The goal of this [type of study: randomized controlled clinical trial] is to [Determining the effect of prolotherapy use on the wound care process]. The main question it aims to answer is:
• [The use of proliferative substances in the care of 1st, 2nd and 3rd stage pressure injuries has a positive effect on the wound healing period].
Participants will [in patients with pressure injuries, wound irrigation with saline and wound irrigation with gelofusin were applied]. Researchers will compare [depth, length and width of the wound].

开始日期2023-06-10

申办/合作机构-

NCT03246659 / Completed临床1期IIT

Phase I Clinical Trial Using a Novel CCK-2/Gastrin Receptor-localizing Radiolabelled Peptide Probe for Personalized Diagnosis and Therapy of Patients With Progressive or Metastatic Medullary Thyroid Carcinoma

The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to investigate the IMP, namely 111In-CP04.
The study consists of preclinical (to establish a clinically useful formulation for the radiolabelled peptide CP04), and a clinical step. The main objective of the clinical part of the project is to establish the safety of i.v. administration of a high peptide amount and to assess the tracer biodistribution and dosimetry in MTC and normal tissues and to determine critical organs as well as the evaluation of the potential of CCK2 receptor scintigraphy to detect cancer lesions for both low (10ug) and high (50ug) peptide amount and the decrease of kidney dose after co-administration of gelofusine /gelaspan as a nephroprotective agent. To achieve this, the following study design has been accepted: the first 4 patients will receive 2 peptide amount of CP04: low peptide amount (for diagnostic purpose) and high peptide amount (for therapeutic purpose) of CP04. If no SAE is present, the remaining pts will be randomized for 2 arms: high peptide amount of 111In-CP04 with and without gelofusine/gelaspan infusion.
It is expected that CCK-2/gastrin receptor imaging will become a valid diagnostic method for a specific non-invasive staging and follow-up of patients with MTC, and treatment of recurrent and disseminated disease will be more efficient with minimized nephro- and myelotoxicity (if 111In labelled).

开始日期2016-08-01

申办/合作机构

Azienda Ospedaliero-Universitaria di Modena

[+4]

NCT02808325 / Completed临床3期

Prospective Controlled Randomized Double-blind Multicentre Study in Parallel Groups on the Efficacy and Safety of Gelaspan in Combination With Sterofundin ISO in Comparison With Gelofusine in Combination With Sodium Chloride Braun in Patients Scheduled for Abdominal or Pelvic Surgery

It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.

开始日期2016-06-01

申办/合作机构

B. Braun Melsungen AG

100 项与琥珀酰明胶相关的临床结果

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100 项与琥珀酰明胶相关的转化医学

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100 项与琥珀酰明胶相关的专利（医药）

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172

项与琥珀酰明胶相关的文献（医药）

2024-10-01·Perfusion

Changes in colloid oncotic pressure during cardiac surgery with different prime fluid strategies

Article

作者: Vonk, Alexander ; Loer, Stephan Alexander ; Beukers, Anne Maria ; Boltje, Jan Willem Taco ; Ie, Evy Loan Khiam ; Haumann, Renard Gerardus ; Bulte, Carolien Suzanna Enna ; Hugo, Juan de Villiers

Objective:

In cardiac surgery, colloid oncotic pressure (COP) is affected by haemodilution that results from composition and volume of prime fluid of cardiopulmonary bypass (CPB). However, the extent to which different priming strategies alter COP is largely unknown. Therefore, we investigated the effect of different priming strategies on COP in on-pump cardiac surgery.

Methods:

Patients ( n = 60) were divided into 3 groups ( n = 20 each), based on the center in which they were operated and the specific prime fluid strategy used in that center during the inclusion period. CPB prime fluids were either gelofusine-, albumin-, or crystalloid based, the latter two with or without retrograde autologous priming.

Results:

In all groups, COP was lowest after weaning from CPB and one hour after CPB. Between groups, COP was lowest with gelofusine prime fluid (16.4, 16.8 mmHg, respectively) compared with crystalloids (MD: -1.9; 95% CI:-3.6, -0.2; p = .02 and MD: -2.4, 95% CI: -4.2, -0.7; p = .002) and albumin (MD: -1.8, 95% CI: -3.5, -0.50; p = .041 and MD: -2.4, 95% CI: -4.1, -0.7; p = .002). In all groups, the decrease in COP one hour after bypass compared to baseline correlated positively with fluid balance at the end of surgery ( p < .001).

Conclusions:

COP significantly decrease during CPB surgery with the largest decrease in COP at the end of surgery, while at the same time fluid balance increases. We suggest that prime fluid strategy should be carefully selected when maintenance of COP during cardiac surgery is desirable.

2024-09-01·EUROPEAN JOURNAL OF PEDIATRICS

Efficiency of succinylated gelatin and amino acid infusions for kidney uptake reduction of radiolabeled αvβ6-integrin targeting peptides: considerations on clinical safety profiles

Article

作者: Weber, Wolfgang A ; Šimeček, Jakub ; Brosch-Lenz, Julia ; Nguyen, Nghia Trong ; Stangl, Stefan ; Notni, Johannes ; Kossatz, Susanne

Abstract:

Purpose:

68Ga-Trivehexin is an investigational PET radiopharmaceutical (NCT05799274) targeting αvβ6-integrin for PET imaging of carcinomas. 177Lu-D0301 is a structurally related therapeutic peptide tetramer. However, it showed considerable kidney uptake in rodents, impeding clinical applicability. We therefore evaluated the impact of different kidney protection strategies on the biodistribution of both agents in normal and tumor-bearing mice.

Methods:

Ex-vivo biodistribution of 68Ga-Trivehexin (90 min p.i.) and 177Lu-D0301 (90 min and 24 h p.i.) was determined in healthy C57BL/6N and H2009 (human lung adenocarcinoma) xenografted CB17-SCID mice without and with co-infusion of 100 µL of solutions containing 2.5% arginine + 2.5% lysine (Arg/Lys), 4% succinylated gelatin (gelofusine, gelo), or combinations thereof. Arg/Lys was injected either i.p. 30 min before and after the radiopharmaceutical, or i.v. 2 min before the radiopharmaceutical. Gelo was administered either i.v. 2 min prior activity, or pre-mixed and injected together with the radiopharmaceutical (n = 5 per group). C57BL/6N mice were furthermore imaged by PET (90 min p.i.) and SPECT (24 h p.i.).

Results:

Kidney uptake of 68Ga-Trivehexin in C57BL/6N mice was reduced by 15% (Arg/Lys i.p.), 25% (Arg/Lys i.v.), and 70% (gelo i.v.), 90 min p.i., relative to control. 177Lu-D0301 kidney uptake was reduced by 2% (Arg/Lys i.p.), 41% (Arg/Lys i.v.), 61% (gelo i.v.) and 66% (gelo + Arg/Lys i.v.) 24 h p.i., compared to control. Combination of Arg/Lys and gelo provided no substantial benefit. Gelo furthermore reduced kidney uptake of 177Lu-D0301 by 76% (90 min p.i.) and 85% (24 h p.i.) in H2009 bearing SCID mice. Since tumor uptake was not (90 min p.i.) or only slightly reduced (15%, 24 h p.i.), the tumor/kidney ratio was improved by factors of 3.3 (90 min p.i.) and 2.6 (24 h p.i.). Reduction of kidney uptake was demonstrated by SPECT, which also showed that the remaining activity was located in the cortex.

Conclusions:

The kidney uptake of both investigated radiopharmaceuticals was more efficiently reduced by gelofusine (61–85%) than Arg/Lys (25–41%). Gelofusine appears particularly suitable for reducing renal uptake of αvβ6-integrin targeted 177Lu-labeled peptide multimers because its application led to approximately three times higher tumor-to-kidney ratios. Since the incidence of severe adverse events (anaphylaxis) with succinylated gelatin products (reportedly 0.0062–0.038%) is comparable to that of gadolinium-based MRI or iodinated CT contrast agents (0.008% and 0.04%, respectively), clinical use of gelofusine during radioligand therapy appears feasible if similar risk management strategies as for contrast agents are applied.

2024-07-01·AMERICAN JOURNAL OF PHYSIOLOGY-RENAL PHYSIOLOGY

Mechanisms of gelofusine protection in an in vitro model of polymyxin B-associated renal injury

Article

作者: Kumar, Ashok ; Tam, Vincent H. ; Joshi, Aniket S. ; Roy, Anirban ; Hudson, Cole S. ; Li, Qingtian ; Sheikh-Hamad, David ; Yin, Taijun

Gelofusine is a gelatinous saline solution with the potential to attenuate polymyxin-associated nephrotoxicity. We demonstrated that the mechanisms of gelofusine renal protection involve reducing polymyxin B uptake by proximal tubule cells, limiting subsequent oxidative stress and apoptosis activation. In addition, gelofusine was more effective at reducing cellular injury than a known antioxidant control, methionine, and a megalin knockout cell line, indicating that gelofusine likely has additional pharmacological properties besides only megalin inhibition.

项与琥珀酰明胶相关的新闻（医药）

2024-10-15

·米内网

【瞩目】南京正大天晴拿下大涨732%注射剂首仿

精彩内容近日，国家药监局官网显示，南京正大天晴制药的4类仿制药来特莫韦注射液获批生产并视同过评，此前该产品仅原研厂家默沙东在售。米内网数据显示，2024上半年中国公立医疗机构终端来特莫韦注射液的销售额增速超过732%。来特莫韦是一种新型巨细胞病毒末端酶抑制剂，与传统的DNA聚合酶抑制剂相比，来特莫韦对巨细胞病毒的选择性更高，作用强度也有显著提高。近年来，默沙东的来特莫韦在全球的销售额保持快速增长态势，2023年超过了6亿美元。 2021及2022年，默沙东的来特莫韦片及来特莫韦注射液先后获批进入国内市场，目前均已通过谈判纳入全国医保乙类目录；2024年4月及10月，南京正大天晴制药的来特莫韦片及来特莫韦注射液获批上市，均为国内首仿（含剂型首仿）。此外，齐鲁制药、重庆希韦医药的来特莫韦片，以及齐鲁制药、山东诚创蓝海医药、重庆希韦医药的来特莫韦注射液报产在审。来特莫韦片及来特莫韦注射液新分类报产情况来源：米内网一致性评价进度数据库米内网数据显示，2024上半年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端来特莫韦片的销售额超过1亿元，同比增长约159%，而来特莫韦注射液的销售额增速则超过732%。今年以来，南京正大天晴制药已有来特莫韦注射液、达比加群酯胶囊、氯苯唑酸葡胺软胶囊、沙库巴曲缬沙坦钠片、舒更葡糖钠注射液、来特莫韦片6个品种获批上市并视同过评，其中来特莫韦片、来特莫韦注射液为首仿（含剂型首仿）+首家过评，氯苯唑酸葡胺软胶囊国产第2家获批。在产品申报方面，今年以来南京正大天晴制药有8个品种以新注册分类提交上市/临床申请，其中氘丁苯那嗪片、琥珀酰明胶电解质醋酸钠注射液、奥贝胆酸片、苯磺酸美洛加巴林片、瑞舒伐他汀依折麦布片(Ⅰ)等均暂无首仿获批（不含原研地产化）。 2024年以来南京正大天晴制药新分类申报的品种来源：米内网中国申报进度（MED）数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至10月15日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准一致性评价

2024-09-30

·米内网

【火热】南京正大天晴出手了！抢复方降脂药首仿

精彩内容近日，南京正大天晴制药的瑞舒伐他汀依折麦布片（I）以仿制4类报产获受理，这是一款复方降脂药，目前国内仅原研厂家拥有生产批文。2024年以来，南京正大天晴制药有8个品种以新注册分类提交上市/临床申请，其中有5个暂无首仿（含剂型首仿）获批。瑞舒伐他汀依折麦布片是由瑞舒伐他汀（HMG-CoA还原酶抑制剂）和依折麦布（选择性胆固醇吸收抑制剂）两种作用机制互补的降脂药组成的复方制剂，通过抑制胆固醇的吸收和合成，降低血浆总胆固醇(T-C)、低密度脂蛋白胆固醇(LDL-C)、载脂蛋白B(ApoB)、甘油三脂(TG)和非高密度脂蛋白胆固醇(non-HDL-C)的水平，并能提高高密度脂蛋白胆固醇(HDL-C)水平。赛诺菲的瑞舒伐他汀依折麦布片(Ⅰ)于2023年底获批进入国内市场。仿制药申报方面，浙江诺得药业、石家庄四药、北京福元医药、山东朗诺制药、南京正大天晴制药、韩美药品等企业的产品以新注册分类报产，目前均在审评审批中。近年来中国三大终端六大市场（统计范围详见本文末）血脂调节剂（化药+生物药）销售额均超过200亿元。从治疗小类看，近年来HMGCoA还原酶抑制剂占比均超7成。近年来中国三大终端六大市场血脂调节剂（化药+生物药）销售情况（单位：万元）来源：米内网格局数据库 2023年中国三大终端六大市场血脂调节剂（化药+生物药）TOP5品牌中，辉瑞的阿托伐他汀钙片以约28%的市场份额稳居首位，阿斯利康的瑞舒伐他汀钙片销售额超过30亿元，安进的依洛尤单抗注射液销售额增速超过80%。 2023年中国三大终端六大市场血脂调节剂（化药+生物药）TOP5品牌来源：米内网格局数据库米内网数据显示，今年以来，南京正大天晴制药有8个品种以注册分类提交上市/临床申请，涵盖血液和造血系统药物、神经系统药物、消化系统及代谢药、心脑血管系统药物等治疗大类。 2024年至今南京正大天晴新分类申报品种来源：米内网中国申报进度（MED）数据库8个品种中，氘丁苯那嗪片、琥珀酰明胶电解质醋酸钠注射液、奥贝胆酸片、苯磺酸美洛加巴林片、瑞舒伐他汀依折麦布片(Ⅰ)等品种暂无首仿（不含原研地产化）获批；伊布替尼胶囊、琥珀酰明胶注射液等品种拥有生产批文的国内企业仅有1家。资料来源：米内网数据库、CDE官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至9月30日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准诊断试剂

2024-05-20

·信狐药迅

新药上市申请1个品规、仿制药上市申请5个品规发通知件；临床申请品种均默示许可| 新获批（5.13-5.19）

每周药品注册获批数据，分门别类呈现，一目了然。(5.13-5.19）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号SPH3127片上海上药信谊药厂有限公司1CXHS2300055艾司奥美拉唑镁碳酸氢钠胶囊厦门恩成制药有限公司2.2CXHS2200049国;CXHS2200049泽布替尼胶囊百济神州(苏州)生物科技有限公司2.4CXHS2300057盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2300010盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2300009盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2300008新药临床申请药品名称企业注册分类受理号CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400275CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400274CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400273CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400272SC0245片无锡智康弘义生物科技有限公司1CXHL2400248SC0245片无锡智康弘义生物科技有限公司1CXHL2400247BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400239BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400238BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400237HRS-5346片山东盛迪医药有限公司1CXHL2400234HRS-5346片山东盛迪医药有限公司1CXHL2400233SHR0302碱凝胶江苏恒瑞医药股份有限公司1CXHL2400224SHR0302碱凝胶江苏恒瑞医药股份有限公司1CXHL2400223SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400211SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400210SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400209RAG-17注射液中美瑞康核酸技术(南通)研究院有限公司1CXHL2400208SG1001片深圳市祥根生物有限公司1CXHL2400203吸入用XQ-001成都倍特新启生物医药有限责任公司1CXHL2400201苯磺酸氨氯地平颗粒杭州百诚医药科技股份有限公司2.2CXHL2400245苯磺酸氨氯地平颗粒杭州百诚医药科技股份有限公司2.2CXHL2400244BTP0209江苏诺和必拓新药研发有限公司2.2CXHL2400242BTP0209江苏诺和必拓新药研发有限公司2.2CXHL2400241BTP0209江苏诺和必拓新药研发有限公司2.2CXHL2400240阿戈美拉汀透皮贴剂鑫稳生物医药科技(嘉善)有限公司2.2CXHL2400225四价流感病毒裂解疫苗(MDCK细胞)成都新诺明生物科技有限公司2.2CXSL2400138注射用MK-2870默沙东研发(中国)有限公司1CXSL2400175SYS6002石药集团巨石生物制药有限公司1CXSL2400174重组抗PD-1全人源单抗注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400173SSGJ-707注射液沈阳三生制药有限责任公司1CXSL2400171注射用ILB-3101英诺湖医药(杭州)有限公司1CXSL2400169JMT202注射液上海津曼特生物科技有限公司1CXSL2400164注射用ZB001上海泽纳仕生物科技有限公司1CXSL2400133VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400123VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400122VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400121重组人绒促性素注射液苏州晟济药业有限公司3.3CXSL2400176仿制药申请药品名称企业注册分类受理号地高辛注射液安徽长江药业有限公司3CYHS2302574地高辛注射液安徽长江药业有限公司3CYHS2302573利伐沙班颗粒南京海纳制药有限公司3CYHS2302483头孢地尼干混悬剂广东金城金素制药有限公司3CYHS2301983注射用拉氧头孢钠山东蓝晶生物技术有限公司3CYHS2300800注射用拉氧头孢钠山东蓝晶生物技术有限公司3CYHS2300799盐酸去氧肾上腺素注射液成都瑞尔医药科技有限公司3CYHS2300675盐酸去氧肾上腺素注射液成都瑞尔医药科技有限公司3CYHS2300674帕拉米韦注射液国药集团容生制药有限公司3CYHS2300304帕拉米韦注射液国药集团容生制药有限公司3CYHS2300303帕拉米韦注射液石药集团中诺药业(石家庄)有限公司3CYHS2300186注射用尼可地尔天大药业(云南)有限公司3CYHS2202132国;CYHS2202132盐酸多巴酚丁胺注射液安徽茂康药业有限公司3CYHS2202060国;CYHS2202060奥美拉唑碳酸氢钠胶囊厦门恩成制药有限公司3CYHS2201919国;CYHS2201919注射用尼可地尔海口天行健药物研究有限公司3CYHS2201772国;CYHS2201772美索巴莫注射液浙江美迪深生物医药有限公司3CYHS2201665国;CYHS2201665盐酸利多卡因凝胶南京汉欣医药科技有限公司3CYHS2201594国;CYHS2201594地高辛注射液河北坤安药业有限公司3CYHS2201563国;CYHS2201563葡萄糖酸钙氯化钠注射液回音必集团抚州制药有限公司3CYHS2201498葡萄糖酸钙氯化钠注射液回音必集团抚州制药有限公司3CYHS2201497注射用盐酸罗沙替丁醋酸酯四川汇宇制药股份有限公司3CYHS2201160国;CYHS2201160马来酸氯苯那敏注射液南京泽恒医药技术开发有限公司3CYHS2101157国;CYHS2101157注射用头孢他啶阿维巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201877注射用盐酸万古霉素海南普利制药股份有限公司4CYHS2200588国;CYHS2200588布立西坦片四川科伦药业股份有限公司3CYHL2400055布立西坦片四川科伦药业股份有限公司3CYHL2400054布立西坦片四川科伦药业股份有限公司3CYHL2400053醋酸地非法林注射液齐鲁制药(海南)有限公司3CYHL2400051艾氟洛芬贴剂湖南九典制药股份有限公司3CYHL2400047环孢素滴眼液(II)深圳欣祺医药科技有限公司3CYHL2400044琥珀酰明胶注射液山东齐都药业有限公司4CYHL2400046琥珀酰明胶电解质醋酸钠注射液山东齐都药业有限公司4CYHL2400045进口申请药品名称企业注册分类受理号瑞普替尼胶囊Bristol-Myers Squibb Company1JXHS2300056利多卡因凝胶贴膏Teikoku Pharma USA, Inc.5.1JXHS2200056国;JXHS2200056吸入用复方异丙托溴铵溶液M/s Cipla Ltd.5.2JYHS2300052ARV-471(PF-07850327)片Pfizer Inc.1JXHL2400052Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400056Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400055Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400054Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400053RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2400051RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2400050RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2400049BAY 2965501口服溶液Bayer AG1JXHL2400044拉索昔芬片Sermonix Pharmaceuticals, Inc.2.4JXHL2400042AZD2936AstraZeneca AB1JXSL2400057Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400052Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400051LerodalcibepLIB Therapeutics, Inc.1JXSL2400049LerodalcibepLIB Therapeutics, Inc.1JXSL2400050中药相关申请药品名称企业注册分类受理号灵香片浙江佐力药业股份有限公司1.1CXZL2400010注：灰色字体部分结论为不批准或收到通知件；

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