Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.
Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

开始日期2024-01-01

申办/合作机构

Armed Forces Hospital

CTR20140186 / Recruiting临床2期

甲磺酸桂哌齐特注射液治疗急性脑梗死随机、双盲、安慰剂平行对照并剂量探索、多中心Ⅱ期临床试验

以安慰剂为对照，评价甲磺酸桂哌齐特注射液减轻急性脑梗死患者残障程度的有效性和安全性，并探索最佳安全有效剂量和给药方法。

开始日期2013-06-20

申办/合作机构

北京四环制药有限公司

[+1]

CTR20192591 / Recruiting临床1期

健康志愿者中单中心、开放、均衡、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性预试验

比较在空腹及餐后给药条件下，海南全星制药有限公司提供的胞磷胆碱钠胶囊（0.2g/粒）与齐鲁制药有限公司生产的胞磷胆碱钠胶囊（0.2g/粒）在健康成年人群中吸收程度和速度的差异，估算其药代动力学参数及个体内变异度，用于计算和调整正式试验样本量，同时验证分析方法、试验流程、采血点和试验设计的合理性。

开始日期-

申办/合作机构

海南全星制药有限公司

100 项与胞磷胆碱钠相关的临床结果

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100 项与胞磷胆碱钠相关的转化医学

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100 项与胞磷胆碱钠相关的专利（医药）

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项与胞磷胆碱钠相关的文献（医药）

2021-05-01·Georgian medical news

[PHARMACEUTICAL DEVELOPMENT OF TABLETS WITH MODIFIED RELEASE OF CYTICOLINE AND MEMANTINE].

Article

作者: Salakhetdinov, D ; Sysuev, B

According to the WHO data, over 35 million people in the world suffer from severe forms of cognitive impairment. Due to the insufficient effectiveness of separate therapy for amyloid or vascular pathologies, an opinion is expressed about the prospects of combined pharmacotherapy of cognitive impairments. The aim of the study was the pharmaceutical development of the combined tablet dosage form formulation with modified release of citicoline and memantine for the treatment of cognitive impairments. Information bases (eLibrary, PubMed) were used, content analysis on State Register of Medicinal Remedies database (grls.rosminzdrav.ru). The compatibility assessment was carried out by stress experiments method in combination with chromatographic analysis. Comparative pharmacokinetic studies were carried out on rabbits. The justification of the pharmacological and clinical feasibility of the proposed fixed dose combination has been carried out, the objective advantage of which is the potentiation of the pharmacotherapeutic action due to the unidirectional effect of memantine and citicoline, and the expected effect is to improve cognition, functioning and behavior and / or slow down their deterioration. The use of the combination will allow achieving ease of treatment, reducing costs, and, accordingly, compliance. The choice of the optimal dosage form for the developed combination was carried out: a tablet containing two release methods: memantine - immediate release, citicoline - prolonged release. The compatibility of the pharmaceutical substances memantine hydrochloride and citicoline monosodium salt with each other and the excipients planned for use in the formulation has been experimentally revealed. Comparative pharmacokinetic studies of the developed combined drug have been carried out.

2020-12-01·BMC neurology4区 · 医学

Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial

4区 · 医学

ArticleOA

作者: Lu, Xiaodong ; Lü, Hua ; Li, Xiaohong ; Tang, Yamei ; Lu, Tianming ; Zheng, Shengzhe ; Wang, Zhiyong ; Zhao, Liandong ; Zhang, Tong ; Wang, Baojun ; Wang, Jianfeng ; Wang, Dong ; Liu, Ying ; Cai, Xueli ; Huang, Lina ; Li, Juntao ; Ji, Yong ; Qu, Xinhui ; Yang, Yi ; Yi, Fei ; Wu, Jin ; Zhou, Chengfang ; Fang, Qi ; Huang, Yonghua ; Zhou, Jinghua ; Zhang, Zhuobo ; Gong, Tao ; Bi, Hongye ; Gao, Junfeng ; Zhu, Runxiu ; Ni, Jun ; Han, Shugen ; Zhao, Liang ; Geng, Deqin ; Cui, Liying ; Shao, Bei ; Gao, Wei ; Li, Yaguo ; Ke, Kaifu ; Zhuang, Xiaorong ; Yao, Xiaoxi ; Wei, Yan ; Guo, Libin ; Chen, Guofang ; Yu, Xiaofei ; Li, Luoqing ; Ma, Qilin ; Wang, Shifang ; Hu, Weimin ; Zhang, Qing ; Tan, Guojun ; Deng, Youqing ; Zang, Dawei ; Chen, Huisheng ; Huang, Yining ; Tian, Chenglin ; Wei, Xiue ; Wen, Guoqiang ; Li, Li ; Ding, Jianping ; Xiao, Bo ; Lin, Haiyan ; Yang, Hong ; Liu, Yafang ; Gao, Xiaoping ; Dong, Hongliang

Abstract:

Background:

Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.

Methods:

Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.

Results:

In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.

Conclusions:

The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.

Trial registration:

Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

2020-08-12·Zhongguo zhen jiu = Chinese acupuncture & moxibustion

[Clinical observation on post-stroke oculomotor nerve palsy treated with the interaction of twelve meridian muscle regions and contralateral needling therapy].

Article

作者: Wu, Jiang-Ying ; Zhao, Ying ; Liu, Xiao-Xin

OBJECTIVE:

To observe the clinical effect on post-stroke oculomotor nerve palsy treated with the interaction of twelve meridian muscle regions and contralateral needling therapy.

METHODS:

A total of 46 patients with post-stroke oculomotor nerve palsy were randomized into an observation group and a control group, 23 cases in each one. In the control group, the intramusclar injection of mecobalamine at the buttock region was given, 1 mL each time, once every two days, 3 times weekly. Besides, citicoline sodium capsules were prescribed for oral administration, 0.2 g each time, 3 times daily. In the observation group, on the base of the treatment as the control group, the interaction of twelve meridian muscle regions and contralateral needling therapy was supplemented. Acupoints on the health sides included Juliao (ST 3) and Hanyan (GB 4), acupoints on the affected side included Jingming (BL 1), Sibai (ST 2), Yangbai (GB 14), Cuanzhu (BL 2), Shangming (Extra), Sizhukong (TE 23), Tongziliao (GB 1) and bilateral Fengchi (GB 20), Quchi (LI 11), Pianli (LI 6), Waiguan (TE 5), Hegu (LI 4) were selected. The needles were retained for 30 min in each acupuncture treatment, once a day, 5 times weekly. The treatment for 4 weeks was required in the two groups. Before and after treatment, the score of cervical range of motion (CROM), pupil size, eye fissure width and eyeball mobility were observed in the patients of the two groups. The clinical effect was evaluated in the two groups.

RESULTS:

After treatment, CROM scores and pupil size were reduced in the patients of the two groups (P<0.05), and the values in the observation group were lower than the control group (P<0.05). The eye fissure width and eyeball mobility were increased in the two groups (P<0.05), the eye fissure width and the mobility of the muscles of rectus internus, inferior rectus and inferior oblique in the observation group were larger than the control group (P<0.05). The effective rate was 82.6% (19/23) in the observation group, higher than 65.2% (15/23) in the control group (P<0.05).

CONCLUSION:

The interaction of twelve meridian muscle regions and contrallateral needling therapy effectively relieves diplopia, pupil dilation, narrow eye fissure and limited eyeball mobility in the patients with post-stroke oculomotor nerve palsy.

项与胞磷胆碱钠相关的新闻（医药）

2024-10-17

·Pharma CMC

今日新批件，6个一致性评价受理号获批

NMPA发布2024年10月17日药品批准证明文件送达信息，本批次共有12个受理号获批，其中6个为一致性评价申请，过评品种为：遂成药业的胞磷胆碱钠注射液；西南药业的3品规注射用青霉素钠；新乡市常乐制药的马来酸氯苯那敏注射液；深圳澳美制药的阿莫西林克拉维酸钾片。

一致性评价

2024-08-13

·米内网

【瞩目】7亿大品种！湖北药企过评了

精彩内容 8月12日，津药药业公告称，子公司湖北津药药业的乳酸钠林格注射液通过仿制药一致性评价。乳酸钠林格为平衡盐溶液，2023年在中国公立医疗机构终端销售额超过7亿元。乳酸钠林格注射液为全球首个上市含缓冲碱的平衡盐溶液，成分组成接近生理状态，能有效调节体液、电解质及酸碱平衡，用于代谢性酸中毒或有代谢性酸中毒的脱水患者。该药为国家医保甲类品种、国家基药目录品种。米内网数据显示，近年来乳酸钠林格注射液市场呈现出快速增长的态势，2023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）终端销售额超过7亿元，同比增长36.33%。中国公立医疗机构终端乳酸钠林格注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局国内共有46家企业拥有乳酸钠林格注射液的生产批文。目前，该产品已有10家企业通过仿制药一致性评价，包括科伦药业、石家庄四药、杭州民生药业、双鹤药业、齐都药业、津药药业等。湖北津药药业过评品种来源：米内网一致性评价进度数据库截至目前，湖北津药药业已有11款注射剂乳酸钠林格注射液、盐酸氨溴索注射液、胞磷胆碱钠注射液、吡拉西坦注射液、盐酸利多卡因注射液、甘油果糖氯化钠注射液、法莫替丁注射液、氟康唑氯化钠注射液、克林霉素磷酸酯注射液、呋塞米注射液、地塞米松磷酸钠注射液通过/视同通过仿制药一致性评价。资料来源：米内网数据库、公司公告注：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。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 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

一致性评价上市批准

2024-07-24

·米内网

【市场】27亿注射剂，湖北药企过评了

精彩内容 7月23日，NMPA官网显示，湖北津药药业的法莫替丁注射液通过仿制药一致性评价。法莫替丁是第三代H2受体拮抗剂，2023年中国公立医疗机构终端法莫替丁注射剂销售额超过27亿元，有望入选第十批集采。法莫替丁是继西咪替丁和雷尼替丁后出现的又一种H2受体桔抗剂，具有对H2受体亲和力高的特点，对胃酸分泌有明显的抑制作用，对基础分泌及因给予各种刺激而引起的胃酸及胃蛋白酶增加有抑制作用。适用于消化性溃疡（胃、十二指肠溃疡），急性胃黏膜病变，反流性食管炎以及胃泌素瘤。米内网数据显示，2023年中国城市公立医院、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）终端法莫替丁注射剂销售额超过27亿元。其中，山西威奇达光明制药、江西赣南海欣药业、开封康诺药业3家企业的市场份额均超过10%。中国公立医疗机构终端法莫替丁注射剂销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局国内已上市的法莫替丁注射剂有3种，包括注射用法莫替丁、法莫替丁注射液、法莫替丁氯化钠注射液。其中，注射用法莫替丁、法莫替丁氯化钠注射液尚未有企业过评；法莫替丁注射液已有8家企业过评，包括亚邦医药、辰欣药业、北京布霖生物、汇宇制药、湖北津药药业等，有望被纳入第十批集采。湖北津药药业过评品种来源：米内网一致性评价进度数据库截至目前，湖北津药药业已有10款注射剂盐酸氨溴索注射液、胞磷胆碱钠注射液、吡拉西坦注射液、盐酸利多卡因注射液、甘油果糖氯化钠注射液、法莫替丁注射液、氟康唑氯化钠注射液、克林霉素磷酸酯注射液、呋塞米注射液、地塞米松磷酸钠注射液通过/视同通过仿制药一致性评价。资料来源：米内网数据库、NMPA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。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

一致性评价

100 项与胞磷胆碱钠相关的药物交易

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