This study aims to determine the effect of online education structured according to Pender's Health Promotion Model on symptom burden, medication adherence, and nutritional behaviour in patients with heart failure. The sample size was calculated using the 'G. Power-3.1.9.2' programme at a 95% confidence level prior to data collection. Accordingly, the minimum sample size required for the independent sample t-test for the study was determined to be 44 (22 for each group) based on an alpha value of 0.05, an effect size of 1.128, and a theoretical power of 95%. Taking data losses into account, a total of 60 patients (30 for each group) were planned to be included in the sample. Data will be collected using the Heart Failure Symptom Status Scale, Medication Adherence and Prescription Printing Scale (İURYÖ-7), Heart Failure Nutrition Behaviour Scale. 1: Prior to providing education to patients, they will be informed about the purpose of the study, the data collection method, and the topics to be covered in the education. Patients who agree to participate in the study will be asked to sign an informed consent form. All patients in the experimental and control groups will be asked to complete the Heart Failure Nutrition Behaviour Scale (HFNBS), Heart Failure Symptom Status Scale (HFSSS), and Medication Adherence and Prescription Writing Scale (MAPWS-79) before receiving education.
2: The contact information of all patients in the experimental group will be collected. Training will be provided online at a time and date convenient for the patients.
3: Patients in the control group will receive a digital training booklet prepared by the researcher at the contact address they provide.
4: Participants will be contacted 2 weeks, 1 month, and 2 months after the initial education session to obtain feedback on post-education dietary behaviours, medication adherence, and symptoms.
5: Four to six weeks after the training is completed, the 'Nutritional Behaviour Scale in Heart Failure,' 'Heart Failure Symptom Status Scale,' and 'Medication Adherence and Prescription Writing Scale (İURYÖ-7)' will be completed online again. The same forms will also be completed online by patients in the control group 4-6 weeks later.

开始日期2025-07-15

申办/合作机构

Canakkale Onsekiz Mart University

NCT07057973

/ RecruitingN/AIIT

The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly

Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.

开始日期2025-07-01

申办/合作机构

首都医科大学宣武医院

CTRI/2025/06/088448

/ Not yet recruitingN/A

A Double Blind Balanced Randomized Single Dose Two Treatment Parallel Truncated Bioequivalence Study Comparing Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL by Jodas Expoim Private Limited Telangana Manufactured For Nova Pharmaceuticals Australasia Pty Ltd With Ferinject Injection Ferric Carboxymaltose 1000mg per 20mL Manufactured by Vifor Pharma Pty Ltd Level 8 80 Dorcas Street Southbank Melbourne Vic 3006 Australia in Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions - NIL

开始日期2025-06-26

申办/合作机构

Nova Pharmaceuticals Australasia Pty Ltd.

100 项与羧基麦芽糖铁相关的临床结果

登录后查看更多信息

100 项与羧基麦芽糖铁相关的转化医学

登录后查看更多信息

100 项与羧基麦芽糖铁相关的专利（医药）

登录后查看更多信息

863

项与羧基麦芽糖铁相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Evaluating the cost-utility of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anaemia in Norway

Article

作者: Detlie, T. E. ; Karlsen, L. N. ; Pollock, R. F. ; Nanu, N. ; Jørgensen, E.

AIMS:

Iron deficiency anemia (IDA) is among the most common extraintestinal sequelae of inflammatory bowel disease (IBD). Intravenous iron is often the preferred treatment in patients with active inflammation with or without active bleeding, iron malabsorption, or intolerance to oral iron. The aim of the present study was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboyxymaltose (FCM) in patients with IBD and IDA in Norway.

MATERIALS AND METHODS:

A published patient-level simulation model was used to evaluate the cost-utility of FDI versus FCM in patients with IBD and IDA from a Norwegian national payer perspective. Iron need was modelled based on bivariate distributions of hemoglobin and bodyweight combined with simplified tables of iron need from the FDI and FCM summaries of product characteristics. Patient characteristics and disease-related quality of life data were obtained from the PHOSPHARE-IBD trial. Cost-utility was evaluated in Norwegian Kroner (NOK) over a five-year time horizon.

RESULTS:

Patients required 1.64 fewer infusions of FDI than FCM over five years (5.62 versus 7.26), corresponding to 0.41 fewer infusions per treatment course. The reduction in the number of infusions resulted in cost savings of NOK 5,236 (NOK 35,830 with FDI versus NOK 41,066 with FCM). The need for phosphate testing in patients treated with FCM resulted in further cost savings with FDI (no costs with FDI versus NOK 4,470 with FCM). Total cost savings with FDI were therefore NOK 9,707. FDI also increased quality-adjusted life expectancy by 0.071 quality-adjusted life years (QALYs) driven by reduced incidence of hypophosphatemia and fewer interactions with the healthcare system.

CONCLUSIONS:

FDI resulted in cost savings and improved quality-adjusted life expectancy versus FCM in patients with IDA and IBD in Norway. FDI therefore represents the economically preferable iron formulation in Norwegian patients with IBD and IDA in whom it is indicated.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

A Swedish cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in the treatment of iron deficiency anemia in patients with inflammatory bowel disease

Article

作者: Manxhuka, Bardh ; Lindgren, Stefan C. ; Strid, Hans ; Nanu, Neesha ; Hjortswang, Henrik ; Pollock, Richard F.

OBJECTIVES:

Iron deficiency anemia (IDA) is a common extraintestinal manifestation of inflammatory bowel disease (IBD), driven by impaired iron absorption, inflammation of intestinal mucosa and blood loss due to intestinal bleeding. Exogenous iron is indicated to correct iron deficiency, with intravenous iron preferred in patients with malabsorption or intolerance of oral iron, active bleeding, systemic inflammation, or a need for rapid iron replenishment. The objective was to assess the cost-utility of two high-dose, rapid-infusion iron formulations-ferric derisomaltose (FDI) and ferric carboxymaltose (FCM)-in the treatment of patients with IBD and IDA in Sweden.

METHODS:

The analysis used a previously-published micro-simulation model. Phosphate monitoring was modeled based on the product labelling, while iron need and disease-related quality of life (QoL) were modeled based on data from the PHOSPHARE-IBD randomized controlled trial. Cost-utility was evaluated from the national healthcare payer perspective over a five-year time horizon. Sensitivity and scenario analyses were performed.

RESULTS:

For each iron treatment course, patients treated with FDI required 0.41 fewer infusions than those treated with FCM. The reduced number of infusions resulted in savings of SEK 9,876 over five years from iron administration costs alone (SEK 44,216 with FCM versus SEK 34,340 with FDI). Phosphate monitoring in patients treated with FCM cost SEK 2,776 over five years versus no monitoring costs with FDI. Total cost savings with FDI were SEK 14,962. FDI also resulted in a 0.076 quality-adjusted life year (QALY) improvement versus FCM driven primarily by the QoL improvements reported in PHOSPHARE-IBD, and FDI was therefore the dominant intervention.

LIMITATIONS:

The analysis did not capture costs or outcomes associated with hypophosphatemic osteomalacia or fractures.

CONCLUSION:

Relative to FCM, fewer infusions of FDI were required, there was no need for phosphate monitoring, and disease-related QoL was improved, while overall costs were reduced.

2025-08-01·EJHaem

Cutaneous Reactions to Iron Infusions: A Case Report and Clinical Review

Article

作者: Ravichandran, Sairekha ; Patil, Neil ; Kubal, Timothy ; Phuoc, Vania ; Kirtane, Kedar ; Messina, Jane ; Maharaj, Satish

ABSTRACT:

Anemia is prevalent globally and often treated with intravenous (IV) iron formulations, including iron sucrose, iron dextran, ferric carboxymaltose, ferric derisomaltose, and ferumoxytol. IV iron has a high efficacy and safety profile, quickly improving hemoglobin levels with low rates of adverse events. In this work, we report an uncommon case of a cutaneous hypersensitivity reaction following IV iron. A review of the literature shows that acute and delayed cutaneous reactions are possible but rare and respond well to management. Patients should be educated, and staff should be vigilant as to these cutaneous reactions.Clinical Trial Registration:The authors have confirmed that clinical trial registration is not needed for this submission.

项与羧基麦芽糖铁相关的新闻（医药）

2025-07-13

·信狐药迅

三个1类新药：天晴库莫西利、信诺维亚胺培南西司他丁钠福诺巴坦和先声乐德奇拜单抗提交上市申请|新受理（7.7-7.13）

本周药品注册受理数据，分门别类呈现，一目了然。(7.7-7.13）新药上市申请药品名称企业注册分类受理号库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2500076库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2500075注射用亚胺培南西司他丁钠福诺巴坦苏州信诺维医药科技股份有限公司1CXHS2500074多西他赛注射用浓溶液(自乳化型)北京德立英捷医药科技有限公司2.2CXHS2500079硫酸阿托品滴眼液兆科(广州)眼科药物有限公司2.2CXHS2500078氟维司群注射液正大天晴药业集团股份有限公司2.4CXHS2500077示踪用盐酸米托蒽醌注射液深圳华润九创医药有限公司2.4CXHS2500073乐德奇拜单抗注射液先声药业有限公司1CXSS2500074乐德奇拜单抗注射液先声药业有限公司1CXSS2500073注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSS2500072新药临床申请药品名称企业注册分类受理号IMP9064片上海瑛派药业有限公司1CXHL2500694BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500693BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500692HRS-4642注射液上海恒瑞医药有限公司1CXHL2500691HRS-7058胶囊山东盛迪医药有限公司1CXHL2500689HRS-7058胶囊山东盛迪医药有限公司1CXHL2500688HRS-7058片山东盛迪医药有限公司1CXHL2500687HRS-7058片山东盛迪医药有限公司1CXHL2500686225Ac-LNC1011注射液烟台蓝纳成生物技术股份有限公司1CXHL2500697HJ-004-02片和径医药科技(上海)有限公司1CXHL2500696HJ-004-02片和径医药科技(上海)有限公司1CXHL2500695DF-006口服溶液浙江药苑生物科技有限公司1CXHL2500690GFH375片劲方医药科技(上海)股份有限公司1CXHL2500685HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500684HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500683HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500682CA111注射液重庆宸安生物制药有限公司1CXHL2500678CA111注射液重庆宸安生物制药有限公司1CXHL2500677BIOS-0623-Z4片杭州百诚医药科技股份有限公司1CXHL2500676BIOS-0623-Z4片杭州百诚医药科技股份有限公司1CXHL2500675LXH-1211片山东新华制药股份有限公司1CXHL2500674LXH-1211片山东新华制药股份有限公司1CXHL2500673LXH-1211片山东新华制药股份有限公司1CXHL2500672LXH-1211片山东新华制药股份有限公司1CXHL2500671SGB-3383注射液苏州圣因生物医药有限公司1CXHL2500667BGM0504片博瑞制药(苏州)有限公司1CXHL2500681BGM0504片博瑞制药(苏州)有限公司1CXHL2500680BGM0504片博瑞制药(苏州)有限公司1CXHL2500679注射用TRD208北京泰德制药股份有限公司1CXHL2500666BW-40202注射液上海舶望制药有限公司1CXHL2500668HRS-2129片山东盛迪医药有限公司1CXHL2500664HRS-2129片山东盛迪医药有限公司1CXHL2500663HRS-2129片山东盛迪医药有限公司1CXHL2500662HRS-2129片山东盛迪医药有限公司1CXHL2500661注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500660注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500659TT-00420片药捷安康(南京)科技股份有限公司1CXHL2500658TT-00420片药捷安康(南京)科技股份有限公司1CXHL2500657TT-00420 片药捷安康(南京)科技股份有限公司1CXHL2500656HRS-3095片成都盛迪医药有限公司1CXHL2500655HRS-3095片成都盛迪医药有限公司1CXHL2500654LSCCB-PtNNN注射液金铂药业(深圳)有限公司1CXHL2500653EP-0206SI成都苑东生物制药股份有限公司2.2CXHL2500670EP-0206SI成都苑东生物制药股份有限公司2.2CXHL2500669尼莫地平脂肪乳注射液江苏九旭药业有限公司2.2CXHL2500665盐酸右美托咪定微针贴剂广州新济药业科技有限公司2.2CXHL2500652盐酸右美托咪定微针贴剂广州新济药业科技有限公司2.2CXHL2500651吸附无细胞百白破b型流感嗜血杆菌联合疫苗长春百克生物科技股份公司2.2CXSL2500582人脐带间充质干细胞注射液北京葆来生物科技有限公司1CXSL2500581注射用FH-006江苏恒瑞医药股份有限公司1CXSL2500573注射用IBB0979盛禾(中国)生物制药有限公司1CXSL2500580注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500583注射用SHR-A2102上海恒瑞医药有限公司1CXSL2500575SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500579匹康奇拜单抗注射液信达生物医药科技(杭州)有限公司1CXSL2500571匹康奇拜单抗注射液信达生物医药科技(杭州)有限公司1CXSL2500570GR2301注射液重庆智翔金泰生物制药股份有限公司1CXSL2500569注射用SHR-1802上海恒瑞医药有限公司1CXSL2500572DCTY0801注射液北京鼎成肽源生物技术有限公司1CXSL2500568VGN-R08b上海天泽云泰生物医药有限公司1CXSL2500565Astem-101人脐带间充质干细胞(hUC-MSCs)注射液上海昂昇生物医药科技有限公司1CXSL2500564VGN-R08b上海天泽云泰生物医药有限公司1CXSL2500563脐带间充质干细胞注射液山东佰鸿干细胞生物技术有限公司1CXSL2500562LBM801上海利康瑞生物工程有限公司1CXSL2500560NGGT006注射液苏州诺洁贝生物技术有限公司1CXSL2500559SHR-4298注射液苏州盛迪亚生物医药有限公司1CXSL2500558HC006注射液上海宏成药业有限公司1CXSL2500567注射用HC010上海宏成药业有限公司1CXSL2500566GR1803注射液智翔(上海)医药科技有限公司1CXSL2500553自体自然杀伤细胞注射液广州达博生物制品有限公司1CXSL2500552注射用ZGGS34苏州泽璟生物制药股份有限公司1CXSL2500561SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500577阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500578贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500574阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500576仿制药申请药品名称企业注册分类受理号吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2502485吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2502484西咪替丁注射液森淼(山东)药业有限公司3CYHS2502505复方聚乙二醇电解质散(II)上海朝晖药业有限公司3CYHS2502504复方电解质醋酸钠葡萄糖注射液山东化药医药科技有限公司3CYHS2502503复方电解质醋酸钠葡萄糖注射液山东化药医药科技有限公司3CYHS2502502米诺地尔搽剂科笛生物医药(无锡)有限公司3CYHS2502500米诺地尔搽剂科笛生物医药(无锡)有限公司3CYHS2502499复方电解质醋酸钠葡萄糖注射液南京正大天晴制药有限公司3CYHS2502498复方电解质醋酸钠葡萄糖注射液南京正大天晴制药有限公司3CYHS2502497碳酸氢钠林格注射液(I)南京正科医药股份有限公司3CYHS2502496米诺地尔搽剂湖北午时药业股份有限公司3CYHS2502494米诺地尔搽剂湖北午时药业股份有限公司3CYHS2502493注射用乳糖酸红霉素苏州朗科生物技术股份有限公司3CYHS2502490注射用乳糖酸红霉素苏州朗科生物技术股份有限公司3CYHS2502489盐酸西替利嗪干糖浆海南元盈医药科技有限公司3CYHS2502516注射用苯唑西林钠北京元延医药科技股份有限公司3CYHS2502475注射用苯唑西林钠北京元延医药科技股份有限公司3CYHS2502474盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502473盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502472盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502471盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502470比拉斯汀口服溶液珠海北杉生物科技有限公司3CYHS2502467利格列汀二甲双胍缓释片北京福元医药股份有限公司3CYHS2502482利格列汀二甲双胍缓释片北京福元医药股份有限公司3CYHS2502481马来酸曲美布汀片平光制药股份有限公司3CYHS2502462马来酸曲美布汀片平光制药股份有限公司3CYHS2502461醋酸特利加压素注射液武汉人福药业有限责任公司3CYHS2502457醋酸钠林格葡萄糖注射液(I)南京正科医药股份有限公司3CYHS2502456盐酸毛果芸香碱滴眼液山东华铂凯盛生物科技有限公司3CYHS2502428地拉罗司颗粒裕松源药业有限公司3CYHS2502427洛索洛芬钠凝胶上海延安医药洋浦股份有限公司3CYHS2502451硝酸咪康唑乳膏江苏盈科生物制药有限公司3CYHS2502449复方聚乙二醇电解质散(儿童型)郑州泰丰制药有限公司3CYHS2502447腺苷钴胺胶囊国药集团容生制药有限公司3CYHS2502444钠钾镁钙注射用浓溶液西安安健药业有限公司3CYHS2502439维生素K1注射液江苏安必生制药有限公司3CYHS2502437生理氯化钠溶液四川青山利康药业有限公司3CYHS2502453普瑞巴林口服溶液浙江致新医药科技有限公司3CYHS2502452醋酸钠林格葡萄糖注射液(I)南京正大天晴制药有限公司3CYHS2502429福多司坦口服溶液海南全星制药有限公司3CYHS2502419注射用氢化可的松琥珀酸钠南京泽恒医药技术开发有限公司3CYHS2502416注射用硫酸多黏菌素B烟台鲁银药业有限公司3CYHS2502410葡萄糖酸钙注射液河南普瑞药业有限公司3CYHS2502405盐酸甲氧氯普胺注射液广东南国药业有限公司3CYHS2502403盐酸溴己新注射液成都华宇制药有限公司3CYHS2502423比拉斯汀口服溶液江苏长泰药业股份有限公司3CYHS2502424氯雷他定片华益药业科技(安徽)有限公司4CYHS2502486二十碳五烯酸乙酯软胶囊华北制药股份有限公司4CYHS2502483瑞维那新吸入溶液遂成药业股份有限公司4CYHS2502515腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502514腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502513腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502512腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502511腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502510腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502509恩格列净片广东彼迪药业有限公司4CYHS2502508双氯芬酸二乙胺乳胶剂浙江寰领医药科技有限公司4CYHS2502507恩格列净片广东彼迪药业有限公司4CYHS2502506玻璃酸钠注射液重庆药友制药有限责任公司4CYHS2502501盐酸尼卡地平注射液上海葆隆生物科技有限公司4CYHS2502495替米沙坦氢氯噻嗪片南京黄龙生物科技有限公司4CYHS2502492利格列汀二甲双胍片(II)山东朗诺制药有限公司4CYHS2502491沙库巴曲缬沙坦钠片复星万邦(江苏)医药集团有限公司4CYHS2502488艾拉莫德片璟济生物医药科技(泰州)股份有限公司4CYHS2502487米格列醇片北京北陆药业股份有限公司4CYHS2502479利那洛肽胶囊湖北远大永晟药业有限公司4CYHS2502478巴瑞替尼片海化生命(厦门)科技有限公司4CYHS2502477甲磺酸多沙唑嗪缓释片常州制药厂有限公司4CYHS2502476甲氨蝶呤注射液四川汇宇海玥医药科技有限公司4CYHS2502469甲氨蝶呤注射液四川汇宇海玥医药科技有限公司4CYHS2502468艾普拉唑肠溶片江苏飞马药业有限公司4CYHS2502466双氯芬酸钠盐酸利多卡因注射液山西威奇达光明制药有限公司4CYHS2502465酒石酸溴莫尼定滴眼液成都普什制药有限公司4CYHS2502464噻托溴铵吸入喷雾剂浙江仙琚制药股份有限公司4CYHS2502480吗啉硝唑氯化钠注射液浙江康吉尔药业有限公司4CYHS2502463培哚普利氨氯地平片(III)山东朗诺制药有限公司4CYHS2502460恩格列净片江西施美药业股份有限公司4CYHS2502459恩格列净片江西施美药业股份有限公司4CYHS2502458聚乙烯醇滴眼液合肥利民制药有限公司4CYHS2502433艾普拉唑肠溶片宁波科尔康美诺华药业有限公司4CYHS2502430盐酸曲唑酮缓释片华益泰康药业股份有限公司4CYHS2502426注射用磷丙泊酚二钠成都苑东生物制药股份有限公司4CYHS2502450瑞维那新吸入溶液山东达因金控儿童制药有限公司4CYHS2502448注射用甲泼尼龙琥珀酸钠海南倍特药业有限公司4CYHS2502446注射用甲泼尼龙琥珀酸钠海南倍特药业有限公司4CYHS2502445哌柏西利片浙江麒正药业有限公司4CYHS2502443哌柏西利片浙江麒正药业有限公司4CYHS2502441左氧氟沙星滴眼液重庆药谷制药有限公司4CYHS2502440注射用盐酸表柔比星吉斯美(武汉)制药有限公司4CYHS2502438戊酸雌二醇片扬州奥锐特药业有限公司4CYHS2502436富马酸伏诺拉生片江西山香药业有限公司4CYHS2502455富马酸伏诺拉生片江西山香药业有限公司4CYHS2502454瑞舒伐他汀依折麦布片(I)烟台鲁银药业有限公司4CYHS2502442富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502435富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502434富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502432富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502431二甲硅油乳剂江苏广承药业有限公司4CYHS2502422依伏卡塞片南京正大天晴制药有限公司4CYHS2502421依伏卡塞片南京正大天晴制药有限公司4CYHS2502420达格列净片浙江麒正药业有限公司4CYHS2502418达格列净片浙江麒正药业有限公司4CYHS2502417甲硝唑凝胶杭州呋欧医药科技有限公司4CYHS2502415甲硝唑凝胶杭州呋欧医药科技有限公司4CYHS2502414恩格列净片江西迪赛诺医药集团有限公司4CYHS2502413恩格列净片江西迪赛诺医药集团有限公司4CYHS2502412氟比洛芬凝胶贴膏中曦(福建)药业有限公司4CYHS2502411癸酸氟哌啶醇注射液四川尚锐生物医药有限公司4CYHS2502409癸酸氟哌啶醇注射液四川尚锐生物医药有限公司4CYHS2502408非奈利酮片石家庄四药有限公司4CYHS2502407瑞维那新吸入溶液海南斯达制药有限公司4CYHS2502406非奈利酮片复星万邦(江苏)医药集团有限公司4CYHS2502404比索洛尔氨氯地平片广东大鹏医药科技有限公司4CYHS2502402氟马西尼注射液岳阳新华达制药有限公司4CYHS2502401盐酸达泊西汀片江苏润邦药业有限公司4CYHS2502400盐酸达泊西汀片江苏润邦药业有限公司4CYHS2502399盐酸替罗非班注射用浓溶液安徽丰原药业股份有限公司4CYHS2502398洛索洛芬钠凝胶贴膏河南羚锐制药股份有限公司4CYHS2502397瑞维那新吸入溶液南京力成药业有限公司4CYHS2502396艾拉莫德片东阳祥昇医药科技有限公司4CYHS2502395瑞维那新吸入溶液江西科伦药业有限公司4CYHS2502394丁溴东莨菪碱注射液石家庄四药有限公司4CYHS2502393盐酸维洛沙秦缓释胶囊西安远大科创医药科技有限公司3CYHL2500127盐酸维洛沙秦缓释胶囊西安远大科创医药科技有限公司3CYHL2500126艾氟洛芬贴剂湖南华纳大药厂股份有限公司3CYHL2500125克霉唑阴道片株洲千金药业股份有限公司4CYHL2500124甲型肝炎灭活疫苗(人二倍体细胞)北京科兴生物制品有限公司3.3CXSL2500554仑卡奈单抗注射液石药集团巨石生物制药有限公司3.3CXSL2500555QL2106注射液齐鲁制药有限公司3.3CXSL2500545人纤维蛋白原国药集团昆明血液制品有限公司3.4CXSL2500557人纤维蛋白原国药集团昆明血液制品有限公司3.4CXSL2500556进口申请药品名称企业注册分类受理号洛索洛芬钠凝胶膏LEAD CHEMICAL CO., LTD.5.1JXHS2500076醋酸锌片Nobelpharma Co., Ltd.5.1JXHS2500075醋酸锌片Nobelpharma Co., Ltd.5.1JXHS2500074羧基麦芽糖铁注射液M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500027羧基麦芽糖铁注射液M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500026AZD9574AstraZeneca AB1JXHL2500182AZD9574AstraZeneca AB1JXHL2500181AZD9574AstraZeneca AB1JXHL2500180AZD9574AstraZeneca AB1JXHL2500179RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500178RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500177RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500176RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500175Orforglipron片Eli Lilly and Company1JXHL2500174Orforglipron片Eli Lilly and Company1JXHL2500173Orforglipron片Eli Lilly and Company1JXHL2500172Orforglipron片Eli Lilly and Company1JXHL2500171Orforglipron片Eli Lilly and Company1JXHL2500170Orforglipron片Eli Lilly and Company1JXHL2500169Mezigdomide胶囊Celgene Corporation1JXHL2500168Mezigdomide胶囊Celgene Corporation1JXHL2500167Mezigdomide胶囊Celgene Corporation1JXHL2500166Mezigdomide胶囊Celgene Corporation1JXHL2500165Mezigdomide胶囊Celgene Corporation1JXHL2500164Mezigdomide胶囊Celgene Corporation1JXHL2500163ALXN2420注射液Alexion Pharmaceuticals, Inc.1JXHL2500162注射用六氟化硫微泡Bracco International B.V.2.4JXHL2500183AZD5335AstraZeneca AB1JXSL2500121替利珠单抗注射液Sanofi-Aventis Recherche & Développement2.2JXSL2500120中药相关申请药品名称企业注册分类受理号JIZM01湖南九典制药股份有限公司1.1CXZL2500053JIZM01湖南九典制药股份有限公司1.1CXZL2500052和肤止痒凝胶广东省中医院1.1CXZL2500051JIZM02湖南九典制药股份有限公司1.1CXZL2500050JIZM02湖南九典制药股份有限公司1.1CXZL2500049柴胡鼻腔喷雾剂河南利欣制药股份有限公司2.1CXZS2500029扶正通淋丸山东康众宏医药科技开发有限公司1.1CXZL2500047ZY-A002亚宝药业集团股份有限公司1.1CXZL2500046馥感啉颗粒广州一品红制药有限公司2.2CXZL2500048半夏白术天麻颗粒石家庄以岭药业股份有限公司3.1CXZS2500028淫羊藿素软胶囊北京珅诺基医药科技有限公司2.3CXZL2500045真武颗粒武汉康乐药业股份有限公司3.1CXZS2500027注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

2025-05-29

·Science Daily

Unlocking precise composition analysis of nanomedicines

Current regulations for nanomedicines overlook the effects of the different forms of the same element, such as ions, nanoparticles, and aggregates. In a recent study, researchers developed a new analytical method combining an asymmetric flow field-flow fractionation system and mass spectrometry to separately quantify these forms. This technique allows for better quality control and safety evaluation of metal-based nanomedicines, promoting their development and clinical use, with applications also extending to food, cosmetics, and the environment. Current regulations for nanomedicines overlook the effects of the different forms of the same element, such as ions, nanoparticles, and aggregates. In a recent study, Japanese researchers developed a new analytical method combining an asymmetric flow field-flow fractionation system and mass spectrometry to separately quantify these forms. This technique allows for better quality control and safety evaluation of metal-based nanomedicines, promoting their development and clinical use, with applications also extending to food, cosmetics, and the environment. Nanomedicines, especially those based on nanoparticles, are revolutionizing healthcare in terms of both diagnostics and therapeutics. These particles, often containing metals like iron or gold, can serve as contrast agents in medical imaging, act as nutritional supplements, and even function as carriers for drug delivery. Thanks to their unique properties plus careful engineering, nanomedicines can reach and accumulate in places within the body that conventional medicines cannot, making them promising for cancer detection and treatment. However, the same characteristics that make nanomedicines valuable also present challenges in ensuring their safety and quality. Current pharmaceutical guidelines, including those from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), have a significant blind spot: they evaluate only the total amount of elements present in a medication without distinguishing between their different forms, such as ions or differently sized particles. This distinction is crucial because these different forms can have different effects on the body, including varying toxicity pro Against this backdrop, a research team led by Assistant Professor Yu-ki Tanaka from the Graduate School of Pharmaceutical Sciences, Chiba University, Japan, has developed a new analytical method to address the existing regulatory gap. Their study, which was made available online in the journal Talanta on April 8, 2025, introduces a technique to separately quantify ions, nanoparticles, and aggregated particles in nanomedicines. Co-authored by Yasumitsu Ogra and Sana Hasegawa, also from Chiba University, the study showcases how this method can improve quality control for these advanced pharmaceutical products. "By incorporating a novel evaluation method that addresses a previously overlooked issue in current evaluation guidelines, we can ensure the safe use of metal-based nanomedicines such as Resovist® and Ferinject®" explains Dr. Tanaka. The researchers combined two existing technologies -- asymmetric flow field-flow fractionation (AF4) and inductively coupled plasma mass spectrometry (ICP-MS). They used the AF4 method in a novel way, taking advantage of its initial 'focus step.' During this step, particles are held inside the AF4 channel by two opposing flows. Using a special permeable membrane, cross-flows filter out the tiniest dissolved particles (ions), enabling quantification based on the differences in ICP-MS signals between samples with and without ion removal−namely, with and without the focus step. Once the ions are separated, the system then uses AF4's standard separation process to sort the retained nanoparticles by size. Finally, the ICP-MS device attached to the output can determine the approximate number of nanoparticles of each size. This combination enabled the team to distinguish between free metal ions, small hydroxide colloids, and nanoparticles of various sizes, all containing the same metal element. They tested their approach on Resovist®, a nanomedicine used as a contrast agent in liver magnetic resonance imaging scans. The analysis revealed that only 0.022% of the iron in Resovist® was present in ionic form. At approximately 6.3 micrograms per milliliter, this negligible amount falls well below levels of concern. Additionally, the team confirmed that the active nanoparticles were smaller than 30 nanometers in diameter, with some aggregates around 50 nanometers. Importantly, no large aggregates were detected, which could reduce the effectiveness of the contrast agent. These results confirm both the safety and stability of Resovist® as a nanomedicine. The proposed technique is particularly relevant for emerging cancer treatments that use gold nanoparticles as drug delivery systems or metallic particles for photothermal therapy. These advanced treatments rely on the 'enhanced permeability and retention (EPR) effect,' by which nanoparticles leak from blood vessels around tumors and accumulate in cancerous tissue. "Since many novel nanomedicines consist of metal-based nanoparticles as their active ingredients, providing reliable methods for evaluating their safety and quality control will promote their development and clinical use," notes Dr. Tanaka. Additionally, this novel analytical approach extends beyond pharmaceuticals. It can also assess the safety of metal nanoparticles in food additives, cosmetics, and environmental samples -- helping to ensure public health across multiple sectors. The researchers showcased its versatility by successfully analyzing both negatively charged ions (silicon) and positively charged ions (iron), indicating its potential for a wide range of nanomaterials. Overall, by offering a more comprehensive assessment of the composition, quality, and stability of nanoparticles, this research paves the way for safer and more effective nanomedicines and nanoparticle-based technologies.

2025-04-25

·医脉通

精准选择静脉铁剂，护航围手术期贫血患者安全——姚宏伟教授解析PREVENTT研究发现特定铁剂相关性低磷血症的临床危害

导读大手术术前贫血发生率高达30%-60%，其带来的输血风险增加、院内并发症增加、出院延迟等不良预后，严重影响患者术后康复。口服铁剂因胃肠道吸收限制、血红蛋白提升较慢、胃肠道不良反应高发等原因，治疗外科贫血患者的效果不佳。静脉铁剂可快速改善患者的血红蛋白水平、功能状态和生活质量1，成为围手术期贫血患者的理想治疗选择。然而，各类研究及病例报道显示，静脉铁剂羧基麦芽糖铁（Ferric carboxymaltose，FCM）给药后低磷血症高发2-4。荟萃分析已经证实FCM治疗所致低磷血症发生率可达50%-92%，显著高于其他静脉铁剂（2%-8%）5-6。尤为重要的是，FCM导致的低磷血症可发生在任何接受FCM治疗的患者中，引发药源性疾病——6H综合征，即高成纤维细胞生长因子23（FGF23）、高磷尿、低血磷、维生素D缺乏、低血钙及继发性甲状旁腺功能亢进，影响患者生活质量，甚至导致骨软化症和骨折6-7。目前，术前低磷血症对手术患者术后结局的影响备受关注。近日，JAMA Network Open发表的一项重要研究为术前贫血管理与低磷血症的关联问题提供了关键解答。值此之际，医脉通特邀首都医科大学附属北京友谊医院姚宏伟教授深度解读该研究，并作出精彩点评，为临床医生处理术前贫血及低磷血症提供重要参考，最终改善手术患者的治疗结局。FCM显著增加术前低磷血症风险，导致住院时间延长及存活且出院天数缩短研究背景：静脉铁剂是治疗铁缺乏和缺铁性贫血的常用药物，可实现快速补铁，是口服铁剂无效或不耐受患者以及临床上需要快速补铁患者（如围手术期、围产期患者等）的优选治疗药物8。然而，静脉铁剂FCM可通过FGF23介导低磷血症，且已有报道称其与骨软化症和骨折相关9。PREVENTT研究比较了静脉注射FCM与安慰剂在腹部大手术前治疗贫血的效果（n=487）。结果显示，FCM组干预后8周和6个月时血红蛋白水平显著更高，且因并发症再入院风险降低，但两组在输血、死亡或围手术期并发症等主要临床终点上无差异1。本研究旨在探讨PREVENTT研究中术前低磷血症的发生率，以及在接受FCM治疗的患者中，低磷血症是否影响患者或试验结局9。研究方法：作为PREVENTT研究方案的一部分，于2014年1月6日至2018年9月28日期间，在随机分组时（n=421）和手术当天（n=392）采集血样。低磷血症的定义为：正常（＞0.8mmol/L）、轻度（0.65-0.8mmol/L）以及中度或重度（＜0.65mmol/L）。此外，对FCM队列中的患者数据进行探索性分析，描述根据磷酸盐水平（＜0.65mmol/L与≥0.65mmol/L）划分的基线特征和关键研究结果的差异9。研究结果：在PREVENTT研究中，腹部大手术前静脉注射FCM（中位时间为术前14天），显著降低了术前血清磷酸盐水平（-0.21mmol/L；P＜0.001，图1），而且这与完整的FGF23（iFGF23）水平升高相关（平均差异为30.3pg/mL；P＜0.001）。图1 安慰剂组和FCM组从基线到术前血清磷酸盐水平变化与安慰剂组（4.5%，9/198）相比，接受FCM治疗的患者更容易发生低磷血症（＜0.8mmol/L）（26%，51/194）（OR：9.22；P＜0.001）。未发现患者特征与FCM导致的低磷血症风险增加相关（表1）。FCM诱导的低磷血症与中位住院时间延长（12天 vs 9天；P=0.01）以及中位存活且出院天数缩短（19天 vs 22天；P=0.02）相关（表1）。对FCM队列的二次分析表明，FCM诱导的中度或重度低磷血症（20/194）与术后不良事件发生率增加相关：55%（11/20） vs 26%（44/174），P=0.0089。表1 FCM组中发生与未发生低磷血症（<0.65mmol/L）患者结局比较研究结论：在PREVENTT研究中，随机分配至FCM组的患者术前低磷血症风险增加9倍，且与住院时间延长和存活且出院天数缩短相关。然而，PREVENTT研究通过Clavien-Dindo分级评估并发症，未常规记录磷酸盐水平。因此，与其他静脉铁剂相关研究类似，本研究的局限性在于不良事件监测可能缺乏足够的细致度，以检测低磷血症的症状，如肌肉无力或疼痛、疲劳或意识模糊，这些症状可能在大手术后被忽视或视为正常9。精彩点评姚宏伟教授我在外科领域深耕多年，主要研究方向为胃癌、结肠癌、直肠癌的腹腔镜微创外科手术。术后加速康复（ERAS）一直是我重视的理念，也参与了多部ERAS相关指南的制定。术前贫血治疗10和术中器官保护及术后早期功能恢复等措施11-12是ERAS方案的重要环节，这些措施可以减少并发症、提升康复质量，对优化外科诊疗路径、实现快速康复目标至关重要。而静脉铁剂是术前贫血治疗的重要治疗药物。近日，发布在JAMA上的一篇关于成人铁缺乏的综述13指出：静脉注射FCM与低磷血症风险增加相关，且这种低磷血症可能持续存在，并伴有疲劳、抽筋和肌肉无力等症状。鉴于术前贫血治疗对术后加速康复的重要意义，以及静脉铁剂应用中低磷血症风险的客观存在，深入剖析贫血危害、治疗策略及低磷血症的临床应对措施，对优化外科诊疗、保障患者安全具有重要意义。缺铁性贫血是一个全球性的重大健康问题，其常见病因包括营养不良、失血、铁吸收障碍或持续性炎症5。此外，贫血在手术前患者中也比较常见。研究显示，普通外科择期手术患者的术前贫血发生率为30.36％14，老年肝胆疾病患者术前贫血发生率甚至高达58.44％15。贫血可使机体处于缺氧状态，影响人体组织器官的功能和机体的抗感染能力14，且对患者术后发病率、死亡率、再入院率以及住院时长产生不利影响16。因此，临床中应及时有效地处理术前贫血。在贫血的治疗方面，与口服铁剂相比，静脉铁剂具有吸收率高、起效快、无胃肠道刺激等优点，可快速持久地维持围手术期贫血患者的血红蛋白水平，已成为围手术期患者血液管理的重要组成部分17。然而，特定静脉铁剂会导致低磷血症，给患者带来安全隐患。一项纳入11700例使用静脉铁剂患者的汇总分析18结果显示，FCM导致的低磷血症发生率显著高于异麦芽糖酐铁（47% vs 4%；P<0.001)。在上述详细分析的PREVENTT研究中，随机分配至FCM组的患者术前低磷血症风险增加9倍，且与住院时间延长和存活且出院天数缩短相关9。此外，研究表明，FCM导致的低磷血症也可能会引发骨软化症及骨折。一项研究检索了PubMed和Web of Science数据库中静脉铁剂引起的低磷血症的病例报告文献，共检索到77篇符合条件的病例报告，结果发现，全部为输注FCM相关病例，其中“伴有骨折的骨软化症”占有症状患者的77.3%19。大手术后患者低磷血症高发，其发生率在普通外科重症监护人群中为44.8%，在重大肝脏手术患者中达67%20。不仅如此，低磷血症还会增加患者术后并发症风险。一项纳入8034例胃肠手术患者的回顾性研究21显示，早期术后持续低磷血症与器官特异性并发症（包括吻合口漏、瘘、腹腔脓肿等）的发生相关。此外，研究显示，ICU入院时的低磷血症与更长的ICU住院时间和机械通气时间相关22。而纠正低磷血症，可为手术患者带来诸多益处。一项回顾性研究23分析了3893例接受腹部大手术患者的围手术期血磷水平，结果显示，术后血磷每升高1mg/dL，住院费用减少702.5美元，住院时间缩短3.4天。因此，临床医生需高度重视围手术期低磷血症风险，尤其警惕FCM所致低磷血症带来的额外风险，做到早期识别与干预，以降低患者不良预后风险。针对FGF23介导的低磷血症，目前尚无统一的诊疗共识。DeFICIT研究5曾针对围手术期患者使用FCM时的磷酸盐补充效果展开探索，发现围手术期口服补充磷酸盐并不能预防FCM诱导的低磷血症。而静脉铁剂临床应用和药学监护专家共识（2024）24则进一步明确了临床管理原则：强调静脉铁剂相关低磷血症的预防重于治疗，无症状轻度病例可密切观察；由于补充磷酸盐效果有限且可能增加尿磷排泄，不推荐常规使用；若发生低磷血症，建议停止可疑静脉铁剂治疗（如FCM），换用低磷血症发生率更低的静脉铁剂（如异麦芽糖酐铁），并针对性治疗继发性甲状旁腺功能亢进。此外，美国静脉铁剂使用、配方、给药以及不良反应处理专家共识指南25建议：无论有无临床症状，使用FCM治疗后均应进行血磷监测；据美国食品药品监督管理局（FDA）收集的不良反应事件报告的数据库统计显示，2014-2023年共有FCM相关低磷血症报告1270例，FCM相关的严重（主要与死亡、危及生命的并发症或住院有关）低磷血症病例的报告数量从2014年的10例每年增加到2023年的244例6。美国乔治城大学医学院的Auerbach教授和威尔康奈尔医学中心肾内科的Wolf教授同时呼吁医生应该明确FCM相关低磷血症的高风险，建议所有患者治疗前后监测血磷26。FDA批准的FCM说明书规定，对于需要重复使用FCM且存在低磷血症高风险患者，临床医生应监测其血清磷酸盐水平6,27。中国获批的FCM药品说明书28提示，在治疗过程中，如果患者出现疲劳加重、肌痛或骨痛，需及时就医，且专家建议，需要重复剂量给药的患者应避免使用FCM7。综上所述，对于静脉铁剂导致的低磷血症，临床医生应高度重视，并及时诊断和个体化处理。展望未来，随着静脉铁剂的应用增加及仿制药的上市，低磷血症相关临床问题可能加剧。在接受大手术的患者中，FCM诱导的低磷血症可能有症状，并且会延长住院时间9，需引起临床医生重视，尤其需要关注反复失血或者因吸收不良需要长期/多次静脉补铁、慢性肾病、炎症性肠病、术后等低磷血症高风险患者29。未来，需要开展更多前瞻性、多中心的临床研究，进一步明确静脉铁剂相关低磷血症的发病机制、高危人群特征及最佳监测频率，从而优化包括风险评估、预防性干预及症状管理在内的全流程诊疗策略，最终改善患者的临床结局。专家简介姚宏伟教授首都医科大学附属北京友谊医院（国家消化临床医学研究中心）普通外科胃肠外科主任，主任医师/教授/博士生导师中华医学会外科学分会-结直肠外科学组学组委员兼秘书中华结直肠外科学院秘书长中国研究型医院学会结直肠外科专委会副主委美国结直肠外科医师学会荣誉会员（ Honorary Fellow，ASCRS）欧洲结直肠病学会-全球影响力委员会委员（Global Reach Committee，ESCP）国际多中心COLOR IV, 研究主管（Study chair, COLOR IV, an international RCT trial）《中华外科杂志》,《中国实用外科杂志》,《中华胃肠外科杂志》,《中华消化外科杂志》编委《Disease of Colon ＆ Rectum》杂志编委,《Ann Surg》《Surg Endosc》杂志审稿专家参考文献1.Lancet. 2020 Oct 24;396(10259):1353-1361. 2.JAMA. 2020 Feb 4;323(5):432-443.3.Gut. 2023 Apr;72(4):644-653.4.JBMR Plus. 2024 Nov 9;8(12):ziae139.5.J Clin Anesth. 2025 Feb;101:111727. 6.Am J Hematol. 2025 May;100(5):840-846. 7.临床药物治疗杂志,2024,22(08):1-5.8.临床药物治疗杂志,2025,23(03):19-22+27.9.JAMA Netw Open. 2025 Apr 1;8(4):e253093. 10.J Thorac Dis. 2019 Sep;11(9):3692-3695.11.中国实用外科杂志,2018,38(1):1-20. 12.中国实用外科杂志,2021,41(9):961-992. 13.JAMA. 2025 Mar 30.14.中国输血杂志,2020,33(2):95-98.15.中国输血杂志,2020,33(2):102-106. 16.Transfus Apher Sci. 2019 Aug;58(4):369-374. 17.中华骨与关节外科杂志,2023,16(1):85-89.18.Br J Clin Pharmacol. 2021 May;87(5):2256-2273. 19.Bone. 2022 Jan;154:116202.20.Eur J Cardiothorac Surg. 2004 Aug;26(2):306-10.21.World J Surg. 2019 Feb;43(2):385-394. 22.J Clin Med. 2022 Jan 24;11(3):581.23.J Clin Med. 2018 Sep 22;7(10):299. 24.药物不良反应杂志. 2025, 27(3): 129-14125.Am J Hematol. 2024 Jul;99(7):1338-1348. 26.Am J Hematol. 2025 May;100(5):752-754.27.Ferric Carboxymaltose prescribing information28.羧基麦芽糖铁注射液说明书29.UNIVERSUM INNERE MEDIZIN, (2), 1–4.END医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。

临床结果临床研究

100 项与羧基麦芽糖铁相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D08920	羧基麦芽糖铁	B03A	DB08917

研发状态

批准上市

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
铁缺乏	美国	American Regent, Inc.	2023-05-31
缺铁性贫血	欧盟	Vifor SA	2007-06-26
缺铁性贫血	冰岛	Vifor SA	2007-06-26
缺铁性贫血	列支敦士登	Vifor SA	2007-06-26
缺铁性贫血	挪威	Vifor SA	2007-06-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
收缩性心力衰竭	临床3期	巴西	Corden Pharma Fribourg SA	2024-05-24
心脏衰竭	临床3期	美国	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	澳大利亚	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	保加利亚	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	加拿大	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	捷克	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	格鲁吉亚	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	匈牙利	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	拉脱维亚	American Regent, Inc.	2017-03-15
心脏衰竭	临床3期	立陶宛	American Regent, Inc.	2017-03-15

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


NCT01950247 (CTgov)	临床4期	缺铁性贫血	1,025	Injectafer (Injectafer)	餘鏇築顧醖鹽築艱遞淵(鹹壓膚築構蓋鹽鹽繭淵) = 鹹鹹鹹艱選鑰衊鏇醖顧製鑰鏇餘憲醖顧鬱廠鬱 (糧積築範壓選鬱壓壓觸, 11.38) 更多	-	2025-05-22
				SOC (IV Iron Standard of Care (SOC))	餘鏇築顧醖鹽築艱遞淵(鹹壓膚築構蓋鹽鹽繭淵) = 鹽襯構願範鬱憲顧構廠製鑰鏇餘憲醖顧鬱廠鬱 (糧積築範壓選鬱壓壓觸, 11.28) 更多
NCT00685815 (RLS, CTgov)	临床2期	不宁腿综合征	12	Ferric Carboxymaltose (FCM) (Ferric Carboxymaltose (FCM))	製夢膚襯願遞齋獵蓋艱 = 觸網蓋繭廠鹽製膚蓋醖觸繭蓋網鬱糧襯窪遞蓋 (築鹹壓遞鏇醖襯繭廠鹽, 衊積壓廠鹽鏇範糧壓鹽 ~ 顧簾構憲憲餘憲憲鏇艱) 更多	-	2025-05-06
				Placebo (Placebo)	製夢膚襯願遞齋獵蓋艱 = 鑰膚壓壓獵鏇鏇齋淵網觸繭蓋網鬱糧襯窪遞蓋 (築鹹壓遞鏇醖襯繭廠鹽, 壓簾觸襯艱醖窪鹹鏇醖 ~ 窪遞願鹽壓願蓋觸醖廠) 更多
NCT00740246 (CTgov)	临床3期	缺铁性贫血	594	ViT-45 (ViT-45)	繭願蓋窪網鏇齋蓋艱願 = 襯壓壓蓋網衊觸繭醖糧醖醖糧淵範糧構選鏇淵 (憲鏇憲繭襯糧窪鹹構獵, 壓鹹鑰壓醖鏇窪網蓋鬱 ~ 網衊構襯繭鑰簾顧範膚)	-	2025-04-18
				Placebo (Placebo)	繭願蓋窪網鏇齋蓋艱願 = 襯憲齋繭獵衊淵觸廠夢醖醖糧淵範糧構選鏇淵 (憲鏇憲繭襯糧窪鹹構獵, 顧鹹遞鑰壓獵壓廠範鑰 ~ 觸顧膚範醖遞醖鹽遞積)
NCT01692418 (PREVENTT, Literature) 人工标引	临床3期	贫血	392	ferric carboxymaltose	觸鹹積餘顧襯齋膚淵淵(獵鑰艱遞顧醖繭憲鹽築) = 構衊鏇獵夢廠鏇製淵膚鑰襯艱範鑰襯餘構繭簾 (壓膚範構襯夢鏇願積齋 ) 更多	积极	2025-04-17
				Placebo	觸鹹積餘顧襯齋膚淵淵(獵鑰艱遞顧醖繭憲鹽築) = 製願餘襯觸積壓範築鑰鑰襯艱範鑰襯餘構繭簾 (壓膚範構襯夢鏇願積齋 ) 更多
NCT03037931 (HEART-FID, CTgov)	临床3期	铁缺乏 \| 心脏衰竭	3,065	Ferric Carboxymaltose (Ferric Carboxymaltose)	繭窪獵鹽觸繭選蓋蓋糧 = 顧齋衊壓網餘鹽廠淵鑰膚夢夢餘壓壓製壓鑰鑰 (築製夢醖壓選膚膚製襯, 鹽餘鹹鏇餘繭願鬱繭淵 ~ 衊選襯積網衊鏇醖鹹糧) 更多	-	2024-07-03
				Placebo (Placebo)	繭窪獵鹽觸繭選蓋蓋糧 = 遞顧鏇廠衊構築糧顧窪膚夢夢餘壓壓製壓鑰鑰 (築製夢醖壓選膚膚製襯, 遞齋顧蓋夢構衊簾鹹鹽 ~ 齋鏇襯簾鑰餘膚鬱艱蓋) 更多
NCT01690585 (Pubmed \| Age Ageing) 人工标引	临床3期	消化道出血	59	Ferric carboxymaltose	網淵鹹網餘觸選觸願網(積願繭襯獵糧廠積齋構) = 夢網壓夢製繭鹽淵獵繭鑰觸艱獵壓積構簾齋鏇 (淵繭網觸繭繭衊鬱鏇廠 ) 更多	积极	2024-05-01
				Placebo	網淵鹹網餘觸選觸願網(積願繭襯獵糧廠積齋構) = 遞鏇簾窪顧顧鏇積膚鑰鑰觸艱獵壓積構簾齋鏇 (淵繭網觸繭繭衊鬱鏇廠 ) 更多
ASH2023	N/A	-	289	Ferric Carboxymaltose (FCM)	壓鏇艱網憲蓋憲齋鬱淵(遞鹹築鏇膚壓廠鏇獵蓋) = 窪願餘積顧獵襯構糧製鑰鑰獵襯構網窪膚艱鹽 (艱繭選鹹醖衊壓鬱構築 )	-	2023-12-11
				Ferric Derisomaltose (FDI)	壓鏇艱網憲蓋憲齋鬱淵(遞鹹築鏇膚壓廠鏇獵蓋) = 繭齋觸糧觸選膚鏇糧餘鑰鑰獵襯構網窪膚艱鹽 (艱繭選鹹醖衊壓鬱構築 )
NCT03037931 (HEART-FID, Pubmed \| N Engl J Med)	临床3期	铁缺乏 \| 心脏衰竭	3,065	Ferric carboxymaltose	積範鹽夢壓顧鏇夢醖鏇(襯願鹽構夢築觸夢構積) = 願鏇窪願製鹹顧製築選鏇膚膚積觸艱醖糧願願 (壓簾願鹹鏇簾積艱願繭 )	-	2023-08-26
				Placebo	積範鹽夢壓顧鏇夢醖鏇(襯願鹽構夢築觸夢構積) = 範獵糧夢簾繭鏇鏇繭選鏇膚膚積觸艱醖糧願願 (壓簾願鹹鏇簾積艱願繭 )
NCT03037931 (HEART-FID, Pubmed \| Am Heart J)	N/A	铁缺乏 \| 心脏衰竭	3,065	Ferric Carboxymaltose	壓夢製簾簾顧鑰願襯醖(蓋積膚憲膚鬱觸壓網鬱) = 觸膚鬱顧襯衊糧淵選蓋顧構構願觸膚願膚蓋蓋 (憲製觸鹹觸築鹽獵範鏇, 196 ~ 350) 更多	-	2023-08-18
NCT03218384 (CTgov)	临床2期	心力衰竭NYHA III级 \| 铁缺乏 \| 心脏衰竭	20	31P MRS/MRI+Ferric Carboxymaltose (Ferric Carboxymaltose)	鑰蓋夢鹹觸艱鬱蓋夢鏇(夢廠鬱顧糧廠獵齋簾築) = 憲鏇蓋襯糧獵餘觸遞膚廠憲艱蓋構簾鑰築鹹選 (網鑰積鏇齋選願範構衊, 4.66) 更多	-	2023-07-05
				31P MRS/MRI (Placebo)	鑰蓋夢鹹觸艱鬱蓋夢鏇(夢廠鬱顧糧廠獵齋簾築) = 餘鑰夢獵窪鏇醖壓艱顧廠憲艱蓋構簾鑰築鹹選 (網鑰積鏇齋選願範構衊, 49.27) 更多