胞磷胆碱钠氯化钠注射液及其注射液细菌内毒素检查法的研究

目的:胞磷胆碱钠氯化钠注射液是一种新型制剂,我们对其进行了细菌内毒素检查方法的研究,同时对原剂型胞磷胆碱钠注射液也进行了该方法研究。方法:对五个厂家的10批样品,采用不同生产厂家和规格的TAL,进行了干扰试验和细菌内毒素检查。结果:本品高浓度时对TAL与细菌内毒素的凝集反应有干扰作用,经稀释后可排除。结论:本品的不干扰浓度,以胞磷胆碱钠计为0.25mg·ml~(-1),可采用细菌内毒素检查法进行质量控制。     

Citicoline as Adjuvant Therapy in Parkinson's Disease: A Systematic Review

PurposeParkinson disease (PD) medications are not readily available in all countries. Citicoline increases dopamine synthesis and inhibits dopamine uptake. This systematic review aims to synthesize current existing evidence on the efficacy of citicoline adjunctive therapy in improving PD symptoms.MethodsAn extensive literature search of Scopus, Embase, PubMed, Cochrane Library, and Google Scholar was conducted for articles published on or before December 31, 2019. The studies were screened and selected by 2 independent reviewers. We included all studies that explored the efficacy of citicoline as an adjunct therapy in PD.FindingsA total of 7 studies (2 crossover, 3 randomized controlled, and 2 open prospective studies) were included. Despite the varied outcome tools, this review found that patients with PD who were taking citicoline had significant improvement in rigidity, akinesia, tremor, handwriting, and speech. Citicoline allowed effective reduction of levodopa by up to 50%. Significant improvement in cognitive status evaluation was also noted with citicoline adjunctive therapy.ImplicationsCiticoline adjuvant therapy has beneficial effects as an adjuvant therapy in patients with PD. However, due to the heterogeneity of the studies, there is a need for more high-quality studies.     

吡拉西坦注射液联合胞磷胆碱注射液治疗缺血性脑卒中的临床研究

目的观察吡拉西坦注射液联合胞磷胆碱注射液治疗缺血性脑卒中的临床疗效与安全性。方法将94例缺血性脑卒中患者随机分为对照组47例和试验组47例。对照组予以吡拉西坦每次20 g,qd,静脉注射;试验组在对照组治疗的基础上,予以胞磷胆碱每次0.5 g,qd,静脉滴注。2组患者均治疗14 d。比较2组患者的临床疗效、血清单核细胞趋化蛋白-1(MCP-1)、同型半胱氨酸(HCY)、高密度脂蛋白胆固醇(HDL-C)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为87.23%(41例/47例)和63.83%(30例/47例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清MCP-1分别为(90.74±10.33)和(120.71±15.42)pg·mL^-1,HCY分别为(16.68±2.24)和(21.01±3.03)μmol·L^-1,HDL-C分别为(1.31±0.16)和(1.12±0.13)mmol·L^-1,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应以失眠、食欲缺乏和口干为主,对照组发生的药物不良反应以皮疹、腹泻和低血压为主。试验组和对照组的总药物不良反应发生率分别为10.64%和14.89%,差异无统计学意义(P>0.05)。结论吡拉西坦注射液联合胞磷胆碱注射液治疗缺血性脑卒中的临床疗效确切,其能显著降低患者的血清MCP-1及HCY水平,升高HDL-C水平,且不增加药物不良反应的发生率。     

Citicoline in addictive disorders: a review of the literature

Background: Citicoline is a dietary supplement that has been used as a neuroprotective agent for neurological disorders such as stroke and dementia. Citicoline influences acetylcholine, dopamine, and glutamate neurotransmitter systems; serves as an intermediate in phospholipid metabolism; and enhances the integrity of neuronal membranes. Interest has grown in citicoline as a treatment for addiction since it may have beneficial effects on craving, withdrawal symptoms, and cognitive functioning, as well as the ability to attenuate the neurotoxic effects of drugs of abuse. Objectives: To review the literature on citicoline’s use in addictive disorders. Methods: Using PubMed we conducted a narrative review of the clinical literature on citicoline related to addictive disorders from the years 1900–2013 using the following keywords: citicoline, CDP-choline, addiction, cocaine, alcohol, substance abuse, and substance dependence. Out of approximately 900 first hits, nine clinical studies have been included in this review. Results: Most addiction research investigated citicoline for cocaine use. The findings suggest that it is safe and well tolerated. Furthermore, citicoline appears to decrease craving and is associated with a reduction in cocaine use, at least at high doses in patients with both bipolar disorder and cocaine dependence. Limited data suggest citicoline may also hold promise for alcohol and cannabis dependence and in reducing food consumption. Conclusions: Currently, there is limited research on the efficacy of citicoline for addictive disorders, but the available literature suggests promising results. Future research should employ larger sample sizes, increased dosing, and more complex study designs.     

Improvements in concentration,working memory and sustained attention following consumption of a natural citicoline–caffeine beverage

This study examined the neurocognitive and electrophysiological effects of a citicoline–caffeine-based beverage in 60 healthy adult participants enrolled in a randomized, double-blind, placebo-controlled trial. Measures of electrical brain activity using electroencephalogram (EEG) and neuropsychological measures examining attention, concentration and reaction time were administered. Compared to placebo, participants receiving the citicoline–caffeine beverage exhibited significantly faster maze learning times and reaction times on a continuous performance test, fewer errors in a go/no-go task and better accuracy on a measure of information processing speed. EEG results examining P450 event-related potentials revealed that participants receiving the citicoline–caffeine beverage exhibited higher P450 amplitudes than controls, suggesting an increase in sustained attention. Overall, these findings suggest that the beverage significantly improved sustained attention, cognitive effort and reaction times in healthy adults. Evidence of improved P450 amplitude indicates a general improvement in the ability to accommodate new and relevant information within working memory and overall enhanced brain activation.     

胞磷胆碱钠及其注射液的HPLC测定

建立了测定胞磷胆碱钠和有关物质的HPLC法。采用阴离子交换柱（Partisil-5 SAX柱），0．05mol/L磷酸盐缓冲液（pH3．2－3．4）为流动相，流速1．0ml/min，检测波长为280nm。胞磷胆碱钠在20－250μg/ml浓度范围内，线性良好，r＝0．9991；平均回收率为100．2％。胞磷胆碱钠、胞嘧啶核苷、尿嘧啶核苷、5′－磷酸胞苷、磷酸胞苷－酰替吗啉－DDC、5′－磷酸尿苷和5′－尿苷二磷酸胆碱酯的日内与日间精密度均小于2．0％；最低检测限为0．1－5．2ng。     

Development and Validation of Reverse-phase High-performance Liquid Chromatography Method for Estimation of Citicoline Sodium in Bulk and Dosage Form

A simple, accurate, precise and sensitive reverse-phase high-performance liquid chromatography method for the determination of citicoline sodium has been developed and validated. Drug was resolved on a C18 column (Phenomenex Luna, 250×4.6 mm, 10μ), utilizing mobile phase of potassium dihydrogen phosphate buffer and acetonitrile in a ratio of 30:70. Mobile phase was delivered at the flow rate of 1.0 ml/min and detection was carried out at 272 nm. Separation was completed within 2.22 min. Calibration curve was linear with good correlation coefficient (R²=0.999) over a concentration range 10-60 μg/ml. Recovery was between 98.84 and 101.76%. Method was found to be reproducible with relative standard deviation for intra and interday precision of <2.0% over the said concentration range. The method was successfully applied to the determination of the citicoline sodium, it can be very useful and an alternate to performing the stability studies.     

Efficacy of Cytidine-5'-diphosp-bocholine Combined with Compound Anisodine in the Treatment of Early Optic Nerve Contusion

 Purpose: To investigate the efficacy of anisodine combined with cytidine-5'-diphosp-bocholine (citicoline) in the treatment of early optic nerve contusion. Methods: A total of 33 subjects eligible for inclusion were selected from 105 patients clinically diagnosed with optic nerve contusion.These patients , and were subsequently divided into the control group(n=16) and the interventionexperimental group (n=17). In the control group, the participants received therapy consisting of glucocorticoids, mannitol, vasodilators and vitamin B. The patients in the experimental intervention group additionally received anisodine in combination with citicoline. The visual acuity was graded on a scale from 0 to 8. Results: Prior to treatment, the 25th, 50th and 75th percentiles of visual acuity grade were 3, 4 and 6.75 for the controls, and 3, 4 and 6.5 for the patients in the experimentalintervention group. (P＝0.97). After treatment, the 25th, 50th and 75th percentiles of visual acuity grade were 4, 6 and 7.75 in the control group, and 7, 7 and 8 in the interventionexperimental group. (P＝0.046). A significant difference was observed in both control (P＝0.005) and experimentalintervention groups (P＝0.001) when comparing presenting visual acuity before and after treatment.  Conclusion: The combination of anisodine and citicoline with standard steroid and mannitol therapy appears to be effective in the treatment of early optic nerve contusion.     

口服胞二磷胆碱治疗弱视的疗效观察

目的探讨口服胞二磷胆碱在弱视治疗中的临床效果。方法选择80例(80只眼)3~9岁的弱视患者,随机分为观察组和对照组各40例(40只眼)。观察组在传统治疗的基础上口服胞二磷胆碱,对照组为单纯传统治疗。比较两组患者治疗3个月后的视力变化情况。结果观察组总有效率70.0%,对照组总有效率42.5%,两组差异有统计学意义(P=0.003)。未见明显并发症。结论口服胞二磷胆碱在弱视治疗中有效、安全。     

胞磷胆碱钠联合甘露醇和依达拉奉治疗大面积脑梗死疗效观察

目的观察胞磷胆碱钠、甘露醇和依达拉奉联合治疗大面积脑梗死的临床疗效。方法 32例大面积脑梗死患者分为2组,每组16例,2组患者均给予保持呼吸道通畅、吸氧、营养支持等常规治疗,在此基础上,对照组患者给予甘露醇治疗,观察组患者给予胞磷胆碱钠、甘露醇、依达拉奉联合治疗,14 d为1个疗程。治疗1个疗程后,对2组患者的治疗效果及并发症发生率进行比较。结果对照组和观察组患者总有效率分别为68.75%和87.50%,观察组患者治疗总有效率高于对照组(P<0.05)。2组患者治疗第7、14天神经功能缺损评分均显著低于治疗前(P<0.05),治疗前及治疗第7天2组患者神经功能缺损评分比较差异无统计学意义(P>0.05);治疗第14天,观察组患者神经功能缺损评分显著低于对照组(P<0.05)。观察组和对照组患者并发症发生率分别为31.25%、68.75%,观察组患者并发症发生率显著低于对照组(P<0.05)。结论胞磷胆碱钠、甘露醇和依达拉奉联合治疗可明显改善大面积脑梗死患者的临床症状和神经功能。