COVID-19 Pandemic and IBS. Results of the All-Russian Observational Non-interventional Program to Study the Effectiveness of the Drug Kolofort® in Real Clinical Practice in Patients with Irritable Bowel Syndrome After a New Coronavirus Infection (VESNA)
V. T. Ivashkin,
R. A. Abdulkhakov,
I. G. Bakulin,
S. V. Zaitsev,
V. I. Luchina,
S. N. Mekhtiyev,
S. G. Peshekhonov,
E. A. Poluektova,
T. I. Semenova,
S. N. Serikova,
G. N. Tarasova,
E. A. Trush,
Y. P. Uspenskiy,
I. B. Khlynov,
V. V. Tsukanov,
N. P. Chernus https://doi.org/10.22416/1382-4376-2023-33-5-41-53
Abstract
Aim: to study the effectiveness and safety of using the drug Kolofort® in outpatients with irritable bowel syndrome (IBS) after a new coronavirus infection.
Materials and methods. An observational non-interventional program was conducted in patients with exacerbation of IBS symptoms after a new coronavirus infection. One hundred forty-one patients took part in the study. The final efficacy analysis included data from 127 study participants. All patients complained of increased/appearing gastrointestinal symptoms that appeared within 1–6 months after the infection (all patients had a history of COVID-19 infection). To assess the presence and severity of symptoms of the disease, the “7 × 7” questionnaire was used before the start of treatment and three months after the start of treatment.
Results. At the stage of inclusion in the program, the average total score on the “7 × 7” questionnaire was 17.36, which corresponded to a moderately severe disorder. During the treatment period, the average total score decreased to 6.14, which corresponded to borderline disorder. In addition, significant improvement was observed for each symptom separately. After three months of therapy, doctors rated the overall impression of the treatment on a 5-point Likert scale from “very effective” to “ineffective”. The average score was 4.24. In addition, no serious adverse events were identified while taking the drug.
Conclusion. In real clinical practice, the drug Kolofort® demonstrated high clinical efficacy in the treatment of patients with IBS after COVID-19 infection.
Keywords
Supporting agencies: a grant was received from the company “NPF Materia Medica Holding” to conduct the observational program
About the Authors
V. T. Ivashkin
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Vladimir T. Ivashkin — Dr. Sci. (Med.), Professor, Member of the Russian Academy of Sciences, Head of the Department of Internal Diseases Propedeutics, Gastroenterology and Hepatology, Director
19435, Moscow, Pogodinskaya str., 1, build. 1
R. A. Abdulkhakov
Kazan State Medical University
Russian Federation
Russian Federation
Rustam A. Abdulkhakov — Dr. Sci. (Med.), Professor, Honored Doctor of the Republic of Tatarstan, Professor of the Department of Hospital Therapy of the Faculty of Medicine
420012, Kazan, Butlerova str., 49
I. G. Bakulin
North-Western State Medical University named after I.I. Mechnikov
Russian Federation
Russian Federation
Igor G. Bakulin — Dr. Sci. (Med.), Professor, Head of the Department of Internal Diseases Propedeutics, Gastroenterology and Dietetics
191015, Saint-Petersburg, Kirochnaya str., 41
S. V. Zaitsev
Regional Clinical Hospital
Russian Federation
Russian Federation
Sergey V. Zaitsev — Head of the Regional Gastroenterological Center, Yaroslavl Regional Clinical Hospital, Chief Gastroenterologist of Yaroslavl Region
150062, Yaroslavl, Yakovlevskaya str., 7
V. I. Luchina
City Clinical Hospital No. 1
Russian Federation
Russian Federation
Veronika I. Luchina — Gastroenterologist
160012, Vologda, Sovetskiy ave., 94
S. N. Mekhtiyev
Academician I.P. Pavlov First St. Petersburg State Medical University
Russian Federation
Russian Federation
Sabir N. Mekhtiyev — Dr. Sci. (Med.), Professor of the Department of Internal Diseases, Academician
197022, Saint-Petersburg, L’va Tolstogo str., 6–8
S. G. Peshekhonov
Diagnostic and Treatment Centre “Zdorov'e”
Russian Federation
Russian Federation
Sergey G. Peshekhonov —Cand. Sci. (Med.), Gastroenterologist
173021, Veliki Novgorod, Mira ave., 44/20
E. A. Poluektova
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Elena A. Poluektova — Dr. Sci. (Med.), Professor of the Department of Internal Diseases Propedeutics, Gastroenterology and Hepatology, Gastroenterologist, Department of Chronic Intestinal and Pancreatic Diseases of the Clinic of Internal Diseases Propedeutics, Gastroenterology and Hepatology named after V.Kh. Vasilenko
119435, Moscow, Pogodinskaya str., 1, build. 1
T. I. Semenova
City Hospital
Russian Federation
Russian Federation
Tatyana I. Semenova — Headof theGastroenterologyDepartment, Pskov City Hospital, Chief Freelance Gastroenterologist of the Pskov Region State Committee for Health and Pharmacy
180016, Pskov, Kommunalnaya str., 23
S. N. Serikova
Kuban State Medical University
Russian Federation
Russian Federation
Svetlana N. Serikova — Dr. Sci. (Med.), Professor of the Department of Surgery No 3 of Faculty of Advanced Training and Professional Retraining of Specialists
350063, Krasnodar, Mitrofana Sedina str., 4
G. N. Tarasova
Rostov State Medical University
Russian Federation
Russian Federation
Galina N. Tarasova — Dr. Sci. (Med.), Professor
344022, Rostov-on-Don, Nakhichevanskiy lane, 29
E. A. Trush
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Elizaveta A. Trush — Postgraduate at the Department of of Internal Diseases Propedeutics, Gastroenterology and Hepatology
119435, Moscow, Pogodinskaya str., 1, build. 1
Y. P. Uspenskiy
Saint-Petersburg State Paediatric Medical University
Russian Federation
Russian Federation
Yury P. Uspenskiy — Dr. Sci. (Med.), Professor, Chief Gastroenterologist of Saint-Peterburg, Head of the Department of Intermediate Level Therapy named after Professor V.A. Valdman
194100, Saint-Peterburg, Litovskaya str., 2
I. B. Khlynov
Ural State Medial University
Russian Federation
Russian Federation
Igor B. Khlynov — Dr. Sci. (Med.), Associate Professor of the Department of Intermediate Level Therapy, Faculty of Dentistry
620028, Yekaterinburg, Repina str., 3
V. V. Tsukanov
Federal Research Center “Krasnoyarsk Science Center of the Siberian Branch of the Russian Academy of Sciences”, Research Institute of Medical Problems of the North
Russian Federation
Russian Federation
Vladislav V. Tsukanov — Dr. Sci.(Med.), Professor, Head of the Clinical Department of Pathology of the Digestive System in Adults and Children, Federal Research Center “Krasnoyarsk Science Center of the Siberian Branch of the Russian Academy of Sciences”
660022, Krasnoyarsk, Partizana Zheleznyaka str., 3g
N. P. Chernus
I.M. Sechenov First Moscow State Medical University (Sechenov University); Consultative and Diagnostic Center No. 4 of the Moscow Health Department, Branch No. 3, Policlinic No. 2
Russian Federation
Russian Federation
Natalia P. Chernus — Cand. Sci. (Med.), Teaching Assistant at the Department of Polyclinic Therapy
121165, Moscow, Kievskaya str., 24
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For citations:
Ivashkin V.T., Abdulkhakov R.A., Bakulin I.G., Zaitsev S.V., Luchina V.I., Mekhtiyev S.N., Peshekhonov S.G., Poluektova E.A., Semenova T.I., Serikova S.N., Tarasova G.N., Trush E.A., Uspenskiy Y.P., Khlynov I.B., Tsukanov V.V., Chernus N.P. COVID-19 Pandemic and IBS. Results of the All-Russian Observational Non-interventional Program to Study the Effectiveness of the Drug Kolofort® in Real Clinical Practice in Patients with Irritable Bowel Syndrome After a New Coronavirus Infection (VESNA). Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2023;33(5):41-53. https://doi.org/10.22416/1382-4376-2023-33-5-41-53
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