The course of labor in term patients with concomitant acute intestinal infections

2021 ◽  
Vol 70 (4) ◽  
pp. 57-63
Author(s):  
Alexey S. Kovalchuk ◽  
Eduard N. Popov ◽  
Dmitry A. Lioznov ◽  
Dmitry S. Sudakov
Keyword(s):  
Continuous Monitoring ◽  
Study Groups ◽  
Clinical Infectious Disease ◽  
Main Group ◽  
Labor Management ◽  
Intestinal Infections ◽  
Labor Complications ◽  
Disease Hospital ◽  
Clear Idea ◽  
Maternal Injury

BACKGROUND: Literature data on the course of labor in women with concomitant acute intestinal infections are very scarce. Individual works and articles are devoted to the coverage of this most important final stage of pregnancy. There are no developed specific tactics of labor management in patients with acute intestinal infections, therefore obstetricians and gynecologists have to use generally accepted standards of labor management in this group of patients, without having a clear idea of the frequency and nature of clinically relevant complications in childbirth. AIM: The aim of this study was to evaluate the course of labor in women with concomitant AIIs at full-term pregnancy. MATERIALS AND METHODS: We examined 120 patients aged 19 to 39 years, delivered in Clinical Infectious Disease Hospital named after S.P. Botkin, St. Petersburg in 2017-2019. The main group consisted of 60 women with concomitant acute intestinal infections who gave birth, and the comparison group comprised 60 conditionally healthy women. The spectrum of acute intestinal infection pathogens in pregnant women, the course of labor, complications during labor and the condition of newborns were evaluated. RESULTS: Women of the both study groups did not differ in the duration of labor and the anhydrous interval, the frequency of birth abnormalities, the volume of blood loss, and the frequency of maternal injury and complications in the postpartum period. The frequency of premature rupture of membranes, acute and chronic fetal hypoxia, and episiotomy was higher in patients of the main group. Asphyxia in the first minute after birth was also more common in newborns from women with concomitant acute intestinal infections. CONCLUSIONS: Acute intestinal infections may complicate the course of labor. Labor management in women with concomitant acute intestinal infections requires continuous monitoring of the condition of the fetus during labor and the provision of timely medical care to the newborn.

scholarly journals Vasculotoxicity of Chemotherapy: Assessment оf Endothelial Dysfunction Biomarkers’ Levels in Gastric Cancer Patients

Kardiologiia ◽  
2020 ◽  
Vol 60 (5) ◽  
pp. 35-40
Author(s):  
Yu. Yu. Kirichenko ◽  
Yu. N. Belenkov ◽  
E. V. Privalova ◽  
Yu. I. Naymann ◽  
E. P. Gitel ◽  
...  
Keyword(s):  
Endothelial Dysfunction ◽  
Healthy Volunteers ◽  
Stomach Cancer ◽  
Specific Treatment ◽  
Study Groups ◽  
Main Group ◽  
Control Group ◽  
Instrumental Evaluation ◽  
Oncological Patients ◽  
Before And After

Aim To evaluate dynamics of biomarkers for endothelial dysfunction (ED), including endothelin-1 (ET-1) and von Willebrand factor (VWF) in patients with stomach cancer (adenocarcinoma) before and after polychemotherapy (PCT); to compare these results with respective values in healthy volunteers and patients with cardiovascular diseases (CVD); to study correlations of the ED biomarkers with indexes of instrumental evaluation of endothelial dysfunction.Material and methods The study included 75 participants, including 25 healthy volunteers (control group), 25 patients with documented CVDs (arterial hypertension + ischemic heart disease), and 25 patients of the main group with histologically documented stage II-IV stomach cancer (adenocarcinoma) who received different courses of PCT with platinum-based agents (oxaliplatin, cisplatin) and fluoropyrimidines (5 fluorouracil, capecitabin). Laboratory measurement of ED biomarkers, computerized nailfold video capillaroscopy (CNVC), and finger laser photoplethysmography (PPG) (methods for noninvasive evaluation of vascular wall and ED), electrocardiography, 24-h ECG Holter monitoring, and echocardiography (EchoCG) were performed for all patients of the main group prior to PCT and within one months after the last course completion. This evaluation was performed once for healthy volunteers and patients of the CVD group upon inclusion into the study.Results In the main group, ET-1 levels were non-significantly lower than normal and did not change during the courses of antitumor treatment (0.95 [0.6; 1.4] and 0.94 [0.7; 1.4] pg /ml (р<0.9) before and after PCT, respectively). Statistically significant differences were found between the control group and oncological patients after the treatment (р<0.04). Levels of VWF remained within the normal range in all examined participants and did not significantly differ between study groups, including oncological patients before and after the specific treatment (р>0.05 for all comparisons). The correlation analysis detected significant correlations of ET-1 levels with functional disorders of microcirculation, ET-1 with the occlusion index (rs=0.56; p=0.005), ЕТ-1 with percentage of capillary restoration (PCR, rs= –0.72; p=0.018) and with the incidence rate of supraventricular extrasystole (rs=0.48; p=0.032).Conclusion The dynamics of ED biomarkers was studied for the first time in patients with stomach cancer receiving a specific antitumor therapy. Although no significant changes in ЕТ-1 and VWF were observed during the PCT (probably due to exhaustion of the endothelial system and a small patient sample), these indexes can be considered as early vasculotoxicity markers due to the presence of significant correlations with indexes of impaired endothelial function according to the results of instrumental evaluation.

scholarly journals THE PREVALENCE OF PERIODONTAL TISSUE DISEASES IN YOUNG INDIVIDUALS ON THE BACKGROUND OF CROWDED TEETH

2018 ◽  
pp. 28-31
Author(s):  
A.V. Mandych
Keyword(s):  
Comparison Group ◽  
Periodontal Diseases ◽  
Adult Population ◽  
Study Groups ◽  
Main Group ◽  
Periodontal Tissue ◽  
Facial Skeleton ◽  
Old Patients ◽  
Periodontal Tissues ◽  
Upper Jaw

The abnormalities of maxillodental system take one of the leading places among diseases of the maxillofacial area. Thus, they are diagnosed more than in 50% cases among the younger population and in 30% cases among the adult population.   Most often, there are prerequisites for the incorrect position of individual teeth: anomalies are formed at the genetic level because of heredity of pathologies of size, amount, shape of teeth and size of the jaw bones of the facial skeleton. If the position of the teeth is incorrect, the periodontium retains the occlusal load of the functional injury. Therefore, the aim of our research was to study the prevalence of periodontal tissue diseases in young individuals on the background of crowded teeth. The material and research methods. The study was conducted on the base of Dental Center of Danylo Galytsky Lviv National Medical University during 2015−2017 years. 1146 people at the age from 18 to 44 years were examined. Every participant of research underwent general dental examination, as well as a special examination aimed at clarification of orthodontic treatment. The diagnosis of periodontal tissue diseases was made according to the classification of N. F. Danilevskyi and was determined using paraclinical indicators. The obtained results were worked out statistically using functions of MS Excel and Statistica 6. Results of the research and their discussion. The total number of the examined with orthodontic pathology was found on average in 77.24% of patients (885 people). At the same time, abnormalities of dental jaw system were not detected in about 261 (22.76%) of the examined. As a result of the conducted studies we found that among the examined without dental jaw abnormalities 38.89±.,32% of patients had intact periodontium, that was 1.6 times more for data in individuals with crowding − 23.73±2.00, p<0.01. At the same time, in patients of the main group the prevalence of periodontal tissue diseases was 1.2 times higher than in the examined of the comparative group (76.27±2.00% against 61.11±3.32%, respectively, p<0.01). It should be noted, that with the increase of the age of patients the prevalence of periodontal tissue diseases increased in both study groups, but in patients with crowded teeth this tendency was more pronounced. So, in the younger age group in patients with crowding the prevalence of periodontal diseases was 1.5 times higher in relation to the data of their peers from the comparison group (71.37±3.00% vs. 46.99±5.48%, p<0.01). In 27−35-year-old patients the prevalence of periodontal tissue diseases amounted to 72.38±4.03% of the examined of the main group and 65.62±5.94% of the examined of the comparison group, but the obtained data were not statistically significant, p>0.05. At the same time, in the patients of the main group aged 36−44 years the prevalence of periodontal tissue diseases was maximal and exceeded the value of their peers in the comparison group by 1.2 times (92.08±2.69% vs. 73.91±5.29%, respectively, p<0.01). The analysis of the obtained data allowed to assert that on average crowding of teeth on the upper jaw was found in 237 patients (52.55%) and on the lower jaw in 214 patients (47.45%). Thus, the maximum frequency of crowded teeth on the upper jaw was observed in the examined in the age range of 27−35 years, 60.16±4.41% of patients, with the minimum prevalence of this pathology in the youngest group (18−26 years), 49.34±4, 72%. The analysis of diagnostic structure of periodontal tissue diseases showed that inflammatory diseases of periodontal tissues (gingivitis, localized periodontitis) were found in patients with crowded teeth, on average 1.2 times more often than in patients without orthodontic pathology (42.42±1.88% vs. 36.33±3.54%, respectively, p<0.05). Conclusions. Thus, as a result of the conducted studies, higher prevalence of periodontal tissue diseases was proved in patients with crowding of teeth, which made progress in increasing the age of the examined than in patients without orthodontic pathology.

scholarly journals Peculiarities of the course of pregnancy in women with common helminth infestations

2020 ◽  
pp. 52-55
Author(s):  
Babashova Fidan Mahmud kizi ◽  
Keyword(s):  
Pregnant Women ◽  
Visual Detection ◽  
Study Groups ◽  
Main Group ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Rare Form ◽  
Helminth Eggs ◽  
Acute Yellow Atrophy ◽  
Symptom Complex

The objective: peculiarities of pregnancy in women with common worm infestations in Baku. Materials and methods. During the period from 2015 to 2017, 152 women with common worm infestations were examined, in the gestation period from 16 to 40 weeks in the age group from 18 to 38 years. Depending on the nature of the infestation, 2 main groups were formed: the 1st main group included 84 women who had monoinvasia of helminths, and the 2nd main group included 68 women who had mixed helminth infestation. The control group consisted of 42 women who were pregnant without helminthiasis. All women were examined at 16–22, 23–29, 30–36 and 37–40 weeks of pregnancy. Helminthosis diagnostics was performed by detecting helminth eggs in faecal smears, pinworm eggs in scraping from perianal folds, and visual detection of helminth eggs or pinworms in faeces and vomit. Results. Common symptoms of early toxicosis are nausea, hypersalivation, and vomiting. A rare form of morning sickness treat dermatosis pregnant women, pregnant bronchial asthma, tetany, acute yellow atrophy of the liver, osteomalacia. Symptoms of toxicosis were evaluated in 152 pregnant women. The main symptoms of early toxicosis–nausea, hypersalivation and vomiting–were more common in pregnant women with helminthiasis than in women of the control group. In women with helminthiasis, a symptom complex similar to the manifestations of early toxicosis may persist throughout pregnancy, despite ongoing toxicosis therapy. Since persistent nausea and vomiting can be etiologically caused by helminthic-protozoic intoxication, the frequency of nausea and vomiting in different groups in the second and third trimesters was compared. In the second half of pregnancy, women with complaints of nausea and vomiting were present in all study groups, but they were more common in pregnant women with helminthiasis than in women in the control group. Conclusions. The data obtained on the more frequent manifestation of early toxicosis in pregnant women with helminthiasis and its demonstrated resistance throughout pregnancy prove that helminth infestations negatively affect the course of pregnancy. Key words: helminth-protozoal invasion, placental insufficiency, pregnancy.

scholarly journals Problems of diagnostics and treatment of gastrointestinal perforations in patients with acute intestinal infections

2018 ◽  
Vol 20 (1) ◽  
pp. 145-148
Author(s):  
G M Magomedov ◽  
V P Zemlyanoy ◽  
M M Nakhumov ◽  
B B Namazov
Keyword(s):  
Diagnostic Laparoscopy ◽  
Diagnostic Errors ◽  
Diagnostic Algorithm ◽  
Study Groups ◽  
Intestinal Infection ◽  
Surgical Interventions ◽  
Results Of Treatment ◽  
Abdominal Organs ◽  
Intestinal Infections ◽  
Instrumental Methods

The results of treatment of 97 patients with perforations of the hollow organs of the gastrointestinal tract were analyzed, 31 acute intestinal infections of which were verified. Clinical features of perforation of hollow organs on the background of acute intestinal infection have been revealed. A comparative analysis of clinical and instrumental methods for diagnosing perforations in patients with intestinal infections and without them was carried out. The most sensitive in identifying perforations of hollow organs in patients with acute intestinal infections instrumental methods of investigation were diagnostic laparoscopy (100%) and radiography of abdominal organs (80%). It was established that the combination of the two diseases contributes to the growth of diagnostic errors, increase in the number of common forms of peritonitis and development of the syndrome of mutual aggravation. Analysis of surgical interventions showed that in patients with confirmed diagnosis of acute intestinal infection the primary surgical interventions in most patients resulted in the formation of laparostoma with programmed relaparotomy, in connection with the presence of contraindications for the formation of a primary interintestinal anastomosis. Postoperative complications in the study groups developed in 61,3; 41.7 and 23,8% of cases, respectively. In patients with confirmed diagnosis of acute intestinal infection, lethality was 32,3%, in patients with atypical flow of perforations of hollow organs, simulating the symptoms of acute intestinal infection - 16,7 and 14,3% - in patients with perforations of hollow organs without concomitant acute intestinal infection. The results of the research testify to the relevance of the problem under study and the need to optimize therapeutic-diagnostic algorithm for this category of patients.

scholarly journals PSYCHOEMOTIONAL CHARACTERISTICS OF PREGNANT WOMEN AS A RESULT OF THE ASSISTED REPRODUCTIVE TECHNOLOGIES APPLICATION

2019 ◽  
pp. 42-51
Author(s):  
Antonina Kotenok ◽  
Liliya Vygivska ◽  
Іgor Maidannyk ◽  
Viktor Оleshko
Keyword(s):  
Pregnant Women ◽  
Emotional State ◽  
Assisted Reproductive Technologies ◽  
Study Groups ◽  
Reproductive Technologies ◽  
Main Group ◽  
Control Group ◽  
Male Factor ◽  
Reactive Anxiety ◽  
Personal Anxiety

                                  The issue of preserving the reproductive health of the nation in Ukraine is very acute. The psycho-emotional state of a woman is of particular importance for the prolongation of pregnancy and the normal course of labor. Violation of adaptive mechanisms which are aimed at restructuring the functional systems of the body during pregnancy and on the eve of childbirth, as well as the state of chronic stress contribute to the increase in the of obstetric and perinatal complications frequency and have an adverse effect on the course of pregnancy. The aim of the reaserch was to study the dynamics of psycho-emotional state features in pregnant women after assisted reproductive technologies (ART) application in order to improve the tactics of antenatal surveillance. To achieve this goal, 299 pregnant women were comprehensively examined in the dynamics of prospective observation, which were distributed as follows – the main group included 249 women whose pregnancy occurred as a result of the ART application. The control group consisted of 50 pregnant women with spontaneous pregnancy and its physiological course, which were registered for pregnancy at 6-8 weeks. The women of main group whose pregnancy occurred as a result of ART application were divided into three groups, depending on the factor that caused infertility. The first group included 94 women with tubal-peritoneal factor of infertility, the second group was formed by 87 women with endocrine factor of infertility, the third group included 68 women whose infertility was caused by the male factor. Pregnant women of the study groups by age, marital and social status, place of residence were representative, which allowed further to judge the differences caused by etiological factors of infertility. In order to determine the psycho-emotional state of pregnant women in the study groups in the screening mode, a clinical interview was conducted by filling out questionnaires that contained the constituent questions of the STAI tests in the modification of Yu. L. Khanin and the "Pregnant Attitude Test" by the method of I. V. Dobryakov. The obtained test results indicate that the average score of reactive anxiety in pregnant women of the main group exceeded the same indicator of the control group and was: 49 - pregnant women with tubal-peritoneal type of infertility, 56 - pregnant women with endocrine type of infertility, 44 - pregnant women with male factor of infertility, 24 - control group. According to the results of testing, a significant difference was revealed in the indicators of personal anxiety. The values of indicators of personal anxiety were: 51 - pregnant women with tubal-peritoneal type of infertility, 54 - pregnant women with endocrine type of infertility, 31  -pregnant women with male factor of infertility, 31 - control group. Low level of personal anxiety was observed in 26 (27,6%) pregnant women of I group, 29 (33,3%) pregnant women of II group, which is significantly less in comparison with the indicator of pregnant women of the control group – 33 (66,0%) and III group - 33 (48,5%) (p < 0,05). Moderate type of personal anxiety was observed in 46 (48.9%) pregnant women of group and 40 (45.9%) pregnant women of II group compared to the indicator of the control group – 11 (22, 0%) (p < 0,05). Moderate type of personal anxiety was determined in 25 (36,7%) cases in pregnant women of III group and did not differ significantly from the indicators of I, II and control groups (p > 0,05). A high level of personal anxiety was observed in 22 (23,5%) pregnant women of group I, 18 (20,8%) pregnant women of group II, which is significantly higher in comparison with the indicator of pregnant women of the control group – 6 (12,0%) (p < 0,05). Thus, the study of the psycho-emotional state of pregnant women after the application of ART deviations in the level of personal and reactive anxiety and pathological types of gestational dominant, which are inherent in pregnant women of the main group. Taking into account the above, we consider it appropriate to involve a psychologist to work with the examined pregnant women in order to correct the identified abnormalities.

scholarly journals RADIO-FREQUENCY AND LASER SURGERY FOR LUMBAR DISC HERNIATIONS

2006 ◽  
pp. 059-063
Author(s):  
Aleksandr Kuzmich Chertkov ◽  
Aleksey Olegovich Dubskikh
Keyword(s):  
Lumbar Spine ◽  
Radio Frequency ◽  
Lumbar Disc ◽  
Lower Extremities ◽  
Study Groups ◽  
Main Group ◽  
Control Group ◽  
Duration Of Illness ◽  
Disc Herniations ◽  
Operation Results

Objective. To compare the effectiveness of laser discectomy and radio-frequency nucleoplasty in patients with nonsequestrated disc herniations accompanied with lumbar osteochondrosis. Material and Methods. Radio-frequency nucleoplasty and laser discectomy were performed in patients from 24 to 57 years old with nonsequestrated disc herniations. Thirty patients who underwent radio-frequency nucleoplasty (main group) and 30 patients after vaporization (control group) were included in the study. Groups were similar in age, gender, concomitant diseases, hernia localization and duration of illness. Pre- and postoperative examination consisted of clinical, radiological, CT and MRI data. The outcomes were assessed in two-three days, one month and 6 months after operation. Results. In two-three days all patients of both groups reported absence of pain or its significant reduction in the lumbar spine or lower extremities. In 6 months 5 patients of a control group suffered of lumbar spine and lower extremities pain, which restricted their labor ability and demanded inpatient treatment. In a main group only 2 patients demanded inpatient care for the reasons given above. Conclusion. The assessment of two technologies suggests that radio-frequency nucleoplasty is a safety technique for treatment of patients with disc herniation accompanied with osteochondrosis. It has obvious advantages over laser intervention.

scholarly journals THE INFLUENCE OF OSTEOPATHIC CORRECTION OF PELVIS DYSFUNCTIONS IN WOMEN IN LABOR WITH PRETERM AMNIORRHEA IN CASE OF FULL-TERM PREGNANCYON THE LABOR COURSE AND RESULT

2021 ◽  
Vol 83 (3) ◽  
pp. 24-36
Author(s):  
Natalia Noritsyna ◽  
Svyatoslav Novoseltsev
Keyword(s):  
Pregnant Women ◽  
Main Group ◽  
Full Term ◽  
Control Group ◽  
Term Pregnancy ◽  
Labor Management ◽  
Management Protocol ◽  
Cesarian Section

The eff ectiveness of applying osteopathic methods to patients with amniorrhea in case of full-term pregnancy was evaluated. 40 pregnant women with singleton full-term pregnancy without severe somatic and obstetric pathologies, with preterm amniorrheaunder the absence of regular labor activity were included into the study. The main group (n = 20) included women who underwent treatmentwith osteopathic methods. In the control group (n = 20) the labor was managed in accordance with the labor management protocol in case of amniorrhea. The osteopathic examination, which was performed in the course of the study, showed that all patients had biomechanical disorders at the pelvis level. The women in labor, who underwent osteopathic correction, started to deliver on their own in a greater percentage of cases as compared with the control group; there was a signifi cant decrease of frequency of labor anomalies and the total number of complications in labor and, as a consequence, a signifi cant decrease of obstetric aids and frequency of the emergency deliveryby cesarian section. A decrease in the frequency of episiotomy was noted. A decrease in the duration of the rupture-to-delivery interval was also noted.

scholarly journals GOUT AND ARTERIAL HYPERTENSION: THERAPY PECULIARITIES

2020 ◽  
Vol 20 (1) ◽  
pp. 100-105
Author(s):  
V.М. Zhdan ◽  
V.G. Lebid ◽  
H.S. Кhaimenova ◽  
G.A. Isheikina
Keyword(s):  
Uric Acid ◽  
Arterial Hypertension ◽  
Combined Therapy ◽  
Study Groups ◽  
Main Group ◽  
High Density Lipoproteins ◽  
Professional Activity ◽  
Control Group ◽  
Uric Acid Concentration ◽  
Clinical Effects

The article highlights the issues on comorbidity between gout and hypertension. Emphasis is placed on the necessity in searching for a well-balanced approach toward the treatment this type of comorbidity. Gout is a major social and economic problem in the modern society that leads to a progressive physical incapability, limitation of professional activity, thus impairing the quality of life. Arterial hypertension occurs in patients with gout in 5 - 50% of cases, and in combination with components of metabolic syndrome its prevalence rises up to 80%. As a result, the development of hypertension in patients with gout leads to a deterioration of the kidney functioning due to the combination of two pathological conditions for which the kidneys are either functioning organs or target organs. Management of arterial hypertension by general practitioner requires the searching for the most optimal approach in using metabolically neutral antihypertensives to avoid provoking medication-induced exacerbation of arthritis. In addition, the treatment of such category of patients should also provide the optimal nephroprotective effect and decrease the uric acid concentration in the serum that will contribute to the additional prevention of gout attacks. The aim of the study is to evaluate the nephroprotective, antihypertensive, hypolipidemic effects of the proposed combined therapy in the patients with comorbidity between gout arthritis and arterial hypertension. The study was conducted at the Regional Medical and Diagnostic Centre of Rheumatological Diseases, M.V. Sklifosovskyi Poltava Regional Clinical Hospital, which is the clinical base of the Department of Family Medicine and Therapy, Ukrainian Medical Stomatological Academy. 60 patients with mean age of 54.2 ± 8.6 years were enrolled to the study. The patients suffering from gout arthritis and comorbid hypertension formed the main group. The control group consisted of 60 patients matched by age, demographic and clinical parameters. Following the 12-month treatment period, we have registered clinical effects of the combination therapy proposed in patients with gout and comorbid hypertension. We observed a decrease in blood lipids values in the study groups: total cholesterol decreased by 16.0% in the main group and by 8.0% in the control group, high-density lipoproteins – by 5.6% in the main group and by 6.4% in the control group, low density lipoproteins – by 3.3% in the main group and by 3.4% in the control group, triglycerides – by 22.2% in the main group and 12.3% in the control group. We observed statistically significant improvement in the glomerular filtration rate in the main group (6.4% of cases vs. 1.3% in the control group). The blood creatinine in the both study groups decreased significantly. The uric acid blood concentration decreased by 32.6% in the main group compared to 24.6% in the control group. During the six month period of the therapy the necessity for non-steroidal anti-inflammatory drugs cut down by 58% in the study group vs. 37% in the control group. Conclusions. After 12 month period of therapy proposed, the patients with gout and comorbid hypertension demonstrated clinically confirmed improvement in both study groups (87.7% of patients in the main group vs. 48.6% in the control group). The efficacy of the proposed treatment was assessed by physicians up to 87%, vs.  88% efficacy assessed by the patients in the main group.

Key Results of International Randomized Open-Label Clinical Study of BCD-020 (rituximab biosimilar candidate) in Patients with B-Cell Non-Hodgkin’s Lymphoma

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5467-5467 ◽  
Author(s):  
Kamil Kaplanov ◽  
Andrey Zaritskiy ◽  
Sergey Alexeev ◽  
Elena Volodicheva ◽  
Alexander Loginov ◽  
...  
Keyword(s):  
B Cell ◽  
Hodgkin’S Lymphoma ◽  
Reference Group ◽  
Study Groups ◽  
Main Group ◽  
Hodgkin's Lymphoma ◽  
Open Label ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Ann Arbor

Abstract BCD-020 (Acellbia, rituximab biosimilar candidate) was shown to be highly similar to innovator rituximab (MabThera®/Rituxan®) in terms of its quality characteristics, in vitro biological activity, as well as toxicology and PK/PD characteristics in non-human primates. International multicenter comparative randomized open-label clinical study was carried out in a period from 2011 to 2013 and involved over 30 centers in Russia, Ukraine and India. Its methodology and design complies with current EMA guidelines on similar biological products containing monoclonal antibodies (EMA/CHMP/BMWP/403543/2010). 92 patients with follicular non-Hodgkin’s lymphoma, stage I-IV by Ann Arbor, or marginal zone lymphoma, stage I-IV by Ann Arbor, ECOG 0-2, who had at least 1 measurable lesion were enrolled. According to study protocol patients with secondary transformed B-cell lymphomas or with highly aggressive types of tumor, bulky disease, severe concomitant somatic disorders and some other conditions were excluded. If a patient had previous story of chemotherapy or radiation he could be included after at least 3 weeks post-treatment. Participation of patients who were previously treated with any kind of monoclonal antibodies was prohibited. After signing standard informed consent form and completion of 28-days screening period eligible patients underwent stratification in accordance to their prognostic risk (FLIPI or IPI) and previous treatment (naïve or pretreated). Subsequently patients were randomized (1:1) into 2 groups: 46 patients were included in the main group where Acellbia (rituximab biosimilar) was administered at a dose of 375 mg/m2 as a slow IV infusion on day 1, 8, 15 and 22; 46 patients were included in the reference group where MabThera was used at the same regimen. Use of any other medicines for the treatment of lymphoma was strictly prohibited. Efficacy was assessed on the basis of computed tomography and bone marrow evaluation which were performed 1 month after the completion of treatment. Median age of patients in each group was 57.5 years (main group [50.0-64.0], reference group [47.0-65.0]). Manageable comorbidities were reported in 50% of patients in the main group and 34.78% of patients in the reference group, p=0.2053. Comparative analysis of the prognostic risk factors confirmed the equivalence of study groups. The number of pretreated patients in both groups was equal – 8 individuals per group. Statistical analysis didn’t find any difference in overall response rate in general population of patients (39.52% patients in the main group vs. 36.57% patients in the reference group, p=0.8250), as well as in population of pretreated patients (28.6% vs 37.5% respectively, p=1.00) and in population of naïve patients (42.8% vs 39.4% respectively, p=1.00). The lower limit of the two-tailed 95% CI for difference in proportions of ORR was equal to -0.17 and exceeded the predefined non-inferiority margin -0.2, which confirmed non-inferiority of Acellbia to MabThera in terms of efficacy. Treatment-associated AE of any grade were reported in 21.74% patients in both arms, in the absence of statistically or clinically significant difference (p = 0.8005). There were 2 cases of CTCAE 4.03 grade 3-4 AEs in each group. PK and PD parameters were shown to be equivalent in both study groups. Thus, study results suggest that Acellbia has same efficacy and safety in patients with B-cell non-Hodgkin’s lymphoma. Disclosures Chernyaeva: JCS BIOCAD: Employment. Ivanov:JCS BIOCAD: Employment. Isaev:JCS BIOCAD: Employment.

scholarly journals Ways to increase compliance in patients with acute otitis externa

2021 ◽  
pp. 71-76
Author(s):  
Oleksandr O. Semenyuk ◽  
Oksana Ye. Moskalyk
Keyword(s):  
Otitis Externa ◽  
Study Groups ◽  
Main Group ◽  
Antifungal Drugs ◽  
Empirical Treatment ◽  
Control Group ◽  
Number Of Patients ◽  
Adults And Children ◽  
Mean Compliance ◽  
Ear Drops

Topicality: The problem of diagnosis and treatment of otitis externa (OE) has been posed to doctors for a long time, and until the discovery of antibiotics (AB) and antifungal drugs (AFD) remained unresolved. OE can affect up to 10% of people at different periods of their lives, manifesting itself in the form of acute OE (AOE) in 95% of cases after the age of 2 years. There is a reduction in the number of patients admittance to the ENT specialist with the onset of the COVID-19 pandemic while maintaining the structure of the pathology, where AOE - in the top three of frequency. At the same time, there are a reports of an increasing amount of AOE cases in patients with COVID-19. Aim: To evaluate the dynamics of pain, the need for additional analgesia, systemic antibacterial therapy (ABT) or topical antifungal therapy (TAT), the level of compliance in patients with AOE in empirical treatment with a complex drug «Candibiotic» in comparison with protocol treatment. Material and methods: The study included adults and children from 2 years of age with a diagnosis of AOE: 30 patients in the main (17 adults, 13 children) and 25 patients in the control (15 adults, 10 children) groups. Patients in the main group as a basic treatment received topical ear drops «Candibiotic». Patients in the control group received protocol treatment. If necessary, patients were additionally prescribed analgesic therapy (ibuprofen in the appropriate dose), systemic ABT or TAT. For subjective pain asses, a visual analog scale (VAS) was used. Compliance was assessed using the Morisky-Green questionnaire. The obtained results were processed by common statistical methods. Results and discussion: In the main group of patients receiving «Candibiotic», there were fewer needs for additional systemic analgesia, systemic ABT, no one needed additional TAT. Comparison of the obtained results (percentage) in the form of arbitrary tables using the chi-squared test established that the relationship between factor and performance traits is not statistically significant (p>0.05). The mean compliance score between the two study groups differed significantly as a whole and separately between the groups of adults and children (p<0.05). Conclusion: In patients of adult and pediatric age with a diagnosis of AOE at the initial empirical appointment of the drug «Candibiotic» there was less need for additional analgesia, the appointment of systemic ABT and AFT. Such results did not differ statistically significantly from the results in adult and pediatric patients who were prescribed protocol treatment of AOE. Patients with «Candibiotic» monotherapy had a significantly higher average compliance score compared with the control group, especially among parents of children with AOE. The complex composition of ear drops «Candibiotic» contributes to a high adherence to treatment in patients, and the lack of an absolute analogue makes it the means of choice for the initial empirical treatment of AOE in adults and children over 2 years.

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