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 详细处方信息以本药内容附件PDF文件（201892521545114.pdf）的“原文Priscribing Information”为准
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部分尼可林处方资料（仅供参考）

【中文品名】胞磷胆碱

【药效类别】脑代谢调节药

【通用药名】CITICOLINE

【别　　名】Audes, CDP-choline, Citiolase, Cytidil diphosphocholone, IP-302, Metanervon, Neurodynamicum, Nicholin, Reagin, Rexort, Sauran, Somazina, Startonyl

【别名】胞磷胆碱;胞嘧啶核甘;二磷酸胞嘧啶胆碱;二磷酸胆碱;尼古林,胞二磷胆碱,尼可林,尼可灵

【化学名称】 Cytidine 5'-(trihydrogen diphosphate)hydroxide mono[2-(trimethylamminio)ethyl ester

【CA登记号】[987-78-0]

【分 子 式】C14H26N4O11P2

【分 子 量】488.33

【开发单位】武田

【首次上市】1967年，日本

【用　　途】

脑代谢活化剂，用于大脑梗塞引起的急性意识障碍、缺血性中风。

【药理毒理】本品为核苷衍生物，通过降低脑血管阻力,增加脑血流而促进脑物质代谢，改善脑循环。另外,可增强脑干网状结构上行激活系统的机能,增强锥体系统的机能,改善运动麻痹,故对促进大脑功能的恢复和促进苏醒，有一定作用。

【药代动力学】注入本品可迅速进入血流,并有部分通过血脑屏障进入脑组织。其中胆碱部分在体内成为良好的甲基化供体,可对多种化合物有转甲基化作用，约有1％的胆碱可从尿中排出。

【适应证/功效】

①颅脑损伤、颅脑术后和急性脑梗塞引起的意识障碍，但须在改善呼吸、循环及纠正脑缺氧等措施的基础上使用。

②辅助治疗帕金森综合征：与抗胆碱药合用对震颤有效，但不宜与左旋多巴合用。

③神经性耳聋和耳鸣。

④脑血管病亚急性期和恢复期。

【不良反应】偶有恶心、呕吐、食欲不振等。

【禁忌】对本品过敏者禁用

【注意事项】严重脑损伤和活动性颅内出血者慎用。脑出血急性期不宜大剂量应用。肌注一般不采用，若用时应经常更换注射部位。

【孕妇及哺乳期妇女用药】尚不明确。

【儿童用药】：尚不明确。

【老年用药】尚不明确。

【药物相互作用】尚不明确。

【药物过量】尚不明确。

【贮藏】遮光，密闭保存

【生产厂家】日本武田药品工业株式会社

【临床研究】

临床观察急性脑梗死患者在发病3天内和治疗1周后血清NSE变化和神经功能缺损评分变化，并观察尼可林对其的影响。结果显示急性脑梗死常规治疗组和尼可林组发病3天内血清NSE均高于对照组(P<0．01)。治疗1周后常规治疗组血清NSE含量仍高于对照组(p<0．05)，而尼克林组与对照组之间无明显差异(P>0．05)；尼克林组神经功能缺损评分与对照组相比有显著性差异(P<0．05)。显示急性脑梗死患者血清NSE含量增高．而尼可林可显著降低血NSE的含量；尼克林的近期临床疗效也优予常规治疗组。表明尼可林对急性脑梗死患者具有脑保护作用。

[Chinese name]Citicoline

[Drug Effect Category] Brain Metabolism Regulator

[Universal drug name] CITICOLINE

[alias]Audes, CDP-choline, Citiolase, Cytidil diphosphocholone, IP-302, Metanervon, Neurodynamicum, Nicholin, Reagin, Rexort, Sauran, Somazina, Startonyl

[alias] citicoline; cytosine nucleoside; cytosine choline; choline diphosphate; nicotine, citicoline, nicolin, nicotine

[Chemical name] Cytidine 5'-(trihydrogen diphosphate)hydroxide mono[2-(trimethylamminio)ethyl ester

[CA registration number][987-78-0]

[Molecular] C14H26N4O11P2

[Molecular weight] 488.33

[Development Unit] Takeda

[First listing] 1967, Japan

[Use]

A brain metabolism activator for acute disturbance of consciousness caused by cerebral infarction, ischemic stroke.

[Pharmacology and Toxicology] This product is a nucleoside derivative, which promotes brain metabolism and reduces brain circulation by reducing cerebral vascular resistance and increasing cerebral blood flow. In addition, it can enhance the function of the brain stem network upward activation system, enhance the function of the cone system, and improve the movement paralysis, so it has a certain effect on promoting the recovery of brain function and promoting wakefulness.

[Pharmacokinetics] Injecting this product can quickly enter the bloodstream, and some enter the brain tissue through the blood-brain barrier. Among them, the choline part becomes a good methylation donor in the body, which can be transmethylated to various compounds, and about 1% of choline can be excreted from the urine.

[Indications/Efficacy]

1 Headache damage, post-cranial surgery and acute cerebral infarction caused by disturbance of consciousness, but must be used on the basis of measures such as improving breathing, circulation and correcting cerebral hypoxia.

2 adjuvant treatment of Parkinson's syndrome: combined with anticholinergic drugs is effective for tremor, but should not be combined with levodopa.

3 neurological deafness and tinnitus.

4 subacute phase and recovery phase of cerebrovascular disease.

[Adverse reactions] Occasionally, nausea, vomiting, loss of appetite, etc.

[Contraindications] Disabled for those who are allergic to this product

[Note] Severe brain injury and active intracranial hemorrhage should be used with caution. Acute cerebral hemorrhage should not be applied in large doses. Intramuscular injection is generally not used, and the injection site should be changed frequently if used.

[Pregnant women and lactating women] are not clear.

[Child medication]: Not clear.

[Geriatric medication] is not clear.

[Drug interactions] are not yet clear.

[Drug overdose] is not clear.

[Storage] shading, confined storage

[Manufacturer] Japan Takeda Pharmaceutical Co., Ltd.

[Clinical Research]

Clinical observation of changes in serum NSE and neurological deficit scores in patients with acute cerebral infarction within 3 days of onset and 1 week after treatment, and observed the effect of nicoline on it. The results showed that serum NSE was higher in the conventional treatment group and the nicorin group than in the control group (P<0.01). After 1 week of treatment, serum NSE levels in the conventional treatment group were still higher than those in the control group (p<0.05), but there was no significant difference between the Nikolin group and the control group (P>0.05); the Nikolin group neurological deficit score There was a significant difference compared with the control group (P<0.05). It shows that serum NSE levels in patients with acute cerebral infarction increase. Nicolin can significantly reduce the content of blood NSE; the recent clinical efficacy of Niklin is also superior to the conventional treatment group. It indicates that nicorin has a brain protective effect on patients with acute cerebral infarction.

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 详细处方信息以本药内容附件PDF文件（201892521545114.pdf）的“Prescribing Information”为准
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