益髓生血颗粒(Yisuishengxue Granule) - 在研适应症：非输血依赖性地中海贫血_专利_临床

概要

基本信息

药物类型

中药

别名-

靶点-

作用方式-

作用机制-

治疗领域

遗传病与畸形血液及淋巴系统疾病其他疾病

在研适应症

非输血依赖性地中海贫血

非在研适应症-

原研机构-

在研机构

中国中医科学院广安门医院北京植物世纪营养品有限公司

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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关联

3

项与益髓生血颗粒相关的临床试验

NCT05687513

/ Not yet recruiting早期临床1期IIT

Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation

The goal of this clinical trial is to explore the mechanism of Yisui Granule(YSG) in the treatment of myelodysplastic syndrome(MDS) through demethylation.
Under the same condition of basic western medicine treatment, the treatment group used the same traditional Chinese medicine decoction pieces as YSG, and the control group was given placebo. Through a randomized controlled clinical study, we focused on observing the effects of MDS patients on clinical symptoms (including single symptom), fatigue relief, quality of life, peripheral blood picture, blood transfusion interval and blood transfusion volume, and measured the expression of DNMTs, the expression and methylation level of Wnt3a、β-catenin、SFRP and other indicators, as well as cytokines, were used to explore the mechanism of YSG in the treatment of MDS through demethylation.

开始日期2023-01-01

申办/合作机构

北京中医药大学东直门医院

CTR20201285

/ Recruiting临床2期

评价益髓生血颗粒治疗非输血依赖型地中海贫血的有效性及安全性的多中心随机双盲安慰剂平行对照Ⅱ期临床试验

评价益髓生血颗粒治疗非输血依赖型地中海贫血（脾肾两虚、精血不足证）的有效性和安全性，同时对量-效关系进行探索，为Ⅲ期临床试验设计提供数据支持。

开始日期2020-09-27

申办/合作机构

北京植物世纪营养品有限公司

[+1]

NCT01549080

/ CompletedN/AIIT

A Double-blind, Placebo-controlled, Randomized, Parallel-group Study of the Safety and Effects of YisuiShengxueGranules on Thalassemia Presenting the Syndrome of Deficiency of Liver/Kidney-yin, and Asthenia of Essence/Blood.

The primary objectives of this study are to evaluate whether Yisui Shengxue Granules therapy can increase the hemoglobin level in peripheral blood and alleviate the symptoms, and at the same time, evaluate its safety in the treatment of Thalassemia with the syndrome of deficiency of liver-yin and kidney-yin, and asthenia of essence and blood.

开始日期2011-07-01

申办/合作机构

中国中医科学院广安门医院

100 项与益髓生血颗粒相关的临床结果

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100 项与益髓生血颗粒相关的转化医学

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100 项与益髓生血颗粒相关的专利（医药）

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2

项与益髓生血颗粒相关的文献（医药）

2024-02-01·Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan

Efficacy of Yisui granule on myelodysplastic syndromes in SKM-1 mouse xenograft model through suppressing Wnt/β-catenin signaling pathway.

Article

作者: Jieya, W U ; Xiaoyuan, Zhang ; Jing, Wang ; Chong, Gao ; Gullen, Elizabeth ; Li, Hou

OBJECTIVETo unmask the underlying mechanisms of Yisui granule (, YSG) for the treatment of Myelodysplastic syndromes (MDS).METHODSOur study used an SKM-1 mouse xenograft model of MDS to explore the anti-tumor potential of YSG and its safety, assess its effect on overall survival (OS), and evaluate whether its mechanism is associated with the demethylation of the secreted frizzled related protein 5 (sFRP5) gene and suppressing Wnt/β-catenin pathway. Bisulfite amplicon sequencing was applied to detect the level of methylation of the sFRP5 gene; western blotting, immunofluorescence staining, and real-time Polymerase Chain Reaction were performed to detect DNA methyltransferase 1 (DNMT1), sFRP5, and other Wnt/β-catenin pathway-related mRNA and protein expression.RESULTSThe results showed that high-dosage YSG exerted an anti-tumor effect similar to that of decitabine, improved OS, and reduced long-term adverse effects in the long term. Mechanically, YSG reduced the expression of DNMT1 methyltransferase, decreased the methylation, and increased the expression of the Wnt/β-catenin pathway antagonist-sFRP5. Furthermore, components of the Wnt/β-catenin pathway, including Wnt3a, β-catenin, c-Myc, and cyclinD1, were down-regulated in response to YSG, suggesting that YSG could treat MDS by demethylating the sFRP5 gene and suppressing the Wnt/β-catenin pathway.CONCLUSIONSOur findings demonstrated that YSG could be used alone or in combination with decitabine to improve outcomes in the MDS animal model, providing an alternative solution for treating MDS.

2007-01-01·Biological and Pharmaceutical Bulletin4区 · 医学

Clinical Observation on YiSuiShengXueGranule on Treating 156 Patients with .BETA.-Thalassemia Major and the Molecular Mechanism Study

4区 · 医学

Article

作者: Lv, Xinxia ; Wang, Lei ; Liu, Yongmei ; Zhang, Xinhua ; Wang, Wenjuan ; Wang, Rongxin ; Fang, Suping ; Chen, Peizhen ; Huang, Youwen ; Chai, Limin ; Yi, Jie ; Wu, Zhikui ; Cai, Huiguo ; Chen, Yuying

OBJECTIVETo investigate the clinical effects and security of YiSuiShengXueGranule (YSSXG) on treating 156 patients with beta-thalassemia major.METHODSYSSXG was given orally to 156 patients with beta-thalassemia in GuangXi Autonomous Region (the high incidence area of beta-thalassemia in China) for 3 months as one therapeutic course, 3 times a day, 10 g each time (for children, the dose should be reduced properly according to their body weight and age), and no blood transfusion used during the course. Clinical symptoms and levels of hemoglobin (Hb), red blood cell (RBC), reticulocyte (Ret) and hemoglobin F (HbF) were observed before and after treatment, and side-effects were observed during the course. A 3-6 months follow up study was performed after withdrawal of YSSXG. And systemic gene analysis was conducted with PCR, SSCP-PCR, RT-PCR and DNA sequences analysis and mRNA differently expression technique, in order to study the molecular mechanism from the relationships between genetic mutation and clinical efficacy, gene expression and its regulation.RESULTSLevels of Hb, RBC, Ret and HbF obviously elevated, and clinical symptoms markedly ameliorated in patients after treated with YSSXG from the 1st to 3rd month (all p<0.01). Dynamical observation showed that the improvement of symptoms kept accordance with the elevation of hemorrheological indexes. The treatment was effective in 145 patients and ineffective in 11, and the total effective rate was 92.9%, without any adverse reaction founded. Follow-up studies showed the therapeutic effect could sustain for 3 to 4 months after drug-withdrawal. The molecular mechanism study showed: YSSXG did not change the genetic mutation type, but could obviously increase gamma/(beta+gamma) globin ratio, both gamma-globin mRNA and GM-CSF mRNA expression were significantly enhanced so as to induce HbF synthesis increasing after treated with YSSXG.CONCLUSIONYSSXG had obvious effects in treating beta-thalassemia by unlocking gamma-gene, increasing the gamma-globin expression and enhancing HbF synthesis so as to compensate for the gene defect. This study has provided a new path for the treatment of beta-thalassemia with Traditional Chinese Medicine.

100 项与益髓生血颗粒相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非输血依赖性地中海贫血	临床2期	中国	中国中医科学院广安门医院	2020-09-27
非输血依赖性地中海贫血	临床2期	中国	北京植物世纪营养品有限公司	2020-09-27