Ultravist, but they want to learn more about specific medical problems called hypersensitivity reactions (HSRs). These are undesirable immune system reactions to the study drug. In this study, the researchers will compare the risk of HSRs in children and in the elderly to the risk of HSRs in middle aged adults.
The researchers will look at information about medical problems that happened in people in 4 other studies. These studies are called PMS I, IMAGE, TRUST, and Ultravist in CT. A total of about 139,000 people will be included in this study.
All of the people in the earlier 4 studies received Ultravist as an injection into the vein or artery before having a scan. In this study, the researchers will compare the number of children, middle aged adults, and elderly patients who had HSRs after receiving Ultravist.

开始日期2020-10-31

申办/合作机构

Bayer AG

NCT03622801

/ CompletedN/A

Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration

Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.

开始日期2018-10-12

申办/合作机构

Bayer AG

100 项与碘普罗胺相关的临床结果

登录后查看更多信息

100 项与碘普罗胺相关的转化医学

登录后查看更多信息

100 项与碘普罗胺相关的专利（医药）

登录后查看更多信息

1,651

项与碘普罗胺相关的文献（医药）

2025-09-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous determination of three iodinated contrast media in human plasma by LC/MS-MS and its clinical application

Article

作者: Wu, Xiaofei ; Wang, Hongyun ; Wang, Yaoyao ; Cai, Jianfang ; Liu, Shupeng

Iodinated contrast media (ICM), including iohexol, iopromide and iodixanol, have significantly enhanced diagnostic accuracy, particularly in cardiovascular and cerebrovascular diseases. The three ICM is tailored to specific patient needs and diagnostic contexts. However, excessive doses of ICM may induce adverse reactions, including nephrotoxicity. Accurate measurement of ICM concentration is essential for reducing renal burden and ensuring patient safety. Current methods for quantifying ICM are often limited to single-analyte detection (especially iohexol), which is inefficient for clinical practice. Therefore, this method aims to develop and validate a rapid, generic LC-MS/MS method for simultaneously quantifying iohexol, iopromide, and iodixanol in human plasma to improve patient management and prognosis. An LC-MS/MS-based approach was established utilizing an C18 column coupled with a Xevo TQ-S triple quadrupole mass spectrometer. Sample preparation involved protein precipitation, while chromatographic separation was achieved using acetonitrile and 0.1 % formic acid in water. The developed LC-MS/MS method achieved satisfactory separation of the three ICM within 1.5 min. Calibration curves for iohexol, iopromide, and iodixanol showed good linearity in 5.00-5000, 5.00-5000 and 10.0 ∼ 10000 µg/mL, respectively. The method was effectively applied to analyze 71 plasma samples from 9 patients, highlighting its clinical utility. A rapid and generic LC-MS/MS method streamlines sample preparation and standardizes laboratory workflows, making it suitable for clinical bio-samples.

2025-07-01·JOURNAL OF HAZARDOUS MATERIALS

Association between organic micropollutants in tap water and human exposure and birth outcomes: Implications for environmental health in northern Puerto Rico

Article

作者: Kaeli, David ; Padilla, Ingrid Y ; Rich, Stephanie L ; Manjourides, Justin ; Alshawabkeh, Akram N ; Gao, Griffith ; Feng, Yinmei ; Rosario-Pabón, Zaira ; Helbling, Damian E ; Li, Guangyu ; Gu, April Z ; Vega, Carmen Velez ; Meeker, John D

The presence of micropollutants in Puerto Rico's tap water, potentially linked to nearby Superfund sites, was hypothesized to contribute to the region's higher preterm birth rate than the US mainland. This study analyzed the presence of 175 micropollutants in tap water samples collected from participant households and evaluated their association with human exposure using 14 oxidative stress and inflammation biomarkers in urine samples collected from pregnant participants, and further with the subsequent birth outcome information. Notably, three out of four oxidative stress biomarkers consistently showed negative correlations with five micropollutant categories, highlighting the oxidative stress induced by these contaminants. For the ten selected inflammation-related biomarkers, two showed positive yet not significant correlations with the five categories of micropollutants and, only one biomarker (MMP1), an inflammation biomarker whose down-regulation was associated with pre-mature birth implications, showed significant negative correlation with industrial chemicals and pesticides. Interestingly, the detected urinary phthalate metabolites in pregnant women could not be linked with the two parent phthalates found in the tap water, suggesting that the two phthalates in tap water may not be the primary source of phthalate exposure to human body. Furthermore, hormones in tap water showed significant moderate-to-strong negative correlations with birth outcomes, raising specific health concerns for pregnant women in northern Puerto Rico. This is the first study to investigate the association among a wider spectrum of tap water micropollutants with pregnancy exposure and birth outcome in Puerto Rico and provide insights into water quality and associated human health impacts.

2025-06-01·ACTA RADIOLOGICA

Objective assessment of immediate iodine-based contrast media hypersensitivity reactions using skin and drug provocation testing

Article

作者: H’ng, Martin Weng Chin ; Tan, Sze-Chin ; Lee, Chau Hung ; Chiow, Si Min ; Wong, Pearlyn Mei Ping

Background:

With increasing importance of iodine-based contrast media (ICM) in radiology, a label of allergy to ICM has significant impact on patient management, and objective testing for ICM allergy can help guide subsequent administration.

Purpose:

To correlate skin testing with drug provocation test (DPT) outcomes and determine cross-reactivity between our institution's three available ICMs.

Material and Methods:

Eligible patients who presented to our institution's radiology department within a 3-year period with suspected ICM allergy were referred to the allergist for evaluation with skin testing ± DPT. Patients who tested negative were followed up to evaluate for any reaction after ICM re-exposure in subsequent contrast-enhanced computed tomography scans.

Results:

A total of 72 cases underwent testing. Concordance between skin testing and DPT was 85.7% (6/7) for iohexol, 65.1% (28/43) for iodixanol, and 100% (2/2) for iopromide. Cross-reactivity was in the range of 59.6%–75.9% between iohexol and iodixanol, 75.0%–77.4% between iohexol and iopromide, and 43.3%–60.0% between iodixanol and iopromide. Only 1/14 patients who were skin test and DPT negative developed a reaction on re-exposure to ICM after testing.

Conclusion:

Objective testing for ICM hypersensitivity, particularly within 6 months of initial exposure, allows the majority of patients to be administered the same or an alternative ICM with no adverse reaction, with iodixanol having the lowest cross-reactivity.

140

项与碘普罗胺相关的新闻（医药）

2025-06-23

·药闻康策

第十一批国采,14个品种或将待定！

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策近日，一份《关于征求<第十一批国家组织药品集中采购拟采购药品清单>意见的函》在业内流传，《清单》包含了第十一批国采拟采购的75个药品，最低竞争格局仍为7家。（来源:一度医药）75个品种中包含国采首个贴剂品种洛索洛芬贴剂，并纳入地氯雷他定一个口服液体剂，未纳入任何一个滴眼剂品种。75个品种中还有14个有额外备注，需要专家重点研判，决定是否纳入第十一批国采，主要包括以下两种情况：一、仿制药适应症少于原研药的5个品种：1. 达格列净片。原研药和过评仿制药说明书均有糖尿病适应症，但原研还有心衰和慢性肾脏病适应症。2. 艾曲泊帕乙醇胺片。原研药和过评仿制药说明书均有慢性免疫性(特发性)血小板减少症(ITP)适应症，但原研还有重型再生障碍性贫血(SAA)适应症。3. 阿伐曲泊帕口服常释剂型。原研药和过评仿制药说明书均有慢性肝病相关血小板减少症(CLDT)适应症，但原研药和部分仿制药还有慢性原发免疫性血小板减少症(ITP)适应症。4. 奥拉帕利片。原研药和过评仿制药说明书均有上皮性卵巢癌输卵管或原发性腹膜癌适应症，但原研药还有前列腺癌、乳腺癌适应症。5. 乙磺酸尼达尼布软胶囊过评仿制药和原研药均有系统性硬化病相关间质性肺疾病、进行性表型慢性纤维化性间质性肺疾病适应症，原研药还有特发性肺纤维化适应症.二、临床使用风险相对较高的9个品种：1. 万古霉素注射剂和头孢他啶阿维巴坦注射剂。均为特殊使用级抗菌药物，按照以往做法，我们拟降低此类抗菌药物带量比例。2. 麦考酚钠口服常释剂型。为器官移植抗排异用药，属于窄治疗指数药物，我们拟对该药品降低带量比例与医疗机构原常用厂牌不同的中选产品仅用于新患者。3. 甲氨蝶呤注射剂和阿糖胞苷注射剂。为抗代谢类化疗药物，专家提出两药品有时须采取鞘内注射，存在一定临床风险。4. 碘普罗胺注射剂。为增强CT检查的造影剂，有专家提出该药品为高警示药物，可能导致过敏性休克。5. 拉莫三嗪口服常释剂型。用于治疗癫痫，部分国家将其列为窄治疗指数药物。6. 曲普瑞林注射剂(0.1mg)和西曲瑞克注射剂。为辅助生殖药品，专家反映辅助生殖方案的容错率低，且目前我国辅助生殖成功率较低(不足40%)，如纳入集采可能面临使用和舆情的风险。根据上文提到的几种情况和相关药品，可在此前的基础上进一步总结几种可能影响药品纳入国采的条件：1. 仿制药适应症少于原研药。2. 特殊使用级抗菌药：可能不影响纳入，但必定削减采购量比例，可参考各地发布的抗菌药目录。3. 窄治疗指数药物：目前国内暂无官方发布的窄治疗指数药物目录，仅有早期流传的一份《属于治疗窗窄的部分药物目录》，涉及30个品种的口服制剂。此外，在其他国家被列入窄治疗窗药物也可能作为一个评判依据，以下是美、日、加三国发布的国家级窄治疗指数药品目录清单。来源：2008年1月《已上市化学药品变更研究的技术指导原则（一）》仅供参考曾发布的国家级窄治疗指数药品目录清单（来源陈志东《窄治疗指数药物安全性的再认识》《上海医药》2020年第41卷第19期仅供参考）4. 须采取鞘内注射等操作的药品，存在一定临床风险。5. 高警示药物：中国医药教育协会于2023年9月28日发布的《医疗机构高警示药品风险管理规范》中包含一份《医疗机构高警示药品分级管理推荐目录》，将高警示药品分为A、B、C三个登记，涉及多种药物。需要注意的是，艾司洛尔注射剂等A级高警示药品已纳入国采，因此暂时无法将此作为影响国采品种遴选的决定性因素。医疗机构高警示药品分级管理推荐目录（来源：中国医药教育协会《医疗机构高警示药品风险管理规范》仅供参考）6. 辅助生殖药品。总体来看，在保持7家过评门槛的情况下，第十一批国采纳入品种数可能将创下历史新高，并首次纳入贴剂剂型。同时，随着2025年1月《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》明确“将仿制药质量和疗效一致性评价逐步向滴眼剂、贴剂、喷雾剂等剂型拓展”，本次未纳入的众多滴眼剂品种也可能在将来集中纳入国采。(来源:易联招采网)有需要完整版《第十一批国采拟采购品种清单征求意见函》，请扫描下方二维码添加客服微信咨询，申请加入药闻康策高端会员群获取。药闻康策新媒体矩阵微信公众号点击下方一键关注欢迎转发分享、点赞、点在看

带量采购

2025-06-23

·药通社

废标重选？第十一批拟国采品种分析

这两天，最大的事情莫过于业内流传的第十一批国采拟采购药品清单（涉及75个品种）。据该文件内所写，目前拟采购的75个品种之中，有14个品种还须进行研判。这14个品种分两类：第一类是仿制药适应症少于原研药的，共5个品种，分别是达格列净片、艾曲泊帕乙醇胺片、阿伐曲泊帕口服常释剂型、奥拉帕利片和乙磺酸尼达尼布软胶囊。第二类是专家认为临床使用风险相对较高的，共9个品种，分别是万古霉素注射剂、头孢他啶阿维巴坦注射剂、麦考酚钠口服常释剂型、甲氨蝶呤注射剂、阿糖胞苷注射剂、碘普罗胺注射剂、拉莫三嗪口服常释剂型、曲普瑞林注射剂(0.1mg)、西曲瑞克注射剂。这14个品种仍存在不确定性，须等待进一步研判结果。再分析其他拟采购的品种，首先有一个废标重选品种：盐酸溴己新注射液。该品种第七批集采已集采，经串标被查后废标，现又重新被纳入十一批国采。截至3月31日（网传十一批国采遴选关门时间），盐酸溴己新注射液共15家企业过评，除6家禁标企业外，还有9家企业过评，可参与此次竞标。值得注意的是，按处罚时间来看，仁合益康、广州一品红、石家庄四药三家公司已过处罚期（截至2025年2月），理论上也可参与此次竞标。而剩下三家成都欣捷、上海旭东海普、江西亿友禁标时间仍未到，不可参与此次竞标。另外，目前目录内存在专利未到期品种，包括沙库巴曲缬沙坦口服常释剂型（专利期至2026年11月）、伏诺拉生口服常释剂型（专利期至2026年8月）、吲哚布芬口服常释剂型（专利期至2040年）。尤其是吲哚布芬口服常释剂型，中美华东强势的专利要求已经使得多家企业暂停挂网，浙江美迪深、浙江同伍、湖南九典三家均已撤网。这三个有专利限制的品种，最终或被剔除。此前药通社进行过统计，截至6月下旬，已有149个品种满足十一批国采要求（≥7家）的要求。详见：十一批国采首个！超40家！将该目录与此次拟纳入的75个品种进行对比，除去截止3月末不满足≥7家的31个品种，还剩下45个品种符合过评竞争企业数要求，但未被纳入。这45个品种未被纳入的原因是什么？首先是由于“新老文号交叉”。简单解释一下。2023年8月23日，国家组织药品联合采购办公室曾发布一份说明文件，对于口服固体制剂和注射剂以外的剂型（口服溶液、吸入剂、滴眼液等）既有老批件又有新批件的产品暂不列入本次集采。此份说明原本只限于第八批国采，但实际上第九批和第十批集采大部分品种也在遵循此原则。这一次很多品种也存在这种情况（详见下表），大概率也是因为这个原因而未被纳入。这里面包括很多大品种——如18亿市场的乳果糖口服液体剂（33+1）、30亿市场的乙酰半胱氨酸吸入剂（28+1）等。但也并非所有新老批件交叉的品种都不纳入，比如这次纳入的地氯雷他定口服制剂被纳入，该品种就存在老文号未过评情况。第二个主要原因就是临床需求太小。比如ω-3脂肪酸乙酯90口服常释剂型、利托那韦口服常释剂型等目前市场还不到百万。除此之外，还涉及到剂型的问题。截止目前还没有乳膏和洗剂之类纳入国采，此次也有很多乳膏满足要求，但均未被纳入。还有一些就是条件全都符合但就是未被纳入的品种，比如他氟前列素滴眼剂市场上亿，过评8家，全是新批件。像这种的品种，其实每一批都有，只是还未轮到。8 月 1-2 日，“仿制药和改良新药立项‘稳准狠’大会”，苏州开幕！风云药谈创始人张廷杰现场解析《新集采（11 批）、大接续、价格治理下的产品布局》，线下直击政策红利期的立项策略，速抢席位共探行业破局点。CMC制药工业博览会附表一：3月31号满足竞争≥7家，但未被纳入的45个品种附表二：第十一批国采拟采购的75个品种↓ 关注药通社，洞见行业趋势 ↓投稿/企业合作/内容沟通：华籍美人（Ww_150525）

专利到期带量采购

2025-06-21

·药筛

74个产品销售数据排名，最高近50亿，最低不足1亿元

大家关心的75个品种，实际是74个，其中序号62和63的产品充分，都是复方电解质注射剂。我统计了各品种2024年医院市场销售规模，达格列净以49亿元排名第一，沙库巴曲缬沙坦以43.6亿排名第二。最少的是丙卡特罗吸入剂，只有0.4亿；头孢丙烯口服液体剂等几个品种，也不足亿元。优化方案中，说好的市场规模小的品种，暂不考虑，难道1亿元也算不小？哎，目录真是个玄学啊！以下是产品销售额排名，数据来自摩熵医药全终端药品销售数据。产品名称2024年销售额（亿元）过评企业数达格列净口服常释剂型4924沙库巴曲缬沙坦口服常释剂型43.622头孢唑肟注射剂36.232福莫特罗吸入剂35.815奥司他韦颗粒剂34.28罗沙司他口服常释剂型24.516亚胺培南西司他丁注射剂23.27万古霉素注射剂19.87法莫替丁注射剂18.729碘普罗胺注射剂18.78吲哚布芬口服常释剂型18.613洛索洛芬贴剂18.47溴己新注射剂16.315苯唑西林注射剂13.57头孢他啶阿维巴坦注射剂12.113奥拉帕利口服常释剂型129麦考酚钠口服常释剂型10.510复方醋酸钠林格注射剂9.18阿戈美拉汀口服常释剂型815伏诺拉生口服常释剂型7.812腺苷蛋氨酸注射剂7.59帕利哌酮缓释控释剂型7.47多巴丝肼口服常释剂型78瑞巴派特口服常释剂型6.713贝尼地平口服常释剂型6.57二羟丙茶碱注射剂6.530尼可地尔口服常释剂型6.412普伐他汀口服常释剂型6.28贝前列素口服常释剂型6.29厄他培南注射剂6.27倍他米松注射剂6.19地诺孕素口服常释剂型6.111氟伏沙明口服常释剂型5.515福沙匹坦双葡甲胺注射剂5.47恩扎卢胺口服常释剂型5.29右丙亚胺(右雷佐生)注射剂5.27碳酸氢钠注射剂515阿伐曲泊帕口服常释剂型4.816中/长链脂肪乳(C6-24)注射剂4.67复方电解质注射剂4.58拉莫三嗪口服常释剂型4.58艾曲泊帕乙醇胺口服常释剂型4.412阿瑞匹坦口服常释剂型4.27奥卡西平口服常释剂型47尼达尼布口服常释剂型47艾多沙班口服常释剂型3.99阿仑膦酸口服常释剂型3.78尼麦角林口服常释剂型3.49布比卡因注射剂3.28二甲双胍恩格列净口服常释剂型3.112腺苷钴胺口服常释剂型3.112阿糖胞苷注射剂3.18替考拉宁注射剂3.110地氯雷他定口服液体剂324卢帕他定口服常释剂型2.711西曲瑞克注射剂2.78硫酸镁钠钾口服用浓溶液2.617氯诺昔康注射剂2.517甲氨蝶呤注射剂2.410西洛他唑口服常释剂型2.17钆布醇注射剂27阿莫西林克拉维酸口服液体剂27吡拉西坦(乙酰胺吡咯烷酮)口服常释剂型28阿格列汀口服常释剂型1.916美索巴莫注射剂1.812沙丁胺醇注射剂1.88肾上腺素注射剂1.77异烟肼注射剂1.67去氧肾上腺素注射剂1.514曲普瑞林注射剂(0.1mg)1.48维库溴铵注射剂1.27甲氧氯普胺注射剂18头孢丙烯口服液体剂17丙卡特罗吸入剂0.48用摩熵药筛小程序，快速查询产品市场销售数据！

临床研究临床结果

100 项与碘普罗胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D01893	碘普罗胺	V08AB05	DB09156

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
乳腺疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2023-05-25
主动脉疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	1995-05-10
心血管疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	1995-05-10
脑血管疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	1995-05-10
冠状动脉疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	1995-05-10
外周动脉疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	1995-05-10
尿道疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	1995-05-10
造影剂	澳大利亚	Bayer Australia Ltd.	1991-09-12

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04605471 (Pubmed \| Invest Radiol)	N/A	-	132,850	Iopromide (Children (<18 years))	願繭構觸淵願鹽淵壓壓(鏇網窪艱顧窪網觸夢壓) = 選衊憲製膚夢遞糧築積淵簾鑰觸繭鬱憲繭糧鑰 (窪淵壓醖鑰糧廠衊積襯 )	-	2021-12-01
				Iopromide (Elderly (≥65 years))	願繭構觸淵願鹽淵壓壓(鏇網窪艱顧窪網觸夢壓) = 簾衊觸衊壓鑰簾艱鬱襯淵簾鑰觸繭鬱憲繭糧鑰 (窪淵壓醖鑰糧廠衊積襯 )
NCT00926562 (DIRECT, Pubmed \| EuroIntervention)	临床4期	-	562	iopromide	鏇蓋觸鬱鹹觸簾獵製壓(鑰窪鏇夢艱夢鹽鏇壓鬱) = 獵壓壓蓋網鑰遞壓廠範齋壓襯齋膚繭繭襯製夢 (鑰淵鏇醖憲鏇範壓獵窪 ) 更多	-	2012-11-22
				iodixanol	鏇蓋觸鬱鹹觸簾獵製壓(鑰窪鏇夢艱夢鹽鏇壓鬱) = 衊簾鬱築鹹製鏇選網齋齋壓襯齋膚繭繭襯製夢 (鑰淵鏇醖憲鏇範壓獵窪 ) 更多
NCT00244140 (CTgov)	临床3期	诊断试剂	435	Iopromide (Iopromide 370 mg I/mL)	齋窪鑰蓋鏇鑰廠網襯繭 = 鬱獵範網鹹選衊願鹽餘觸窪願鹽齋膚築蓋願艱 (壓襯構選繭範觸鑰憲遞, 淵夢獵膚襯淵衊糧築淵 ~ 網遞憲遞鏇觸醖網遞積) 更多	-	2009-07-20
				Iopromide (Iopromide 300 mg I/mL)	齋窪鑰蓋鏇鑰廠網襯繭 = 襯艱選餘網築製築築顧觸窪願鹽齋膚築蓋願艱 (壓襯構選繭範觸鑰憲遞, 壓鏇積淵觸窪窪襯夢鹹 ~ 築鹽壓網壓壓鹹襯鹹觸) 更多