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11MEDICAL SCIENCES
ANALYSIS OF THE EFFECTIVENESS OF GASTRIC ULCER ERADICATIONAL THERAPY IN
SERVICEMEN
Kotyk Yu.
Adjunct, Department of Military Therapy, Ukrainian Military Medical Academy (Kyiv, Ukraine)
ORCID ID: 0000-0001-7261-7083
Abstract
The article analyzes the clinical effectiveness and pharmacoeconomic efficiency of modern regimens for gastric ulcer therapy in servicemen. It was found that the use of colloidal bismuth and rabeprazole of the domestic producer in the treatment has a higher clinical effectiveness compared to the standard scheme of anti-Helicobacter pylori therapy with using omeprazole. Pharmacoeconomic analysis demonstrates better cost- efficiency and higher cost-utility when using a combination of rabeprazole and colloidal bismuth subcitrate in the treatment of patients with gastric ulcer.
Keywords: gastric ulcer, H.pylori, pharmacoeconomic indicators, efficiency.
Introduction. Among servicemen of the Armed Forces of Ukraine digestive diseases rank fourth among other internal diseases [1, 6]. In the structure of the digestive system diseases about 81% are acid-dependent conditions, almost half of which at the hospital stage is gastric ulcer (GU) and duodenal ulcer (DU) [6]. It should be noted that among the combatants there are often such features of GU as asymptomatic course, prone to recurrence and bleeding [8]. In addition, in the period 2014-2018 among servicemen there was an increase in the number of hospitalizations for gastric ulcer, which may be due to the negative impact of stress, at this time the share of duodenal ulcer has a general tendency to decrease [5]. It was found that the use of anti-Helicobacter pylori therapy schemes according to Maastricht V with the addition of colloidal bismuth subcitrate (CBS) increases the effectiveness of eradication in Ukraine up to 90% [2]. The use of CBS may be recommended for empirical initial therapy of H.pylori-associated diseases of the stomach and duodenum [9]. In addition, the success of eradication depends on the choosing of proton pump inhibitor (PPI). Research data indicate a higher efficiency of rabeprazole compared to first-generation PPI in eradication therapy schemes [4, 7].
Objective. To analyze the clinical effectiveness and pharmacoeconomic efficiency of treatment regimens for gastric ulcer among servicemen.
Materials and methods. The study was conducted by analyzing the clinical course, clinical effectiveness and pharmacoeconomic efficiency of treatment regimens of servicemen treated at the National Military Medical Clinical Center "Main Military Clinical Hospital" for H.pylori-associated GU. There were 40 patients with H.pylori-associated GU under observation, and the diagnosis was confirmed by clinical and endoscopic examinations. The inclusion criteria were actual servicemen of the Armed Forces with gastric ulcer associated with H.pylori. Exclusion criteria - patients with non-ulcer affections of the stomach, retirees of the Armed Forces, servicemen of other military formations. All patients had a clinical examination which consisted of collecting complaints of patients with the
main gastric symptoms (epigastric pain, nausea, epigastric severity, bloating), collecting medical history, determining risk factors and physical examination of patients. General clinical examinations, gastroscopy, ultrasound of abdominal organs, diagnosis of H.pylori infections by determination of H.pylori antigen in feces at the beginning and 4 weeks after completion of anti-Helicobacter pylori therapy were also performed. Quality of life studies (QOL) were performed using the «SF-36 Health Status Survey» questionnaire.
Patients were distributed into 2 groups according to the treatment regimen.
Clinical group I included 20 servicemen who received rabeprazole 20 mg twice a day, CBS 120 mg 4 times a day, amoxicillin 1000 mg twice a day, and clar-ithromycin 500 mg twice a day. The duration of anti-Helicobacter pylori therapy course was 14 days.
Clinical group II included 20 servicemen who received omeprazole 20 mg twice a day, clarithromycin 500 mg twice a day, and amoxicillin 1000 mg twice a day. The duration of anti-Helicobacter pylori therapy course was 14 days.
In the absence of endoscopic healing of the ulcer defect after 14 days additional antisecretory and cyto-protective therapy was prescribed:
- for clinical group I - rabeprazole 20 mg 2 twice a day, CBS 120 mg 4 times a day. The duration of therapy is 28 days;
- for clinical group II - omeprazole 20 mg 2 twice a day, CBS 120 mg 4 times a day. The duration of therapy is 28 days.
In case of unsuccessful eradication 4 weeks after treatment, patients from both groups were recommended second-line anti-Helicobacter pylori therapy which included rabeprazole 20 mg twice a day, CBS 120 mg 4 times a day, metronidazole 500 mg 3 times a day, tetracycline 500 mg 4 times day. The duration of treatment is 14 days.
The effectiveness of treatment (integral indicator) was calculated using the formula of A. P. Gradov, V. B. Grinevich, 2000 [3] (1)
E = clinical efficacy (points)*0.7 + AQOL*0.3 (1)
where: AQOL is an increase in the quality of life of the examined during the course of treatment, in points.
Clinical effectiveness was calculated using the formula (2):
Clinical effectiveness = K1*Xe1 + K2*Xe2 (2) where: Xe1 is an effectiveness parameter (from 1 to 7 points) which is inversely proportional to the healing time of the ulcer;
Xe2 is an effectiveness parameter (from 1 to 7 points) which is directly proportional to the frequency of eradication
K1 and K2 are the corresponding coefficients of significance (K1 = 0.2, K2 = 0.8).
The cost of an extra cost-utility unit (CU) per patient was calculated using the formula (3): ACU = CU1-CU2/n (3) where: CU1 - cost-utility for clinical group I; CU2 - cost-utility for clinical group I; n is the number of patients. Pharmacoeconomic analysis was performed by comparing cost-efficiency and cost-utility in comparison groups. The cost of treatment was determined by the price of drugs in the pharmacy network at the time of the study.
The cost of drugs for patients of clinical group I was: rabeprazole (20 mg № 20) - UAH 94.76, CBS (120 mg № 100) - UAH 224.40, amoxicillin (500 mg № 20) - UAH 68.56, clarithromycin 500 mg № 14) -UAH 127.25, total UAH 704.8 per 1 patient.
The cost of drugs for patients of clinical group II was: omeprazole (20 mg № 30) - UAH 56.28, amoxicillin (500 mg № 20) - UAH 68.56, clarithromycin (500 mg № 14) - UAH 127.25, total UAH 499.00 per 1 patient.
The cost of additional cytoprotective and antise-cretory therapy for 28 days:
- for clinical group I - rabeprazole (20 mg № 20) -UAH 94.76, CBS (120 mg № 100) - UAH 224.40; total for 1 patient UAH 516.66;
Table 1
The cost of medical care for servicemen with different schemes of anti-Helicobacter pylori therapy, antisecretory
and cytoprotective therapy of gastric ulcer
- for clinical group II - omeprazole (20 mg № 30)
- UAH 56.28, CBS (120 mg № 100) - UAH 224.40; total UAH 356.38 per 1 patient.
The cost for the second line of anti-Helicobacter pylori therapy for patients of both groups was: rabeprazole (20 mg № 20) - 94.76 UAH, CBS (120 mg № 100)
- 224.40 UAH, metronidazole (500 mg № 10) - 29.65 UAH, tetracycline (100 mg № 20) - UAH 16.50; total UAH 613.86 per 1 patient.
The cost of endoscopic examination was UAH 600.0. The cost of consultation with a gastroenterologist was UAH 350.0. The cost of the test to determinate of H.pylori antigen in feces - UAH 300.0.
Results. Clinical remission (significant reduction of pain, dyspeptic and emetic syndromes) in patients of group I who received bismuth-containing scheme based on rabeprazole was achieved by (4.6±1.1) days, in patients of group II who received standard scheme with omeprazole - by (5.0±1.4) days from the beginning of treatment. Eradication, confirmed 4 weeks after the end of anti-Helicobacter pylori therapy, occurred in 18 (90.0%) patients of group I and in 15 (75.0%) patients of group II. The cost of the course of treatment for patients in group II using AGBT with omeprazole was 29.2% lower than the cost of the course for patients in group I.
Taking into account the additional outlays of treatment (the need for the second line anti-Helicobacter pylori therapy, endoscopic examination, eradication control, additional consultations with a gastroenterologist) the cost of treatment in group II was 1.12 times higher (12%) (Table 1).
The overall clinical effectiveness (clinical effectiveness index) in patients of group I was 5.6 points, in patients of group II - 4.9 points. The integrated indicator of treatment effectiveness, which takes into account the index of clinical effectiveness and increase in quality of life during treatment, reached 5.8 points in group I, and 4.9 points in group II.
Parameter Group I n=20 Group II n=20
Cost of treatment (per patient), UAH 704,8 499,0
Number of patients x20=14096,0 x20=9980,0
Additional PPI and CBS therapy for 28 days 516,66 356,38
Number of patients x2=1033,32 x5=1781,9
Extra cost of for the second line anti-Helicobacter pylori therapy, UAH 613,86 x2=1227,72 613,86
Number of patients x5=3069,30
Additional endoscopic examination, UAH 600 600
Number of patients x2=1200 x5=3000
Additional eradication control, UAH 300 300
Number of patients x2=600 x5=1500
Additional consultation with a gastroenterologist, UAH 350 350
Number of patients x2=700 x5=1750
Total, UAH 18857,04 21081,2
Table 2
Cost- efficiency analysis of medical care for servicemen with different schemes of anti-Helicobacter pylori ther-_apy, antisecretory and cytoprotective therapy of gastric ulcer_
Parameter Group I n=20 Group II n=20
Total costs, UAH 18857,04 21081,2
Clinical effectiveness index, points 5,6 4,9
Cost- efficiency, UAH/point 3367,3 4302,3
Cost- efficiency ratio of treatment regimens with rabeprazole and omeprazole 1,28
Table 3 Cost-utility analysis of medical care for servicemen with different regimens of anti-Helicobacter pylori therapy, antisecretory and cytoprotective therapy of gastric ulcer
Parameter Group I n=20 Group II n=20
Total costs, UAH 18857,04 21081,2
Clinical effectiveness index, points 5,6 4,8
Increase in the quality of life (points) 6,3 5
Integral indicator of treatment effectiveness 5,8 4,9
Cost-utility (UAH/point) 3251,2 4302,3
Cost of an extra cost-utility unit (UAH/point) per patient 52,6
Cost-utility ratio of treatment regimens with rabeprazole and omeprazole 1,32
Analysis of the effectiveness of various gastric ulcer treatment regimens shows a positive effect of treatment to the disease course with increasing QOL in the group of patients receiving rabeprazole, CBS, amoxi-cillin and clarithromycin by 6.3 points, and in the group of omeprazole, clarithromycin and amoxicillin - by 5.0 points.
Analyzing the costs of different regimens of anti-Helicobacter pylori, acid-suppressive and cytoprotec-tive therapy of GU found a higher cost of treatment in group I patients (12%), compared with group II (Table 1). However, further analysis of other pharmacoeco-nomic indicators revealed that the cost- efficiency of the course of treatment with rabeprazole, CBS, amoxicillin and clarithromycin 1.28 times (28%) is better (Table 2), as well as the cost-utility - 1,32 times (32%) higher than for treatment with omeprazole, clarithro-mycin and amoxicillin (Table 3). The anti-Helicobacter pylori activity of the second treatment complex did not reach the values recommended by international agreements, and contributed to the eradication of H.pylori infection after 4 weeks in 75% of patients.
Conclusions. Clinical and pharmacoeconomic analysis of modern anti-Helicobacter pylori, antisecre-tory and cytoprotective therapy of HP-associated gastric ulcer showed the advantage of a bismuth-containing regimen of anti-Helicobacter pylori therapy using domestic rabeprazole compared to first-generation PPI (omeprazole). This is substantiated by higher anti-Hel-icobacter pylori activity and faster scarring of the ulcer defect (in 90% of patients of group I against 75% of patients of group II), better cost- efficiency (by 28%) and higher (by 32%) cost-utility in group I.
The use of modern anti-Helicobacter pylori therapy regimens based on domestic rabeprazole and colloidal bismuth in servicemen with H.pylori-associated peptic ulcer is optimal from the point of view of phar-macoeconomics, and thus will improve the efficiency
and quality of treatment and avoid unnecessary budgetary costs for treatment.
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THE EFFECTIVENESS OF CYTOLOGICAL EXAMINATION IN THE DIAGNOSIS OF CERVICAL
INTRAEPITHELIAL NEOPLASIAS
Gasanguseynova Zh.,
- 4th year student, FSBEI HE «Dagestan State Medical University», Ministry of Health of the Russian
Federation, Makhachkala; Gasanbekova Z.,
PhD, doctor-oncogynecologist of LLC m/k "Your Doctor";
Isaeva Z.
PhD, Chief Physician of LLC m /c "Your Doctor".
ЭФФЕКТИВНОСТЬ ЦИТОЛОГИЧЕСКОГО ИССЛЕДОВАНИЯ ПРИ ДИАГНОСТИКЕ ЦЕРВИКАЛЬНЫХ ИНТРАЭПИТЕЛИАЛЬНЫХ НЕОПЛАЗИЙ
Гасангусейнова Ж.А.,
студентка, ФГБОУ ВО «Дагестанский государственный
медицинский университет» МЗ РФ, Махачкала; Гасанбекова З.А., к.м.н., врач-онкогинеколог ООО м/к «Ваш доктор»;
Исаева З.У.
к.м.н., главный врач ООО м/к «Ваш доктор».
Abstract
Despite the introduction of cytological screening in most countries, there is a disproportionately high incidence and death rate from cervical cancer.
The quality of the cytological examination is influenced by the skills of the doctor - gynecologist, the experience of the doctor - cytologist and the design of the device for sampling material from the cervix. Inadequate smears tend to give incorrect results. Diagnostic errors made during cytological examination, as the most significant stage in the diagnostic search for cervical pathology, formed the basis of this article.
Аннотация
Несмотря на внедрение цитологического скрининга в большинстве стран, существует непропорционально высокий уровень заболеваемости и смертности от рака шейки матки.
На качество цитологического исследования влияют навыки врача - гинеколога, опыт врача - цитолога и конструкция устройства для забора материала с шейки матки. Неадекватные мазки, как правило, дают неверные результаты. Диагностические ошибки, допущенные при цитологическом исследовании, как наиболее значимого этапа диагностического поиска патологии шейки матки, легли в основу данной статьи.
Keywords: cervical cancer; cervical screening; cytology; prevention.
Ключевые слова: рак шейки матки; цервикальный скрининг; цитология; профилактика.
Введение.
Проблема рака шейки матки в настоящее время остается актуальной, так как затрагивает наиболее активную во всех отношениях социально значимую часть женского населения и приобретает все большее значение.
Основная цель организованных национальных программ скрининга рака шейки матки - снизить заболеваемость и смертность от этого злокачественного новообразования [1].
Частота выявления аномалий шейки матки существенно различается в зависимости от того, проводится ли обследование в плановом порядке в смотровом кабинете или в специализированных кабинетах по патологии ш/матки [2]. Цервикальная интраэпителиальная неоплазия требует межпрофессионального командного подхода, включающего врачей, специалистов, специально обученных медсестер и цитологов, сотрудничающих в разных дисциплинах для достижения оптимальных результатов для пациентов. [3].
