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CLINICAL AND ECONOMIC ANALYSIS OF GENETICALLY ENGINEERED BIOLOGICS CONSUMPTION BY PATIENTS WITH COVID-19 COVID-19患者基因工程生物制剂消费的临床和经济分析
Pub Date : 2022-05-11 DOI: 10.19163/2307-9266-2022-10-2-198-206
V. Petrov, N. Y. Ryazanova, A. V. Ponomareva, O. Shatalova, Ya. V. Levina
The aim of the article is a comparative clinical and economic assessment of genetically engineered monoclonal antibodies against interleukins in infectious diseases facilities in Volgograd region, reassigned to treat COVID-19 patients.Materials and methods. ABC analysis of the drug consumption in infectious disease facilities in Volgograd region in 2020 and 2021, cost-minimization analysis, and volume of consumption (standard dose per 1000 patients) for genetically engineered monoclonal antibodies against interleukins, were performed on the basis of pharmacies dispensing drug reports on infectious diseases facilities, Russian State Register of maximum selling prices, and Russian guidelines for COVID-19 treatment.Results. Only a small proportion of COVID-19 patients (43.6 standard doses per 1000 patients in 2020 and 137.8 per 1000 patients in 2021) received genetically engineered biologics in infectious disease facilities in Volgograd Region. Ne-vertheless, in the studied facilities, medical drug expenses on them exceeded from 20% in 2020 to 40% of the total inventory value in 2021. In mild COVID-19 patients with a high comorbidity index, netaquimab was the least expensive drug therapy and levilimab was the most expensive one. For moderate COVID-19, a standart recommended dose of sarilumab was the least expensive among the drugs used in the studied facilities, and anakinra was the least expensive drug among all the recommended GEBs. In severe and extremely severe COVID-19 courses, tocilizumab and sarilumab were less the least expensive among the GEBs used in the infectious disease facilities, and anakinra was the least expensive among all the recommended GEBs.Conclusion. Accepting a possible equal effectiveness based on the currently available data, sarilumab is the least expensive for moderate COVID-19 and tocilizumab is the least expensive for severe and extremely severe COVID-19.
本文的目的是对伏尔加格勒地区传染病设施中针对白细胞介素的基因工程单克隆抗体进行比较临床和经济评估,重新分配用于治疗COVID-19患者。材料和方法。根据药店分发传染病设施药物报告、俄罗斯国家最高销售价格登记册和俄罗斯COVID-19治疗指南,对伏尔加格勒地区2020年和2021年传染病设施的药物消耗进行了ABC分析、成本最小化分析和抗白细胞介素基因工程单克隆抗体的消费量(每1000名患者的标准剂量)。在伏尔加格勒地区的传染病设施中,只有一小部分COVID-19患者(2020年为每千名患者43.6个标准剂量,2021年为每千名患者137.8个标准剂量)接受了基因工程生物制剂。然而,在所研究的设施中,医疗药品费用占总库存价值的比例从2020年的20%上升到2021年的40%。在合并症指数高的COVID-19轻度患者中,奈他昔单抗是最便宜的药物治疗,而利非利单抗是最昂贵的药物治疗。对于中度COVID-19,标准推荐剂量的sarilumab是研究设施中使用的药物中最便宜的,而anakinra是所有推荐的geb中最便宜的药物。在严重和极严重的COVID-19病程中,托珠单抗和沙伐单抗在传染病机构使用的geb中价格最低,而阿那单抗在所有推荐的geb中价格最低。根据目前可获得的数据,sarilumab可能具有相同的有效性,因此对于中度COVID-19来说,sarilumab是最便宜的,对于严重和极严重的COVID-19来说,tocilizumab是最便宜的。
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引用次数: 2
STUDY OF LONG-TERM CLINICAL AND PATHOGENETIC EFFECTS OF FAVIPIRAVIR-BASED ANTI-VIRAL DRUG IN PATIENTS WITH METABOLIC SYNDROME IN POST-COVID PERIOD 基于favipiravirv的抗病毒药物治疗后代谢综合征患者的长期临床和发病效应研究
Pub Date : 2022-05-11 DOI: 10.19163/2307-9266-2022-10-2-217-228
O. Radaeva, L. Balykova, K. Zaslavskaya, A. Taganov, P. A. Bely, Y. Kostina, E. Negodnova, S. V. Mashnina, D. D. Bessheinov, M. S. Iskandyarova, V. Eremeev, N. M. Chumakov
The article presents modern scientific data on long-term clinical and pathogenetic effects of the antiviral drug Areplivir (Favipiravir) in patients with metabolic syndrome in the post-COVID period.The aim of the article is to study long-term cytokine-mediated (IL-6/sIL6r and LIF/sLIFr) pathogenetic effects of the favipiravir (Areplivir®) based drug on the incidence of complications in patients with metabolic syndrome in the post-COVID period.Material and methods. With the approval of the local ethics committee at the N.P. Ogarevs Mordovia State University (Protocol No. 5 dated May 17, 2020) “An open prospective comparative study of the Areplivir® (Favipiravir) drug effectiveness in reducing the risk of complications in the post-COVID period in patients with metabolic syndrome” in the Republic of Mordovia was carried out.The study included 190 metabolic syndrome patients who received the outpatient treatment for COVID-19 at Saransk polyclinics from February 2021 to March 2021. The case of COVID-19 was diagnosed in accordance with the current Temporary Guidelines for the prevention, diagnosis and treatment of the new coronavirus infection.Results. The analysis of the metabolic syndrome patients’ follow-up within 1 year after undergoing COVID-19, revealed significant differences in the incidence of complications depending on the intake of the favipiravir based drug. The patients who were administrated with favipiravir at the early stage of infection, were characterized by lower serum levels of four members of the interleukin 6 family – IL-6 (IL-6, sIL6r and LIF, sLIFr) 10, 30 and 180 days after a clinical and laboratory recovery (p<0.001). The average statistical changes in the IL-6 /sIL6r system of the group administrated with favipiravir, were 90%, and they were higher than in the group not administrated with antiviral drugs. In the group of the patients administrated with favipiravir, there was a significant (p<0.001) positive dynamic of the sLIFr indicator, while in the comparison group, there was an increase in this indicator.A protective effect of the early favipiravir use was characterized by a decrease in the frequency of cardiovascular complications, a 2.66-fold decrease in the risk of a stroke and the ACS in the post-COVID period.Conclusion. The areplivir therapy in the acute period of coronavirus infection made it possible to timely reduce the viral load. It helps to correct the pro-inflammatory vector of the immune response at the post-COVID stage and, accordingly, reduces the risk of progression of atherosclerosis, transient cerebrovascular accidents with a cognitive decline, an endothelial dysfunction, and can be considered a secondary prevention of life-threatening cardiovascular complications.
本文介绍了抗病毒药物阿雷普利韦(Favipiravir)在新冠肺炎后代谢综合征患者中的长期临床和发病作用的现代科学数据。本文旨在研究基于favipiravir (Areplivir®)的药物对新冠肺炎后代谢综合征患者并发症发生率的长期细胞因子介导(IL-6/sIL6r和LIF/sLIFr)致病作用。材料和方法。经N.P. Ogarevs Mordovia州立大学当地伦理委员会批准(2020年5月17日第5号议定书),在Mordovia共和国进行了“Areplivir®(Favipiravir)药物有效性在降低代谢综合征患者covid后期并发症风险方面的开放性前瞻性比较研究”。该研究包括190名代谢综合征患者,他们于2021年2月至2021年3月在萨兰斯克综合诊所接受了COVID-19门诊治疗。根据现行《新型冠状病毒感染预防、诊断和治疗暂行指南》诊断该病例。通过对新冠病毒感染后1年内代谢综合征患者的随访分析,发现不同剂量的favipiravir类药物在并发症发生率上存在显著差异。在感染早期给予favipiravir的患者在临床和实验室恢复后10、30和180天的血清中白细胞介素6家族的4个成员IL-6 (IL-6、sIL6r和LIF、sLIFr)水平较低(p<0.001)。给予favipiravir组IL-6 /sIL6r系统的平均统计学变化为90%,高于未给予抗病毒药物组。在给予favipiravir的患者组中,sLIFr指标有显著的(p<0.001)阳性动态,而在对照组中,该指标有所增加。早期使用favipiravir的保护作用的特点是心血管并发症的频率降低,卒中和ACS的风险降低2.66倍。在冠状病毒感染急性期给予阿雷普利韦治疗,可以及时降低病毒载量。它有助于在covid - 19后阶段纠正免疫反应的促炎载体,从而降低动脉粥样硬化进展、伴有认知能力下降的短暂性脑血管事故、内皮功能障碍的风险,并可被视为危及生命的心血管并发症的二级预防。
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引用次数: 1
COMPARATIVE PHARMACOECONOMIC ANALYSIS OF LONG-ACTING LANREOTIDE USED IN ACROMEGALY THERAPY WITHIN CONDITIONS OF THE RUSSIAN FEDERATION HEALTH CARE SYSTEM 长效lanreotide在俄罗斯联邦卫生保健系统条件下用于肢端肥大症治疗的比较药物经济学分析
Pub Date : 2022-05-03 DOI: 10.19163/2307-9266-2022-10-2-164-173
I. Krysanov, E. Makarova, V. Ermakova
The aim of this study is to conduct a comprehensive pharmacoeconomic evaluation of the use of long-acting subcutaneous lanreotide gel compared to alternative drugs, for the treatment of acromegaly.Materials and methods. Based on the literature data, a treatment model with a 1-year outlook was developed, a cost-effectiveness analysis (CEA) in pharmacoeconomics and a sensitivity analysis of changes in the model parameters were carried out. Direct medical costs for the annual therapy course were calculated. The data on the medicines costs were taken from the register of marginal prices of the State Register of Medicines.Results. According to the unified Russian registry of the pituitary-hypothalamic tumors area, the achievement of remission in the acromegaly patients using lanreotide, a long-acting gel for a subcutaneous administration, compared to the long-acting octreotide, is 51% vs 24%. During the first year of treatment with octreotide, the total pharmacotherapy costs were lower than with lanreotide (RUB 225,496.07 vs RUB 574,451.84). According to the results of the cost-effectiveness analysis for one achieved case of remission, the advantage of using lanreotide over long-acting octreotide was revealed (RUB 1,251,870.56 versus RUB 1,431,005.31). The sensitivity analysis demonstrated the model’s stability to increases in the lanreotide price (up to +18%), decreases in the octreotide prices (up to –22%), increases in the transsphenoidal adenomectomy prices (up to +59%), and decreased lanreotide remission rates (up to –12%).Conclusion. Although the treatment costs analysis showed lower total per year costs of the treatment with long-acting octreotide compared to lanreotide, the calculation of the cost-effectiveness ratio per remission showed that lanreotide had been superior to long-acting octreotide.
本研究的目的是对长效皮下lanreotide凝胶与替代药物治疗肢端肥大症进行综合药物经济学评价。材料和方法。在文献资料的基础上,建立1年展望治疗模型,进行药物经济学成本-效果分析(CEA)和模型参数变化敏感性分析。计算每年治疗过程的直接医疗费用。药品成本数据取自国家药品注册中心的边际价格登记册。根据俄罗斯垂体-下丘脑肿瘤区域的统一登记,与长效奥曲肽相比,使用lanreotide(一种长效皮下给药凝胶)治疗肢端肥大症患者的缓解率为51%对24%。在奥曲肽治疗的第一年,总药物治疗费用低于lanreotide(225,496.07卢布对574,451.84卢布)。根据1例获得缓解的病例的成本-效果分析结果显示,使用lanreotide优于长效奥曲肽(1,251,870.56卢布对1,431,005.31卢布)。敏感性分析表明,该模型对lanreotide价格的上升(高达+18%)、奥曲肽价格的下降(高达-22%)、经蝶窦腺瘤切除术价格的上升(高达+59%)和lanreotide缓解率的下降(高达-12%)具有稳定性。虽然治疗成本分析显示长效奥曲肽治疗的年总成本低于lanreotide,但每次缓解的成本-效果比计算显示lanreotide优于长效奥曲肽。
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引用次数: 0
ECONOMIC DAMAGE OF PNEUMOCOCCAL VACCINATION ABSENCE AS A RISK FACTOR FOR COMPLICATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE 肺炎球菌疫苗接种缺失作为慢性阻塞性肺疾病并发症的危险因素的经济损失
Pub Date : 2022-05-03 DOI: 10.19163/2307-9266-2022-10-2-187-197
E. Orlova, I. Dorfman, A. R. Umerova, B. Kantemirova, M. A. Orlov, M. Abdullaev
The aim of the article is the evaluation of the economic damage (ED) because of the absence of pneumococcal vaccination as a leading risk factor for the development of community-acquired pneumonia (CAP) and acute exacerbations of а chronic obstructive pulmonary disease (COPD).Materials and methods. The method of attributive statistics was used for the first time to assess the ED of the vaccination absence as an independent risk factor contributing to the development of CAP and COPD exacerbations in the Astrakhan region for the period of 2015–2019. To do this, at the beginning of the study based on the literature data, a relative risk of COPD complications associated with the absence of pneumococcal vaccination was determined. Using it as a risk factor, prevalence rates (a proportion of non-vaccinated patients with COPD), the population attributable risk (PAR) was calculated. Further, the annual economic damage (ED) from the development of CAP and COPD exacerbations was determined. To assess the cost-effectiveness of the COPD complications prevention, vaccination costs of newly registered patients were calculated and the ratio of these costs to the average annual ED was determined.Results. A decrease in the non-vaccinated patients’ proportion corresponds to the decrease in the total ED from COPD complications: from 13.16 million rubles to 6.06 million rubles during the observation period. The calculations showed that due to the increase in the vaccinated patients’ proportion over a five-year observation period, the ED from the CAP development decreased by 2.1 times, from exacerbations of COPD – by 2.3 times. The vaccination costs of newly diagnosed COPD cases amounted to 0.63 million rubles. Thus, to prevent the annual ED of 3.24 million rubles, the sum for the state to spend, should be 5.2 times as small.Conclusion. A study on the evaluation of the ED due to the risk factor (RF), the pneumococcal vaccination absence, showed that its elimination reduces the risk of acute COPD exacerbations and the development of CAP, as well the ED, as associated with them. Reducing the economic costs of the health care system with significantly lower vaccination costs, makes this preventive measure economically viable.
本文的目的是评估由于缺乏肺炎球菌疫苗接种而造成的经济损失(ED),作为发展为社区获得性肺炎(CAP)和慢性阻塞性肺疾病(COPD)急性加重的主要危险因素。材料和方法。首次采用属性统计方法评估了2015-2019年阿斯特拉罕地区疫苗接种缺失作为CAP和COPD恶化发展的独立危险因素的ED。为此,在研究开始时,基于文献数据,确定了与未接种肺炎球菌疫苗相关的COPD并发症的相对风险。将其作为危险因素,计算患病率(未接种COPD患者的比例)、人口归因风险(PAR)。此外,还确定了CAP和COPD恶化造成的年度经济损失(ED)。为了评估预防COPD并发症的成本-效果,我们计算了新登记患者的疫苗接种费用,并确定了这些费用与年平均ED的比率。未接种疫苗的患者比例的减少与COPD并发症导致的ED总数的减少相对应:在观察期间,从1316万卢布减少到606万卢布。计算表明,在5年的观察期内,由于接种疫苗的患者比例增加,CAP发展导致的ED减少了2.1倍,COPD恶化导致的ED减少了2.3倍。新诊断的慢性阻塞性肺病病例的疫苗接种费用为63万卢布。因此,为了防止每年324万卢布的ED,国家支出的金额应该减少5.2倍。一项对危险因素(RF)即肺炎球菌未接种导致ED的评估研究表明,消除RF可降低急性COPD加重的风险、CAP的发生以及与之相关的ED。通过显著降低疫苗接种成本来降低卫生保健系统的经济成本,使这一预防措施在经济上可行。
{"title":"ECONOMIC DAMAGE OF PNEUMOCOCCAL VACCINATION ABSENCE AS A RISK FACTOR FOR COMPLICATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE","authors":"E. Orlova, I. Dorfman, A. R. Umerova, B. Kantemirova, M. A. Orlov, M. Abdullaev","doi":"10.19163/2307-9266-2022-10-2-187-197","DOIUrl":"https://doi.org/10.19163/2307-9266-2022-10-2-187-197","url":null,"abstract":"The aim of the article is the evaluation of the economic damage (ED) because of the absence of pneumococcal vaccination as a leading risk factor for the development of community-acquired pneumonia (CAP) and acute exacerbations of а chronic obstructive pulmonary disease (COPD).Materials and methods. The method of attributive statistics was used for the first time to assess the ED of the vaccination absence as an independent risk factor contributing to the development of CAP and COPD exacerbations in the Astrakhan region for the period of 2015–2019. To do this, at the beginning of the study based on the literature data, a relative risk of COPD complications associated with the absence of pneumococcal vaccination was determined. Using it as a risk factor, prevalence rates (a proportion of non-vaccinated patients with COPD), the population attributable risk (PAR) was calculated. Further, the annual economic damage (ED) from the development of CAP and COPD exacerbations was determined. To assess the cost-effectiveness of the COPD complications prevention, vaccination costs of newly registered patients were calculated and the ratio of these costs to the average annual ED was determined.Results. A decrease in the non-vaccinated patients’ proportion corresponds to the decrease in the total ED from COPD complications: from 13.16 million rubles to 6.06 million rubles during the observation period. The calculations showed that due to the increase in the vaccinated patients’ proportion over a five-year observation period, the ED from the CAP development decreased by 2.1 times, from exacerbations of COPD – by 2.3 times. The vaccination costs of newly diagnosed COPD cases amounted to 0.63 million rubles. Thus, to prevent the annual ED of 3.24 million rubles, the sum for the state to spend, should be 5.2 times as small.Conclusion. A study on the evaluation of the ED due to the risk factor (RF), the pneumococcal vaccination absence, showed that its elimination reduces the risk of acute COPD exacerbations and the development of CAP, as well the ED, as associated with them. Reducing the economic costs of the health care system with significantly lower vaccination costs, makes this preventive measure economically viable.","PeriodicalId":20031,"journal":{"name":"Pharmacology &amp; Pharmacy","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79660136","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: 1
EVALUATION OF ANTIOXIDANT ACTIVITY LEVEL OF ACTINIDIA ARGUTA (SIEBOLD ET ZUCC.) PLANCH. EX MIQ. PLANT RAW MATERIAL, GROWN IN THE CAUCASIAN MINERAL WATERS REGION 软枣猕猴桃抗氧化活性水平的评价木板。进行筛选。植物原料,生长在高加索矿泉水地区
Pub Date : 2022-05-03 DOI: 10.19163/2307-9266-2022-10-2-207-216
D. Pozdnyakov, S. Adzhiakhmetova, N. Vdovenko-Martynova
The aim of the study is the identification and evaluation of a new antioxidant activity in a potentially new medicinal raw material of Actinidia arguta folia.Materials and methods. The total content of antioxidants was measured on a Tsvet Yauza-01-AA liquid chromatograph using the amperometric method. In parallel, the antioxidant activity of Actinidia arguta extracts was studied in vitro in the following dilution range: 62.5 µg/ml, 125 µg/ml, 250 µg/ml, 500 µg/ml and 1000 µg/ml. Herewith, DPPH, superoxide, and hydroxyl radical inhibitory properties of the analyzed samples were evaluated.The studies of the antioxidant activity with the determination of the activity of superoxide dismutase, glutathione peroxidase, catalase, the concentration of malondialdehyde and diene conjugates, have been conducted in vivo.Results. When studying the antiradical activity (in vitro tests), it was found out that the highest radical-inhibiting activity comparable to the individual compound - quercetin, has the extraction from Actinidia arguta folia, obtained by the extraction with 40% ethyl alcohol. The IC50 value for the given extract in relation to DPPH; superoxide and hydroxyl radical, amounted to 537.6±23.924 µg/ml; 26.6±2.627 µg/ml and 72.6±3.264 µg/ml, respectively, which may indicate that this extract has reducing and radical scavenging properties. In parallel, the study of the total content of antioxidants in terms of quercetin and gallic acid has been carried out. It has also been found out that in the Actinidia arguta folia extract, obtained by the extraction with 40% ethyl alcohol, the content of the antioxidants is maximum.Conclusion. The data obtained using the in vitro test were confirmed in the in vivo study, in which the course application of the Actinidia arguta folia extract, obtained by the extraction with 40% ethyl alcohol to the degree comparable to quercetin, contributed to an increase in the superoxide dismutase activity, a decrease in the lipid peroxidation products. The maximum content of antioxidants for Actinidia arguta folia was 0.73±0.007 and 0.47±0.005 mg/g in terms of quercetin and gallic acid, respectively. The extractant was 40% ethyl alcohol.
本研究的目的是鉴定和评价一种潜在的新型药用原料枣叶猕猴桃的抗氧化活性。材料和方法。在Tsvet Yauza-01-AA型液相色谱仪上采用安培法测定抗氧化剂的总含量。同时,在62.5µg/ml、125µg/ml、250µg/ml、500µg/ml和1000µg/ml的稀释范围内,研究了猕猴桃提取物的体外抗氧化活性。因此,分析样品的DPPH,超氧化物和羟基自由基抑制性能进行了评估。通过测定其体内超氧化物歧化酶、谷胱甘肽过氧化物酶、过氧化氢酶的活性、丙二醛和二烯偶联物的浓度,对其抗氧化活性进行了研究。在研究抗自由基活性(体外试验)时,发现用40%乙醇提取的杏叶猕猴桃提取物的抗自由基活性最高,可与单个化合物槲皮素相比较。给定提取物与DPPH的IC50值;超氧化物和羟基自由基,为537.6±23.924µg/ml;分别为26.6±2.627µg/ml和72.6±3.264µg/ml,表明该提取物具有还原和清除自由基的作用。同时对抗氧化剂槲皮素和没食子酸的总含量进行了研究。结果表明,用40%乙醇提取的软枣猕猴桃叶提取物中抗氧化剂含量最高。体外实验得到的数据在体内实验中得到了证实,用40%的乙醇提取得到与槲皮素相当程度的猕猴桃叶提取物,在施用过程中,有助于提高超氧化物歧化酶活性,降低脂质过氧化产物。柚叶猕猴桃抗氧化剂含量最高,槲皮素和没食子酸含量分别为0.73±0.007和0.47±0.005 mg/g。萃取剂为40%乙醇。
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引用次数: 0
MINIMISATION OF RISKS ASSOCIATED WITH THE USE OF POLLEN-BASED MEDICINES, AT THE STAGE OF POLLEN COLLECTION 在花粉采集阶段,尽量减少与使用花粉基药物相关的风险
Pub Date : 2022-05-03 DOI: 10.19163/2307-9266-2022-10-2-154-163
A. Taube, T. A. Buyanova, E. I. Sakanyan
The aim of the study is the elaboration of Rules for Harvesting/Collecting of Pollen to minimize the risks associated with the use of pollen-based medicinal products.Materials and methods. The following electronic resources were used in the study: PubMed, Medline, ScienceDirect, Web of Science, Scopus, Google Scholar, eLibrary, World Allergy Organization, Cochrane Database, Stallergenesgreer, Allergenscienceandconsulting, Pharmacopoeia, Fda.gov, fs.usda.gov, Ema.europa.eu. The analysis covered the period from January 1, 2010 until December 31, 2021.Results. Currently, there are some general requirements for the quality of pollen in Russia, but there are no controls or standardised procedures for harvesting, drying, and purification of pollen. The USA and EU also lack established qualification programmes for pollen-collecting companies and/or individual pollen collectors. Regulatory authorities establish requirements only for visual control of raw materials or delegate responsibility to the manufacturer. The analysis of the existing regulatory documentation revealed lack of requirements for collection, storage, and processing of pollen used as the raw material for the production of allergen products. This calls for the elaboration of appropriate regulatory documents. The authors have compiled the Rules for Harvesting/Collection of Pollen, which include 6 parts. The Rules are intended for individuals directly involved in harvesting/collection of pollen, and contain requirements for pollen collectors, the process of pollen collection, documentation, storage, and transportation.Conclusion. The authors have prepared the Rules for Harvesting/Collecting of Pollen, which include 6 parts. The Rules cover the whole process of pollen collection and all related processes. The implementation of this document will improve the process of pollen collection, thus reducing the risks associated with the use of pollen-based medicines. Further studies will assess the impact of the pollen quality on the safety of medicinal products.
这项研究的目的是制定花粉收获/采集规则,以尽量减少与使用花粉医药产品相关的风险。材料和方法。本研究使用了以下电子资源:PubMed、Medline、ScienceDirect、Web of Science、Scopus、Google Scholar、图书馆、世界过敏组织、Cochrane数据库、Stallergenesgreer、Allergenscienceandconsulting、药典、Fda.gov、fs.usda.gov、Ema.europa.eu。该分析涵盖了2010年1月1日至2021年12月31日期间的结果。目前,俄罗斯对花粉的质量有一些一般的要求,但对花粉的收获、干燥和纯化没有控制或标准化的程序。美国和欧盟也缺乏针对采集花粉公司和/或个人采集花粉者的既定资格计划。监管机构只建立对原材料的目视控制或将责任委托给制造商的要求。对现有监管文件的分析发现,作为过敏原产品生产原料的花粉缺乏收集、储存和处理要求。这就要求制订适当的规章文件。作者编制了《花粉收获/采集规则》,包括6个部分。本规则适用于直接参与花粉采集的人员,包含对花粉采集人员、花粉采集过程、记录、储存和运输的要求。作者编制了《花粉采收规则》,包括6个部分。该规则涵盖了花粉采集的整个过程和所有相关的过程。该文件的实施将改善花粉采集过程,从而降低与使用花粉基药物相关的风险。进一步的研究将评估花粉质量对药品安全性的影响。
{"title":"MINIMISATION OF RISKS ASSOCIATED WITH THE USE OF POLLEN-BASED MEDICINES, AT THE STAGE OF POLLEN COLLECTION","authors":"A. Taube, T. A. Buyanova, E. I. Sakanyan","doi":"10.19163/2307-9266-2022-10-2-154-163","DOIUrl":"https://doi.org/10.19163/2307-9266-2022-10-2-154-163","url":null,"abstract":"The aim of the study is the elaboration of Rules for Harvesting/Collecting of Pollen to minimize the risks associated with the use of pollen-based medicinal products.Materials and methods. The following electronic resources were used in the study: PubMed, Medline, ScienceDirect, Web of Science, Scopus, Google Scholar, eLibrary, World Allergy Organization, Cochrane Database, Stallergenesgreer, Allergenscienceandconsulting, Pharmacopoeia, Fda.gov, fs.usda.gov, Ema.europa.eu. The analysis covered the period from January 1, 2010 until December 31, 2021.Results. Currently, there are some general requirements for the quality of pollen in Russia, but there are no controls or standardised procedures for harvesting, drying, and purification of pollen. The USA and EU also lack established qualification programmes for pollen-collecting companies and/or individual pollen collectors. Regulatory authorities establish requirements only for visual control of raw materials or delegate responsibility to the manufacturer. The analysis of the existing regulatory documentation revealed lack of requirements for collection, storage, and processing of pollen used as the raw material for the production of allergen products. This calls for the elaboration of appropriate regulatory documents. The authors have compiled the Rules for Harvesting/Collection of Pollen, which include 6 parts. The Rules are intended for individuals directly involved in harvesting/collection of pollen, and contain requirements for pollen collectors, the process of pollen collection, documentation, storage, and transportation.Conclusion. The authors have prepared the Rules for Harvesting/Collecting of Pollen, which include 6 parts. The Rules cover the whole process of pollen collection and all related processes. The implementation of this document will improve the process of pollen collection, thus reducing the risks associated with the use of pollen-based medicines. Further studies will assess the impact of the pollen quality on the safety of medicinal products.","PeriodicalId":20031,"journal":{"name":"Pharmacology &amp; Pharmacy","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76827156","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: 1
GENDER CHARACTERISTICS OF ADVERSE DRUG REACTIONS DEVELOPMENT: EXPERIENCE OF REGIONAL DATABASE ANALYSIS 药物不良反应发展的性别特征:区域数据库分析的经验
Pub Date : 2022-05-03 DOI: 10.19163/2307-9266-2022-10-2-174-186
A. V. Matveev, A. E. Krasheninnikov, E. .. Egorova, E. I. Konyaeva, N. V. Matveeva
The aim of the article is the gender characteristics study of the adverse drug reactions (ADRs) development based on the data of the notification forms registered in the regional database ARCADe (Adverse Reactions in Crimea, Autonomic Database), for the period from 2009 to 2018.Materials and methods. The objects of the study were 6903 notification forms about adverse drug reactions recorded in the regional database called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2009 to 2018. The classification of drugs for separate pharmacological groups was carried out using the codes of the Anatomical Therapeutic Chemical (ATC) classification system of the World Health Organization (WHO) medicinal products, the instructions data of the State Registers of medicinal preparations used in the Russian Federation and Ukraine (for the cases registered before the entry of the Republic of Crimea into the Russian Federation).Results. A general analysis of the number of cases of the adverse drug reactions (ADRs) development in patients of different genders made it possible to determine that 59.9% (4132 notification forms) of ADRs cases were observed in female patients; 37.7% (2602 cases) – in male patients. In 169 cards (2.4%), information about a patient’s gender was missing. The groups with the largest number of the registered cases of ADRs were antimicrobial agents for a systemic use (2864 cases, 41.5% of the total number of the ADRs registered cases), the drugs affecting the cardiovascular (811 cases, 11.7%) and nervous (734 cases, 10.6%) systems. In each of the presented groups, the incidence rate of ADRs in female patients exceeded that in men.Conclusion. The study of the gender characteristics of the pharmacotherapy safety, carried out on the basis of the notification forms of the ADRs data registered in the Republic of Crimea, confirmed a higher likelihood of developing ADRs in female patients. This may be due to the peculiarities of the pharmacokinetics and pharmacodynamics of drugs in the female body, psychological factors, a more frequent use of drugs by this category of people. The implementation of the drug, taking into account specific features of each gender, can lead not only to better treatment outcomes, but also to increased patients’ compliance.
基于克里米亚自治区数据库ARCADe (adverse reactions in Crimea, Autonomic database) 2009 - 2018年的药品不良反应(adr)通报表数据,对adr发展的性别特征进行研究。材料和方法。研究对象为2009年至2018年期间记录在克里米亚地区数据库ARCADe (adverse reactions in Crimea, Autonomic database)中的6903份药物不良反应通报表。使用世界卫生组织(WHO)药品解剖治疗化学(ATC)分类系统的代码,俄罗斯联邦和乌克兰使用的制剂国家登记册(克里米亚共和国进入俄罗斯联邦之前登记的病例)的说明数据,对不同药理学组的药物进行分类。综合分析不同性别患者发生药物不良反应(adr)的例数,女性患者占59.9%(4132例);37.7%(2602例)——男性患者。在169张卡片(2.4%)中,缺少关于患者性别的信息。adr登记病例数最多的是系统用药(2864例,占adr总登记病例数的41.5%)、心血管系统用药(811例,11.7%)和神经系统用药(734例,10.6%)。在每一组中,女性患者的不良反应发生率均高于男性。根据克里米亚共和国登记的adr数据通报表,对药物治疗安全性的性别特征进行了研究,证实女性患者发生adr的可能性更高。这可能是由于药物在女性体内的药代动力学和药效学的特殊性,心理因素,这类人更频繁地使用药物。考虑到每个性别的具体特征,药物的实施不仅可以带来更好的治疗结果,还可以提高患者的依从性。
{"title":"GENDER CHARACTERISTICS OF ADVERSE DRUG REACTIONS DEVELOPMENT: EXPERIENCE OF REGIONAL DATABASE ANALYSIS","authors":"A. V. Matveev, A. E. Krasheninnikov, E. .. Egorova, E. I. Konyaeva, N. V. Matveeva","doi":"10.19163/2307-9266-2022-10-2-174-186","DOIUrl":"https://doi.org/10.19163/2307-9266-2022-10-2-174-186","url":null,"abstract":"The aim of the article is the gender characteristics study of the adverse drug reactions (ADRs) development based on the data of the notification forms registered in the regional database ARCADe (Adverse Reactions in Crimea, Autonomic Database), for the period from 2009 to 2018.Materials and methods. The objects of the study were 6903 notification forms about adverse drug reactions recorded in the regional database called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2009 to 2018. The classification of drugs for separate pharmacological groups was carried out using the codes of the Anatomical Therapeutic Chemical (ATC) classification system of the World Health Organization (WHO) medicinal products, the instructions data of the State Registers of medicinal preparations used in the Russian Federation and Ukraine (for the cases registered before the entry of the Republic of Crimea into the Russian Federation).Results. A general analysis of the number of cases of the adverse drug reactions (ADRs) development in patients of different genders made it possible to determine that 59.9% (4132 notification forms) of ADRs cases were observed in female patients; 37.7% (2602 cases) – in male patients. In 169 cards (2.4%), information about a patient’s gender was missing. The groups with the largest number of the registered cases of ADRs were antimicrobial agents for a systemic use (2864 cases, 41.5% of the total number of the ADRs registered cases), the drugs affecting the cardiovascular (811 cases, 11.7%) and nervous (734 cases, 10.6%) systems. In each of the presented groups, the incidence rate of ADRs in female patients exceeded that in men.Conclusion. The study of the gender characteristics of the pharmacotherapy safety, carried out on the basis of the notification forms of the ADRs data registered in the Republic of Crimea, confirmed a higher likelihood of developing ADRs in female patients. This may be due to the peculiarities of the pharmacokinetics and pharmacodynamics of drugs in the female body, psychological factors, a more frequent use of drugs by this category of people. The implementation of the drug, taking into account specific features of each gender, can lead not only to better treatment outcomes, but also to increased patients’ compliance.","PeriodicalId":20031,"journal":{"name":"Pharmacology &amp; Pharmacy","volume":"35 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74857761","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
ACTIVITY MODULATION OF VARIOUS NITRIC OXIDE SYNTASES AS AN APPROACH TO ENDOTHELIAL DYSFUNCTION THERAPY 各种一氧化氮合成酶的活性调节作为内皮功能障碍治疗的途径
Pub Date : 2022-05-02 DOI: 10.19163/2307-9266-2022-10-2-130-153
D. Kurkin, E. Abrosimova, D. A. Bakulin, N. Kovalev, M. Dubrovina, A. Borisov, A. Strygin, E. Morkovin, I. Tyurenkov
Nitric oxide as a therapeutic approach to the treatment of cardiovascular diseases attracted the attention of researchers at the end of the 19th century. As a vasodilator, nitric oxide may be a unique therapeutic agent for the treatment of hypertension and, as a result, renal failure and left ventricular hypertrophy.The aim of the article is to analyze the literature data on possible ways of modulating the activity of various nitric oxide synthases as an approach to the treatment of endothelial dysfunction.Materials and methods. When searching for materials for writing a review article, such abstract databases as PubMed, Google Scholar, e-Library, etc., were used. The search was carried out on the publications for the period from 1990 to 2021. The following words and phrases were chosen as parameters for the literature selection: nitric oxide; NO synthase; endothelial dysfunction; NO synthase activator; NO synthase inhibitor.The following words and phrases were chosen as parameters for the literature selection:Results. The article presents the history of the nitric oxide discovery and its biological role, the process of its biosynthesis, as well as the isoforms of its synthesizing enzymes (NOS): neuronal – nNOS, endothelial – eNOS and inducible iNOS, and their role in normal and pathological physiology. The process of NOS uncoupling (its molecular mechanisms) has been considered as the basis of endothelial dysfunction.The examples of the pharmacological correction (BH4, arginase inhibitors, statins, resveratrol) are presented. In addition, NO synthase activators (calcium dobesilate, cavNOxin, and some NOS transcription activators), as well as non-selective (L-NMMA, 1-NNA, L-NAME, ADMA, 546C88, VAS203) and selective (L-NIO, 7-nitroindazole, aminoguanidine, L-NIL, GW273629, GW274150, cavtratin) inhibitors of nitric oxide synthasehave been described.Conclusion. Nitric oxide synthases continue to be promising targets for the development of agents that modulate their activity to correct various pathologies. As a therapeutic approach, modulation of the nitric oxide synthase activity can be implemented to treat endothelial dysfunction, which is the cause for complications of many diseases.
一氧化氮作为一种治疗心血管疾病的方法在19世纪末引起了研究人员的注意。作为一种血管扩张剂,一氧化氮可能是一种独特的治疗高血压的药物,因此可以治疗肾功能衰竭和左心室肥厚。本文的目的是分析关于调节各种一氧化氮合酶活性的可能方法的文献数据,作为治疗内皮功能障碍的方法。材料和方法。在检索撰写综述文章的资料时,主要使用PubMed、谷歌Scholar、e-Library等抽象数据库。对1990年至2021年期间的出版物进行了检索。以下单词和短语被选为文献选择的参数:一氧化氮;没有合酶;内皮功能障碍;NO合成酶激活剂;NO合成酶抑制剂。选择以下单词和短语作为文献选择的参数:本文介绍了一氧化氮的发现历史及其生物学作用,一氧化氮的生物合成过程,一氧化氮的合成酶(NOS)的异构体:神经元-一氧化氮、内皮-一氧化氮和诱导型一氧化氮,以及它们在正常和病理生理中的作用。NOS解偶联过程及其分子机制被认为是内皮功能障碍的基础。药理学校正的例子(BH4,精氨酸酶抑制剂,他汀类药物,白藜芦醇)提出。此外,还报道了一氧化氮合酶的非选择性(L-NMMA、1-NNA、L-NAME、ADMA、546C88、VAS203)和选择性(L-NIO、7-硝基茚唑、氨基胍、L-NIL、GW273629、GW274150、cavtratin)抑制剂。一氧化氮合酶仍然是开发调节其活性以纠正各种病理的药物的有希望的目标。作为一种治疗方法,一氧化氮合酶活性的调节可以用于治疗内皮功能障碍,这是许多疾病并发症的原因。
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引用次数: 6
EFFECTIVENESS AND SAFETY OF FAVIPIRAVIR INFUSION IN PATIENTS HOSPITALIZED WITH COVID-19 法匹拉韦输注治疗新冠肺炎住院患者的有效性和安全性
Pub Date : 2022-03-09 DOI: 10.19163/2307-9266-2022-10-1-113-126
L. Balykova, K. Zaslavskaya, V. Pavelkina, N. Pyataev, N. Selezneva, N. V. Kirichenko, A. Ivanova, G. V. Rodoman, K. Kolontarev, K. S. Skrupsky, E. Simakina, O. A. Mubarakshina, A. Taganov, D. Pushkar
Research in the development of new therapeutic agents with a wide spectrum of the antiviral activity and a low ability to develop resistance remains the main dimension in combating the global threat to public health. The need for a parenteral form of favipiravir was dictated by the necessity to increase the efficacy of therapy in COVID-19 inpatients. This dosage form has expanded the possibilities of drug therapy in the inpatients, for whom a therapeutic effect acceleration and a high safety profile of the drugs used are especially important.The aim of the article is the evaluation of the efficacy and safety of a medicinal product containing favipiravir for the parenteral administration against the background of pathogenetic and symptomatic therapy, in comparison with standard therapy in hospitalized COVID-19 patients.Materials and methods. An open, randomized, multicenter comparative study was conducted in 6 research centers in the Russian Federation to evaluate the efficacy and safety of favipiravir, a lyophilisate for the preparation of a concentrate for the infusion solution administrated to the patients hospitalized with COVID-19. Screening procedures and randomization were completed in 217 patients, 209 of which had completed the study in accordance with the protocol.Results. Between the study groups, statistically significant differences have been found out, making it possible to consider the hypothesis of the drug Areplivir (favipiravir) superiority for the parenteral administration over the standard therapy, which included favipiravir (p. o.) and remdesivir. A comparative analysis has shown that a course of therapy with the parenteral favipiravir drug leads to a significant improvement in the condition of patients with COVID-19, significant benefits in terms of the speed and frequency of improvement in the clinical status of patients, as well as a reduction in the hospital stay length. It has been proven that therapy with a drug containing favipiravir for the parenteral administration does not adversely affect the parameters of clinical and biochemical blood tests, urinalysis, coagulograms, vital signs and ECG, which indicates the therapy safety. The study drug is characterized by a high safety profile and tolerability.Conclusion. The versatility and resistance to mutations of RNA-dependent RNA polymerase make it possible to consider it as the main target for combating the most common RNA viruses that cause ARVI, that determines the need  further studies of favipiravir to expand the range of its indications.
研究开发具有广泛抗病毒活性和产生耐药性能力较低的新治疗剂,仍然是抗击对公众健康的全球威胁的主要方面。为了提高COVID-19住院患者的治疗效果,需要使用非注射形式的法匹拉韦。这种剂型扩大了住院患者药物治疗的可能性,对他们来说,加速治疗效果和使用药物的高安全性尤为重要。本文的目的是在病原和对症治疗的背景下,评价含有法匹拉韦的药物用于肠外给药的有效性和安全性,并与住院COVID-19患者的标准治疗进行比较。材料和方法。在俄罗斯联邦的6个研究中心开展了一项开放、随机、多中心的比较研究,以评估favipiravir的有效性和安全性。favipiravir是一种冻干液,用于制备COVID-19住院患者输注液的浓缩物。217例患者完成了筛选程序和随机化,其中209例按照方案完成了研究。在研究组之间,已经发现了统计学上显著的差异,这使得有可能考虑药物Areplivir (favipiravir)在肠外给药方面优于标准治疗的假设,标准治疗包括favipiravir (p. o.)和remdesivir。一项对比分析显示,一个疗程的非肠外favipiravir药物治疗可显著改善COVID-19患者的病情,显著改善患者临床状况的速度和频率,缩短住院时间。经证实,使用含法匹拉韦的药物进行肠外给药治疗,对临床和生化血液检查、尿液分析、凝血图、生命体征和心电图等参数均无不良影响,表明治疗是安全的。该研究药物具有较高的安全性和耐受性。RNA依赖性RNA聚合酶的多功能性和对突变的抗性使其有可能被视为对抗引起ARVI的最常见RNA病毒的主要靶标,这决定了需要进一步研究favipiravir以扩大其适应症范围。
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引用次数: 4
CURRENT STATE OF RESEARCH IN THE FIELD OF CHEMICAL COMPOSITION AND PHARMACOLOGICAL EFFECTS OF ZEA MAYDIS STYLI CUM STIGMATIS 玉米柱头化学成分及药理作用的研究现状
Pub Date : 2022-03-06 DOI: 10.19163/2307-9266-2022-10-1-4-18
E. B. Nikiforova, N. Bat, N. A. Davitavyan
Zea maydis styli cum stigmatis (Engl. corn silk) are well known in medical practice. In the scientific literature, a lot of information has been accumulated about the chemical composition and pharmacotherapeutic actions of this medicinal plant material. A chronological analysis of this information shows that earlier, the scope of scientific publications was mainly devoted to the study of the choleretic, diuretic, hemostatic kinds of Zea maydis styli cum stigmatis activity, and the identification of the active substances responsible for these types of action. Currently, there is a growing scientific interest not only in the individual natural compounds of the Zea maydis styli cum stigmatis composition, but also in the search for new aspects of their medical application.The aim of the article is a review and systematization of modern scientific data in the field of the Zea maydis styli cum stigmatis chemical composition and their pharmacological action.Materials and methods. For the information and analytical search, the scientific data posted on the following electronic resources were used: PubMed, Web of Science, ScienceDirect, Scopus, Google Scholar, eLibrary. The search was carried out in the period from 2005 to 2021 using the following keywords: Zea mays L.; Zea maydis styli cum stigmatis; corn silk; chemical composition; pharmacological action.Results. The review is devoted to the generalization and analysis of modern scientific data on the Zea maydis styli cum stigmatis chemical composition and their pharmacological action. It has been shown that, as before, the greatest attention of scientists is attracted by flavonoids in the Zea maydis styli cum stigmatis chemical composition. Alongside with them, phenolcarboxylic acids, vitamin K, phytosterols, volatile compounds and polysaccharides are of no small importance for the Zea maydis styli cum stigmatis pharmacological activity. Modern ideas about the Zea maydis styli cum stigmatis pharmacological activity have been expanded by summarizing the study results of their antioxidant, anti-inflammatory, antidiabetic, hypotensive, neuro- and photoprotective activities. The data on the effectiveness of their use as parts of the complex tumor diseases therapy have been published.Conclusion. As a result of the data analysis of modern scientific literature, it has been found out that Zea maydis styli cum stigmatis are still in the sphere of scientists’ interest. Alongside with the flavonoids of this raw material, other groups of pharmacologically active substances are also being actively studied. It has been revealed that the information about potentially significant and confirmed types of the Zea maydis styli cum stigmatis therapeutic action is significantly updated. The results of this review may be useful for identifying promising directions for the development of the drugs based on Zea maydis styli cum stigmatis.
玉米花柱和柱头(英文)。玉米丝)在医疗实践中是众所周知的。在科学文献中,对这种药用植物的化学成分和药物治疗作用积累了大量的信息。对这些信息的时间顺序分析表明,早期,科学出版物的范围主要致力于研究玉米柱头的胆利、利尿、止血活性,以及对这些作用的活性物质的鉴定。目前,不仅对玉米柱头成分的单个天然化合物,而且对其医学应用的新方面也有越来越大的科学兴趣。本文对玉米柱头化学成分及其药理作用的现代科学研究资料进行了综述和系统整理。材料和方法。在信息和分析搜索方面,我们使用了PubMed、Web of Science、ScienceDirect、Scopus、Google Scholar、eLibrary等电子资源上发布的科学数据。检索时间为2005 - 2021年,检索关键词为:Zea mays L.;玉米花柱和柱头;玉米丝;化学成分;药理action.Results。本文对玉米柱头化学成分及其药理作用的现代科学资料进行了归纳和分析。研究表明,和以前一样,科学家们最关注的是玉米柱头化学成分中的类黄酮。此外,酚羧酸、维生素K、植物甾醇、挥发性化合物和多糖对玉米柱头的药理活性也具有重要意义。通过对玉米抗氧化、抗炎、抗糖尿病、降血压、神经和光保护等方面的研究成果进行综述,扩展了现代对玉米柱头药理活性的认识。关于它们作为复杂肿瘤疾病治疗的一部分的有效性的数据已经发表。通过对现代科学文献的数据分析,发现玉米的柱头和柱头仍然是科学家们感兴趣的领域。除了这种原料的类黄酮外,其他组的药理活性物质也正在积极研究中。揭示了潜在的重要和已确认的玉米柱头柱头治疗作用类型的信息有了显著的更新。本文的研究结果可为玉米柱头花药物的开发指明有前景的方向。
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引用次数: 1
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Pharmacology &amp; Pharmacy
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