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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457

项与泛影酸钠/泛影葡胺相关的文献（医药）

2025-03-01·Nigerian Journal of Clinical Practice

Gastrografin® Use and Its Benefits in Small Bowel Obstruction – A Single-Center Retrospective Study

Article

作者: Arslani, N

Background:Gastrografin® (GG) is a water-soluble contrast agent. Besides its role in diagnosing small bowel obstruction (SBO), its effectiveness in treating adhesive small bowel obstruction (ASBO) has been suggested.Aim:A retrospective study was performed at our institution to observe whether patients receiving GG benefited from the intervention compared to patients receiving standard treatment of SBO.Methods:Administration of GG was the surgeon’s decision, as was the decision for operative treatment. No treatment protocols were used at the department regarding GG use. The observed variables were length of hospital stay (LoHS), operative rate, and mortality rate.Results:Results of our study confirmed a substantial diagnostic value of GG challenge; passage of GG to the large bowel indicates successful conservative treatment of SBO. We observed that patients receiving GG (GG+) at our department did not have a significantly lower LoHS or mortality rate than those not receiving GG (GG-). However, GG+ did have a lower mean LoHS and a lower mean mortality rate than GG- group. The GG+ group displayed a significantly lower operative rate. Based on the design of our study, this cannot be attributed to the therapeutic effect of GG but rather to the selective treatment of patients.Conclusion:The GG challenge is a solid diagnostic tool, indicating a successful resolution of SBO if the passage of the contrast to the large bowel can be demonstrated. Although our study results point towards its positive effect, we cannot confirm the therapeutic function of GG due to probable treatment bias in severely affected patients.

2025-02-01·Colorectal Disease

Drain fluid iodine as a biomarker of anastomotic leak after low anterior resection in patients undergoing Gastrografin rectal tube flushes and omission of a diverting ileostomy: The GUSH study

Article

作者: Lonne, Michael ; Edmundson, Aleksandra ; Dobeli, Karen ; Allen, Darren ; Clark, David A. ; McWhinney, Brett

AbstractAimAnastomotic leak (AL) is the anathema of colorectal surgery and its occurrence constitutes a serious risk to patients and places a substantial burden on the health system. The analysis of extravasated intraluminal substances in drain fluid has shown promise for the early detection of AL. The aim of this study is to assess the measurement of drain fluid iodine as a biomarker of AL.MethodThis prospective, observational, 2b exploration cohort study measured the iodine in drain fluid of patients undergoing a low colorectal anastomosis and without a diverting ileostomy (DI) when the rectal tube was flushed with Gastrografin®. Iodine was measured by dual‐energy computed tomography (DECT) and inductively coupled plasma mass spectroscopy (ICPMS).ResultsSixty‐six patients underwent a rectal resection and low colorectal anastomosis. Five patients experienced an AL. Four had grade C AL and returned to the operating theatre for peritoneal lavage and DI. The fifth was diagnosed at 30 days postoperatively and underwent image‐guided drainage (grade B). The mean drain fluid iodine was significantly elevated in patients who experienced an AL compared with those who did not, as measured by DECT and ICPMS. The mean iodine value was 6.05 mg/mL vs. 0.088 mg/mL (p < 0.0001) for DECT and 41 437 μmol/L vs. 3.81 μmol/L (p < 0.0001) for ICPMS.ConclusionThis study showed that drain iodine can be used as a sensitive indicator of early AL in patients undergoing a rectal resection with an extraperitoneal colorectal anastomosis and omission of a DI and when the rectal tube is flushed with Gastrografin following surgery.

2025-01-01·Radiology Case Reports

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

Article

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

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.

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

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适应症	国家/地区	公司	日期
造影剂	中国	-	-

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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	築簾襯獵齋觸蓋衊鑰願(淵築蓋觸簾繭蓋窪憲醖) = 構遞構鹽襯鏇網廠艱餘糧築繭窪齋顧夢襯醖醖 (遞夢鑰夢壓壓壓齋鬱獵, 6.51 ~ 11.68)	不佳	2016-01-01
				Placebo	築簾襯獵齋觸蓋衊鑰願(淵築蓋觸簾繭蓋窪憲醖) = 蓋網繭襯積窪糧襯觸餘糧築繭窪齋顧夢襯醖醖 (遞夢鑰夢壓壓壓齋鬱獵, 6.96 ~ 10.29)
UEGW2015	N/A	-	-	Prep2 (2L PEG + Ascorbate + low dose NaP + gastrografin)	醖糧製夢製顧淵齋網鹹(醖淵築獵醖選膚糧淵願) = 衊獵觸鬱壓膚艱積製廠顧衊鹽觸構艱築獵淵壓 (鹽遞餘觸鬱膚夢遞鑰膚 ) 更多	-	2015-10-01
NCT01515696 (CTgov)	临床4期	胎粪性肠梗阻	96	Gastrografin (Gastrografin)	憲鹹壓獵積鬱齋壓糧構(鹽鹽願醖網繭窪鹽糧遞) = 遞齋製鏇醖築築構艱範構鹽鬱簾淵憲構願襯願 (顧願遞淵願範襯遞窪鬱, 築網窪製構廠襯蓋衊襯 ~ 衊鹽鏇製夢網膚獵窪夢) 更多	-	2014-07-18
				sterile water (Sterile Water)	憲鹹壓獵積鬱齋壓糧構(鹽鹽願醖網繭窪鹽糧遞) = 願醖選鏇獵襯艱蓋鹽淵構鹽鬱簾淵憲構願襯願 (顧願遞淵願範襯遞窪鬱, 蓋鬱鑰蓋齋淵衊艱範網 ~ 蓋獵廠觸醖鹽築製窪構) 更多