[Translation] A multicenter, randomized, double-blind phase II clinical study to evaluate the effect of monosialotetrahexosylganglioside sodium injection (GM1) in preventing peripheral neuropathy caused by adjuvant/neoadjuvant treatment of breast cancer patients with paclitaxel (albumin-bound) injection

主要目的:评价不同剂量的GM1预防注射用紫杉醇（白蛋白结合型）方案辅助/新辅助治疗乳腺癌患者引起的周围神经病变的有效性。次要目的:评价GM1预防注射用紫杉醇（白蛋白结合型）方案辅助/新辅助治疗乳腺癌患者所致周围神经病变的安全性。评价GM1在以注射用紫杉醇（白蛋白结合型）方案辅助/新辅助治疗的乳腺癌患者中的药代动力学（PK）特征。

[Translation]

Primary objective: To evaluate the effectiveness of different doses of GM1 in preventing peripheral neuropathy caused by adjuvant/neoadjuvant therapy of breast cancer patients with paclitaxel (albumin-bound) injection. Secondary objective: To evaluate the safety of GM1 in preventing peripheral neuropathy caused by adjuvant/neoadjuvant therapy of breast cancer patients with paclitaxel (albumin-bound) injection. To evaluate the pharmacokinetic (PK) characteristics of GM1 in breast cancer patients treated with adjuvant/neoadjuvant therapy of paclitaxel (albumin-bound) injection.

Start Date21 Jul 2023

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

ChiCTR2100042537 / RecruitingPhase 4IIT

Efficacy and safety of GM-1 in the treatment of Parkinson's disease: a prospective, multicenter, self controlled clinical study

Start Date01 Mar 2021

Sponsor / Collaborator

Qilu Hospital of Shandong University

CTR20202440 / CompletedPhase 4

急性缺血性脑卒中患者的确证性临床研究

[Translation] Confirmatory clinical study in patients with acute ischemic stroke

评估单唾液酸四己糖神经节苷脂钠注射液治疗急性缺血性脑卒中患者的有效性和安全性

[Translation]

To evaluate the efficacy and safety of monosialotetrahexosylganglioside sodium injection in the treatment of patients with acute ischemic stroke

Start Date02 Nov 2020

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Sodium Monosialotetrahexosylganglioside

100 Translational Medicine associated with Sodium Monosialotetrahexosylganglioside

100 Patents (Medical) associated with Sodium Monosialotetrahexosylganglioside

Literatures (Medical) associated with Sodium Monosialotetrahexosylganglioside

01 Mar 2023·Experimental Brain Research

A combination of umbilical cord mesenchymal stem cells and monosialotetrahexosy 1 ganglioside alleviates neuroinflammation in traumatic brain injury

Article

Author: Tan, Yi ; Jin, Qianxu ; Li, Xin ; Fang, Yanwei ; Zhao, Jianhui ; Yu, Ning ; Qiu, Wenna ; Yan, Hongshan ; Zhao, Zongmao

Neuro-inflammation and activated microglia play important roles in neuron damage in the traumatic brain injury (TBI). In this study, we determined the effect of neural network reconstruction after human umbilical cord mesenchymal stem cells (UMSCs) combined with monosialotetrahexosy 1 ganglioside (GM1) transplantation and the effect on the neuro-inflammation and polarization of microglia in a rat model of TBI, which was established in male rats using a fluid percussion brain injury device. Rats survived until day 7 after TBI were randomly treated with normal control (NC), saline (NS), GM1, UMSCs, and GM1 plus UMSCs. Modified neurological severity score (mNSS) was assessed on days 7 and 14, and the brain tissue of the injured region was collected. Immunofluorescence, RT-PCR, and western blot analysis found that inhibitory neuro-inflammatory cytokines TGF-β and CD163 protein expression levels in injured brain tissues were significantly increased in rats treated with GM1 + UMSCs, GM1, or UMSCs and were up-regulated compared to saline-treated rats. Neuro-inflammatory cytokines IL-6, COX-2 and iNOS protein expressions were down-regulated compared to rats treated with saline. The protein expression levels of NE, NF-200, MAP-2 and β-tubulin III were increased in the injured brain tissues from rats treated with GM1 + UMSCs, or GM1 and UMSCs alone compared to those in the rats treated with NS. The protein expression levels in rats treated with GM1 plus UMSCs were most significant on day 7 following UMSC transplantation. The rats treated with GM1 plus UMSCs had the lowest mNSS compared with that in the other groups. These data suggest that UMSCs and GM1 promote neural network reconstruction and reduce the neuro-inflammation and neurodegeneration through coordinating injury local immune inflammatory microenvironment to promote the recovery of neurological functions in the TBI.

06 Jan 2021·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Changes and clinical significance of serum NSE and MBP levels in children with cerebral palsy at high altitude during comprehensive rehabilitation].

Article

Author: Ren, P L ; Chen, S Z ; Liu, J L ; A, X R ; Yang, Y

Objective: To explore the changes of serum neuron-specific enolase (NSE) and myelin basic protein (MBP) in children with cerebral palsy at high altitude during comprehensive rehabilitation and their clinical significance. Methods: A clinical randomized controlled study design was used to select 144 children with cerebral palsy who were diagnosed and treated in the Rehabilitation Center of Xining Traditional Chinese Medicine Hospital of Qinghai Province from June 2018 to October 2019, including 83 males and 61 females, aged 3-5 years old. According to the order of admission, the random number table was used to divide into a conventional treatment group (n=72, 40 males and 32 females) and a comprehensive treatment group (n=72, 43 males and 29 females). The conventional treatment group was treated with conventional rehabilitation. The comprehensive treatment group was treated with monosialotetrahexose ganglioside sodium on the basis of conventional rehabilitation. In addition, 30 healthy children aged 3-5 years, 16 males and 14 females, were selected as the control group during the physical examination of the Pediatrics Department of Xining Hospital of Traditional Chinese Medicine, Qinghai Province. The serum levels of NSE and MBP in each group were detected, and the children's GMFM-88 scores were evaluated before and after treatment. The SPSS19.0 software was used for statistical analysis, the count data was tested by χ². Results: The serum NSE and MBP levels of the control group were (5.96±0.80), (0.71±0.15) μg/L. Before treatment, the serum NSE and MBP levels of children with severe, moderate, and mild cerebral palsy were [(21.63±1.92), (3.63±0.49) μg/L], [(17.86±1.43) μg/L, (2.21±0.07) μg/L] and [(15.14±0.95), (1.76±0.30) μg/L], respectively. After treatment, the serum NSE and MBP levels of the conventional treatment group and the comprehensive treatment group were [(13.54±2.41), (2.07±0.85) μg/L] and [(12.09±2.37), (1.81±0.69) μg/L], respectively, and the GMFM-88 score was (116.75±27.41) points and (125.94±24.93) points. The levels of NSE and MBP in the serum of children with cerebral palsy were significantly higher than those of normal children in the control group, and their levels increased with the degree of disease, and the corresponding gross motor function scores were lower. After treatment, the GMFM-88 scale assessment scores of the two groups of children were significantly improved (t values were 310.97 and 70.86, P values were both<0.05), and serum NSE and MBP levels decreased to varying degrees compared with before treatment. The decline in the comprehensive treatment group was greater than that in the conventional treatment group. Conclusions: Serum NSE and MBP levels in children with cerebral palsy at high altitude are significantly higher than those in healthy children, and their levels are closely related to the degree of impairment and GMFM-88 scores in children with cerebral palsy. Dynamic monitoring of changes in NSE and MBP levels may be responsible for the condition and treatment effects of children with cerebral palsy judgments based.

01 Jul 2020·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Tabu search algorithm analysis on effect of Xingnaojing Injection in treatment of craniocerebral injury and complications in real world].

Article

Author: Zhang, Min ; Geng, Hong-Jiao ; Xie, Yan-Ming

In this study, Tabu search algorithm was used to analyze the drug combination of Xingnaojing Injection in the treatment of brain injury and complications in the real world, and the clinical drug combination of Xingnaojing Injection in the treatment of brain injury and complications was selected and summarized. The combination of Xingnaojing Injection, Namefen and Citicoline were recommended in the treatment of brain injury and complications. For brain edema and nerve injury, Mannitol/Glycerol Fructose/Furosemide+Tetrahexose Monosialate Ganglioside Sodium should be recommended. For those with pulmonary infection, Xingnaojing Injection+Xiyanping+Ambroxol Hydrochloride+Tanreqing Injection should be recommended. For those with shock, Hydroxyethyl Starch+Dopamine Hydrochloride/Dobutamine Hydrochloride+Sodium Bicarbonate should be recommended. The combination reflected the characteristics of Chinese and Western medicine. The above medication regimen was only for clinicians' reference. The clinical application should be based on patients' specific conditions, clinical benefits and risks, as well as the incompatibility. On the basis of the findings, further studies can be carried out for prospective clinical efficacy evaluation and safety evaluation for a specific subgroup module.

100 Deals associated with Sodium Monosialotetrahexosylganglioside

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Craniocerebral Trauma	CN	-	-
Spinal Cord Injuries	CN	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 3	CN	Hunan Province Sailong Pharmaceutical Co. Ltd.	05 Dec 2019
Breast Cancer	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	21 Jul 2023
Peripheral Nervous System Diseases	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	21 Jul 2023

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