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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.37489/2588-0519-2024-2-43-50</article-id><article-id custom-type="edn" pub-id-type="custom">PGOWSD</article-id><article-id custom-type="elpub" pub-id-type="custom">clinvest-716</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>КЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL PHARMACOLOGY</subject></subj-group></article-categories><title-group><article-title>Фокус на ломефлоксацин: эффективность и безопасность</article-title><trans-title-group xml:lang="en"><trans-title>Focus on lomefloxacin: effectiveness and safety</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0032-0341</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хохлов</surname><given-names>А. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Khokhlov</surname><given-names>A. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Хохлов Александр Леонидович - д. м. н., профессор, академик РАН, зав. кафедрой фармакологии и клинической фармакологии, ректор</p><p>Ярославль</p></bio><bio xml:lang="en"><p>Alexander L. Khokhlov - Dr. Sci (Med.), Professor, Academician of the Russian Academy of Sciences, Head of the Department of Pharmacology and Clinical Pharmacology, Rector</p><p>Yaroslavl</p></bio><email xlink:type="simple">al460935@yandex.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8041-8770</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Рыбачкова</surname><given-names>Ю. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Rybachkova</surname><given-names>Ju. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Рыбачкова Юлия Владимировна - к. м. н., ассистент кафедры фармакологии и клинической фармакологии</p><p>Ярославль</p></bio><bio xml:lang="en"><p>Juliya V. Rybachkova - PhD, Cand. Sci. (Med), Assistant of the Department of Pharmacology and Clinical Pharmacology</p><p>Yaroslavl</p></bio><email xlink:type="simple">julia3111@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Ярославский государственный медицинский университет» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Yaroslavl State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2024</year></pub-date><pub-date pub-type="epub"><day>25</day><month>06</month><year>2024</year></pub-date><volume>0</volume><issue>2</issue><fpage>43</fpage><lpage>51</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Хохлов А.Л., Рыбачкова Ю.В., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Хохлов А.Л., Рыбачкова Ю.В.</copyright-holder><copyright-holder xml:lang="en">Khokhlov A.L., Rybachkova J.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.clinvest.ru/jour/article/view/716">https://www.clinvest.ru/jour/article/view/716</self-uri><abstract><p>Представлены результаты клинических исследований применения ломефлоксацина при широком спектре заболеваний.Цель работы — провести анализ эффективности и безопасности применения ломефлоксацина по результатам клинических исследований, опубликованных в научной литературе. Большой клинический опыт применения фторхинолонов у миллионов больных свидетельствует о высокой их эффективности при лечении инфекций различного генеза и локализации. Ломефлоксацин — дифторированный представитель группы фторхинолонов, является бактерицидным средством и обладает широким спектром антимикробного действия с повышенной активностью в отношении грамотрицательных и грамположительных микроорганизмов. Важнейшим свойством ломефлоксацина является высокая биодоступность — более 98 % при его пероральном применении.Антибактериальная эффективность ломефлоксацина для перорального применения исследовалась при инфекциях дыхательных путей, мочевыводящих путей, акушерских и гинекологических инфекциях, суставных, кожных, а также при инфекциях в области рта, ушей, носа, горла и глаз. Более того, ломефлоксацин применялся в качестве ушного раствора для лечения среднего отита, а также в форме офтальмологического раствора при лечении глазных инфекций.В исследованиях, проведённых в западных странах, от 72 до 94 % пациентов с инфекциями дыхательных путей, получавших ломефлоксацин (400 мг один раз в день), наблюдалось улучшение клинических симптомов: возбудители бактерий были уничтожены в 80–90 % случаев.Ломефлоксацин хорошо переносился, большинство побочных эффектов имели лёгкую или умеренную степень тяжести и были обратимыми. Самыми частыми нежелательными явлениями были симптомы со стороны желудочно-кишечного тракта (тошнота, диарея, боль/дискомфорт). Кроме того, головная боль, головокружение, преходящая бессонница и реакции со стороны кожи или гиперчувствительности, включая фоточувствительность, отмечались у меньшего количества пациентов.Исходя из обширного клинического опыта применения ломефлоксацина, можно утверждать, что препарат зарекомендовал себя, как лекарственное средство с доказанной эффективностью и известным профилем безопасности.</p></abstract><trans-abstract xml:lang="en"><p>The results of clinical studies on the use of lomefloxacin for various diseases are presented.The purpose of this study was to analyze the effectiveness and safety of lomefloxacin based on the results of clinical studies published in the scientific literature. Extensive clinical experience with the use of fluoroquinolones in millions of patients indicates their high effectiveness in treating infections of various origins and localities. Lomefloxacin, a difluorinate representative of the fluoroquinolone group, is a bactericidal agent with a wide spectrum of antimicrobial activity against gram-negative and gram-positive microorganisms. The most important property of lomefloxacin is its high bioavailability — more than 98 % when administered orally.The effectiveness of oral lomefloxacin against respiratory tract, urinary tract, obstetric, and gynecological infections, joint infections, skin infections, and mouth, ears, nose, throat, and eyes infections has been studied. Moreover, lomefloxacin has been used as an otic solution to treat otitis media and in the form of an ophthalmic solution to treat eye infections.In studies conducted in Western countries, 72 to 94 % of patients with respiratory tract infections treated with lomefloxacin (400 mg once daily) experienced improvement in clinical symptoms: the causative bacteria were eliminated in 80 to 90 % of cases. Lomefloxacin was well tolerated, and most adverse effects were mild to moderate and reversible. The most common adverse events were gastrointestinal symptoms (nausea, diarrhea, pain/discomfort). In addition, headache, dizziness, transient insomnia, skin hypersensitivity reactions, including photosensitivity, were reported in fewer patients.Based on extensive clinical experience with the use of lomefloxacin, it can be argued that the drug has established itself as a drug with proven effectiveness and a known safety profile.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>ломефлоксацин</kwd><kwd>фторхинолоны</kwd><kwd>эффективность</kwd><kwd>безопасность</kwd><kwd>клинические исследования</kwd></kwd-group><kwd-group xml:lang="en"><kwd>lomefloxacin</kwd><kwd>fluoroquinolones</kwd><kwd>efficiency</kwd><kwd>safety</kwd><kwd>clinical researches</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Wadworth AN, Goa KL. Lomefloxacin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs. 1991 Dec;42(6):1018-60. doi: 10.2165/00003495-199142060-00009. Erratum in: Drugs 1992 Jul;44(1):8.</mixed-citation><mixed-citation xml:lang="en">Wadworth AN, Goa KL. Lomefloxacin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs. 1991 Dec;42(6):1018-60. doi: 10.2165/00003495-199142060-00009. Erratum in: Drugs 1992 Jul;44(1):8.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Kemper P, Köhler D. A double-blind study of two dosage regimens of lomefloxacin in bacteriologically proven exacerbations of chronic bronchitis of gram-negative etiology. Am J Med. 1992 Apr 6;92(4A):98S-102S. doi: 10.1016/0002-9343(92)90318-6.</mixed-citation><mixed-citation xml:lang="en">Kemper P, Köhler D. A double-blind study of two dosage regimens of lomefloxacin in bacteriologically proven exacerbations of chronic bronchitis of gram-negative etiology. Am J Med. 1992 Apr 6;92(4A):98S-102S. doi: 10.1016/0002-9343(92)90318-6.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Gotfried MH, Ellison WT. Safety and efficacy of lomefloxacin versus cefaclor in the treatment of acute exacerbations of chronic bronchitis. Am J Med. 1992 Apr 6;92(4A):108S-113S. doi: 10.1016/0002-9343 (92)90320-b.</mixed-citation><mixed-citation xml:lang="en">Gotfried MH, Ellison WT. Safety and efficacy of lomefloxacin versus cefaclor in the treatment of acute exacerbations of chronic bronchitis. Am J Med. 1992 Apr 6;92(4A):108S-113S. doi: 10.1016/0002-9343 (92)90320-b.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">www.accessdata.fda.gov. Maxaquin® lomefloxacin hydrochloride tablets. 2005. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf</mixed-citation><mixed-citation xml:lang="en">www.accessdata.fda.gov. Maxaquin® lomefloxacin hydrochloride tablets. 2005. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Kawamura N, Nishizawa K, Kawashima T, et al. [Clinical effect of NY- 198 (lomefloxacin) for sexually transmitted disease--bacteriological effect of U. urealyticum]. Kansenshogaku Zasshi. 1990 Jan;64(1):1-11. Japanese. doi: 10.11150/kansenshogakuzasshi1970.64.1.</mixed-citation><mixed-citation xml:lang="en">Kawamura N, Nishizawa K, Kawashima T, et al. [Clinical effect of NY- 198 (lomefloxacin) for sexually transmitted disease--bacteriological effect of U. urealyticum]. Kansenshogaku Zasshi. 1990 Jan;64(1):1-11. Japanese. doi: 10.11150/kansenshogakuzasshi1970.64.1.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Kumamoto Y, Henmi I, Tsunekawa T, et al. [Epidemiological and therapeutic study on gonorrheal infection--study on NY-198 (lomefloxacin) single administration therapy. Sapporo Clinical Research Group for STD]. Hinyokika Kiyo. 1990 Aug;36(8):969-77. Japanese.</mixed-citation><mixed-citation xml:lang="en">Kumamoto Y, Henmi I, Tsunekawa T, et al. [Epidemiological and therapeutic study on gonorrheal infection--study on NY-198 (lomefloxacin) single administration therapy. Sapporo Clinical Research Group for STD]. Hinyokika Kiyo. 1990 Aug;36(8):969-77. Japanese.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Kumamoto Y, Miyagishi T, Hirose T, et al. [Epidemiological and therapeutic study on urethritis of male and cervicitis from viewpoint of STD--a study using NY-198. Sapporo Clinical Research Group for STD]. Hinyokika Kiyo. 1990 Aug;36(8):979-87. Japanese.</mixed-citation><mixed-citation xml:lang="en">Kumamoto Y, Miyagishi T, Hirose T, et al. [Epidemiological and therapeutic study on urethritis of male and cervicitis from viewpoint of STD--a study using NY-198. Sapporo Clinical Research Group for STD]. Hinyokika Kiyo. 1990 Aug;36(8):979-87. Japanese.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Morihana T, Kaneko A. Clinical study of NY-198 in oral infections. Chemotherapy. 1988;36(Suppl. 2, Pt 2):1371-1377. doi: 10.11250/chemotherapy1953.36. Supplement2-Clinical_1371.</mixed-citation><mixed-citation xml:lang="en">Morihana T, Kaneko A. Clinical study of NY-198 in oral infections. Chemotherapy. 1988;36(Suppl. 2, Pt 2):1371-1377. doi: 10.11250/chemotherapy1953.36. Supplement2-Clinical_1371.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Aoki T, Saito M, Shimizu N, et al. Clinical study of NY-198 in infectious enteritis. Chemotherapy. 1988;36 (Suppl. 2, Pt 2):792-802. doi: 10.11250/chemotherapy1953.36.Supplement2-Clinical_792.</mixed-citation><mixed-citation xml:lang="en">Aoki T, Saito M, Shimizu N, et al. Clinical study of NY-198 in infectious enteritis. Chemotherapy. 1988;36 (Suppl. 2, Pt 2):792-802. doi: 10.11250/chemotherapy1953.36.Supplement2-Clinical_792.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Martín-Luengo F, Fontana L, Rico JL, et al. Prophylaxis in transurethral surgery: oral lomefloxacin versus intravenous cefuroxime. Methods Find Exp Clin Pharmacol. 1993 Jan-Feb;15(1):57-9.</mixed-citation><mixed-citation xml:lang="en">Martín-Luengo F, Fontana L, Rico JL, et al. Prophylaxis in transurethral surgery: oral lomefloxacin versus intravenous cefuroxime. Methods Find Exp Clin Pharmacol. 1993 Jan-Feb;15(1):57-9.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Neringer R, Forsgren A, Hansson C, Ode B. Lomefloxacin versus norfloxacin in the treatment of uncomplicated urinary tract infections: three-day versus seven-day treatment. The South Swedish Lolex Study Group. Scand J Infect Dis. 1992;24(6):773-80. doi: 10.3109/00365549209062463.</mixed-citation><mixed-citation xml:lang="en">Neringer R, Forsgren A, Hansson C, Ode B. Lomefloxacin versus norfloxacin in the treatment of uncomplicated urinary tract infections: three-day versus seven-day treatment. The South Swedish Lolex Study Group. Scand J Infect Dis. 1992;24(6):773-80. doi: 10.3109/00365549209062463.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Iravani A. Efficacy of lomefloxacin as compared to norfloxacin in the treatment of uncomplicated urinary tract infections in adults. Am J Med. 1992 Apr 6;92(4A):75S-81S. doi: 10.1016/0002-9343(92)90314-2.</mixed-citation><mixed-citation xml:lang="en">Iravani A. Efficacy of lomefloxacin as compared to norfloxacin in the treatment of uncomplicated urinary tract infections in adults. Am J Med. 1992 Apr 6;92(4A):75S-81S. doi: 10.1016/0002-9343(92)90314-2.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Grassi C, Albera C, Pozzi E. Lomefloxacin versus amoxicillin in the treatment of acute exacerbations of chronic bronchitis: an Italian multicenter study. Am J Med. 1992 Apr 6;92(4A):103S-107S. doi: 10.1016/0002-9343(92)90319-7.</mixed-citation><mixed-citation xml:lang="en">Grassi C, Albera C, Pozzi E. Lomefloxacin versus amoxicillin in the treatment of acute exacerbations of chronic bronchitis: an Italian multicenter study. Am J Med. 1992 Apr 6;92(4A):103S-107S. doi: 10.1016/0002-9343(92)90319-7.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Klimberg IW, Childs SJ, Madore RJ, Klimberg SR. A multicenter comparison of oral lomefloxacin versus parenteral cefotaxime as prophylactic agents in transurethral surgery. Am J Med. 1992 Apr 6;92(4A):121S-125S. doi: 10.1016/0002-9343(92)90323-4.</mixed-citation><mixed-citation xml:lang="en">Klimberg IW, Childs SJ, Madore RJ, Klimberg SR. A multicenter comparison of oral lomefloxacin versus parenteral cefotaxime as prophylactic agents in transurethral surgery. Am J Med. 1992 Apr 6;92(4A):121S-125S. doi: 10.1016/0002-9343(92)90323-4.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Nicolle LE, Louie TJ, Dubois J, et al. Treatment of complicated urinary tract infections with lomefloxacin compared with that with trimethoprim-sulfamethoxazole. Antimicrob Agents Chemother. 1994 Jun;38(6):1368-73. doi: 10.1128/AAC.38.6.1368.</mixed-citation><mixed-citation xml:lang="en">Nicolle LE, Louie TJ, Dubois J, et al. Treatment of complicated urinary tract infections with lomefloxacin compared with that with trimethoprim-sulfamethoxazole. Antimicrob Agents Chemother. 1994 Jun;38(6):1368-73. doi: 10.1128/AAC.38.6.1368.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Cox CE. A comparison of the safety and efficacy of lomefloxacin and ciprofloxacin in the treatment of complicated or recurrent urinary tract infections. Am J Med. 1992 Apr 6;92(4A):82S-86S. doi: 10.1016/0002-9343(92)90315-3.</mixed-citation><mixed-citation xml:lang="en">Cox CE. A comparison of the safety and efficacy of lomefloxacin and ciprofloxacin in the treatment of complicated or recurrent urinary tract infections. Am J Med. 1992 Apr 6;92(4A):82S-86S. doi: 10.1016/0002-9343(92)90315-3.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Westenfelder M, Zeman W. A multicenter study of lomefloxacin versus ciprofloxacin in the treatment of complicated urinary tract infections. Int J Antimicrob Agents. 1992 Dec;2(1):29-32. doi: 10.1016/0924-8579(92)90024-l.</mixed-citation><mixed-citation xml:lang="en">Westenfelder M, Zeman W. A multicenter study of lomefloxacin versus ciprofloxacin in the treatment of complicated urinary tract infections. Int J Antimicrob Agents. 1992 Dec;2(1):29-32. doi: 10.1016/0924-8579(92)90024-l.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Ohmori H, Kumon H, Suzuki K, Kamidono S, Arakawa S, Ishigami J, Tanaka H, Amano M, Fujita Y, Kanemasa Y, et al. [A comparative study on lomefloxacin and norfloxacin in the treatment of acute uncomplicated cystitis]. Jpn J Antibiot. 1989 Apr;42(4):1025-50. Japanese.</mixed-citation><mixed-citation xml:lang="en">Ohmori H, Kumon H, Suzuki K, Kamidono S, Arakawa S, Ishigami J, Tanaka H, Amano M, Fujita Y, Kanemasa Y, et al. [A comparative study on lomefloxacin and norfloxacin in the treatment of acute uncomplicated cystitis]. Jpn J Antibiot. 1989 Apr;42(4):1025-50. Japanese.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
