Vol 49, No 7 (2021)

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Real world practice of medical treatment for moderate and severe inflammatory bowel diseases in Russian Federation, Republic of Belarus and Republic of Kazakhstan: intermediate results of the INTENT study

Knyazev O.V., Belousova E.A., Abdulganieva D.I., Gubonina I.V., Kaibullayeva J.A., Marakhouski Y.K., Chashkova E.Y., Shapina M.V., Shchukina O.B., Gegenava B.B., Oliferuk N.S.


Background: The analysis of data obtained from real world clinical practice of management of patients with inflammatory bowel diseases (IBD) is an effective tool to improve medical care for this patient category. Studies of the kind are rare in Russia, which hinders a critical assessment of the current situation and optimization of the established approaches.

Aim: To study real world practice of medical treatment of patients with moderate and severe IBD in the Russian Federation, Republic of Belarus and Republic of Kazakhstan.

Materials and methods: We analyzed intermediate results from the INTENT study (NCT03532932), which is a multinational, multicenter, retrospective and prospective, non-interventional observation trial being performed in the Russian Federation, Republic of Belarus and Republic of Kazakhstan. The retrospective analysis included data from 706 patients above 18 years of age with confirmed diagnosis of moderate/severe ulcerative colitis (UC) and Crohn's disease (CD) made at least 2 years before the study entry, with acute exacerbations of the disease at the study entry or within the last 2 years. Data were collected during routine management; at the study entry the patients were treated with a standard regimen including 5-aminosalicylic acid (5-ASA) agents, glucocorticosteroids (GCS) and immunosuppressants (IS), as well as genetically engineered biological agents (GEBA).

Results: Among 706 IBD patients, 465 had UC and 241 had CD. The male to female ratios in both groups were similar. Mean age of the UC patients was higher than that of the CD patients (41.8 [95% confidence interval (CI) 40.6–43.0] years vs 35.6 [95% CI 33.9–37.3] years, p = 0.0001). The same difference was noted for the mean age of disease manifestation (34.5 [95% CI 33.29–35.61] vs 29.7 [95% CI 28.03–31.3] years, p = 0.0001) and for mean duration of disease from the time of diagnosis to the study entry (7.3 [95% CI 6.77–7.9] for UC and 5.9 [95% CI 5.3–6.59] years for CD, p = 0.0027). The proportion of patients with familial history of IBD was low (3.2 and 0.8%, respectively, p = 0.0672). The number of smokers with CD was more than 2-fold higher than those with UC (11.2% vs 5%, p < 0.001). 58.1% of the patients in the UC group and 47.0% of those from the CD group were employed (р < 0.05). 36.6% of the UC patients and 56.0% of the CD patients had the legal disability status due to underlying disease (p < 0.005). The relapsing course of the disease was noted in 72.9% with UC and 60.6% with CD, while in the rest of the patients the disease had the continuous course. The degree of UC involvement corresponded to pancolitis in 58.9% of the cases, to left-sided colitis in 33.1%, and to proctitis in 8%. The distribution of CD location was as follows: ileocolitis 54.8%, terminal ileitis 23.7%, colitis 20.3%, isolated upper gastrointestinal tract involvement 1.2%. The prevalence of complicated UC was 12.9%, and that of the complicated CD 57.4% (р = 0.0001). There were no difference in the rate of extraintestinal manifestations between UC and CD (23.4 and 28.2%, respectively, p = 0.1705). UC and CD groups differed by their treatment patterns. In the UC group, 5-ASA + GCS regimens were given to 25.4% of the patients, whereas in the CD group, to 3.7% (р ≤ 0.0001). The second frequent regimens were: 5-ASA with subsequent IS ± GCS (17.9% in UC, 22.8% in CD, p = 0.1331); standard regimen (any 5-ASA agent, IS or GCS, but not GEBA) with subsequent treatment withdrawal or its reduction to GCS monotherapy (14.8% in UC, 5% in CD, р = 0.0001); 5-ASA with a subsequent combination with IS, then any tumor necrosis factor-α inhibitor (iTNF-α) as the basic treatment with continuation of 5-ASA and/or IS (22% in CD vs 13.5% in UC, р = 0.0052); treatment initiation from iTNF-α combined with any standard agent without any subsequent modification (24.1% in CD and 13.6% in UC, р = 0.0007). Less frequent the following treatment regimens were used: initial treatment with 5-ASA and subsequent iTNF-α with continuation of 5-ASA (4.5% in UC and 2.5% in CD, р = 0.2181); initial treatment with iTNF-α in combination with any standard agent with subsequent GEBA withdrawal and continuation of a standard regimen or its withdrawal (4.3% in UC and 7.5% in CD, р = 0.0812). The cumulative frequency of GEBA administration at various stages of treatment for CD (66.4%) was significantly higher than for UC (39.4%). Vedolizumab for CD was administered more frequently than for UC (10.4 and 3.4%, respectively, p = 0.0003). The analysis of habitual GCS use revealed a number of negative trends, namely, half of the IBD patients received more than 2 GCS courses within 2 years, and in some cases the number of GCS courses amounted to 5–8. Mean duration of a GCS course in most regimens for UC and CD was in the range of 91 to 209 days, which is significantly higher than the recommended treatment duration of 12 weeks (83 days).

Conclusion: With a number of its demographic characteristics and clinical particulars, the study cohort of patients with IBD is compatible to global trends: the male to female ratio, mean patients’ age, young age at disease manifestation, smoking status, prevalence of extraintestinal manifestations and the location of CD. It is of note that 5-ASA is included into almost all treatment regimens for CD, which does not meet the treatment strategy recommended in the guidelines. Frequent administration and long duration of GCS therapy also is in contradiction with the guidelines. Of significant concern is rather rare and late administration of GEBA, especially for UC. We believe that the identified pitfalls are associated both with low awareness of doctors on the current strategies of IBD management and with low patients' compliance to treatment.

Almanac of Clinical Medicine. 2021;49(7):443-454
pages 443-454 views

Are physicians ready to comply with the guidelines for diagnosis and management of Helicobacter pylori-associated diseases: the survey results 2020–2021

Bordin D.S., Krolevets T.S., Livzan M.A.


Objective: To assess compliance of physicians with diagnostic and management guidelines for H. pylori-associated diseases with a question-naire-based survey.

Materials and methods: We conducted an anonymous voluntary online survey of 775 physicians of the following specialties: internal medicine 459 (59.2%), gastroenterology 279 (36%), and endoscopy 34 (4.4%). The respondents expressed their level of agreement with the questionnaire items as follows: 0 – I do not know, 1 – disagree, 2 – partially agree, and 3 – fully agree.

Results: 613 (79.4%) of the physicians fully agreed to diagnose and treat H. pylori in patients with chronic atrophic gastritis, 602 (78.0%) in the 1 st degree relatives of gastric cancer patients, 525 (68.0%) in patients with chronic superficial gastritis, 423 (54.8%) in peptic ulcer at remission, and 336 (43.4%) in those with dyspepsia syndrome. The physicians were equally compliant with eradication therapy in the patients, for whom long term use of proton pump inhibitors (PPI) or non-steroid anti-inflammatory drugs (NSAID) is being planned (386 (50.0%) and 397 (51.4%), respectively). Internists were less compliant with diagnosis and management of H. pylori in patients taking both PPI (χ2 = 66.525, p = 0.004) and NSAID (χ2 = 103.354, p = 0.003). Among the primary diagnostic tools for H. pylori the physicians preferred 13/14С-urease breath test (545 physicians, or 70.6%) and gastric bioptate morphology (574, or 74.4%), and among the control diagnostic methods they chose fаeces analyses (enzyme-linked immunosorbent assay and polymerase chain reaction). The respondents considered bismuth-enhanced standard triple therapy with clarithromycin to be the most effective regimen for the 1 st line eradication therapy (606, 78.5%). To increase the efficacy of eradication therapy, the physicians were more prone to administer esomeprazole or rabeprazole (70.6%), bismuth-based agents (79.4%), than to use rebamipid (35%), probiotics (44.9%) and/or to double PPI doses (44.2%). The respondents expressed their concerns with low patient compliance to treatment (59.4%) and limited diagnostic capabilities (49.4%).

Conclusion: Physician's compliance with the guidelines on diagnosis and management of H. pylori-associated diseases is adequate and might depend on both their awareness and availability of the proposed diagnostic and therapeutic methods.

Almanac of Clinical Medicine. 2021;49(7):455-468
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ITGA4, ITGB7, TNFα, IL10 genes polymorphisms in the ethnic Buryat patients with ulcerative colitis

Zhilin I.V., Chashkova E.Y., Zhilina A.A., Tsyrempilova A.C.


Background: Worldwide studies of genetic material, polymorphisms and prognostic gene models for immune-associated disorders have established differences in trans-ethnic population cohorts, which determine phenotypic and other characteristics of the course of these diseases. Ulcerative colitis (UC) is a  chronic immune inflammation of the colon mucosa. More than 100 gene polymorphisms associated with multiple integrated cross-talks have been discovered.

Aim: To study the ITGA4, ITGB7, TNFα, IL10 genes polymorphisms in patients with ulcerative colitis belonging to the Buryat ethnic group and living in Irkutsk region, Buryat Republic and Transbaikal territory.

Materials and methods: The study included a total of 49 subjects, 24 of them being UC patients and 25 healthy volunteers, compatible in gender, age and ethnic background. The molecular genetic analysis by real time polymerase chain reaction was performed with DNA samples from whole peripheral blood leucocytes.

Results: The differences in the prevalence of the ITGA4(rs1143674, rs1449263), ITGB7(rs11574532), TNFα(rs1800629), and IL10(rs1800871) genotypes were non-significant (р>0.05). The IL10(rs1800896) GG homozygote patients had higher odds ratio (OR) for UC compared to the carriers of other polymorphisms (OR 24; 95%  confidence interval (CI) 2.783–206.969; р=0.001). The AA homozygote type was less frequent among UC patients compared to healthy volunteers (OR 0.17; 95%  CI 0.049–0.589; р=0.004). The analysis of genotype frequency distribution of all studied genes including clinical characteristics of the disease showed no significant results (р>0.05). The binary logistic regression analysis has shown that IL10(rs1800896)GG was an UC predictor with sensitivity of 96% and specificity of 50%  (AUC 0.760; 95% CI 0.621–0.899; p=0.002; standard error 0.71).

Conclusion: The GG genotype of IL10(rs1800896) is a  UC predictor, whereas the AA genotype is significantly more prevalent among healthy subjects of the Buryat cohort. 

Almanac of Clinical Medicine. 2021;49(7):469-476
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Preoperative mechanical bowel preparation combined with oral antibacterials in the prevention of complications of surgery for rectal and rectosigmoid junction cancer

Ivanov Y.V., Smirnov A.V., Vinokurov A.V., Zlobin A.I., Stankevich V.R., Danilina E.S.


Aim: To evaluate the efficacy of mechanical bowel preparation (MBP) combined with oral antibacterials for the prevention of postoperative complications when preparing a patient for anterior rectal resection.

Materials and methods: We analyzed shortterm results in 77 patients who had undergone anterior rectal resection for rectal and rectosigmoid junction cancer. Forty five (45) patients were prepared for surgery only with MBP. In 32 patients, in addition to MBP, oral antibacterial agents ciprofloxacin and metronidazole were used preoperatively.

Results: The overall rate of postoperative complications was 6.25% (2/32 patients) in the group of combined preparation for surgery and 15.5% (7/45) in the group using only MBP. Surgical wound infection occurred in 1 patient in the combined preparation group and in 4 patients in the MBP only group. There was no anastomotic leak in the combined preparation group, whereas in the MBP only group, anastomotic leak occurred in 2 patients.

Conclusion: Combined use of oral antibacterials and MBP before anterior rectal resection makes it possible to achieve an extremely low rate of the colorectal anastomosis leak. Further studies into the efficacy of this preparation regimen are needed, along with their discussion in the professional communities.

Almanac of Clinical Medicine. 2021;49(7):477-484
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Immunological aspects of determination of an adequate biological treatment sequence for inflammatory bowel diseases: the expert board statement (St. Petersburg, May 22, 2021)

Belousova E.A., Kozlov I.G., Abdulganieva D.I., Alexeeva O.P., Gubonina I.V., Lishchinskaya A.A., Tarasova L.V., Chashkova E.Y., Shapina M.V., Shifrin O.S., Shchukina O.B.


On May 22, 2021, the Expert Board met in St. Petersburg to discuss their position on immunological aspects of determination of an adequate biological treatment sequence for inflammatory bowel diseases (IBD). The Expert Board aimed at discussion of current strategies, development of a consensus on determination of an adequate biological treatment sequence for IBD. The main topics of the agenda were the contribution of immune system to the pathophysiology of Crohn's disease, ulcerative colitis and their complications, efficacy of genetically engineered biological agents (GEBA) at various stages of IBD management. Participation of the leading Russian experts in IBD, as well as involvement of other specialties, made it possible to consider the topic by a multidisciplinary team, with an in-depth analysis of IBD pathophysiology, to better understand the course of the disease in some contradictory situation, for instance, when clinical remission is not associated with an endoscopically confirmed remission. One of the expected effects of this Expert Board meeting would be an improvement of GEBA administration in clinical practice, mostly due to the modification of clinical guidelines. This would ascertain and confirm the algorithms for GEBA administration for IBD, including the optimal treatment sequence depending on an agent’s mechanism of action and the patient profile. The clarification of the optimal GEBA sequence in the clinical guidelines could lead to more frequent GEBA administration in local medical clinics and institutions in the regions, where GEBA are used insufficiently due to little experience and absence of their precise positioning in the clinical guidelines.

Almanac of Clinical Medicine. 2021;49(7):485-495
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Late onset familial Mediterranian fever: a clinical case

Grinevich V.B., Gubonina I.V., Shperling M.I., Lapteva S.I., Kolodin T.V., Poluektov M.V.


Familial Mediterranean fever (FMF) is a rare genetic autosomal recessive disease typical for special ethnic groups, such as Arabs, Greeks, Armenians, Jews, Turks and other ethnicities inhabiting the Mediterranean coast. The characteristic clinical signs and symptoms of the disease are recurrent episodes of fever, associated with polyserositis, in particular, with benign (aseptic) peritonitis. The disease is caused by mutation in the MEFV gene encoding the synthesis of the protein pyrine, which leads to an uncontrolled release of pro-inflammatory cytokines by granulocytes. The criterion for the severe course of the disease is AA-renal amyloidosis associated with an unfavorable prognosis. Here we present a clinical case of classic FMF with high fever and abdominal pain syndrome. A 26-year-old Armenian patient had a sudden attack of fever and severe pain in the right iliac area several months before his first hospital admission. Non-steroid anti-inflammatory drugs and antispasmodics were unable to relieve the symptoms, with the attack ceasing spontaneously after 3 days from the beginning. Thereafter, the attacks recurred 1 to 2 times per month within a year. During hospital stay at the peak of the attack, peritoneal symptoms at abdominal palpation, together with neutrophilic leukocytosis and a significant increase in acute phase parameters of inflammation (C-reactive protein, fibrinogen, erythrocyte sedimentation rate) were found. Based on the characteristics of the complaints, past history, laboratory and instrumental results, we excluded infections, autoimmune and surgical disorders and made a decision to perform genetic testing to detect the MEFV gene mutation. Confirmation of the mutation has led to the definitive diagnosis of FMF. This clinical case is remarkable for its late onset, which is not typical for FMF. As a result, the patient was prescribed continuous therapy with сolchicine. Six months of the follow up have demonstrated a positive trend with no attacks during this period.

Almanac of Clinical Medicine. 2021;49(7):496-502
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A diaphragmatic tumor mimicking gastric neoplasm: a clinical case report

Burko P.A., Fedorova M.G., Iliasov R.R., Mozhzhukhina I.N.


The vast majority of patients with tumors arising from the diaphragm do not have any specific clinical symptoms, therefore, computed tomography (CT) and magnetic resonance imaging (MRI) are the techniques required for the diagnosis. This is particularly relevant when a  pathological mass has grown to an extent producing a “mass effect” on the adjacent organs. In some cases, clinical symptoms of arise due to the local invasion of the neoplasm to the adjacent tissues or distant metastases. We present a rare clinical case of a mesenchymal diaphragmatic tumor in a  34-year-old patient. After a  review of her clinical status and imaging of the abdomen, including CT and MRI, the preliminary diagnosis of the gastric neoplasm of uncertain behavior (D37.1) was made, despite the initial diagnostic assumption of the exogastric location of the mass based on MRI. After careful consideration of the diagnostic assessment results, a  multidisciplinary decision was made to perform laparoscopic resection of the mass. The intraoperative finding was a  tumor originating from the left diaphragmatic cupula with no involvement of the stomach. The patient's recovery was uneventful. Pathological examination revealed a solitary calcifying fibrous tumor of the diaphragm. This clinical case shows that a  mass arising from the diaphragm can mimic one arising from the gastric fundus, leading to an incorrect diagnosis and subsequent inappropriate management.

Almanac of Clinical Medicine. 2021;49(7):503-507
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Непрерывно мониторируемый долговременный клинический ответ – новый инструмент для оценки активности язвенного колита в реальной клинической практике

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Статья в данном разделе публикуется на правах рекламы.

В статье представлен обзор основных клинических, эндоскопических и  лабораторных методов оценки активности язвенного колита и  существующих подходов к  ведению пациентов с этим заболеванием, достигших ремиссии. Подробно освещен новый метод – определение непрерывно мониторируемого долговременного клинического ответа – для оценки течения язвенного колита в  период между обострениями на примере исследования PURSUIT-M. Предложены современные возможности внедрения непрерывно мониторируемого долговременного клинического ответа в  рутинную медицинскую практику

Almanac of Clinical Medicine. 2021;49(7):II-X
pages II-X views

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