Small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team.
The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO.
This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.

开始日期2024-01-01

申办/合作机构

University of California, Los Angeles

NCT05726097

/ Completed临床3期

Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.

开始日期2023-02-01

申办/合作机构

Region Skåne Holding AB

[+2]

ACTRN12620000710921

/ RecruitingN/AIIT

A Phase 2 study of efficacy: The validation of Gastrografin measurement in postsurgical samples following low anterior resection when the rectal tube is flushed with Gastrografin

开始日期2020-08-18

申办/合作机构-

100 项与泛影酸钠/泛影葡胺相关的临床结果

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100 项与泛影酸钠/泛影葡胺相关的转化医学

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100 项与泛影酸钠/泛影葡胺相关的专利（医药）

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442

项与泛影酸钠/泛影葡胺相关的文献（医药）

2025-01-01·Radiology case reports

Complicated meconium ileus in a male neonate with cystic fibrosis: Case report

Article

作者: Sellouti, Mohamed ; Abilkassem, Rachid ; Agadr, Aomar

In about 10%-15% of instances, meconium ileus (MI) is the first sign of cystic fibrosis (CF). If a newborn exhibits signs of intestinal obstruction and does not pass meconium within a short period of time after birth, MI is suspected. The cystic fibrosis transmembrane conductance regulator gene (CFTR), which is found on chromosome 7q31, is mutated in CF patients. A premature baby, 5 days old, with clinical signs that were typical of MI. These attempts failed in spite of conservative therapies, such as rectal injection of gastrografin. An ileostomy was made and meconium was manually evacuated after an exploratory laparotomy revealed the presence of a typical MI. At ≥1300 µg/L (reference value ≤1000 µg/L), immunoreactive trypsinogen (IRT) levels were increased, which prompted the start of oral pancreatic enzyme replacement treatment. Discharge at 65 days of age included referrals to primary care and a specialized CF clinic. The baby has since shown normal growth and development. This case highlights the rapid onset of CF in a premature infant with complex MI as the initial clinical presentation.

2024-12-01·JOURNAL OF SURGICAL RESEARCH

“The Itsy-Bitsy Water Bead Went Down the Baby's Mouth. Will Drinking Gastrografin Help to Flush It Out?”

Article

作者: Horton, John ; Pumiglia, Luke ; Zhang, Bobby ; Francis, Andrew ; Ciullo, Sean ; Barlow, Meade ; Prey, Beau ; Williams, James

INTRODUCTION:

Foreign body ingestion is a common occurrence in the pediatric population. Superabsorbent polymers (i.e., water beads [WB]), such as Orbeez, are brightly colored spheres, can expand up to 100x their original size and are marketed as toys for kids. Ingested WB may lead to a bowel obstruction and typically require surgical removal.

METHODS:

Fully expanded WBs (N = 15) were placed into 1 of the 3 solutions: water (N = 5), gastrografin (N = 5), or 1:1 mixture of gg and water (N = 5), with serial diameter measurements obtained at 1, 4, 8, and 24 h. Additionally, fully expanded WBs were placed into succus containing post mortem porcine small bowel and mixed with gastrografin (N = 10) or nothing (N = 10), with diameters measured prior to placement and at 4 h.

RESULTS:

At all time points, the mean WB diameter of the gastrografin arm was significantly smaller than the other two arms (P < 0.01). WBs submerged in gastrografin saw a 58% reduction in diameter at 4 h compared to 45% reduction in the 1:1 mixture and a 2% growth in water (P < 0.01). When placed into small bowel containing gastrografin, the mean WB diameter decreased by 47% at 4 h versus 37% in the control arm (P < 0.01).

CONCLUSIONS:

Gastrografin significantly reduced the size of WB in both the in-vitro and ex-vivo post mortem animal study; and it may offer a nonsurgical option for the management of water bead ingestion. Studies assessing the clinical efficacy of a gastrografin nonoperative management strategy are needed.

2024-12-01·Internal medicine (Tokyo, Japan)

Successful Gastrografin Vermifugation for <i>Taenia saginata</i>-associated Appendicitis

Article

作者: Kobayashi, Keigo ; Umekawa, Yasuhiro

In Japan, public health improvements have lessened parasitic infections, but increased global travel has introduced new disease risks. We report the case a Japanese man who had previously resided in Vietnam, who experienced appendicitis and the presence of segments in his stool. Gastrografin led to the expulsion of Taenia saginata, as confirmed by scolex identification. Remarkably, the appendicitis symptoms subsided after deworming. This case underscores the importance of considering cestode infections in the differential diagnosis of appendicitis, particularly for patients with relevant travel histories, and highlights the evolving challenges in global health and the significance of acquiring detailed patient histories.

项与泛影酸钠/泛影葡胺相关的新闻（医药）

2023-04-25

·国家药品监督管理局

国家药监局关于修订泛影葡胺注射液等含碘对比剂说明书的公告（2023年第54号）

根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对含碘对比剂（包括泛影葡胺注射液、复方泛影葡胺注射液、碘海醇注射液、碘美普尔注射液、碘帕醇注射液、碘佛醇注射液、碘克沙醇注射液、碘普罗胺注射液、碘比醇注射液）说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照相应附件要求修订说明书，于2023年7月20日前报国家药监局药品审评中心或省级药品监督管理部门备案。修订内容涉及药品标签的，应当一并进行修订，说明书及标签其他内容应当与原批准内容一致。在备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换。二、药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师合理用药。三、临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。四、患者用药前应当仔细阅读药品说明书，使用处方药的，应严格遵医嘱用药。五、省级药品监督管理部门应当督促行政区域内上述药品的药品上市许可持有人按要求做好相应说明书修订和标签、说明书更换工作，对违法违规行为依法严厉查处。特此公告。附件：1.泛影葡胺注射液说明书修订要求 2.复方泛影葡胺注射液说明书修订要求 3.碘海醇注射液说明书修订要求 4.碘美普尔注射液说明书修订要求 5.碘帕醇注射液、碘佛醇注射液、碘克沙醇注射液、碘普罗胺注射液、碘比醇注射液说明书修订要求国家药监局 2023年4月21日国家药品监督管理局2023年第54号公告附件1.docx国家药品监督管理局2023年第54号公告附件2.docx国家药品监督管理局2023年第54号公告附件5.docx国家药品监督管理局2023年第54号公告附件3.docx国家药品监督管理局2023年第54号公告附件4.docx

2023-04-25

·蒲公英Ouryao

43个品种→涉及九类制剂修订说明书！

来源：国家药监局整理：wangxinglai2004 2023年04月24日，根据药品不良反应监测和安全性评价结果，国家药监局发布了9则制剂修订说明书公告，涉及白芍总苷胶囊、环磷腺苷注射剂、环磷腺苷注射剂金乌骨通胶囊等9类产品，43个品种。 01 白芍总苷胶囊根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对白芍总苷胶囊说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照白芍总苷胶囊说明书修订要求，于2023年7月20日前报省级药品监督管理部门备案。 02 金乌骨通胶囊根据药品不良反应监测和安全性评价结果，为进一步保障公众用药安全，国家药品监督管理局决定对金乌骨通胶囊说明书【不良反应】、【禁忌】和【注意事项】项进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照相应附件要求修订说明书，于2023年7月18日前报省级药品监督管理部门备案。 03 全身用利巴韦林制剂根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对全身用利巴韦林制剂（包括利巴韦林氯化钠注射液、利巴韦林葡萄糖注射液、利巴韦林注射液、注射用利巴韦林、利巴韦林泡腾颗粒、利巴韦林片、利巴韦林口服溶液、利巴韦林分散片、利巴韦林含片、利巴韦林胶囊、利巴韦林颗粒）说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照相应附件要求修订说明书，于2023年7月20日前报省级药品监督管理部门备案。 04 含碘对比剂根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对含碘对比剂（包括泛影葡胺注射液、复方泛影葡胺注射液、碘海醇注射液、碘美普尔注射液、碘帕醇注射液、碘佛醇注射液、碘克沙醇注射液、碘普罗胺注射液、碘比醇注射液）说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照相应附件要求修订说明书，于2023年7月20日前报国家药监局药品审评中心或省级药品监督管理部门备案。 05 吡拉西坦制剂根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对吡拉西坦制剂（包括吡拉西坦分散片、吡拉西坦片、吡拉西坦胶囊、吡拉西坦颗粒、吡拉西坦口服溶液、吡拉西坦氯化钠注射液、吡拉西坦注射液、吡拉西坦葡萄糖注射液、注射用吡拉西坦）说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照相应附件要求修订说明书，于2023年7月20日前报省级药品监督管理部门备案。 06 壮骨止痛胶囊和小儿咳喘灵制剂根据药品不良反应监测和安全性评价结果，为进一步保障公众用药安全，国家药品监督管理局决定对壮骨止痛胶囊和小儿咳喘灵制剂说明书中的【不良反应】、【禁忌】和【注意事项】项进行统一修订。现将有关事项公告如下：一、所有上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照相应附件要求修订说明书，于2023年7月17日前报省级药品监督管理部门备案。 07 二氯醋酸二异丙胺注射剂根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对二氯醋酸二异丙胺注射剂（含复方二氯醋酸二异丙胺）（包括注射用二氯醋酸二异丙胺葡萄糖酸钠、复方二氯醋酸二异丙胺注射液、注射用复方二氯醋酸二异丙胺）说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照相应附件要求修订说明书，于2023年7月20日前报省级药品监督管理部门备案。 08 托法替布制剂根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对托法替布制剂（包括枸橼酸托法替布片、枸橼酸托法替布缓释片）说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照托法替布制剂说明书修订要求（见附件），于2023年7月20日前报国家药品监督管理局药品审评中心或省级药品监督管理部门备案。 09 环磷腺苷注射剂根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对环磷腺苷注射剂（包括注射用环磷腺苷、环磷腺苷注射液、环磷腺苷葡萄糖注射液、环磷腺苷氯化钠注射液）说明书内容进行统一修订。现将有关事项公告如下：一、上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照环磷腺苷注射剂说明书修订要求（见附件），于2023年7月20日前报省级药品监督管理部门备案。扫描二维码，查看以上9类品种具体修订内容：修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换。二、药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师和患者合理用药。三、临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。四、患者用药前应当仔细阅读药品说明书，使用处方药的，应当严格遵医嘱用药。五、省级药品监督管理部门应当督促行政区域内上述药品的药品上市许可持有人按要求做好相应说明书修订和标签、说明书更换工作，对违法违规行为依法严厉查处。 ‍

一致性评价上市批准医药出海

100 项与泛影酸钠/泛影葡胺相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
造影剂	美国	Bracco Diagnostics, Inc.	1955-08-02

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临床结果

适应症

分期

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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


NCT01440712 (Pubmed \| World J Surg)	临床4期	术后肠梗阻	-	Gastrografin	築膚廠淵顧鹽艱衊窪獵(襯夢膚築鹹齋餘醖製襯) = 憲襯醖範願構齋艱簾夢繭遞壓膚築積繭願窪願 (鹽壓觸積壓衊簾獵製遞, 6.51 ~ 11.68)	不佳	2016-01-01
NCT01440712 (Pubmed \| World J Surg)	临床4期	术后肠梗阻	-	Placebo	築膚廠淵顧鹽艱衊窪獵(襯夢膚築鹹齋餘醖製襯) = 遞衊構範簾鏇窪顧簾窪繭遞壓膚築積繭願窪願 (鹽壓觸積壓衊簾獵製遞, 6.96 ~ 10.29)	不佳	2016-01-01
UEGW2015	N/A	-	-	Gastrografin with magnesium citrate	鬱鹹遞積觸範築夢築顧(鑰築構願廠齋膚範鏇衊) = The median GI transit time was 4h 26 min (range 1h 9 min to 10h 11 min) 鑰築願鏇鑰願選蓋遞窪 (餘餘窪製鹹餘獵鏇範衊 ) 更多	-	2015-10-01
UEGW2015	N/A	-	-	Prep2 (2L PEG + Ascorbate + low dose NaP + gastrografin)	製簾網鏇簾積襯蓋網鏇(夢鑰膚醖構膚夢顧淵繭) = 積糧獵鑰廠夢膚膚艱壓獵壓選淵夢夢鬱鏇壓齋 (顧繭膚繭構築鏇廠鹹網 ) 更多	-	2015-10-01
NCT01515696 (CTgov)	临床4期	胎粪性肠梗阻	96	Gastrografin (Gastrografin)	觸積醖鏇蓋鏇糧構鹹壓(鑰襯廠醖鹹淵壓膚簾觸) = 鏇選淵壓醖鹹廠觸膚窪鬱觸願網餘齋觸衊壓積 (簾選鏇觸製壓艱鑰構壓, 鹽糧積積選艱鹽觸襯壓 ~ 齋獵築選艱鑰鑰鏇網積) 更多	-	2014-07-18
NCT01515696 (CTgov)	临床4期	胎粪性肠梗阻	96	sterile water (Sterile Water)	觸積醖鏇蓋鏇糧構鹹壓(鑰襯廠醖鹹淵壓膚簾觸) = 顧繭鬱淵衊襯選顧簾憲鬱觸願網餘齋觸衊壓積 (簾選鏇觸製壓艱鑰構壓, 憲衊鏇衊遞襯憲鏇憲簾 ~ 鏇鹹選窪網遞醖鏇築鬱) 更多	-	2014-07-18