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The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union 对乌克兰、美国和欧盟开展生物等效性研究的方法和结果“透明”政策的分析
Pub Date : 2021-02-26 DOI: 10.24959/cphj.21.1548
О. Popov, І.V. Kravchenko, V.Ye. Dоbrоvа, K. Tkachenko
Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs.Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results.Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted.Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers.Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.
为乌克兰人民提供优质、有效、同时经济上负担得起的药品是卫生保健系统的一项优先任务。考虑到仿制药的开发成本相对较低,该国大多数人口都可以获得仿制药;因此,需要进行生物等效性研究以获得其有效性和安全性的数据。乌克兰目前正在协调国内对非专利药品的管制要求,并与全球进行生物等效性研究。因此,找出乌克兰和其他国家仿制药注册方法和生物等效性研究的差异是很重要的。另一个重要方面是提供生物等效性研究结果的“透明度”政策,这有助于更好地使用药物。分析国内外组织生物等效性研究的方法,并提出其结果“透明”的政策。材料和方法。对乌克兰、美国和欧盟的药品注册方法、仿制药要求和生物等效性研究以及提供其结果“透明度”政策的方法进行了比较分析。分析显示,乌克兰、美国和欧盟的药品注册方法是相同的。提供生物等效性研究结果“透明度”的方法不同,因为在乌克兰,此类信息的发布不是强制性的,而是由制药商自行决定的。国内仿制药评估的监管要求与世界接轨。今天,有必要引入对生物等效性研究发表的强制性要求,这将有助于提供有效的“透明度”政策。
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引用次数: 2
Subunit compositions of GABAA receptors determining the diversity of physiological processes and neurotropic properties of medicines GABAA受体的亚基组成决定了生理过程的多样性和药物的嗜神经特性
Pub Date : 2021-02-26 DOI: 10.24959/cphj.21.1541
M. Golovenko
Gamma-aminobutyric acid (GABA) became known as a potentially important chemical in the brain 50 years ago, but its significance as a neurotransmitter was fully found 16 years later. It is now known that at least 40 % of the inhibitory synaptic activity in the mammalian brain is accounted for by GABA. Аim. To analyze achievements in the study of the physiological and pharmacological role of GABA receptor subtypes, their potential applications in drug development and updated information on the clinical development of subtype-selective GABA receptor compounds. Results. The GABAA-receptor complex (GABA-RC) is ligand-gated ion channels with chloride conductance. These receptors contain α, β, and γ subunits, but δ, ε, θ, and ρ can be also present. The GABA binding site is located at the interface between α and β subunits where a number of important amino acids are also found. GABA-RC is sensitive to a wide range of drugs, e.g. benzodiazepines (BDZ), which are often used for their sedative/hypnotic and anxiolytic effects. Classical BDZ interact non-selectively with α1,3,5 βγ2 GABA-RС in the binding site located at the α+γ− interface. Conclusions.  In addition to the potent and rapid pharmacotherapeutic action BDZ also possess some addictive potential (drug dependence), which appears after the interaction of molecules with α1-receptors. Using the selective targeting to separate subgroups not only the main effect of BDZ without side effects can be provided, but also one can use this approach in creating new analgesic medicines; we have demonstrated it on the example of propoxazepam (full agonist GABA-R).
γ -氨基丁酸(GABA)在50年前就被认为是大脑中一种潜在的重要化学物质,但它作为一种神经递质的重要性在16年后才被完全发现。现在已经知道,哺乳动物大脑中至少40%的抑制性突触活动是由GABA引起的。Аim。分析GABA受体亚型生理药理作用的研究成果、在药物开发中的潜在应用以及亚型选择性GABA受体化合物临床开发的最新进展。结果。gabaa受体复合物(GABA-RC)是具有氯离子电导的配体门控离子通道。这些受体含有α、β和γ亚基,但δ、ε、θ和ρ也可以存在。GABA结合位点位于α和β亚基之间的界面,在那里还发现了许多重要的氨基酸。GABA-RC对多种药物敏感,例如苯二氮卓类药物(BDZ),通常用于镇静/催眠和抗焦虑作用。经典BDZ在α+γ−界面与α1,3,5 βγ2 GABA-RС发生非选择性相互作用。结论。BDZ除了具有快速有效的药物治疗作用外,还具有一定的成瘾性(药物依赖性),这种成瘾性是在分子与α - 1受体相互作用后出现的。利用选择性靶向分离亚群,不仅可以提供BDZ的主要作用而无副作用,而且可以利用这种方法开发新的镇痛药物;我们已经在丙西泮(完全激动剂GABA-R)的例子中证明了这一点。
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引用次数: 2
Ways of medicinal prevention and treatment of doxorubicin-induced cardiomyopathy in oncological patients 肿瘤患者多柔比星致心肌病的药物防治方法
Pub Date : 2021-02-26 DOI: 10.24959/CPHJ.21.1547
V. A. Moroz, R. Al-Hadrawi, O. Andrieieva, Y. Timchenko, A. M. Semenov
The high incidence of malignant tumors is currently supported by the general ageing of the world population and unfavorable environmental factors. In 2018, 18.1 million new cases of cancer and 9.6 million deaths from them were registered in the world. At the same time, a significant increase in the life expectancy of these patients after the treatment noted over the past 20 years highlights the problem of side effects of the anticancer therapy. One of the most serious side effects is the development of doxorubicin-induced cardiomyopathy (DRIC). In all three distinct clinical forms (acute, early and late) DRIC can develop in 58 % of patients after using anticancer treatment regimens with the inclusion of doxorubicin. The review provides a detailed analysis of medicinal treatment regimens and preparations (ACE inhibitors, beta-blockers, statins, etc.) currently used, and evaluates their effectiveness and expected results. Currently, several therapeutic strategies have been proposed for the prevention and treatment of DRIC, each of them has certain positive results. At the same time, some therapeutic methods used in the clinic have some disadvantages.Conclusions. The limitations of the results of DRIC prevention achieved by the existing therapeutic regimens, as well as the possibilities for their prediction, have been stated. The need for further research to improve the effectiveness of medicinal prevention and treatment of DRIC is emphasized.
恶性肿瘤的高发病率是目前世界人口普遍老龄化和不利环境因素共同作用的结果。2018年,全球登记的癌症新发病例为1810万例,死亡病例为960万例。与此同时,在过去的20年里,这些患者在接受治疗后的预期寿命显著增加,这凸显了抗癌治疗的副作用问题。最严重的副作用之一是阿霉素引起的心肌病(DRIC)。在所有三种不同的临床形式(急性、早期和晚期)中,58%的患者在使用含有阿霉素的抗癌治疗方案后可发生DRIC。本综述详细分析了目前使用的药物治疗方案和制剂(ACE抑制剂、β受体阻滞剂、他汀类药物等),并对其有效性和预期结果进行了评价。目前,针对DRIC的预防和治疗已经提出了几种治疗策略,每种策略都有一定的积极效果。同时,临床上采用的一些治疗方法也存在一定的不足。本文指出了现有治疗方案预防DRIC的局限性,以及预测DRIC的可能性。强调需要进一步研究以提高DRIC的药物预防和治疗效果。
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引用次数: 0
The assortment analysis of chlorhexidine-containing medicines and procurement data of state and municipal organizations 含氯己定药品分类分析及国家、市单位采购数据
Pub Date : 2021-02-26 DOI: 10.24959/cphj.21.1543
O. Devinyak, E. M. Vashkeba-Bitler, M. Fizer, I. Stan, Yaroslava Deyak, O. Lytvyn
Chlorhexidine is an effective cationic antiseptic and disinfectant that has been used in medical practice for decades. It is generally recommended to use different concentrations of aqueous or alcoholic solutions of chlorhexidine for different therapeutic purposes. Objective. To determine the proportions of different chlorhexidine concentrations in medicines purchased by state and municipal organizations and to identify possible issue of chlorhexidine formulations utilization in the suboptimal or insufficient concentrations. Results. The vast majority of the chlorhexidine-containing medicines found in the State Register of Medicines of Ukraine are 0.05% solutions for external use, 0.05% gels for dental and urological use and vaginal suppositories (pessaries) with 16 mg of chlorhexidine in one dose. While the most common representatives of chlorhexidine-containing medicines abroad are solutions with a concentration of 4% and 2%, as well as mouthwashes with a concentration of 0.12%. The highest share - 96% - among the procurements of chlorhexidine-containing medicines by state and municipal organizations is 0.05% aqueous solution for external use. Instructions for medical use of 0.05% aqueous chlorhexidine solution for external use contain indications that are not supported by international documents: WHO Model List of Essential Medicines and British National Formulary. Conclusions. The obtained results suggest probable cases of irrational use of chlorhexidine medicines in medical practice in Ukraine. The consequences of such cases are not limited to the failure to achieve therapeutic goals or to the development of nosocomial infection, but includes also the selection of chlorhexidine-resistant strains of microorganisms. Key words: chlorhexidine; assortment analysis; medicinal procurements study; suboptimal concentration; rational pharmacotherapy
氯己定是一种有效的阳离子防腐剂和消毒剂,已在医疗实践中使用了几十年。通常建议使用不同浓度的氯己定水溶液或酒精溶液用于不同的治疗目的。目标。确定国家和市政机构购买的药品中不同氯己定浓度的比例,并确定在不理想或浓度不足的情况下使用氯己定配方可能存在的问题。结果。在乌克兰国家药品登记册中发现的绝大多数含氯己定的药物是0.05%的外用溶液、0.05%的牙科和泌尿用凝胶以及每次含有16毫克氯己定的阴道栓剂(子宫托)。而国外含氯己定药品最常见的代表是浓度为4%和2%的溶液,以及浓度为0.12%的漱口水。在国家和市政组织采购的含氯己定药品中,最高份额(96%)为0.05%的外用水溶液。外用0.05%氯己定水溶液的医疗使用说明包含国际文件未支持的适应症:世卫组织基本药物标准清单和英国国家处方集。结论。所获得的结果表明,在乌克兰的医疗实践中可能存在不合理使用氯己定药物的情况。这些病例的后果不仅限于未能达到治疗目标或发展为医院感染,而且还包括选择对氯己定耐药的微生物菌株。关键词:氯己定;分类分析;药品采购研究;次优的浓度;合理的药物治疗
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引用次数: 0
Laboratory toxicological diagnosis of trazodone intoxications 曲唑酮中毒的实验室毒理学诊断
Pub Date : 2021-02-26 DOI: 10.24959/cphj.21.1544
S. A. Karpushyna, S. V. Baiurka, S. Merzlikin
When determining the cause of poisoning by antidepressant drugs, the data of laboratory toxicological studies of biofluids for the presence of this group of drugs are of key importance.Aim. To develop the methods for determining the antidepressant drug trazodone in the blood and urine samples using high-performance liquid chromatography with a UV spectrophotometric detection, which is suitable for analytical diagnosis of the thymoleptics intoxications.Materials and methods. The model samples of human biofluids spiked with trazodone were studied. The antidepressant was isolated from the blood and urine by the liquid-liquid extraction with methylene chloride from the alkaline medium at pH 9. Concomitant endogenous impurities were removed by extraction with diethyl ether from the acidic medium at pH 1. In the study of the blood the erythrocyte mass was pre-precipitated with the help of 10 % of trichloroacetic acid solution. Chromatographic analysis was performed on a microcolumn chromatograph using a column with a reversed-phase of C18.Results. The absolute retention time of trazodone in extracts from the model samples of biofluids was 17.91±0.09 min. The quantitative content of trazodone was determined at 250 nm by the calibration dependence of the chromatographic peak area on the concentration (μg/ml) y=(1.74∙10-3±1∙10-5)x. Under the indicated extraction conditions, 35±4 % and 78±4 % of trazodone were isolated from the blood and urine, respectively.Conclusions. The methods of trazodone isolation from the biofliuds by liquid extraction followed by the determination of the drug by high performance liquid chromatography with a multiwave UV spectrophotometric detection have been developed. The methods are recommended for using in the practice of forensic and clinical toxicology.
在确定抗抑郁药物中毒的原因时,生物体液中该类药物的实验室毒理学研究数据是至关重要的。建立高效液相色谱-紫外分光光度法测定血液和尿液中抗抑郁药物曲唑酮的方法,使之适用于胸腺中毒的分析诊断。材料和方法。研究了加入曲唑酮的人体生物体液模型样品。在pH为9的碱性培养基中,采用二氯甲烷液液萃取法从血液和尿液中分离出抗抑郁药。在pH为1的酸性培养基中,用乙醚萃取去除伴随的内源性杂质。在血液研究中,红细胞团在10%的三氯乙酸溶液的帮助下进行预沉淀。色谱分析在微柱色谱仪上进行,色谱柱为c18反相。生物液模型样品提取液中曲唑酮的绝对保留时间为17.91±0.09 min。通过色谱峰面积对浓度(μg/ml) y=(1.74∙10-3±1∙10-5)x的定标依赖性,在250 nm处测定曲唑酮的定量含量。在规定的提取条件下,血液和尿液中曲唑酮的提取率分别为35±4%和78±4%。建立了从生物液中提取曲唑酮,然后用高效液相色谱-多波紫外分光光度法测定药物含量的方法。建议在法医和临床毒理学实践中使用这些方法。
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引用次数: 0
Asthma in children. 儿童哮喘。
Pub Date : 2021-02-12 DOI: 10.33140/jpnb.06.01.01
P. A. Simon, C. M. Murphy, S. L. Coonce
Asthma is one of the most common chronic diseases of the airways, characterized by allergic inflammation in the airways, often as a result of exposure to allergens, cold air, tobacco smoke, exercise, or emotional stress. The most common asthma symptoms in children are: cough, shortness of breath with wheezing, chest pressure and shortness of breath. Asthma is an incurable disease, but its symptoms, which range from mild to life-threatening, can be controlled with medication and lifestyle, thus ensuring a full and normal life for the child.
哮喘是最常见的气道慢性疾病之一,以气道过敏性炎症为特征,通常是由于暴露于过敏原、冷空气、烟草烟雾、运动或情绪压力所致。儿童最常见的哮喘症状是:咳嗽、呼吸短促伴喘息、胸闷和呼吸短促。哮喘是一种不治之症,但它的症状,从轻微到危及生命,可以通过药物和生活方式来控制,从而确保孩子的完整和正常的生活。
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引用次数: 0
Clinical and economic aspects of fibrates 贝特类药物的临床和经济方面
Pub Date : 2020-12-01 DOI: 10.24959/cphj.20.1536
O. Mishchenko, K. Kalko, V. F. Оstashko, Yu. I. Greshko, P. Klepach, Y. Honcharuk
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引用次数: 0
Pharmaceutical care in the treatment of acute respiratory viral infections: the phytoneering possibilities from the perspective of evidence-based medicine 急性呼吸道病毒感染治疗中的药学服务:循证医学视角下的植物工程可能性
Pub Date : 2020-12-01 DOI: 10.24959/cphj.20.1530
T. Sakharova, N. Bezugla, I. Otrishko, K. Zupanets, K. Ratushna
{"title":"Pharmaceutical care in the treatment of acute respiratory viral infections: the phytoneering possibilities from the perspective of evidence-based medicine","authors":"T. Sakharova, N. Bezugla, I. Otrishko, K. Zupanets, K. Ratushna","doi":"10.24959/cphj.20.1530","DOIUrl":"https://doi.org/10.24959/cphj.20.1530","url":null,"abstract":"","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"58 1","pages":"4-14"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87441291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of the effect of the combination of glucosamine derivatives with quercetin on the morphofunctional state of the thymus and spleen of rats under the toxic effect of doxorubicin 葡萄糖胺衍生物与槲皮素联用对阿霉素毒性作用下大鼠胸腺和脾脏形态功能状态的影响
Pub Date : 2020-12-01 DOI: 10.24959/cphj.20.1540
K. V. Vietrova, T. Sakharova
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引用次数: 0
The assessment of the oral cavity biocenosis state in patients with type II diabetes mellitus when using removable dentures 2型糖尿病患者使用活动义齿时口腔生物病变状态的评价
Pub Date : 2020-12-01 DOI: 10.24959/cphj.20.1539
R. Badalov, G. Kovalenko
{"title":"The assessment of the oral cavity biocenosis state in patients with type II diabetes mellitus when using removable dentures","authors":"R. Badalov, G. Kovalenko","doi":"10.24959/cphj.20.1539","DOIUrl":"https://doi.org/10.24959/cphj.20.1539","url":null,"abstract":"","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"37 1","pages":"30-36"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84768571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Clinical pharmacy
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