A Randomized Prospective Clinical Trial to Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment Among Breast Cancer Survivals Who Receive Anti-estrogen Therapy

Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.

开始日期2022-12-20

申办/合作机构

Kyungpook National University Hospital

100 项与海藻酸钠相关的临床结果

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100 项与海藻酸钠相关的转化医学

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100 项与海藻酸钠相关的专利（医药）

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713

项与海藻酸钠相关的文献（医药）

2024-04-01·DEN open

Feasibility and safety of 0.6% sodium alginate in endoscopic submucosal dissection for colorectal neoplastic lesion: A pilot study

Article

作者: Hirata, Yuya ; Kanari, Yusuke ; Anbo, Tomonori ; Takanashi, Kunihiro ; Tomita, Natsumi ; Katsuki, Shinichi ; Nakamura, Hajime ; Komatsu, Yuya ; Ito, Ryo ; Sakurada, Akira ; Morita, Rie

Abstract:

Objectives:

The usefulness of 0.6% sodium alginate (SA) as a submucosal (SM) injection solution for endoscopic SM dissection (ESD) has gained attention over the past few years. However, using ESD for colorectal neoplastic lesions is not explicitly researched as yet. Thus, we conducted this study to determine the feasibility and safety of 0.6% SA solution for colorectal ESD.

Methods:

In this single‐center, retrospective pilot study, a total of 100 cases treated with ESD using 0.6% SA as a SM injection solution for colorectal neoplasia at our institute were retrospectively reviewed to clarify the clinical feasibility and safety of 0.6% SA. The primary endpoint was to evaluate the complication rate, and the secondary endpoint was to determine the procedure time and the amount of solution used.

Results:

Intraoperative perforation was observed in 1 case (1.0%), 2 cases (2.0%) presented with postprocedural hemorrhage, and no lethal adverse events were observed. The median ESD procedure times were 39.5 min (10–150), and the amount of solution used was less than 20 mL in 67 cases (67.0%). En‐bloc resection could be achieved in 97 cases (97.0%). Although six cases underwent subsequent surgery due to the deep SM invasion (>1000 μm), there were no cases with nodal involvement, confirmed through histopathological evaluation.

Conclusions:

Our findings indicate that 0.6% SA can potentially ensure safe and secure ESD for colorectal neoplasia.

2024-04-01·Bioactive materials

Antibiofilm and antithrombotic hydrogel coating based on superhydrophilic zwitterionic carboxymethyl chitosan for blood-contacting devices

Article

作者: Kim, Woojin ; Oh, Yong Suk ; Park, Junghun ; Ahn, Yejin ; Lee, Dong Uk ; Yoo, Seung Hwa ; Kang, Yeongkwon ; Choi, Dong Yun ; Park, Jun-Kyu ; Kim, Bong-Gi ; Park, Se Kye ; Kayumov, Mukhammad ; Jeong, In-Seok

Blood-contacting devices must be designed to minimize the risk of bloodstream-associated infections, thrombosis, and intimal lesions caused by surface friction. However, achieving effective prevention of both bloodstream-associated infections and thrombosis poses a challenge due to the conflicting nature of antibacterial and antithrombotic activities, specifically regarding electrostatic interactions. This study introduced a novel biocompatible hydrogel of sodium alginate and zwitterionic carboxymethyl chitosan (ZW@CMC) with antibacterial and antithrombotic activities for use in catheters. The ZW@CMC hydrogel demonstrates a superhydrophilic surface and good hygroscopic properties, which facilitate the formation of a stable hydration layer with low friction. The zwitterionic-functionalized CMC incorporates an additional negative sulfone group and increased negative charge density in the carboxyl group. This augmentation enhances electrostatic repulsion and facilitates the formation of hydration layer. This leads to exceptional prevention of blood clotting factor adhesion and inhibition of biofilm formation. Subsequently, the ZW@CMC hydrogel exhibited biocompatibility with tests of in vitro cytotoxicity, hemolysis, and catheter friction. Furthermore, in vivo tests of antithrombotic and systemic inflammation models with catheterization indicated that ZW@CMC has significant advantages for practical applications in cardiovascular-related and sepsis treatment. This study opens a new avenue for the development of chitosan-based multifunctional hydrogel for applications in blood-contacting devices.

2024-03-01·International journal of biological macromolecules

A sodium alginate intervention strategy to enhance therapeutic effects of bone-targeted alpha therapy via remodeling 223RaCl2 distribution

Article

作者: Wang, Ruizhi ; Lou, Jingjing ; Zhou, Pan ; Zhang, Lan ; Li, Danni ; Bai, Qingyun ; Li, Xiao ; Lu, Xinyu ; Xue, Shuai ; Liu, Xingdang

Radium-223 dichloride is the first approved alpha particle-emitting radiopharmaceutical for patients with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases. A large percentage of intestinal enrichment and a slow clearance rate were the main causes of gastrointestinal adverse events after ²²³RaCl₂ administration. The molecular weight of sodium alginate in aqueous solution was determined to be 656 kDa. Sodium alginate exhibits a higher affinity for adsorbing Ra²⁺ compared to other metal ions belonging to the second main group. Sodium alginate as low as 0.5 g/rat reduced intestinal damage by remodeling ²²³RaCl₂ distribution without affecting bone resorption. Intestinal villi were preserved and enterocyte activity was maintained after sodium alginate intervention. Sodium alginate reduced DNA oxidative damage and lipid peroxidation and maintained endogenous antioxidant status by increasing superoxide dismutase levels and total antioxidant capacity. Furthermore, sodium alginate treatment mitigated DNA damage and apoptosis. The administration of sodium alginate effectively maintained the integrity of the intestinal microbiota, which had undergone perturbations due to radiation exposure. This study demonstrated that sodium alginate could be applied to reduce the adverse effects caused by radiation exposure to the intestine during ²²³RaCl₂-treated and reduced intestinal damage resulted from ²²³RaCl₂ accumulation without affecting bone uptake.

项与海藻酸钠相关的新闻（医药）

2024-04-09

·蒲公英Ouryao

药典委：乙醇、山梨酸等13种辅料标准公示

来源：国家药典委编辑：wangxinglai2004近日，国家药典委发布了13则辅料标准公示，涉及品种包括泊洛沙姆40、泊洛沙姆188、无水乙醇、丁香酚、海藻酸钠、乙醇、山梨酸钾、山梨酸、橄榄油等，其中乙醇、山梨酸钾、山梨酸、橄榄油公示期为1个月，其余品种全部为3个月。 01 泊洛沙姆407国家药用辅料标准我委拟修订泊洛沙姆407国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见，具体如下：重点内容说明：性状：根据《国家药用辅料标准编写细则（2023 年暂行版）》，微有异臭的描述不便于试验验证，故删除此描述；另外将溶解度放在正文最后，以注的形式体现。氧乙烯：2020 年版《中国药典》中 A1为 1.15×10-6 处双峰的积分面积，代表氧丙烯的甲基，因征集样品的核磁图显示，该处的峰型不一定是双峰，将此处的描述修订为“A1 为约 1.15×10-6 处峰的积分面积”。二丁基羟基甲苯（标示含二丁基羟基甲苯时测定）：2020 年版《中国药典》中的供试品溶液在室温较低时会出现析出的情况，故将原标准中的供试品浓度和对照品浓度降低一半，进样体积增加一倍，可避免析出。将供试品浓度由100mg/ml 修订为 50mg/ml，对照品浓度由 20µg/ml 修订为 10µg /ml；进样体积由1µl 修订为 2µl，绝对进样量不变。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 02 泊洛沙姆188国家药用辅料标准我委拟修订泊洛沙姆188国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见，具体如下：重点内容说明：性状：根据《国家药用辅料标准编写细则（2023 年暂行版）》，微有异臭的描述不便于试验验证，故删除此描述；另外将溶解度放在正文最后，以注的形式体现。氧乙烯：2020 年版《中国药典》中 A1 为 1.15×10-6 处双峰的积分面积，代表氧丙烯的甲基，因征集样品的核磁图显示，该处的峰型不一定是双峰，将此处的描述修订为“A1 为约 1.15×10-6 处峰的积分面积”。二丁基羟基甲苯（标示含二丁基羟基甲苯时测定）：2020 年版《中国药典》中的供试品溶液在室温较低时会出现析出的情况，故将原标准中的供试品浓度和对照品浓度降低一半，进样体积增加一倍，可避免析出。将供试品浓度由100mg/ml 修订为 50mg/ml，对照品浓度由 20µg/ml 修订为 10µg /ml；进样体积由1µl 修订为 2µl，绝对进样量不变。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 03 海藻酸钠国家药用辅料标准我委拟修订海藻酸钠国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 04 乙醇国家药用辅料标准我委拟修订乙醇国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起一个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 05 丁香酚国家药用辅料标准我委拟修订丁香酚国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 06 二甲硅油国家药用辅料标准我委拟修订二甲硅油国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 07 山梨醇国家药用辅料标准我委拟修订山梨醇国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 08 无水枸橼酸国家药用辅料标准我委拟修订无水枸橼酸国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 09 山梨酸钾国家药用辅料标准我委拟修订山梨酸钾国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起一个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 10 山梨酸国家药用辅料标准我委拟修订山梨酸国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起一个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 11 无水乙醇国家药用辅料标准我委拟修订无水乙醇国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566，67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 12 黑氧化铁国家药用辅料标准我委拟修订黑氧化铁国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起三个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566、67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 13 橄榄油国家药用辅料标准我委拟修订橄榄油国家药用辅料标准。为确保标准的科学性、合理性和适用性，现将拟修订的标准公示征求社会各界意见（详见附件）。公示期自发布之日起一个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：陈蕾、朱冉电话：010-67079566,010-67079581 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061

申请上市

2023-06-21

·Science Daily

Helping 'good' gut bacteria and clearing out the 'bad' -- all in one treatment

Probiotics can help maintain a healthy gut microbiome or restore populations of 'good bacteria' after a heavy course of antibiotics. But now, they could also be used as an effective treatment strategy for certain intestinal diseases, such as Crohn's disease. Researchers have developed a microgel delivery system for probiotics that keeps 'good' bacteria safe while actively clearing out 'bad' ones. In mice, the system treated intestinal inflammation without side effects. Probiotics can help maintain a healthy gut microbiome or restore populations of "good bacteria" after a heavy course of antibiotics. But now, they could also be used as an effective treatment strategy for certain intestinal diseases, such as Crohn's disease. Researchers reporting in ACS Central Science have developed a microgel delivery system for probiotics that keeps "good" bacteria safe while actively clearing out "bad" ones. In mice, the system treated intestinal inflammation without side effects. In the digestive system, there's a delicate balance of bacterial populations. When this balance is disrupted, bad bacteria can take over the colon, causing it to swell, resulting in colitis. Certain diseases, including inflammatory bowel disease and Crohn's disease, involve chronic colitis and currently require immunosuppressants to treat them. These drugs are expensive and non-specific, sometimes giving rise to antibiotic-resistant bacteria. An alternative strategy is to deliver beneficial bacteria, or probiotics, to help restore balance. But to reach the colon, a treatment must first pass through stomach acid, withstand being cleared out by the intestine, then fight for space alongside the numerous invading bacteria. Pairing probiotics with a drug delivery system could make this strategy feasible, though most current approaches simply protect the probiotics from digestion without affecting the microbes responsible for the condition. So, Zhenzhong Zhang, Junjie Liu, Jinjin Shi and colleagues wanted to combine probiotics with specialized microgel spheres that could not only protect the good bacteria, but also actively help clear out the bad. To create their system, the researchers combined sodium alginate, tungsten and calcium-containing nanoparticles into small, spherical microgels, then coated them with beneficial, probiotic bacteria. The gels protected the bacteria as they made their way through the stomach and increased their retention time in the colon. Once there, calprotectin proteins -- highly expressed during colitis -- bound to the calcium and disassembled the gels, allowing the tungsten to escape. By displacing molybdenum in a key enzyme substrate of the bad bacterium Enterobacteriaceae, tungsten inhibited the microbe's growth while leaving the probiotics unaffected. In experiments using a colitis mouse model, the system allowed probiotics to proliferate in the intestine without any side effects. Additionally, mice with the microgel spheres did not exhibit many of the hallmarks of colitis, such as shortened colons or damaged intestinal barriers, showing that the delivery system could be a viable treatment strategy. Though the researchers also want to prove its utility in more advanced preclinical models, they say that this work provides a new perspective into treatments using colonizing probiotics. The authors acknowledge funding from the National Natural Science Foundation of China, the Outstanding Youth Foundation of Henan Province and the China Postdoctoral Science Foundation.

2023-05-17

·Science Daily

An edible CBD coating could extend the shelf life of strawberries

Soon, you'll be able to get a box of freshly picked, sweet strawberries from the grocery store or local farm stand. But it's disappointing when you get them home and find that the ones at the bottom have started to rot. To increase the berries' shelf life, researchers have incorporated cannabidiol -- a non-hallucinogenic compound from cannabis known as CBD -- and sodium alginate into an edible antimicrobial coating. Soon, you'll be able to get a box of freshly picked, sweet strawberries from the grocery store or local farm stand. But it's disappointing when you get them home and find that the ones at the bottom have started to rot. To increase the berries' shelf life, researchers reporting in ACS Applied Materials & Interfaces have incorporated cannabidiol -- a non-hallucinogenic compound from cannabis known as CBD -- and sodium alginate into an edible antimicrobial coating. CBD is popular because of its potential therapeutic effects. But this cannabinoid has also been shown to have antioxidant and antimicrobial properties. In previous studies, CBD limited the growth of some bacteria and pathogenic fungi, such as the ones that cause fresh fruits and vegetables to rot. However, the oily compound needs to be evenly distributed in water before it can be widely incorporated into foods or used for food preservation. One possible way to do this is to encapsulate the CBD molecules in edible polymers. So, Pongpat Sukhavattanakul, Sarute Ummartyotin and colleagues wanted to see if a food coating made using CBD-filled nanoparticles could promote antimicrobial activity and extend the freshness of strawberries. The researchers encapsulated CBD in poly(D,L-lactide-co-glycolide), a biodegradable polymer used in drug delivery, producing 400-nm-wide particles. They mixed the most stable nanoparticles, containing 20% by weight CBD, with sodium alginate in water. Strawberries were then submerged into solutions containing different amounts of nanoparticles before a second dip into a mixture of ascorbic acid and calcium chloride to turn the colorless coating into a gel. Untreated and treated strawberries were then placed in open plastic containers at refrigerator temperatures. After 15 days, CBD-treated samples ripened and decayed much more slowly than untreated ones, possibly because of reduced microbial growth. The coating with the most CBD-loaded nanoparticles preserved the berries' dark red appearance, enhanced their antioxidant activity the most and exhibited the largest antimicrobial protection over the storage period, suggesting that this version would lead to the longest shelf life. The researchers say that their results demonstrate how encapsulated CBD could be used to create a colorless antimicrobial coating for active food packaging.

100 项与海藻酸钠相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D03336	-	-	-

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适应症	国家/地区	公司	日期
十二指肠溃疡	日本	Kaigen Pharma Co., Ltd.	2009-06-26
糜烂性胃炎	日本	Kaigen Pharma Co., Ltd.	2009-06-26
反流性食管炎	日本	Kaigen Pharma Co., Ltd.	2009-06-26
出血	日本	Kaigen Pharma Co., Ltd.	2009-06-26
胃溃疡	日本	Kaigen Pharma Co., Ltd.	2009-06-26

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适应症	最高研发状态	国家/地区	公司	日期
消化不良	临床3期	中国	Reckitt Benckiser Healthcare (UK) Ltd.	2013-06-01
胃食管反流	临床3期	中国	Reckitt Benckiser Healthcare (UK) Ltd.	2013-06-01

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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


JPRN-UMIN000013113 (OLCSG1401, ESMO2019)	N/A	局部晚期非小细胞肺癌	-	Sodium alginate with concurrent CRT	廠簾鏇醖窪鑰構廠鏇獵(糧糧製築齋選觸憲製齋) = 鹹窪蓋襯繭憲衊願淵醖醖夢夢壓繭構願積艱築 (網選衊艱鹽夢憲構選遞 )	不佳	2019-09-28
				Sodium alginate with mild esophagitis during CRT	廠簾鏇醖窪鑰構廠鏇獵(糧糧製築齋選觸憲製齋) = 艱觸顧願餘願齋艱壓窪醖夢夢壓繭構願積艱築 (網選衊艱鹽夢憲構選遞 )