50 research outputs found
Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections
The inspection of pharmacovigilance systems is regulated by the Good Pharmacovigilance Practices (GVP) and local laws and regulations. Inspections may be carried out by audit teams of competent authorities as part of regulatory activities or business agreements. So far, there have been no studies dealing with rate setting for competent authorities labour costs in connection with onsite or documentary inspections of pharmacovigilance systems.The aim of the study was to develop scientifically valid rate setting criteria for labour costs related to onsite or documentary inspections of pharmacovigilance systems.Materials and methods: the assessment of labour costs was carried out by surveying experts of two Eurasian Economic Union (EAEU) countries who have experience in preparing and conducting evaluation and inspection of pharmacovigilance systems. The calculation of the experts’ time costs was performed automatically using the CrocoTime software. The expected workload for experts in 2022 was estimated based on the reports over the last 5 years (2016–2020) containing information on the number of foreign marketing authorisations, and the number of medicines under development according to national registers of medicinal products of the EAEU member states.Results: the study calculated the average expert labour costs and estimated workload for the EAEU competent authorities in 2022. It was demonstrated that the average labour costs are comparable in EAEU member states, however, estimated amount of labour may change (both increase or decrease).Conclusions: further study of rate setting for labour costs related to pharmacovigilance documentary inspections and study of competent authorities staffing could be performed by a dedicated division, e.g. of the Eurasian Academy of Good Practices. A constructive discussion of approaches to the improvement of control over pharmacovigilance systems will increase availability of efficacious and safe medicines of assured quality for the population and help pharmaceutical companies and regulatory authorities manage financial and reputational risks
Modified Ross operation (literature review)
One of the surgical methods for treating aortic valve pathology is the Ross operation, which was proposed by the British cardiac surgeon D. Ross in 1967. Numerous studies have shown excellent long-term outcomes of this operation. However, in some patients, pulmonary autograft dilatation may occur in the long term. To avoid this complication, technical modifications of this procedure have been proposed. A literature review on modified Ross operation as a prevention of pulmonary autograft dilatation is presented
Transcatheter Aortic Valve Replacement in Aortic Stenosis: a Clinical Case
Background. Aortic valve stenosis is common with prevalence of about 0.5 %, peaking in people aged over 70 years mostly due to age-related valve calcification. The year 2002 was marked by the invention and use of the endovascular aortic replacement valve by an A. Cribier’s group of French surgeons. Russian endovascular surgery introduced transcatheter aortic valve replacement in 2009, having since built an extensive experience in this practice. Perioperative mortality in patients under 70 years with no serious comorbidity ranges from 1 to 3 %, however, reaching two-fold 4–8 % in elderly patients. The emergence of minimally invasive technologies offered cure to critical patients, who would merely not get over an open surgery.Materials and methods. This case study provides video recordings of transcatheter aortic valve replacement (Accurate Neo) in transfemoral approach performed for the first time in the Republic of Bashkortostan. Patient K., 70 yo, diagnosis: Atherosclerosis. Aortic valve stenosis. FC III. Complications: aortic valve calcification st. III, CHF II A, FC III, persistent atrial fibrillation, tachysystole. Comorbid: CHD. Exertional angina. FC III. CHF II A, FC III.Results and discussion. Improving the transcatheter valve type facilitates an optimal individual aortic valve selection. Pre-replacement valvuloplasty was performed in all patients. The valve replacement is followed by transoesophageal echocardiography to justify possible aortic valve post-dilatation upon marked paravalvular regurgitation. The implant positioning relative to the aortic valve fibrous crown and mitral valve flaps is precisely controlled with ultrasound.Conclusion. Interventional radiology currently provides high-quality, effective, minimally invasive medical aid even in aortic stenosis patients with multiple comorbidity. In the patient’s denial of open surgery, transcatheter aortic valve replacement represents a sole alternative treatment, also increasing the life expectancy and quality. A wider diversity of available transcatheter devices enables a better personalisation of the biological valve replacement procedure
Assessment of awareness of workers of the forensic medical service of the republic of Tatarstan (bureau) about tuberculosis infection
Purpose of the study — to examine the awareness of bureau personnel about the main issues of tuberculosis infection, its prevention, ways of infection, diagnosis, and clinical manifestationsЦель исследования — изучить информированность персонала бюро об основных вопросах туберкулезной инфекции, ее профилактике, способах заражения, диагностике и клинических проявления
ОПЫТ ПРИМЕНЕНИЯ СКАФФОЛДОВ «ABSORB» В ОТДЕЛЕНИИ РЕНТГЕНЭНДОВАСКУЛЯРНЫХ ДИАГНОСТИКИ И ЛЕЧЕНИЯ КЛИНИКИ БГМУ
The article gives a short review of сase records of ABSORB Scaffolds Application in patients with ischemic heart disease. All patients underwent endovascular procedures in the Department of Roentgen-Endovascular Diagnostics and Treatment of Bashkir State Medical University Clinic.В статье описан опыт проведения чрескожной транслюминальной коронарной ангиопластики с имплантацией скаффолдов «Absorb» у пациентов с ишемической болезнью сердца в отделении рентгенэндоваскулярных методов диагностики и лечения Клиники БГМУ.
Транскатетерная имплантация аортального клапана при стенозе аортального отверстия: клинический случай
Background. Aortic valve stenosis is common with prevalence of about 0.5 %, peaking in people aged over 70 years mostly due to age-related valve calcification. The year 2002 was marked by the invention and use of the endovascular aortic replacement valve by an A. Cribier’s group of French surgeons. Russian endovascular surgery introduced transcatheter aortic valve replacement in 2009, having since built an extensive experience in this practice. Perioperative mortality in patients under 70 years with no serious comorbidity ranges from 1 to 3 %, however, reaching two-fold 4–8 % in elderly patients. The emergence of minimally invasive technologies offered cure to critical patients, who would merely not get over an open surgery.Materials and methods. This case study provides video recordings of transcatheter aortic valve replacement (Accurate Neo) in transfemoral approach performed for the first time in the Republic of Bashkortostan. Patient K., 70 yo, diagnosis: Atherosclerosis. Aortic valve stenosis. FC III. Complications: aortic valve calcification st. III, CHF II A, FC III, persistent atrial fibrillation, tachysystole. Comorbid: CHD. Exertional angina. FC III. CHF II A, FC III.Results and discussion. Improving the transcatheter valve type facilitates an optimal individual aortic valve selection. Pre-replacement valvuloplasty was performed in all patients. The valve replacement is followed by transoesophageal echocardiography to justify possible aortic valve post-dilatation upon marked paravalvular regurgitation. The implant positioning relative to the aortic valve fibrous crown and mitral valve flaps is precisely controlled with ultrasound.Conclusion. Interventional radiology currently provides high-quality, effective, minimally invasive medical aid even in aortic stenosis patients with multiple comorbidity. In the patient’s denial of open surgery, transcatheter aortic valve replacement represents a sole alternative treatment, also increasing the life expectancy and quality. A wider diversity of available transcatheter devices enables a better personalisation of the biological valve replacement procedure.Введение. На сегодня стеноз аортального клапана является распространенным заболеванием среди населения и составляет порядка 0,5 %. Особенно резко повышаются показатели заболеваемости среди группы лиц старше 70 лет, причиной чего, как правило, служит возрастная кальцификация створок. 2002 год ознаменовался созданием и имплантацией эндоваскулярного протеза аортального клапана французскими хирургами во главе с A. Cribier. Российские эндоваскулярные хирурги внедрили в практику транскатетерное протезирование аортального клапана в 2009 году, и с тех пор накоплен достаточно большой опыт применения подобных технологий. Периоперационная летальность у больных до 70 лет без наличия серьезных сопутствующих заболеваний колеблется от 1 до 3 %. Однако у пациентов пожилого возраста показатели летальности увеличиваются в два раза — 4–8 %. Благодаря малоинвазивным технологиям пациенты с критическими состояниями здоровья, которые бы просто не перенесли «открытую» операцию, получили шанс на излечение.Материалы и методы. В данном клиническом случае продемонстрирован видеоматериал транскатетерной имплантации аортального клапана (модель Accurate Neo) трансфеморальным доступом, впервые выполненной в Республике Башкортостан пациенту К. 70 лет с диагнозом: атеросклероз. Стеноз аортального клапана. ФК III ст. Осложнения: кальциноз аортального клапана III ст., ХСН II А, ФК III ст., фибрилляция предсердий постоянная форма, тахисистолический вариант. Сопутствующий: ИБС. Стенокардия напряжения. ФК III ст. ХСН IIА, ФК III ст.Результаты и обсуждение. Появление нового усовершенствованного вида транскатетерного клапана позволило подбирать для пациента наиболее подходящий аортальный клапан. Перед имплантацией всем пациентам была выполнена вальвулопластика. После имплантации аортального клапана выполняется чреспищеводная эхокардиография, по данным которой, при необходимости, в связи с выраженной паравальвулярной регургитацией пациенту выполняется постдилатация аортального клапана. Также при помощи Эхо-КГ-контроля производится полноценная оценка положения протеза относительно фиброзного кольца аортального клапана и расположения относительно створок митрального клапана.Заключение. В настоящее время рентгенэндоваскулярные методы позволяют пациентам со стенозом аортального отверстия получить качественную, эффективную, малоинвазивную медицинскую помощь даже при условии множественной сопутствующей патологии. При отказе больного от коррекции данной патологии открытым оперативным путем транскатетерная имплантация аортального клапана является альтернативным и единственным методом лечения, а также увеличения качества и продолжительности жизни. Появление различных видов транскатетерных устройств позволяет улучшить подбор биологического клапана под каждого пациента в индивидуальном порядке
КЛИНИЧЕСКИЙ СЛУЧАЙ ЭНДОВАСКУЛЯРНОГО ЛЕЧЕНИЯ ПОСТТРАВМАТИЧЕСКОЙ АНЕВРИЗМЫ ПОЧЕЧНОЙ АРТЕРИИ
Introduction. Aneurysm of renal artery is a rare and complex pathology of renal bloodstream. Large percentage of observations show that renal artery aneurysms are iatrogenic and happen due to urological interventions. Traumatic aneurysms are much less frequent. By the nature of the blood supply arterial aneurysms are subdiveded into those, which occur when the injured organ is only artery and arteriovenous aneurysms that occur while an artery is damaged along with the accompanying veins. Aneurysms may be treated only surgically, and the only exception is pregnancy. It is possible to use the open treatment option such as aneurysm resection with prosthetics, reanastomosing or its collateral plastics of the renal artery; exclusion of aneurysm with shunting of renal artery or its branches; resection of aneurysm with anastomosing of artery with azygos splanchnic arteries; complex reconstruction using autovein or internal iliac artery segment; including kidney resection at local infarction or nephrectomy in the case of evident nephrosclerosis.Materials and methods. This paper presents a clinical case of successful minimally invasive surgical treatment of traumatic aneurysm of renal artery. It was carried out through stenting of the right lowpolar renal artery: a coronary sheath was used to transfuse and implant the Explorer-Itgimedical Aneugraft 3.0 * 18.0 mm graft-system; the stent-graft was implanted into the right lowpolar renal artery so that it covers the aneurysm ostium. Results. The above case shows the possibility to successfully apply the endovascular method to treat posttraumatic aneurysms of renal arteries with derivative circulation.Conclusion. This technique can be safely and successfully used as an alternative to the traditional «open» surgery, as it is minimally invasive, and allows performing a complete blockade of the pathological blood flow and to avoid an additional operating trauma and compromenation of distal branches. Введение. Аневризма почечных артерий – редкая и сложная патология сосудистого русла почки. В большом проценте наблюдений аневризмы почечных артерий являются ятрогенными, возникающими в результате интервенционных урологических вмешательств. Травматические аневризмы встречаются значительно реже. По характеру кровоснабжения различают артериальные аневризмы, возникающие при ранении только артерии, и артериовенозные аневризмы, возникающие при одновременном повреждении артерии и сопутствующей вены. Лечение аневризм возможно только хирургическим способом, исключением является только беременность. Возможно применение открытых методов лечения, таких как резекция аневризмы с протезированием, реанастомозированием или ее боковой пластикой почечной артерии; выключение аневризмы с шунтированием почечной артерии или ее ветвей; резекция аневризмы с анастомозированием артерии с непарными висцеральными артериями; сложные реконструкции с использованием аутовены или сегмента внутренней подвздошной артерии; в том числе применение резекции почки при локальном инфаркте или нефрэктомии в случае выраженного нефросклероза. Материалы и методы. В данной работе представлен клинический случай успешного малоинвазивного хирургического лечения травматической аневризмы почечной артерии. Для этого выполнено стентирование правой нижнеполюсной почечной артерии: по коронарному проводнику проведена и имплантирована графт-система Itgimedical Aneugraft 3,0*18,0 мм – стент-графт имплантирован в нижнеполюсную правую почечную артерию с перекрытием шейки аневризмы.Результаты. Приведенный случай показывает возможность успешного применения эндоваскулярного метода для лечения посттравматических аневризм почечных артерий с артериовенозным сбросом.Заключение. Данная методика может безопасно и с успехом применяться в качестве альтернативы традиционного «открытого» хирургического вмешательства, поскольку она малоинвазивна, позволяет выполнять полную блокаду патологического кровотока, избегать дополнительной операционной травмы и компрометации дистальных ветвей.
Применение нового нутрицевтика для улучшения переносимости адъювантной химиотерапии
Introduction. Treatment of malignant neoplasms often requires adjuvant chemotherapy (ACT). In real-life clinical practice, a high proportion of patients develop serious toxicities of anticancer therapy. Thus, the need to reduce treatment toxicity while maintaining the same dose levels of chemotherapeutic agents is a pressing challenge in oncology. This article presents the results of the study assessing the effects of the complex nutraceutical Oncoxin on ACT tolerability.Materials and methods. The study included 133 patients aged 50 to 70 years with stage IIB — IIIC gastric cancer or stage IIB — IIIA non-small-cell lung cancer; 84 patients received Oncoxin, and 49 were in the control group.Results. The study revealed that after two weeks, patients receiving Oncocoxin had a twice higher chance of significant (obvious) improvement in their quality of life (ESAS questionnaire) compared to the control group: OR 2.07 [95% CI 1.00-4.29]. By the end of the follow-up period (3 weeks), patients receiving Oncoxin had a significantly higher albumin level compared to the control group (38.1 [95% CI 37.1-39.1] g/L and 35.5 [95% CI 33.9-37.0], р =0.03, respectively). Moreover, the use of Oncoxin allowed significant reducing ACT-related liver toxicity.Conclusions. This study conducted within our current clinical practice showed for the first time a high efficacy of Oncoxin in improving the quality of life of patients and reducing ACT toxicity.Введение. Лечение злокачественных новообразований часто требует применения адъювантной химиотерапии (АХТ). В реальной клинической практике доля пациентов, имеющих серьёзные проявления токсичности противоопухолевого лечения, достаточно высока. Таким образом, необходимость снижения токсичности терапии и сохранение интенсивности дозы химиопрепаратов являются актуальной задачей онкологии. Данная статья посвящена результатам исследования влияния многокомпонентного нутрицевтика Онкоксин на переносимость АХТ.Материалы и методы. В исследование было включено 133 больных раком желудка МВ-ШС или немелкоклеточным раком лёгких ПВ-ША в возрасте 50- 70 лет; 84 получали Онкоксин, 49 составили контрольную группу.Результаты. Было установлено, что через две недели шансы больных, получавших Онкоксин, на значимое (безусловное) улучшение качества жизни (вопросник ESAS) были в два раза выше в сравнении с группой контроля: ОШ = 2,07 [95% ДИ 1,00- 4,29]. К окончанию периода наблюдения (3 недели) в группе пациентов, использовавших Онкоксин, уровень альбумина был значительно выше в сравнении с контрольной группой (38,1 [95% ДИ 37,1- 39,1] г /л и 35,5 [95% ДИ 33,9-37,0], р = 0,03, соответственно). Кроме этого, применение Онкоксина позволило существенно снизить печёночную токсичность АХТ.Выводы. Данное исследование, проведённое в рамках существующей клинической практики, впервые показало высокую эффективность Онкоксина в улучшении качества жизни пациентов и снижении токсичности АХТ
Зомета в терапии рака предстательной железы с метастатическим поражением костей на фоне андрогенной депривации (результаты Российского многоцентрового исследования)
Introduction: Hormonal therapy is the method of choice in treating disseminated prostate cancer. Chronic androgenic suppression causes a reduction in bone mineral density. The most common complications of bone metastases are pathological fractures, spinal cord compression, pain, etc.Methods: A multicenter study (11 clinics of Russia) assessing the efficacy of Zometa in preventing skeletal complications of bone metastases was conducted in 2004—2005. Zometa was administered intravenously at a dose of 4 mg every 3Р4 weeks with androgenic deprivation. Its objective effect was evaluated in 70 patients. Changes in bone mineral density were evaluated by densitometry.Results: Complete pain relief was achieved in 73% of the patients; after therapy 86% of the patients had 0—1 WHO activity status score, 97% of the patients had no bone complications. The level of bone resorption marker β-Cross-Laps decreased to the normal values in 51% of the patients.Conclusion: The study has provided an evidence of the efficacy of Zometa and the necessity of using this drug in complex therapy for bone metastases of prostate cancer.Introduction: Hormonal therapy is the method of choice in treating disseminated prostate cancer. Chronic androgenic suppression causes a reduction in bone mineral density. The most common complications of bone metastases are pathological fractures, spinal cord compression, pain, etc.Methods: A multicenter study (11 clinics of Russia) assessing the efficacy of Zometa in preventing skeletal complications of bone metastases was conducted in 2004—2005. Zometa was administered intravenously at a dose of 4 mg every 3Р4 weeks with androgenic deprivation. Its objective effect was evaluated in 70 patients. Changes in bone mineral density were evaluated by densitometry.Results: Complete pain relief was achieved in 73% of the patients; after therapy 86% of the patients had 0—1 WHO activity status score, 97% of the patients had no bone complications. The level of bone resorption marker β-Cross-Laps decreased to the normal values in 51% of the patients.Conclusion: The study has provided an evidence of the efficacy of Zometa and the necessity of using this drug in complex therapy for bone metastases of prostate cancer
Assessment of in Vitro Comparative Dissolution Kinetics of Moxonidine Products as a Factor Potentially Determining Effectiveness of Antihypertensive Treatment
Aim. Investigation of comparative dissolution kinetics of generic medicinal products containing moxonidine versus reference drug. Material and methods. Objects of the research were film-coated tablets containing moxonidine (INN) in a dose 0.4 mg: a reference drug Physiotens® and 4 generic drugs. In vitro dissolution test of moxonidine from the study drugs was performed using comparative dissolution kinetics test (CDKT). The CDKT was performed in the media with the following pH: 1.2 (1:9 mixture of 0.1 M hydrochloric acid and water), 4.5 (acetate buffer solution, prepared as per State Pharmacopoeia, XIII), and 6.8 (phosphate buffer solution, prepared as per State Pharmacopoeia, XIII). The sampling for dissolved moxonidine was performed 5, 10, 15, 20, and 30 min after the test was started. An high performance liquid chromatography method with ultraviolet detection at 220 nm was used to assay. Results. Within 15 min more that 85% of moxonidine dissolved from the reference drug and all study drugs at pH 1.2; dissolution profiles were similar without calculation of similarity factor f2. Similarly, at pH 4.5 dissolution profiles of study drugs #2 and #3 were similar to that of the reference drug, and the similarity factor f2 was not calculated. However, in case of study drugs #1 and #4 significant differences were observed at a single time point (15 min), which suggests that their dissolution profiles are non-similar to that of the reference drug. Similarity factors f2 were calculated 17.52 and 35.30, respectively (less than 50). At pH 6.8 similarity factors f2 for all study generic drugs were also less than 50 (23.8, 49.8, 38.6, and 35.9), so their dissolution curves were non-similar to that of reference drug. Conclusion. In our study we observed difference in release in vitro of medicinal products containing moxonidines: none of the study drugs was fully similar to the reference drug in all media. The differences observed at pH 6.8 were noteworthy, where the samples had or faster kinetics (study drugs #2 and #3), or slower dissolution kinetics (test drugs #1 and #4). Observed differences in moxonidine release rate may impact absorption of active pharmaceutical ingredient into the blood following drug administration