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Сardiac arrhythmias in people who have had a coronavirus infection COVID-19: A review 冠状病毒 COVID-19 感染者的心律失常:综述
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202480
Nail R. Yamoldinov, M. V. Dudarev, D. S. Sarksyan, V. V. Maleev
Heart rhythm disorders are one of the most common complications of coronavirus infection. Heart rhythm disorders can develop in 6–17% of hospitalized patients, and in convalescents, COVID-19 can manifest itself up to 12 months after the completion of the acute phase of the disease. Among the mechanisms for the development of cardiac arrhythmias, there are a direct cytopathic effect of SARS-CoV-2 on the myocardium, systemic inflammatory response syndrome, electrolyte imbalance, hypoxia, the use of antibacterial, antimalarial and antiviral drugs, exudative pericarditis, autonomic dysfunction. The main COVID-19-mediated heart rhythm disorders are sinus tachycardia and bradycardia, atrial fibrillation, ventricular tachycardia, long QT syndrome. Despite a significant amount of research, the literature data on the prevalence of certain types of cardiac arrhythmias (especially in COVID-19 convalescents), as well as methods for their correction, are somewhat contradictory and need to be clarified. Taking into account the impact of arrhythmia on the quality of life and mortality, active monitoring of convalescents of coronavirus infection, identification and development of approaches to the treatment of heart rhythm disorders in patients who have had COVID-19, seem to be relevant and promising areas in modern cardiology.
心律紊乱是冠状病毒感染最常见的并发症之一。6-17% 的住院病人会出现心律失常,在康复者中,COVID-19 可在疾病急性期结束后 12 个月内出现。心律失常的发病机制包括:SARS-CoV-2 对心肌的直接细胞病理效应、全身炎症反应综合征、电解质失衡、缺氧、使用抗菌、抗疟和抗病毒药物、渗出性心包炎、自主神经功能紊乱。COVID-19 介导的心律紊乱主要有窦性心动过速和过缓、心房颤动、室性心动过速、长 QT 综合征。尽管进行了大量研究,但关于某些类型心律失常(尤其是 COVID-19 康复者)的发病率及其纠正方法的文献数据仍存在一些矛盾,需要加以澄清。考虑到心律失常对生活质量和死亡率的影响,积极监测冠状病毒感染康复者、确定和开发治疗 COVID-19 患者心律失常的方法,似乎是现代心脏病学中相关且有前景的领域。
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引用次数: 0
A case of pleuropulmonary dirofilariasis caused by Dirofilaria repens. Case report 一例由代森氏二螺旋体引起的胸膜肺二螺旋体病。病例报告
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202477
S. S. Kozlov, L. A. Ermakova, Y. Lobzin, S. A. Nagorny, I. Kornienko, V. O. Telicheva, Mariia A. Kaliuzhina, N. Pshenichcnaya
The differential diagnosis of neoplasms of various localizations is the primary task in clinical practice of all physicians. We present a description of the case of invasion with Dirofilaria repens in the lung of a 68-year-old patient. In 2016 the patient was diagnosed with cancer of the left kidney and underwent a left-sided nephrectomy. During the dynamic observation in 2019, a lump was found in the left lung, which was regarded as a metastasis. An atypical SIX resection of the left lung was performed. Microscopy of the removed lump revealed the presence of a nematode of the genus Dirofilaria, presumably D. repens. The species identity of D. repens was confirmed by polymerase chain reaction using species-specific primers. It is known that the morphological identification of parasites up to the species in the surgical material presents certain difficulties and requires high professional training of the researcher. Therefore, the diagnosis of dirofilariasis in atypical localizations of nematodes in the human body is of great importance in the differentiation of malignant and benign formations, and the use of the polymerase chain reaction method can significantly increase the accuracy in establishing the final diagnosis.
对不同部位的肿瘤进行鉴别诊断是所有医生在临床实践中的首要任务。我们在此介绍一例68岁患者肺部感染狄氏丝虫的病例。2016 年,患者被诊断为左肾癌,并接受了左侧肾切除术。在2019年的动态观察中,发现左肺有肿块,被认为是转移灶。进行了左肺非典型 SIX 切除术。对切除的肿块进行显微镜检查后发现了一种 Dirofilaria 属线虫,推测为 D. repens。通过使用物种特异性引物进行聚合酶链反应,确认了 D. repens 的物种身份。众所周知,对手术材料中的寄生虫进行形态学鉴定直至确定其种类存在一定的困难,对研究人员的专业素养要求很高。因此,在人体内线虫的非典型定位中诊断双鞭毛虫病对于区分恶性和良性病变非常重要,而使用聚合酶链反应方法可以大大提高最终诊断的准确性。
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引用次数: 0
Efficacy and safety of topical combination therapy in patients with acute otitis externa 急性外耳道炎患者局部综合疗法的疗效和安全性
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202455
A. V. Gurov, Andrey I. Kriukov, Georgy B. Shadrin, G. Izotova, P. K. Zotova
Aim. To study the structure of the microbial landscape in patients with acute otitis externa, as well as to evaluate the efficacy and safety of the combined drug chloramphenicol/clotrimazole/beclomethasone/lidocaine (Candibiotic) as an empirical therapy of this disease.Materials and methods. In this retrospective study of real clinical practice, outpatient records of 963 patients who applied to the KDO of the Sverzhevsky Research Clinical Institute of Otorhinolaryngology with symptoms of otitis externa in the period from 2017 to 2022 were selected. Additional analysis was carried out on the clinical records of patients who received the combined drug Candibiotic. The endpoints of this analysis included data on the clinical and microbiological efficacy of therapy, as well as safety information.Results. According to microbiological testing, 60.6% of microorganisms belonged to bacterial flora, 26% were bacterial-fungal associations, 11.6% were monofungal flora, in 1.8% of cases there was no growth of microorganisms. The most frequently isolated microorganisms were: Pseudomonas spp (n=291; 29.16%), Staphylococcus spp. (n=214; 21.4%), Candida spp. (n=194; 19.4%), Aspergillus spp. (n=133; 13.3%). Most of the patients (71.0%) received Candibiotic. In 69.7% of patients, the resolution of the clinical symptoms of otitis externa occurred within 7 days of therapy with Candibiotic. Complete eradication of microorganisms occurred in 87% of cases. Adverse events were recorded only in 3 (0.04%) cases.Conclusion. The study demonstrated an extremely high level of clinical efficacy and safety of therapy in patients with acute external infectious otitis who received the Candibiotic, which can be used as an initial empirical therapy in patients with otitis externa.
研究目的研究急性外耳道炎患者的微生物结构,并评估氯霉素/克霉唑/倍氯米松/利多卡因(Candibiotic)联合药物作为该病经验性疗法的有效性和安全性。在这项真实临床实践的回顾性研究中,选取了2017年至2022年期间因外耳道炎症状向斯维尔德洛夫斯基耳鼻喉科临床研究所KDO申请的963名患者的门诊记录。此外,还对接受复方药物 "念珠菌素 "治疗的患者的临床记录进行了分析。该分析的终点包括临床和微生物学疗效数据以及安全性信息。微生物检测结果显示,60.6%的微生物属于细菌菌群,26%属于细菌-真菌联合菌群,11.6%属于单真菌菌群,1.8%的病例中没有微生物生长。最常分离出的微生物是假单胞菌属(n=291;29.16%)、葡萄球菌属(n=214;21.4%)、念珠菌属(n=194;19.4%)、曲霉菌属(n=133;13.3%)。大多数患者(71.0%)接受了念珠菌治疗。69.7%的患者在使用念珠菌治疗 7 天内,外耳道炎的临床症状得到缓解。87%的病例完全清除了微生物。仅有 3 例(0.04%)发生了不良反应。该研究表明,接受坎迪比奥特治疗的急性外耳道炎患者具有极高的临床疗效和安全性,可作为外耳道炎患者的初始经验疗法。
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引用次数: 0
Pathogenetic approaches to the correction of vascular homeostasis in patients with COVID-19: A review 纠正 COVID-19 患者血管稳态的病因学方法:综述
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202487
A. Shuldyakov, A. N. Smagina, Kristina Kh. Ramazanova, E. Lyapina, Yusef R. Chabbarov, N.A. Sheshina, Alena A. Zhuk
The adverse outcomes in patients with COVID-19 in the initial phase of the disease are often due to the development of cytokine storm, endothelial dysfunction, shifts in the hemostasis system, microangiopathy, angiocentric inflammation, and pathological angiogenesis, which require targeted therapy. Unfortunately, to date, there is still no drug with proven high efficacy. This review is to analyse the literature data on the pathogenesis of vascular homeostasis lesions and possible ways to correct the existing shifts in patients with COVID-19. When the oxygen content in the tissue decreases, one of the most important mechanisms of adaptation is the activation of the succinate oxidase pathway, but under conditions of prolonged hypoxia and intoxication, the succinate reserve is rapidly depleted. That is why exogenous of succinic acid can enhance the adaptive capabilities of the organism and improve the prognosis in patients with COVID-19. Succinic acid preparations contribute to normalization of energy exchange and reduction of oxidative stress, especially in combination with inosine, nicotinamide and riboflavin and are widely used in clinical practice in various nosological forms. Taking into account the analysis of data on the mechanisms of clinical effects of succinate-containing preparations, this group of drugs can be considered as promising with regard to the correction of vascular disorders in COVID-19.
COVID-19 患者在发病初期的不良预后往往是由于细胞因子风暴、内皮功能障碍、止血系统转变、微血管病变、血管中心炎症和病理性血管生成等因素造成的,需要进行靶向治疗。遗憾的是,迄今为止,仍没有一种药物被证实具有很高的疗效。本综述旨在分析有关血管稳态病变发病机制的文献资料,以及纠正 COVID-19 患者现有转变的可能方法。当组织中的氧含量降低时,最重要的适应机制之一是激活琥珀酸氧化酶途径,但在长期缺氧和中毒的条件下,琥珀酸储备会迅速耗尽。这就是为什么外源性琥珀酸可以增强机体的适应能力,改善 COVID-19 患者的预后。琥珀酸制剂有助于能量交换正常化和减少氧化应激,特别是与肌苷、烟酰胺和核黄素联合使用时,在临床实践中被广泛用于各种病症。考虑到对含琥珀酸制剂临床效果机制的数据分析,可以认为这类药物在纠正 COVID-19 中的血管紊乱方面大有可为。
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引用次数: 0
Clinical efficiency and safety of riamilovir under various dosage regimens for treatment of acute respiratory viral infections in adults 不同剂量方案下利阿米洛韦治疗成人急性呼吸道病毒感染的临床效率和安全性
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202471
K. V. Zhdanov, O. V. Maltsev, K. Kasyanenko, K. Kozlov, V. Sukachev, Nikolai I. Lvov, V. V. Sharabkhanov, Alexander A. Litvinov
Aim. To evaluate the clinical efficacy and safety of antiviral drug riamilovir in patients with acute respiratory viral infections (ARVI) of non-coronavirus (SARS-CoV-2) etiology with different dosing regimens. Materials and methods. The study included 150 patients with ARVI aged 18–27 years (50 patients received riamilovir in the regimen of 250 mg 3 times a day for 5 days, 50 patients received riamilovir in the off label regimen of 250 mg 5 times a day for 5 days, 50 patients received only pathogenetic treatment). Results. The use of riamilovir in both treatment regimens led to a reduction in the duration of inpatient treatment. The shortest periods of hospitalization were noted in patients who received the study drug at higher daily dosages. The use of riamilovir reduced the duration and severity of general infectious manifestations of the disease, while the shortest total duration of fever and a number of respiratory tract syndromes was registered among people who received riamilovir in the regimen of 1250 mg per day for 5 days, no adverse events were registered, additionally, 100% elimination of ARVI pathogens was noted in 1250 mg per day group. Conclusion. Riamilovir has shown clinical efficacy and a good safety profile in in both treatment regimens. The dosage regimen of 1250 mg per day led to more significant clinical effects and to 100% elimination of ARVI pathogens in the study group by the 6th day of hospitalization.
目的评估抗病毒药物利拉米罗韦在非冠状病毒急性呼吸道病毒感染(ARVI)(SARS-CoV-2)患者中不同给药方案的临床疗效和安全性。材料和方法。该研究包括 150 名年龄在 18-27 岁之间的急性呼吸道病毒感染(ARVI)患者(50 名患者接受里亚米洛韦治疗,剂量为 250 毫克,每天 3 次,共 5 天;50 名患者接受里亚米洛韦治疗,剂量为 250 毫克,每天 5 次,共 5 天;50 名患者仅接受病原学治疗)。研究结果在两种治疗方案中使用里亚米洛韦都缩短了住院治疗时间。每日用药量较大的患者住院时间最短。每天服用1250毫克里亚米洛韦、连续服用5天的患者发烧和出现呼吸道综合征的总时间最短,没有出现任何不良反应。结论两种治疗方案中,利米洛韦都具有良好的临床疗效和安全性。每天1250毫克的剂量方案临床效果更显著,研究组在住院第6天时100%清除了ARVI病原体。
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引用次数: 0
Clinical cases of microscopic colitis: Diagnosis and treatment issues. Case report 显微镜下结肠炎的临床病例:诊断和治疗问题。病例报告
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202468
A. M. Osadchuk, Nina A. Fadeeva, Nuriya A. Dashkina, I. D. Loranskaya, Sergey G. Khomeriki
Currently, there is an increase in the incidence of microscopic colitis. There are difficulties in diagnosing this disease due to the variability of histological signs, variability of morphological changes in the mucous membrane of the colon in different parts of the colon, and the combination in one patient of not only various forms of microscopic colitis, but also other intestinal diseases. The article describes the differential diagnosis, an example of its staging and successful treatment of various forms of microscopic colitis with budesonide (two clinical cases presented).
目前,显微镜下结肠炎的发病率有所上升。由于组织学体征的多变性、结肠不同部位结肠粘膜形态变化的多变性,以及一名患者不仅合并各种形式的显微镜下结肠炎,还合并其他肠道疾病,因此诊断这种疾病存在困难。文章介绍了鉴别诊断、分期实例以及用布地奈德成功治疗各种形式的微小结肠炎(两个临床病例)。
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引用次数: 0
A clinical case of three times treatment of hepatitis C with repeated infection in HIV-positive patient. Case Report 一例 HIV 阳性患者三次治疗丙型肝炎均反复感染的临床病例。病例报告
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202476
A. Pokrovskaya, Anna A. Popova
The article presents a clinical case of hepatitis C treatment with repeated reinfection in an HIV-positive patient. Despite the possibility of hepatitis C cure with modern antiviral drugs and long-term duration and quality of patients’ life, remains the risk of reinfection. It is necessary to intensify prevention and regular laboratory screening for viral hepatitis among all population in order to start treatment in time and prevent new cases of hepatitis.
文章介绍了一例艾滋病毒阳性患者在接受丙型肝炎治疗后反复再感染的临床病例。尽管使用现代抗病毒药物可以治愈丙型肝炎,并延长患者的生存期,提高患者的生活质量,但再次感染的风险依然存在。有必要在所有人群中加强病毒性肝炎的预防和定期实验室筛查,以便及时开始治疗,防止出现新的肝炎病例。
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引用次数: 0
Prognostic factors in patients with hematological malignancies and concomitant chronic hepatitis C 血液恶性肿瘤合并慢性丙型肝炎患者的预后因素
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202473
M. S. Nozhkin, D. A. Lioznov, T. V. Antonova, Olga V. Gorchakova, Edward M. Goldstein, M. O. Popova, Tatyana V. Shneyder
The study evaluated the impact of HCV infection on the prognosis in patients with hematological malignancies. A total of 96 patients with anti-HCV antibodies were enrolled, with the age of 37.8 (3.0–81.0) years old, 39.6% had non-Hodgkin’s lymphoma. Chronic hepatitis C (CHC) was diagnosed in 46.9% patients prior to malignancy development, in 38.5% patients simultaneously with malignancy, and in 14.6% patients during malignancy treatment. Clinical and biochemical signs of HCH were mild in most of the patients, minimal liver fibrosis (F0–1 by METAVIR system) was discovered in 47.3% patients, severe fibrosis or cirrhosis (F3–4) was diagnosed in 40% of participants. Only 20 (20.8%) of patients received antiviral therapy against HCV prior to enrollment. Regression analysis demonstrated that age 55 years old, late onset of antiviral therapy, and poor nutritional status were significant predictors of death from hematological malignancy. Survey conducted among physicians of hematological oncology hospitals in Saint-Petersburg revealed gaps in knowledge on presentation and risks of HCV infection, as well as on opportunities of modern antiviral therapy.
该研究评估了HCV感染对血液恶性肿瘤患者预后的影响。研究共纳入了96名抗-HCV抗体患者,他们的年龄为37.8(3.0-81.0)岁,39.6%患有非霍奇金淋巴瘤。46.9%的患者在恶性肿瘤发生前被确诊为慢性丙型肝炎(CHC),38.5%的患者在恶性肿瘤发生的同时被确诊为慢性丙型肝炎,14.6%的患者在恶性肿瘤治疗期间被确诊为慢性丙型肝炎。大多数患者的 HCH 临床和生化指标均较轻微,47.3% 的患者发现轻度肝纤维化(METAVIR 系统显示为 F0-1),40% 的参与者被诊断为重度肝纤维化或肝硬化(F3-4)。只有 20 例(20.8%)患者在入组前接受了针对 HCV 的抗病毒治疗。回归分析表明,55 岁、抗病毒治疗开始较晚和营养状况差是血液恶性肿瘤死亡的重要预测因素。对圣彼得堡血液肿瘤医院医生进行的调查显示,他们对HCV感染的表现和风险以及现代抗病毒疗法的机会缺乏了解。
{"title":"Prognostic factors in patients with hematological malignancies and concomitant chronic hepatitis C","authors":"M. S. Nozhkin, D. A. Lioznov, T. V. Antonova, Olga V. Gorchakova, Edward M. Goldstein, M. O. Popova, Tatyana V. Shneyder","doi":"10.26442/00403660.2023.11.202473","DOIUrl":"https://doi.org/10.26442/00403660.2023.11.202473","url":null,"abstract":"The study evaluated the impact of HCV infection on the prognosis in patients with hematological malignancies. A total of 96 patients with anti-HCV antibodies were enrolled, with the age of 37.8 (3.0–81.0) years old, 39.6% had non-Hodgkin’s lymphoma. Chronic hepatitis C (CHC) was diagnosed in 46.9% patients prior to malignancy development, in 38.5% patients simultaneously with malignancy, and in 14.6% patients during malignancy treatment. Clinical and biochemical signs of HCH were mild in most of the patients, minimal liver fibrosis (F0–1 by METAVIR system) was discovered in 47.3% patients, severe fibrosis or cirrhosis (F3–4) was diagnosed in 40% of participants. Only 20 (20.8%) of patients received antiviral therapy against HCV prior to enrollment. Regression analysis demonstrated that age 55 years old, late onset of antiviral therapy, and poor nutritional status were significant predictors of death from hematological malignancy. Survey conducted among physicians of hematological oncology hospitals in Saint-Petersburg revealed gaps in knowledge on presentation and risks of HCV infection, as well as on opportunities of modern antiviral therapy.","PeriodicalId":22209,"journal":{"name":"Terapevticheskii Arkhiv","volume":"55 17","pages":""},"PeriodicalIF":0.3,"publicationDate":"2023-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138946299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The possibilities of impulse oscillometry in the diagnosis of the lung function disorders after COVID-19 脉冲振荡测量法在诊断 COVID-19 后肺功能紊乱中的可能性
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202474
O. Savushkina, P. Astanin, G. Nekludova, S. Avdeev, A. Zaytsev
Background. Impulse oscillometry (IOS) is an effort independent method of studying lung mechanics.Aim. To study the diagnostic significance of IOS in assessing lung mechanics after COVID-19.Materials and methods. Spirometry, body plethysmography, diffusion test (DLco), IOS parameters were analyzed in 315 patients (the median age 48 years), the median period from the beginning of COVID-19 to the study was 50 days. Statistical analysis included descriptive statistics, correlation analysis and one-dimensional logistic regression analysis with an assessment of odds ratios.Results. In general group, spirometry and body plethysmography parameters were in normal values, while DLCO was reduced in 61% of patients. Parameters of IOS were analyzed in the general group and between the groups, depending on the value of DLco and total lung capacity (TLC): normal or reduced. In general group, reactance area (AX), hererogeneity of resistance Rrs5–Rrs20, resistance at 5 Hz (Rrs5), reactance at 5 Hz (ΔXrs5) were increased in 29.8%, 17.8%, 6%, 4.8% of patients, respectively, and were statistically significantly higher in the group with reduced TLC, whereas in the group with reduced DLco AX, Rrs5–Rrs20 were statistically significantly higher. Logistic regression analysis showed that patients with Rrs5-Rrs200.07 kPa×sec/l or AX0.32 kPa/l had a 1.99-fold and 2.24-fold increased risk for decrease DLco, respectively, while the risk of decrease in TLC was 2.25-fold (p=0.012) and 3.16-fold (p0.001) higher, respectively.Conclusion. IOS allow to detect both dysfunction of small airways (if AX or Rrs5–Rrs20 are increased) and the risk of restrictive pattern and lung diffusion impairment after COVID-19.
背景。脉冲振荡测量法(IOS)是研究肺力学的一种不费力的方法。研究 IOS 在评估 COVID-19 后肺力学方面的诊断意义。对 315 名患者(中位年龄为 48 岁)的肺活量、体温测定、弥散试验(DLco)和 IOS 参数进行了分析,从 COVID-19 开始到研究的中位时间为 50 天。统计分析包括描述性统计、相关性分析和一元逻辑回归分析,并评估了几率比。在普通组中,肺活量和身体胸透参数均为正常值,而 61% 的患者 DLCO 下降。根据 DLco 和总肺活量(TLC)的数值:正常或降低,对普通组和各组之间的 IOS 参数进行了分析。在普通组中,29.8%、17.8%、6%、4.8% 的患者的反应面积(AX)、阻力异质性 Rrs5-Rrs20、5 Hz 时的阻力(Rrs5)、5 Hz 时的反应(ΔXrs5)分别增大,且在 TLC 降低组中显著增大,而在 DLco 降低组中,AX、Rrs5-Rrs20 在统计学上显著增大。逻辑回归分析显示,Rrs5-Rrs200.07 kPa×sec/l或AX0.32 kPa/l的患者DLco下降风险分别增加1.99倍和2.24倍,而TLC下降风险分别增加2.25倍(p=0.012)和3.16倍(p0.001)。IOS可以检测小气道功能障碍(如果AX或Rrs5-Rrs20增高)以及COVID-19后出现限制性模式和肺弥散障碍的风险。
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引用次数: 0
The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial COVID-19病原学疗法对疾病严重程度的影响:多中心双盲安慰剂对照随机试验的结果
IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2023-12-22 DOI: 10.26442/00403660.2023.11.202479
V. V. Nikiforov, V. A. Petrov, A. Stremoukhov., M. Avdeeva, Y. Shvarts, Irina E. Kravchenko, Irina V. Nikolaeva, S. E. Ushakova, Oksana N. Belousova, Natal'ia A. Eremina, S. V. Teplykh, Ekaterina V. Mel'nikova, Natal'ia E. Kostinа
Aim. The search for etiopathogenetic agents to prevent the development of severe and extremely severe COVID-19 remains relevant. A placebo-controlled randomized clinical trial was conducted to evaluate the efficacy and safety of the antibody-based biological drug (Raphamin).Materials and methods. 785 outpatients 18–75 y.o. with laboratory confirmed mild COVID-19 were included within 24 hours from the disease onset. 771 patients were randomized to the group Raphamin (n=382) and the Placebo group (n=389). The study drug/placebo was prescribed for 5 days. The rate of progression to a more severe degree of COVID-19 by day 28 as well as the time to sustained clinical recovery and the frequency of hospitalization were evaluated. Safety was assessed taking into account adverse events, vital signs and laboratory parameters.Results. The number of cases of progression to a more severe degree of COVID-19 in participants receiving Raphamin was 59 (15.5%) [52 (14.6%)] versus placebo – 89 (22.9%) [85 (23.7%)], ITT and [PP] analysis data are presented. The odds ratio between groups was OR=0.6157 [OR=0.5494], 95% confidence interval 0.4276–0.8866 [0.3750–0.8048], which meant a reduction in the chance of progression to a more severe degree by 38.4% [45.1%] or 1.48 [1.62] times; p=0.0088 [p=0.0019]. The time to sustained recovery in the Raphamin group was 4.5±2.4 [4.6±2.4] days, versus placebo – 5.8±4.7 [6.0±4.8] days; p=0.0025 [p=0.0036]. No adverse events with a certain relationship were registered.Conclusion. Raphamin reduces the risk of progression to a more severe degree of the COVID-19 and significantly shortens the duration of clinical symptoms.
目的。寻找病原体制剂以预防重度和极重度 COVID-19 的发生仍具有现实意义。我们进行了一项安慰剂对照随机临床试验,以评估基于抗体的生物药物(雷帕明)的有效性和安全性。785名18-75岁的门诊患者在发病后24小时内被纳入实验室确诊的轻度COVID-19患者。771名患者被随机分为雷帕明组(382人)和安慰剂组(389人)。研究药物/安慰剂的处方为 5 天。对第28天时COVID-19进展到更严重程度的比率、持续临床康复的时间以及住院频率进行了评估。评估安全性时考虑了不良事件、生命体征和实验室参数。ITT和[PP]分析数据显示,接受雷帕明治疗的参与者中,COVID-19进展到更严重程度的病例数为59(15.5%)[52(14.6%)],安慰剂为89(22.9%)[85(23.7%)]。组间的几率比为 OR=0.6157 [OR=0.5494],95% 置信区间为 0.4276-0.8866 [0.3750-0.8048],这意味着病情发展到更严重程度的几率降低了 38.4% [45.1%] 或 1.48 [1.62] 倍;P=0.0088 [P=0.0019]。雷帕明组的持续康复时间为4.5±2.4 [4.6±2.4]天,而安慰剂组为5.8±4.7 [6.0±4.8]天;P=0.0025 [P=0.0036]。没有发现任何不良反应。雷帕明能降低COVID-19发展到更严重程度的风险,并显著缩短临床症状的持续时间。
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引用次数: 0
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Terapevticheskii Arkhiv
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