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Dissimilar populations of EpСam-positive cells in ascitic fluid of ovarian cancer patients: a relationship with the degree of carcinomatosis 卵巢癌患者腹水中EpСam-positive细胞群的差异:与癌变程度的关系
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2021-07-18 DOI: 10.20538/1682-0363-2021-2-44-53
E. Kaigorodova, M. O. Ochirov, S. Molchanov, R. R. Rogachev, D. Dyakov, A. Chernyshova, O. Shpileva, O. I. Kovalev, S. Vtorushin
Background . Peritoneal carcinomatosis (PC) is one of the most unfavorable factors of ovarian cancer progression. It is often accompanied by accumulation of fluid in the abdominal cavity, which is called ascites. However, prognostic factors associated with malignant ascites are not well understood. The aim of this study was to evaluate dissimilar populations of EpCAM-positive cells in ascitic fluid and their relationship with the presence of invasive peritoneal implants and the prevalence of carcinomatosis on the Predictive Index Value (PIV) scale in ovarian cancer patients. Materials and methods . The prospective study included 22 patients aged 36–76 years with newly diagnosed FIGO stage Ic–IV ovarian cancer, who were admitted for treatment to Cancer Research Institute of Tomsk NRMC. The study material included EDTA-stabilized ascitic fluid sampled during laparoscopy. Various populations of ascites tumor cells were identified by laser multicolor flow cytometry. The degree of carcinomatosis was determined according to the PIV scale. Results. The study identified twelve populations of EpCAM-positive cells in the ascitic fluid of ovarian cancer patients. Epcam+CD45-CD44-CD24+CD133-Ncadherin+ cells ( r = 0.58; p = 0.004) and atypical (hybrid) EpCam+CD45+CD44+CD24+/-CD133+/-Ncadherin+/- cells ( r = = 0.51; р = 0.01) had a positive correlation with the PIV index. Conclusion . The obtained results show a high degree of heterogeneity of tumor cells in the ascitic fluid of ovarian cancer patients. Identified atypical (hybrid) forms of EpCam-positive cells are of great interest for cell biology and require further investigation.
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引用次数: 2
Цитокины и атеросклероз – новые направления исследований 细胞因子和动脉粥样硬化-新的研究方向
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2018-12-01 DOI: 10.20538/1682-0363-2018-4-199-207
С. В. Дутова, Ю. В. Саранчина, М. Р. Карпова, О. Ю. Килина, Н. Г. Польша, Т. С. Кулакова, Н. В. Ханарин
This review generalizes the current evidence on the content of the pro- and anti-inflammatory cytokines in patients’ blood serum with atherosclerotic lesions of the coronary, carotid and iliac arteries. The results gave the ability to assess cytokine immune cells of atherosclerotic plaques. Also the results of national and international research allowed the assessment of the prognostic value of cytokine content.
本文综述了目前关于冠状动脉、颈动脉和髂动脉粥样硬化病变患者血清中促炎性和抗炎性细胞因子含量的证据。结果提供了评估动脉粥样硬化斑块的细胞因子免疫细胞的能力。此外,国家和国际研究的结果允许评估细胞因子含量的预后价值。
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引用次数: 3
Моделирование функциональных кист яичников путем введения фолликулостимулирующего гормона 通过注射卵泡刺激激素来模拟功能卵巢囊肿
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2017-10-31 DOI: 10.20538/1682-0363-2017-3-137-144
Daria A. Trus, O. A. Tikhonovskaya, A. Okorokov, Liliya R. Mustafina, O. S. Timofeeva, S. V. Logvinov, A. V. Gerasimov, Elena Yu. Varakuta, Aleksey V. Potapov, G. A. Suhanova, Irina G. Kutsenko
Aim. To study the morphofunctional state of ovaries after the introduction of recombinant FSH. Materials and methods. Two groups of mature female Wistar rats were used in the study. The experimental group consisted of 35 rats with a model of follicular ovarian cysts, while 25 rats were in the control group. Rats were taken out of the experiment on days 3, 7, 15, 30 and 60. Paraffin slides of ovaries were stained with hematoxylin and eosin by Van Gieson. Histological and morphometric investigations were performed. Results. On day 7 of FSH administration, the maximum increase in the size of the ovaries was observed due to the formation of single-cell follicular cysts. Rats in the experimental group showed a marked decrease in the number of growing follicles on day 7 and 15. The increase in atretic bodies and follicles in comparison with the control group was observed on day 7 and lasted until the end of the experiment. Additionally, on day 7 of the experiment, hyperemia and vasoconstriction were noted. The number of yellow bodies decreased during the experiment, and an increase in collagen formation occurred starting from day 15 of the experiment. Conclusion. The introduction of follicle-stimulating hormone for 7 days leads to disruption of folliculogenesis, strengthening of atresia in the ovaries, and the formation of functional cysts.
的目标。目的:研究重组卵泡刺激素对卵巢形态功能的影响。材料和方法。实验采用两组成熟雌性Wistar大鼠。实验组35只大鼠建立卵泡性卵巢囊肿模型,对照组25只大鼠。大鼠于第3、7、15、30、60天退出实验。用Van Gieson染色法对卵巢石蜡切片进行苏木精和伊红染色。进行组织学和形态计量学调查。结果。在FSH给药的第7天,由于单细胞卵泡囊肿的形成,卵巢的大小增加最大。实验组大鼠在第7天和第15天的生长卵泡数量明显减少。在第7天观察到闭锁体和卵泡数量较对照组增加,并持续到试验结束。实验第7天,大鼠充血、血管收缩。实验期间黄体数量减少,从实验第15天开始胶原蛋白形成增加。结论。引入促卵泡激素7天,导致卵泡发生中断,卵巢闭锁加强,形成功能性囊肿。
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引用次数: 0
Пластический бронхит, ассоциированный с корригированным пороком сердца у ребенка 与儿童矫正性心脏病相关的塑性支气管炎
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2017-07-12 DOI: 10.20538/1682-0363-2017-2-180-186
E. M. Kamaltynova, E. V. Krivoshchekov, Olga S. Yanulevich, Elena S. Kavardakova
Plastic bronchitis (PB) is a rare disease that causes airway obstruction with large «rubber» bronchial casts in adults and children, mainly due to concomitant cardiac or pulmonary pathology. It involves the organization of exudate or transudate, which takes the form of the respiratory tract. Mortality with PB reaches 50%. Exact epidemiological data are not known. In most patients, PB occurs in the context of major diseases, which can be conditionally divided into two groups: heart and vascular disease and secondary complication of pulmonary diseases. Usually PB manifests with episodes of dyspnea, tachycardia, hypoxia, fever and cough associated with airway obstruction. Sometimes the symptoms resemble asthma or obstructive bronchitis, accompanied by wheezing and the symptoms of respiratory failure, decreasing of saturation (of what?), the development of pneumothorax. All existing methods of treatment are symptomatic. Promising methods of therapy are the use of inhaled unfractionated heparin and a recombinant tissue plasminogen activator (TAP). The article presents a clinical case of PB in a girl of 5 years with the background of corrected cardiac anomaly.
可塑性支气管炎(PB)是一种罕见的疾病,主要由于伴随的心脏或肺部病理,会导致成人和儿童气道阻塞,并伴有大型“橡胶”支气管铸型。它涉及渗出物或渗出物的组织,其形式为呼吸道。PB的死亡率达到50%。确切的流行病学数据尚不清楚。在大多数患者中,PB发生在重大疾病的背景下,有条件地可分为两组:心脏和血管疾病和肺部疾病的继发并发症。PB通常表现为呼吸困难、心动过速、缺氧、发烧和伴有气道阻塞的咳嗽。有时症状类似于哮喘或阻塞性支气管炎,伴有喘息和呼吸衰竭、饱和度降低(什么?)、发展为肺气肿的症状。所有现有的治疗方法都是有症状的。有希望的治疗方法是使用吸入的普通肝素和重组组织纤溶酶原激活剂(TAP)。本文介绍了一例5岁女孩PB的临床病例,其背景是纠正了心脏异常。
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引用次数: 1
Неинвазивная вентиляция легких у больных ХОБЛ, госпитализированных в стационар 住院COPD患者无创肺通气
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2017-07-11 DOI: 10.20538/1682-0363-2017-2-6-19
S. Avdeev
The use of noninvasive ventilation (NIV) of lungs during the last two decades significantly improved the results of management of severe COPD patients with acute or chronic respiratory failure during both periods of exacerbation and stability. At present, NIV is considered to be the first-line therapy for acute exacerbation of COPD with hypercapnia and respiratory acidosis. This method of airway support turned out to be effective in patients after extubation both for the relief of excommunication from a respirator and for prophylaxis and treatment of postextubation respiratory failure. NIV was proven to be successful in patients with a combination of COPD and obstructive sleep apnea (overlap syndrome), in COPD with pneumonia and in postoperative COPD patients who have undergone lung resectional surgery. The efficacy of NIV under intensive care and intensive therapy unit conditions has stimulated the interest to the use of mask ventilation in hospitals and out-patient departments (for a prolonged domestic therapy). This article presents a review of NIV use in patients with COPD during both periods of exacerbation and stability.
在过去的二十年中,肺部无创通气(NIV)的使用显著改善了严重COPD急性或慢性呼吸衰竭患者在恶化期和稳定期的治疗效果。目前,NIV被认为是COPD急性加重伴高碳酸血症和呼吸性酸中毒的一线治疗方法。事实证明,这种气道支持方法对拔管后的患者有效,既可以缓解呼吸器的沟通障碍,也可以预防和治疗拔管后呼吸衰竭。NIV被证明在COPD和阻塞性睡眠呼吸暂停综合征(重叠综合征)合并患者、COPD合并肺炎患者以及接受肺切除手术的术后COPD患者中是成功的。NIV在重症监护和重症监护室条件下的疗效激发了人们对在医院和门诊部使用口罩通风的兴趣(用于长期的家庭治疗)。本文综述了NIV在COPD患者急性加重期和稳定期的应用。
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引用次数: 8
Исследование реакции системы гемокоагуляции на тканевую гипоксию у пациентов с хронической обструктивной болезнью легких 慢性阻塞性肺病患者血液凝血反应研究
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2017-07-11 DOI: 10.20538/1682-0363-2017-2-87-95
Anna A. Bulanova, Artem E. Aksenenko, Anna S. Bobrovnikova, Galina V. Dudko, Dmitriy S. Slizevich, E. Bukreeva, M. N. Shpisman, Ivan Tyutrin
Background. Nowadays little data related to the hemostatic system and fibrinolysis in patients with chronic obstructive pulmonary disease (COPD) are available. This is due to the lack of standardized methods for studying the hemostasis system, as well as to the lack of a single functional test that allows the evaluation of the complete fibrinogenesis cycle in whole blood. Aim. The aim of our study was to develop a functional test capable of analyzing the blood gas composition in the “point-of-care test” method for the evaluation of the hemostatic potential in patients with COPD, based on a standardized test stimulus, which is tissue hypoxia. The current level of clinical and laboratory diagnostics requires personification and research of the hemo-coagulation system in real time (point-of-care test), which allows low-frequency piezotromboelastography(NVTEG) to be performed. Materials and methods. NVTEG was chosen to estimate the state of the hemocoagulation system. Ten patients with COPD and 10 healthy volunteers were examined. Hypoxia was selected as a standardized test stimulus. Hypoxia conditions were caused by smoking one standard cigarette (composition: resin 10 mg/cig., nicotine 0,7 mg/cig., CO 10 mg/cig.). The degree of tissue hypoxia was assessed with the GASTAT-navi blood gas analyzer. Results. The study has shown that in response to the standard test stimulus, which is the tissue hypoxia caused by smoking of a standardized cigarette, two types of haemostatic potential reaction were detected both in patients with COPD and healthy volunteers. The first type of reaction – “hypercoagulation” – is characterized by the formation of chronometric and structural hypercoagulation at all stages of fibrinogenesis and increased coagulation activity by 25–30% compared with the response in healthy individuals. The second type of reaction – “hypocoagulation” – is characterized by the formation of chronometric and structural hypocoagulation, a decrease in coagulation activity by 25–30% compared with the response in healthy individuals. Conclusion. Test stimulus, which acts as tissue hypoxia, causes a uniform spectrum of changes in the blood gas composition and hemocoagulation system in both healthy volunteers and patients with COPD. The possibility of online assessment of all stages of fibrinogenesis makes it possible to stratify patients with COPD by type of reaction, which is certain to have an important diagnostic and prognostic value and in the future will allow a more personified approach for choosing the treatment tactics.
背景。目前,关于慢性阻塞性肺疾病(COPD)患者的止血系统和纤维蛋白溶解的资料很少。这是由于缺乏研究止血系统的标准化方法,以及缺乏一种单一的功能测试来评估全血中完整的纤维蛋白生成周期。的目标。我们的研究目的是开发一种基于标准化测试刺激(组织缺氧)的功能测试,能够在“即时测试”方法中分析血气成分,以评估COPD患者的止血潜力。目前的临床和实验室诊断水平需要实时的血液凝固系统的拟人化和研究(护理点测试),这允许进行低频压电血栓弹性成像(NVTEG)。材料和方法。选择NVTEG来评估血液凝固系统的状态。对10名COPD患者和10名健康志愿者进行了检查。选择缺氧作为标准化的测试刺激。吸一根标准香烟(成分:树脂10毫克/支)引起缺氧。,尼古丁0.7毫克/支。, CO 10 mg/ cigg)。采用GASTAT-navi血气分析仪评估组织缺氧程度。结果。研究表明,在标准测试刺激下,即吸烟标准香烟引起的组织缺氧,COPD患者和健康志愿者均检测到两种类型的止血电位反应。第一种反应——“高凝”,其特点是在纤维蛋白发生的所有阶段都形成了计时性和结构性高凝,与健康个体的反应相比,凝血活性增加了25-30%。第二种反应——“低凝”,其特点是形成时序性和结构性低凝,与健康人的反应相比,凝血活性降低25-30%。结论。测试刺激起到组织缺氧的作用,在健康志愿者和慢性阻塞性肺病患者中引起血气组成和血液凝固系统的均匀变化。在线评估纤维蛋白发生的所有阶段的可能性使得根据反应类型对COPD患者进行分层成为可能,这肯定具有重要的诊断和预后价值,并且在未来将允许更个性化的方法来选择治疗策略。
{"title":"Исследование реакции системы гемокоагуляции на тканевую гипоксию у пациентов с хронической обструктивной болезнью легких","authors":"Anna A. Bulanova, Artem E. Aksenenko, Anna S. Bobrovnikova, Galina V. Dudko, Dmitriy S. Slizevich, E. Bukreeva, M. N. Shpisman, Ivan Tyutrin","doi":"10.20538/1682-0363-2017-2-87-95","DOIUrl":"https://doi.org/10.20538/1682-0363-2017-2-87-95","url":null,"abstract":"Background. Nowadays little data related to the hemostatic system and fibrinolysis in patients with chronic obstructive pulmonary disease (COPD) are available. This is due to the lack of standardized methods for studying the hemostasis system, as well as to the lack of a single functional test that allows the evaluation of the complete fibrinogenesis cycle in whole blood. Aim. The aim of our study was to develop a functional test capable of analyzing the blood gas composition in the “point-of-care test” method for the evaluation of the hemostatic potential in patients with COPD, based on a standardized test stimulus, which is tissue hypoxia. The current level of clinical and laboratory diagnostics requires personification and research of the hemo-coagulation system in real time (point-of-care test), which allows low-frequency piezotromboelastography(NVTEG) to be performed. Materials and methods. NVTEG was chosen to estimate the state of the hemocoagulation system. Ten patients with COPD and 10 healthy volunteers were examined. Hypoxia was selected as a standardized test stimulus. Hypoxia conditions were caused by smoking one standard cigarette (composition: resin 10 mg/cig., nicotine 0,7 mg/cig., CO 10 mg/cig.). The degree of tissue hypoxia was assessed with the GASTAT-navi blood gas analyzer. Results. The study has shown that in response to the standard test stimulus, which is the tissue hypoxia caused by smoking of a standardized cigarette, two types of haemostatic potential reaction were detected both in patients with COPD and healthy volunteers. The first type of reaction – “hypercoagulation” – is characterized by the formation of chronometric and structural hypercoagulation at all stages of fibrinogenesis and increased coagulation activity by 25–30% compared with the response in healthy individuals. The second type of reaction – “hypocoagulation” – is characterized by the formation of chronometric and structural hypocoagulation, a decrease in coagulation activity by 25–30% compared with the response in healthy individuals. Conclusion. Test stimulus, which acts as tissue hypoxia, causes a uniform spectrum of changes in the blood gas composition and hemocoagulation system in both healthy volunteers and patients with COPD. The possibility of online assessment of all stages of fibrinogenesis makes it possible to stratify patients with COPD by type of reaction, which is certain to have an important diagnostic and prognostic value and in the future will allow a more personified approach for choosing the treatment tactics.","PeriodicalId":43691,"journal":{"name":"Byulleten Sibirskoy Meditsiny","volume":null,"pages":null},"PeriodicalIF":0.2,"publicationDate":"2017-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67686388","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
Protective effect of grapes polyphenol concentrate “Fenokor” in terms of hypoxic myocardial injury 葡萄多酚浓缩液“芬诺高”对缺氧心肌损伤的保护作用
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2017-01-01 DOI: 10.20538/1682-0363-2017-3-34-42
I. Zadnipryany, O. S. Tretiakova, A. Kubyshkin, T. Sataieva
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引用次数: 2
Глютеновая энтеропатия: клинические наблюдения 谷蛋白肠病变:临床观察
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2016-10-04 DOI: 10.20538/1682-0363-2016-4-150-155
Yu. A. Emel’yanova, G. R. Bikbavova, T. V. Tretyakova, A. V. Pavlov, O. V. Martunenko
Presented clinical cases of patients with a diagnosis of gluten enteropathy in treatment in the department of gastroenterology Regional Clinical Hospital. The case is of interest to doctors of different specialties for the differential diagnosis of anemia and malabsorption syndrome, demonstrate both the classic version, and atypical forms of the disease course. Diagnosis of celiac disease is based on three key positions: clinical findings, histology and serological markers. The clinical picture of celiac disease is characterized by pronounced polymorphism, by going beyond the a gastroenterological pathology. For screening of gluten sensitive celiac typically used an antibody to tissue transglutaminase. Morphological research of the mucous membrane of the small intestine is the determining criterion in the diagnosis of celiac disease. The use of specific gluten-free diet leads to the positive dynamics of the disease and improve the quality of life of patients.
介绍了在地区临床医院消化科诊断为麸质肠病的患者的临床病例。该病例对不同专业的医生对贫血和吸收不良综合征的鉴别诊断感兴趣,展示了该疾病病程的经典版本和非典型形式。乳糜泻的诊断基于三个关键位置:临床表现、组织学和血清学标志物。乳糜泻的临床表现以明显的多态性为特征,超越了胃肠病学病理学。对于谷蛋白敏感乳糜泻的筛查通常使用组织转谷氨酰胺酶抗体。小肠粘膜形态学检查是诊断乳糜泻的重要依据。使用特定的无麸质饮食导致疾病的积极动态和提高患者的生活质量。
{"title":"Глютеновая энтеропатия: клинические наблюдения","authors":"Yu. A. Emel’yanova, G. R. Bikbavova, T. V. Tretyakova, A. V. Pavlov, O. V. Martunenko","doi":"10.20538/1682-0363-2016-4-150-155","DOIUrl":"https://doi.org/10.20538/1682-0363-2016-4-150-155","url":null,"abstract":"Presented clinical cases of patients with a diagnosis of gluten enteropathy in treatment in the department of gastroenterology Regional Clinical Hospital. The case is of interest to doctors of different specialties for the differential diagnosis of anemia and malabsorption syndrome, demonstrate both the classic version, and atypical forms of the disease course. Diagnosis of celiac disease is based on three key positions: clinical findings, histology and serological markers. The clinical picture of celiac disease is characterized by pronounced polymorphism, by going beyond the a gastroenterological pathology. For screening of gluten sensitive celiac typically used an antibody to tissue transglutaminase. Morphological research of the mucous membrane of the small intestine is the determining criterion in the diagnosis of celiac disease. The use of specific gluten-free diet leads to the positive dynamics of the disease and improve the quality of life of patients.","PeriodicalId":43691,"journal":{"name":"Byulleten Sibirskoy Meditsiny","volume":null,"pages":null},"PeriodicalIF":0.2,"publicationDate":"2016-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67686298","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
Role of Informed Consent in a Decision-making on Participation in The Clinical Trial: Multicenter study in Russia "Face to Face" 知情同意在临床试验参与决策中的作用:俄罗斯“面对面”多中心研究
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2016-10-03 DOI: 10.20538/1682-0363-2016-4-40-51
O. Zvonareva, E. S. Kulikov, I. Deev, O. Kobyakova, O. S. Fedorova, N. Kirillova, E. A. Starovoytova, N. Zhukova, I. Zhukova, V. V. Esip, E. D. Schastnyy, N. V. Khurkhurova, L. Nikitina, T. Golosova, I. Pimenov, M. A. Netaeva, S. Fedosenko
Introduction . Currently, clinical trials (CT) remain the only technology, which provides proof of efficacy and safety of new drugs and their subsequent release to the market. Medical researcher and informed consent (IC) are the main (and often the only) source of information for the patient about the upcoming clinical trials, and thus have a direct impact on the perception of clinical trials, and on the patient’s decision about participation. However, the degree of influence of these factors on the clinical trials participants still remains unclear. Materials and methods. A multicenter cross-sectional study was conducted in different cities of the Russian Federation. Patients who had previous experience in CTs (or were enrolled in a CT at the time of this study) were asked to complete a questionnaire. Results. To assess the impact of researcher, all respondents were divided into 2 groups: patients that acquainted with IC in collaboration with the researcher, and the other group, which reviewed IC form independently. We evaluated the importance of the factors influencing the decision-making process on participation in clinical trials. According to our data, the most important factors were professional monitoring services (3,72 ± 1,00), regular condition monitoring (3,66 ± 0,98), and better medical care (3,62 ± 1,00). These factors were evaluated at significantly lower score by group of patients that acquainted with IC together with the researcher (3,55 ±0,94, vs 4,01 ± 0,90, p = 0,002; 3,52 ± 1,01 vs 3,87 ± 0,90, p = 0,040; 3,49 ± 0,94, vs 3,83 ± 1,06, p = 0,020 respectively). In assessing the factors that had negative impact on the interest in participating in a clinical trial, the most significant were risk of side effects (3,01 ± 1,27), study of new medication (2,68 ± 1,21), and the risk of getting into the placebo group (2,64 ± 1,34) (so-called “objective” risk factors). At the same time, risk of side effects and risk of getting into the placebo group were also assessed at significantly lower score by  group of patients that acquainted with IC together with the researcher (2,87 ± 1,28, vs 3,33 ± 1,17, p = 0,024; 2,51 ±1,25, vs 3,03 ± 1,34, p = 0,022 respectively). Furthermore, it was found that in the case of the researcher’s assistance acquaintance time with IC reduced threefold. We also evaluated the effect of the complexity of IC text on the decision-making process on participation in clinical trials. The group of respondents, who rated the IC as easy, appeared to be more interested in the final results of the study. Conclusion. Thus, when assessing the impact of the researcher on the review process of informed consent with the decision to participate in clinical trials, we found that in the case of assistance of the researcher, the acquaintance time with IC is reduced three times. In addition, this group of patients during the conversation with the researcher shows better and more clear understanding of the nature and general methodology
介绍。目前,临床试验(CT)仍然是唯一的技术,它可以证明新药的有效性和安全性,并随后将其推向市场。医学研究人员和知情同意(IC)是患者关于即将进行的临床试验的主要(通常也是唯一)信息来源,因此对临床试验的看法和患者是否参与的决定有直接影响。然而,这些因素对临床试验参与者的影响程度仍不清楚。材料和方法。在俄罗斯联邦的不同城市进行了一项多中心横断面研究。有CT治疗经验的患者(或在本研究时正在接受CT治疗的患者)被要求完成一份调查问卷。结果。为了评估研究人员的影响,所有受访者被分为两组:与研究人员合作熟悉IC的患者,另一组独立审查IC表格。我们评估了影响参与临床试验决策过程的因素的重要性。根据我们的数据,最重要的因素是专业监测服务(3,72±1,000),定期状态监测(3,66±0,98)和更好的医疗保健(3,62±1,000)。与研究人员一起熟悉IC的患者组对这些因素的评分明显较低(3,55±0,94,vs 4,01±0,90,p = 0,002;3,52±1,01 vs 3,87±0,90,p = 0,040;3,49±0,94 vs 3,83±1,06,p = 0,020)。在评估对参与临床试验的兴趣产生负面影响的因素中,最显著的是副作用风险(3,01±1,27)、新药研究风险(2,68±1,21)和进入安慰剂组风险(2,64±1,34)(所谓的“客观”风险因素)。与此同时,与研究者一起熟悉IC的患者组也评估了副作用风险和进入安慰剂组的风险,得分明显较低(2,87±1,28,vs 3,33±1,17,p = 0,024;2,51±1,25 vs 3,03±1,34,p = 0,022)。此外,研究发现,在研究人员的协助下,与IC的认识时间减少了三倍。我们还评估了IC文本的复杂性对参与临床试验的决策过程的影响。那些认为IC很简单的受访者似乎对研究的最终结果更感兴趣。结论。因此,在评估研究者对参与临床试验决定的知情同意审查过程的影响时,我们发现,在研究者的协助下,与IC的认识时间减少了三倍。此外,这组患者在与研究者的交谈中对临床试验的性质和一般方法有了更好、更清晰的认识,从而对参与临床试验的“客观”风险因素有了充分的评估。因此,与“独立”组相比,这组患者更了解情况。根据“Face to Face”的研究,我们可以建议在IC的审查过程中强制要求研究者参与。
{"title":"Role of Informed Consent in a Decision-making on Participation in The Clinical Trial: Multicenter study in Russia \"Face to Face\"","authors":"O. Zvonareva, E. S. Kulikov, I. Deev, O. Kobyakova, O. S. Fedorova, N. Kirillova, E. A. Starovoytova, N. Zhukova, I. Zhukova, V. V. Esip, E. D. Schastnyy, N. V. Khurkhurova, L. Nikitina, T. Golosova, I. Pimenov, M. A. Netaeva, S. Fedosenko","doi":"10.20538/1682-0363-2016-4-40-51","DOIUrl":"https://doi.org/10.20538/1682-0363-2016-4-40-51","url":null,"abstract":"Introduction . Currently, clinical trials (CT) remain the only technology, which provides proof of efficacy and safety of new drugs and their subsequent release to the market. Medical researcher and informed consent (IC) are the main (and often the only) source of information for the patient about the upcoming clinical trials, and thus have a direct impact on the perception of clinical trials, and on the patient’s decision about participation. However, the degree of influence of these factors on the clinical trials participants still remains unclear. Materials and methods. A multicenter cross-sectional study was conducted in different cities of the Russian Federation. Patients who had previous experience in CTs (or were enrolled in a CT at the time of this study) were asked to complete a questionnaire. Results. To assess the impact of researcher, all respondents were divided into 2 groups: patients that acquainted with IC in collaboration with the researcher, and the other group, which reviewed IC form independently. We evaluated the importance of the factors influencing the decision-making process on participation in clinical trials. According to our data, the most important factors were professional monitoring services (3,72 ± 1,00), regular condition monitoring (3,66 ± 0,98), and better medical care (3,62 ± 1,00). These factors were evaluated at significantly lower score by group of patients that acquainted with IC together with the researcher (3,55 ±0,94, vs 4,01 ± 0,90, p = 0,002; 3,52 ± 1,01 vs 3,87 ± 0,90, p = 0,040; 3,49 ± 0,94, vs 3,83 ± 1,06, p = 0,020 respectively). In assessing the factors that had negative impact on the interest in participating in a clinical trial, the most significant were risk of side effects (3,01 ± 1,27), study of new medication (2,68 ± 1,21), and the risk of getting into the placebo group (2,64 ± 1,34) (so-called “objective” risk factors). At the same time, risk of side effects and risk of getting into the placebo group were also assessed at significantly lower score by  group of patients that acquainted with IC together with the researcher (2,87 ± 1,28, vs 3,33 ± 1,17, p = 0,024; 2,51 ±1,25, vs 3,03 ± 1,34, p = 0,022 respectively). Furthermore, it was found that in the case of the researcher’s assistance acquaintance time with IC reduced threefold. We also evaluated the effect of the complexity of IC text on the decision-making process on participation in clinical trials. The group of respondents, who rated the IC as easy, appeared to be more interested in the final results of the study. Conclusion. Thus, when assessing the impact of the researcher on the review process of informed consent with the decision to participate in clinical trials, we found that in the case of assistance of the researcher, the acquaintance time with IC is reduced three times. In addition, this group of patients during the conversation with the researcher shows better and more clear understanding of the nature and general methodology ","PeriodicalId":43691,"journal":{"name":"Byulleten Sibirskoy Meditsiny","volume":null,"pages":null},"PeriodicalIF":0.2,"publicationDate":"2016-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67686324","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
Создание и устойчивое развитие специализированных центров как способ повышения качества медицинской помощи 建立和可持续发展专业中心作为提高医疗保健质量的一种方式
IF 0.2 Q4 Biochemistry, Genetics and Molecular Biology Pub Date : 2016-10-03 DOI: 10.20538/1682-0363-2016-4-20-29
V. I. Guzeva, O. V. Guzeva, V. V. Guzeva, D. O. Dukhanina, V. Kasumov
Quality of care is evaluated on the completeness of the survey, the correct diagnosis, treatment efficacy, and its duration. Improving the quality and efficiency of medical care for children with paroxysmal disorders of consciousness is one of topical problems of neurology. Aim. The aim of the work is to justify the relationship between improving the quality of health care and sustainable development in the modern conditions of specialized medical centers on the example of the work on the identification and treatment of children with paroxysmal disorders of consciousness of the Center for diagnosis and treatment of epilepsy, and sleep disorders in children and adolescents at the department neurology, neurosurgery and medical genetics SPbGPMU. Materials and methods. For more accurate diagnosis and treatment at the Center conducted a comprehensive examination, including video-EEG оf 527 children aged 1 month to 18 years. A clinical trial study included medical cases, assessment of neurological and somatic status, the study of seizure types and forms of the disease. Instrumental methods of examination were determined by EEG and MRI studies of the brain. Main results. Comprehensive survey of sick children with monitoring video-EEG revealed that 317 children (60,1%) had epileptic paroxysms and 210 children (39,8%) – non-epileptic paroxysms. Correction treatment was performed in 284 (89,5%) children with epileptic paroxysms and altered the treatment in 190 (90,4%) children with epileptic paroxysms. Conclusion. The presented clinical data show the high effectiveness of the Centre in the diagnosis and treatment of children with paroxysmal disorders of consciousness. The accumulated experience in the Center confirms the relevance of the creation of the structure of scientific and educational institutions specialized centers in which patients will be given to high-quality medical care.
护理质量是根据调查的完整性、正确诊断、治疗效果和持续时间来评估的。提高儿童阵发性意识障碍的医疗质量和效率是神经病学的热点问题之一。的目标。这项工作的目的是证明在现代条件下提高医疗保健质量与专业医疗中心的可持续发展之间的关系,例如癫痫诊断和治疗中心关于发现和治疗患有阵发性意识障碍的儿童的工作,以及SPbGPMU神经病学、神经外科和医学遗传学部门关于儿童和青少年睡眠障碍的工作。材料和方法。为了更准确的诊断和治疗,中心对527名1个月至18岁的儿童进行了包括视频脑电图在内的全面检查。临床试验研究包括医疗病例、神经和躯体状况评估、疾病发作类型和形式的研究。仪器检查方法由脑的脑电图和MRI研究确定。主要的结果。通过监测视频脑电图对患儿进行综合调查,发现317例患儿(60.1%)有癫痫发作,210例患儿(39.8%)无癫痫发作。对癫痫发作患儿284例(89.5%)进行矫正治疗,对癫痫发作患儿190例(904%)进行改变治疗。结论。所提供的临床资料显示该中心在诊断和治疗突发性意识障碍儿童方面具有很高的有效性。该中心积累的经验证实了建立科学和教育机构专门中心结构的重要性,在这些机构中,患者将获得高质量的医疗服务。
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Byulleten Sibirskoy Meditsiny
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