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Эффективность и безопасность применения аГнРГ «Бусерелин-лонг ФС» у пациенток с эндометриозом в позднем репродуктивном возрасте (клиническое исследование)Д.м.н., проф. С.н. БуЯнОвА, к.м.н. е.л. БАБунАшвИлИ, е.С. зуБОвА, к.м.н. н.в. ЮДИнА, к.м.н. И.Д. рИЖИнАшвИлИ ГБуз МО «Московский областной научно-исследовательский институт акушерства и гинекологии» (дир. -акад. рАн, проф. в.И. Краснопольский) Минздрава Московской области, Москва, россия Клиническое исследование проводилось в 2012 г. на базе нескольких лечебных учреждений россии, в том числе и в условиях гинекологического отделения Государственного бюджетного учреждения здравоохранения Московской области «Московский областной научно-исследовательский институт акушерства и гинекологии». Цель исследования -изучение эффективности и безопасности препарата «Бусерелин-лонг ФС» в дозе 3,75 мг, лиофилизата для приготовления суспен-зии для внутримышечного введения пролонгированного действия, производства зАО «Ф-Синтез», россия, у пациенток позднего репродуктивного возраста с эндометриозом матки. Материал и методы. Протокол клинического исследования включал 50 пациенток в возрасте от 35 до 45 лет с диагнозом: эндометриоз матки I, II, III стадии, подтвержденный эхогра-фически и гистероскопически с миомой матки или без нее, которым было проведено лечение препаратом «Бусерелин-лонг ФС» с последующей оценкой эффективности терапии. Результаты. установлено, что эффективность лечения препа-ратом «Бусерелин-лонг ФС» у 44 пациенток соответствовала всем установленным четырем критериям комбинированной конечной точки исследования: снижению показателей лГ менее 7,4±7,3 мМе/мл, ФСГ -менее 7,0±5,6 мМе/мл, эстра-диола -менее 110,0 пмоль/л, толщины срединного маточного эха -до 4-6 мм. у 6 пациенток наблюдалось несоот-ветствие по 1 критерию: снижению уровня эстрадиола -у 5, величине снижения срединного маточного эха -у 1. ухуд-шения состояния здоровья, досрочного прекращения исследования по причине возникновения нежелательных явлений или серьезных нежелательных явлений не отмечено. По отдаленным результатам исследования (в течение 3 лет после окончания исследования) у 86% пациенток улучшилось качество жизни после проведенной терапии. 4 пациентки родили здоровых детей. Заключение. Применение данного препарата является безопасным и эффективным методом лечения больных с эндометриозом матки, который обеспечивает максимальный клинический эффект с минимальными побочными реакциями, что делает его препаратом выбора в терапии данного заболевания.Авторы информируют об отсутствии конфликта интересов. This clinical trial was conducted in 2012 in several healthcare facilities of russia, including at the Department of Gynecology, Moscow regional research Institute of Obstetrics and Gynecology, Ministry of health of the Moscow region.Objective: to investigate the efficacy and safety of Buserelin-long Fs at a dose of 3.75 mg, a lyophilisate (JsC "F-sintez", russia) to prepare a long-acting intramuscular suspension in late reproductive-aged patients with uterine endometriosis. Subjects and methods. The cl...

VACCINE PROPHYLAXIS OF PNEUMOCOCCAL INFECTION AMONG PREMATURE INFANTS WITH BRONCHOPULMONARY DYSPLASIA Introduction. Bronchopulmonary dysplasia (BPD) is the most common chronic lung disease among children of the first year of life, especially children born prematurely with extremely low and very low body weight. Material and methods. To estimate the number of children born alive in Perm Territory between 2015 and 2017, official statistics data were used. Experimental epidemiological studies were used to assess safety, reactogenicity, immunogenic activity and preventive efficacy of the Prevnar 13 vaccine when immunizing preterm infants with bronchopulmonary dysplasia under prospective controlled randomized clinical observation. Results. There were 29 premature infants with bronchopulmonary dysplasia under observation, the control group comprised 29 unvaccinated premature infants with BPD and 30 full-term infants. The PCV 13 vaccination of preterm infants with BPD established good tolerance, poor reactogenicity (17.2±0.57%) and vaccine tolerance like full-term infants (16.5±0.55%), high safety profile, high immunogenic properties (seroconversion-93.1%, seroconversion factor-5.5). Evaluation of immunogenic activity among children with BPD vaccinated with the PCV 13 vaccine revealed high immunological efficacy compared to unvaccinated healthy children. Conclusion. The need for vaccination of premature babies with BDL against pneumococcal infection has been scientifically substantiated. The study has confirmed safety, poor reactogenicity, high immunogenic activity and preventive efficacy of the Prevenar 13 vaccine among premature babies with BDL under the conditions of the catamnesis department of the perinatal center within the follow-up monitoring of vaccinated infants over three years. Cuvinte cheie: vaccin VPC13, infecție pneumococică, displazie bronhopulmonară. VACCINOPROFILAXIA INFECȚIEI PNEUMOCOCICE LA SUGARII NĂSCUȚI PREMATUR, DIAGNOSTICAȚI CU DISPLAZIE BRONHOPULMONARĂ Introducere. Cea mai frecventă boală pulmonară cronică la copii în primul an de viață, în special la sugarii născuți prematur, cu o greutate corporală foarte mică, este displazia bronhopulmonară (DBP). Material și metode. Pentru a estima numărul copiilor născuți vii în perioada 2015-2017, în regiunea Permi, Rusia au fost utilizate datele statistice oficiale. Au fost proiectate studii epidemiologice experimentale pentru evaluarea eficacității profilactice și a reactivității, demonstrarea siguranței și activității imunogene a vaccinului pneumococic conjugat (VPC 13) la imunizarea sugarilor născuți prematur cu DBP. Rezultate. Au fost investigați 29 de copii născuți prematur, diagnosticați cu DBP și pentru comparație-29 de copii născuți prematur, nevaccinați cu DBP și, respectiv, 30 de copii născuți la termen. Vaccinul VPC 13 administrat la sugarii născuți prematur care suferă de DBP a stabilit o toleranță bună, reactivitate scăzută (17,2±0,57%) și toleranță similară la vaccin ca și la copiii născuți la termen (16,5±0,55%), siguranță înaltă, propriet...

Background. It is required to perform estimation of epidemiological and cost efficacy (regarding morbidity rate) of mass routine vaccination against pneumococcal infection in Russian children and carried out earlier selective vaccination of children from high-risk groups on the basis of four-year experience. It is also important to estimate the rate of hospital admissions in this patient group, long-term and annual cycles, morbidity age and etiology structure, and mortality due to community-acquired pneumonia as one of the most common form of pneumococcal disease. The aim is to study the effect of selective and mass immunization against pneumococcal infection on the morbidity and mortality due to community-acquired pneumonia in children under 5 years of age. Methods. The analysis of communityacquired pneumonia morbidity (in 2003–2018) and mortality due to pneumonias (in 2003–2018) in children under the 14 years old in Perm was carried out. Serotypes of circulating pneumococcus, etiology of community-acquired pneumonias and immunization cost efficacy (direct expense on health care) were further studied. The analysis of study indexes was carried out following selective (vaccination of at-risk children in 2011–2014) and mass (vaccination of infants in 2015–2018) immunization strategies. Results. The morbidity rate of community-acquired pneumonias decreased by 4.0 times (from 267.0 to 66.7 for 1000) after performing selective vaccination (2011–2014) in at-risk children (frequently and chronically ill children). The morbidity rate of community-acquired pneumonias in non vaccinated children of the same group increased by 2.0 times (from 40.0 to 80.0 for 1000 non-vaccinated). The prophylactic efficacy index was 46.0. Whereby the antibacterial index among vaccinated frequently and chronically ill children was 0.11 on one child. This index has decreased by 2.6 times (from 0.11 to 0.04 on one child) in a year within the framework of prospective controlled randomized clinical study. The antibacterial index among non-vaccinated children of this group remained slightly the same: 0.09 and 0.12 respectively. During the selective vaccination the mortality rate among infants decreased by 2 times: long-term average index was 17.9 (2011–2014) against 35.2 (2003-2010) on 100 thousand children. Mass vaccination of infants against pneumococcal infection has reduced the incidence of community-acquired pneumonias among children under 2 years of age and has led to absence of multiple sites of pneumococcal infection in children’s organizations. It also has reduced the number of hospitalized children and achieved zero mortality due to pneumonias in infants by the third year of this immunization strategy implementation. The obtained results were achieved mainly due to circulation of 7 pneumococcal serotypes (6A, 6B, 9V, 14, 19A, 19F, 23F) in children under 5 years of age. The threshold level of vaccination against pneumococcal infection advancing morbidity and mortality due to pneumonias in children was specified. The strategy of mass vaccination of infants was cost-effective. Conclusion. The new data on epidemiological and cost efficacy of various immunization strategies against pneumococcal infection in children was obtained.

Relevance. Bronchopulmonary dysplasia (BPD) is the most frequent chronic pathology of the lungs in children of the first year of life, especially among children born with extremely low and very low  birth weight.Goal. The safety, immunogenicity and preventive efficacy of Prevenar 13 in preterm infants with bronchopulmonary dysplasia were assessedMaterials and methods.There were 29 children under observation, as well as 29 non-vaccinated children as a comparison group. Oxygen support was not needed by any child with BPD. Children in both groups had consequences of perinatal involvement of the central nervous system. Prevenar 13 vaccine was used for immunization.Results. The level vaccine adverse event following immunization in the group of vaccinated children was 16.7 ± 0.07%. One child had a  high body temperature up to 39.5 °C, it was required to prescribe  antipyretic drugs in the age-related dosage. All vaccine adverse event following immunization disappeared on 2 day. Local reactions were not recorded.Conclusions.The use of the Prevenar13 vaccine has established high preventive efficacy among preterm infants with BPD, a decrease in the incidence of otitis media by 3.5 times. Evaluation of  the immunogenicity of the Prevenar 13 vaccine among children with  BPD showed good immunological efficacy (a 4-fold increase in the mean geometric titer of antibodies at 28 days after vaccination).