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Инфекции мочевыводящих путей: доказанные возможности растительной фармакотерапии
Инфекции мочевыводящих путей: доказанные возможности растительной фармакотерапии
Инфекции мочевыводящих путей: доказанные возможности растительной фармакотерапии. Consilium Medicum. 2019; 21 (7): 75–80. DOI: 10.26442/20751753.2019.7.190181
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Аннотация
Инфекции мочевыводящих путей (ИМП) являются одним из наиболее распространенных инфекционных заболеваний. В современных протоколах лечения острых неосложненных ИМП в качестве терапии 1-й линии рекомендуется назначение антибиотиков. Однако их частое и зачастую не-оправданное применение может привести к увеличению риска антибиотикорезистентности и нарушению микробиома организма, в связи с чем возникает необходимость поиска новых подходов к терапии ИМП. Лекарственные препараты на растительной основе представляют собой потенциальную альтернативу антибиотикам для лечения острых неосложненных ИМП. Для сравнения эффективности растительного лекарственного препарата Канефрон® Н (BNO 1045) и фосфомицина трометамола (ФТ) для лечения острых неосложненных инфекций нижних мочевыводящих путей (нИНМП) было проведено мультицентровое двойное слепое контролируемое рандомизированное исследование в параллельных группах (регистрационный номер NCT02639520), результаты которого были представлены в статье главного исследователя Флориана М. Вагенленера и со-авт. «Не антибактериальная растительная терапия (BNO 1045) в сравнении с антибактериальной терапией (фосфомицина трометамол) при лечении острых неосложненных инфекций нижних мочевыводящих путей у женщин: двойное слепое, в параллельных группах, рандомизированное, многоцентровое исследование не меньшей эффективности, фазы III. 2018».
Цель. Подтвердить неменьшую эффективность растительного лекарственного препарата Канефрон® Н (BNO 1045) в сравнении с ФТ для лечения острых нИНМП.
Материалы и методы. Женщины 18–70 лет, у которых была впервые диагностирована острая нИНМП с типичными симптомами, были рандомизированы для приема BNO 1045 (n=325) или ФТ (n=334) и соответствующего плацебо.
Результаты. 238 (83,5%) пациенток в группе применения BNO 1045 и 272 (89,8%) – в группе применения ФТ не принимали дополнительных анти-биотиков в период между Днем 1 и Днем 38. При пределе неменьшей эффективности, составляющем 15%, BNO 1045 продемонстрировал немень-шую эффективность в сравнении с ФТ при лечении нИНМП. Частота возникновения нежелательных явлений была одинаковой в обеих группах, хотя в группе применения ФТ отмечалась более высокая частота нарушений со стороны желудочно-кишечного тракта, а в группе BNO 1045 – бо-лее высокая частота пиелонефрита.
Выводы. Препарат BNO 1045 обладает потенциалом снизить потребление антибиотиков при лечении нИНМП и, следовательно, может суще-ственно повлиять на стратегию рационального применения противомикробной терапии.
Ключевые слова: острые неосложненные инфекции нижних мочевыводящих путей, эффективность, безопасность, фосфомицина трометамол, растительный препарат, Канефрон Н.
Цель. Подтвердить неменьшую эффективность растительного лекарственного препарата Канефрон® Н (BNO 1045) в сравнении с ФТ для лечения острых нИНМП.
Материалы и методы. Женщины 18–70 лет, у которых была впервые диагностирована острая нИНМП с типичными симптомами, были рандомизированы для приема BNO 1045 (n=325) или ФТ (n=334) и соответствующего плацебо.
Результаты. 238 (83,5%) пациенток в группе применения BNO 1045 и 272 (89,8%) – в группе применения ФТ не принимали дополнительных анти-биотиков в период между Днем 1 и Днем 38. При пределе неменьшей эффективности, составляющем 15%, BNO 1045 продемонстрировал немень-шую эффективность в сравнении с ФТ при лечении нИНМП. Частота возникновения нежелательных явлений была одинаковой в обеих группах, хотя в группе применения ФТ отмечалась более высокая частота нарушений со стороны желудочно-кишечного тракта, а в группе BNO 1045 – бо-лее высокая частота пиелонефрита.
Выводы. Препарат BNO 1045 обладает потенциалом снизить потребление антибиотиков при лечении нИНМП и, следовательно, может суще-ственно повлиять на стратегию рационального применения противомикробной терапии.
Ключевые слова: острые неосложненные инфекции нижних мочевыводящих путей, эффективность, безопасность, фосфомицина трометамол, растительный препарат, Канефрон Н.
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Urinary tract infection (UTI) is one of the most frequent infectious disorders. In modern protocols of acute uncomplicated UTI treatment antibiotics use is recommended as a first-line therapy. Although its frequent and unreasonable use may result in increase of antibiotic resistance development risk and micro-biome alteration that leads to necessity of new approaches for UTI treatment development. Herbal based medications are a potential alternative for antibiot-ic use in acute uncomplicated UTI treatment. To compare the efficacy of herbal drug Canephron® H (BNO 1045) and fosfomycin trometamol (FT) for treat-ment of acute uncomplicated lower urinary tract infections (uLUTI) was carried out a multicentre double-blind controlled randomized trial in parallel groups (registration number NCT02639520), the results of which were presented in the article of principal investigator: F. Wagenlehner et al. Non-Antibiotic Herbal Therapy (BNO 1045) versus Antibiotic Therapy (Fosfomycin Trometamol) for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections in Women: A Double-Blind, Parallel-Group, Randomized, Multicentre, Non-Inferiority Phase III Trial. Urol Int 2018; 101 (3): 327–36. DOI: 10.1159/000493368. Epub 2018 Sep 19.
Aim. Тo prove non-inferiority of herbal medication Canephron® N (BNO 1045) use in comparison with FT in acute uLUTI treatment.
Materials and methods. Women aged 18–70 years with newly diagnosed acute uLUTI with typical symptoms were randomized for BNO 1045 (n=325) or FT (n=334) or placebo use.
Results. In between Day 1 and Day 38 238 (83.5%) patients in BNO 1045 group and 272 (89.8%) patients in FT group did not use additional antibiotics. With the equivalence limit 15%, BNO 1045 demonstrated non-inferior effectiveness compared with FT in uLUTI treatment. The incidence of adverse events was equal in both groups, although in FT group incidence of gastrointestinal disorders was higher, and in BNO 1045 group – pyelonephritis incidence was higher.
Conclusions. BNO 1045 has a potential to decrease antibiotics use in uLUTI treatment and its use, consequently, can result in significant changes in the strat-egy of antibacterial drugs rational use.
Key words: acute uncomplicated lower urinary tract infections, effectiveness, safety, fosfomycin trometamol, plant extracts, Canephron N.
Aim. Тo prove non-inferiority of herbal medication Canephron® N (BNO 1045) use in comparison with FT in acute uLUTI treatment.
Materials and methods. Women aged 18–70 years with newly diagnosed acute uLUTI with typical symptoms were randomized for BNO 1045 (n=325) or FT (n=334) or placebo use.
Results. In between Day 1 and Day 38 238 (83.5%) patients in BNO 1045 group and 272 (89.8%) patients in FT group did not use additional antibiotics. With the equivalence limit 15%, BNO 1045 demonstrated non-inferior effectiveness compared with FT in uLUTI treatment. The incidence of adverse events was equal in both groups, although in FT group incidence of gastrointestinal disorders was higher, and in BNO 1045 group – pyelonephritis incidence was higher.
Conclusions. BNO 1045 has a potential to decrease antibiotics use in uLUTI treatment and its use, consequently, can result in significant changes in the strat-egy of antibacterial drugs rational use.
Key words: acute uncomplicated lower urinary tract infections, effectiveness, safety, fosfomycin trometamol, plant extracts, Canephron N.
Полный текст
Список литературы
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15. Nausch B, Koeberle A, Werz O et al. 262 CanephronR N reduces pain in experimental cystitis and prostatitis putatively by inhibition of PGE2 production. Eur Urol (Suppl.) 2016; 15: e262.
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17. Naber KG, Kogan M, Wagenlehner FME et al. How the microbiome is influenced by the therapy of urological diseases: standard versus alternative approaches. Clinical Phytoscience 2017; 3: 8.
18. Wullt B, Svanborg C. Deliberate establishment of asymptomatic bacteriuria – a novel strategy to prevent recurrent UTI. Pathogens 2016; 5: 52.
19. Naber K, Steindl H, Abramov-Sommariva D, Eskoetter H. Non-antibiotic herbal therapy of uncomplicated lower urinary tract infection in women – a pilot study. Planta Med 2013; 79: PB1.
20. Alidjanov JF, Abduffattaev UA, Makhsudov SA et al. New self-reporting questionnaire to assess urinary tract infections and differential diagnosis: acute cystitis symptom score. Urol Int 2013; 92: 230–6.
21. Alidjanov JF, Abdufattaev UA, Makhsudov SA et al. The acute cystitis symptom score for patient-reported outcome assessment. Urol Int 2016; 97: 402–9.
22. Kranz J, Schmidt S, Lebert C et al. The 2017 update of the German clinical guideline on epidemiology, diagnostics, therapy, prevention, and management of uncomplicated urinary tract infections in adult patients. Part II: therapy and prevention. Urol Int 2018; 100: 263–70.
23. Christiaens TC, De Meyere M, Verschraegen G et al. Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women. Br J Gen Pract 2002; 52: 729734.
24. Ferry SA, Holm SE, Stenlund H et al. The natural course of uncomplicated lower urinary tract infection in women illustrated by a randomized placebo controlled study. Scand J Infect Dis 2004; 36: 296–301.
25. Stamm WE, Counts GW, Running KR et al. Diagnosis of coliform infection in acutely dysuric women. N Engl J Med 1982; 307: 463–8.
26. Hooton TM, Roberts PL, Cox ME, Stapleton AE. Voided midstream urine culture and acute cystitis in premenopausal women. N Engl J Med 2013; 369: 1883–91.
27. Ferry SA, Holm SE, Stenlund H et al. Clinical and bacteriological outcome of different doses and duration of pivmecillinam compared with placebo therapy of uncomplicated lower urinary tract infection in women: the LUTIW project. Scand J Prim Health Care 2007; 25: 49–57.
28. LaRocco MT, Franek J, Leibach EK et al. Effectiveness of preanalytic practices on contamination and diagnostic accuracy of urine cultures: a laboratory medicine best practices systematic review and meta-analysis. Clin Microbiol Rev 2016; 29: 105–47.
29. Набер К.Г., Коган М.И., Вагенленер Ф. и др. Как терапия урологических заболеваний влияет на микробиом: стандартные подходы в сравнении с альтернативными. Clin Phytosci 2017; 3 (8). DOI. org/10.1186/s40816-017-0045-8
[Naber K.G., Kogan M.I., Vagenlener F. et al. Kak terapiia urologicheskikh zabolevanii vliiaet na mikrobiom: standartnye podkhody v sravnenii s al'ternativnymi. Clin Phytosci 2017; 3 (8). DOI. org/10.1186/s40816-017-0045-8 (in Russian).]
30. EAU Guidelines on Urological Infections 2015 EAU website: http://www.uroweb.org/guidelines/online-guidelines/
31. Wagenlehner FM, Bartoletti R, Cek M et al. Antibiotic stewardship: a call for action by the urologic community. Eur Urol 013; 64: 358–60.
32. Guarner F, Malagelada J-R. Gut flora in health and disease. Lancet 2003; 361: 512–9. DOI: 10.1016/S0140–6736 (03) 12489–0
33. Захарова И.Н., Османов И.М., Касьянова А.Н. и др. Протективные факторы слизистой оболочки мочевого пузыря – ключ к новым подходам к терапии инфекции мочевых путей. Рос. вестн. перинатол. и педиатр. 2018; 63 (2): 16–21. DOI: 10.21508/1027-4065-2018-63-2-16-21
[Zakharova I.N., Osmanov I.M., Kas'ianova A.N. et al. Protektivnye faktory slizistoi obolochki mochevogo puzyria – kliuch k novym podkhodam k terapii infektsii mochevykh putei. Ros. vestn. perinatol. i pediatr. 2018; 63 (2): 16–21. DOI: 10.21508/1027-4065-2018-63-2-16-21 (in Russian).]
2. Foxman B. The epidemiology of urinary tract infection. Nat Rev Urol 2010; 7: 653–60.
3. Loew D, Dieter D, Habs M et al. Erkrankungen der ableitenden Harnwege; in Loew D, Habs M, Klimm H-D, Trunzler G (eds): Phytopharmaka-Report: Rationale Therapie mit pflanzlichen Arzneimitteln. Heidelberg, Steinkopff-Verlag Heidelberg, 2013.
4. EAU Guidelines. Edn. presented at the EAU Annual Congress Copenhagen 2018. ISBN 978-94-92671-01-1. www.http://uroweb.org/ guideline/urological-infections/
5. Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med 2016; 8: 39.
6. Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. Pharm Ther 2015; 40: 277–83.
7. Tandogdu Z, Cek M, Wagenlehner F et al. Resistance patterns of nosocomial urinary tract infections in urology departments: 8-year results of the global prevalence of infections in urology study. World J Urol 2014; 32: 791–801.
8. Bleidorn J, Hummers-Pradier E, Schmiemann G et al. Recurrent urinary tract infections and complications after symptomatic versus antibiotic treatment: follow-up of a randomised controlled trial. Ger Med Sci 2016; 14: Doc01.
9. Gagyor I, Bleidorn J, Kochen MM et al. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ 2015; 351: h6544.
10. Kronenberg A, Butikofer L, Odutayo A et al. Symptomatic treatment of uncomplicated lower urinary tract infections in the ambulatory setting: randomised, double blind trial. BMJ 2017; 359: j4784.
11. Stange R, Schneider B, Albrecht U et al. Results of a randomized, prospective, double-dummy, double-blind trial to compare efficacy and safety of a herbal combination containing Tropaeoli majoris herba and Armoraciae rusticanae radix with co-trimoxazole in patients with acute and uncomplicated cystitis. Res Rep Urol 2017; 9: 43–50.
12. Künstle G, Brenneis C, Haunschild J. Efficacy of Canephron® N against bacterial adhesion, inflammation and bladder hyperactivity. Eur Urol (Suppl.) 2013; 12: e671.
13. Künstle G, Brenneis C, Pergola C et al. Anti-inflammatory effects of Canephron® N and effectiveness in a model of interstitial cystitis. Urologe 2013; 52 (Suppl. 1): e97.
14. Brenneis C, Künstle G, Haunschild J. Spasmolytic Activity of CanephronR N on the Contractility of Rate and Human Isolated Urinary Bladder: 13th International Congress of the Society for Ethnopharmacology. 2nd to 6th September 2012, Graz, Austria.
15. Nausch B, Koeberle A, Werz O et al. 262 CanephronR N reduces pain in experimental cystitis and prostatitis putatively by inhibition of PGE2 production. Eur Urol (Suppl.) 2016; 15: e262.
16. Haloui M, Louedec L, Michel JB, Lyoussi B. Experimental diuretic effects of Rosmarinus officinalis and Centaurium erythraea. J Ethnopharmacol 2000; 71: 465–72.
17. Naber KG, Kogan M, Wagenlehner FME et al. How the microbiome is influenced by the therapy of urological diseases: standard versus alternative approaches. Clinical Phytoscience 2017; 3: 8.
18. Wullt B, Svanborg C. Deliberate establishment of asymptomatic bacteriuria – a novel strategy to prevent recurrent UTI. Pathogens 2016; 5: 52.
19. Naber K, Steindl H, Abramov-Sommariva D, Eskoetter H. Non-antibiotic herbal therapy of uncomplicated lower urinary tract infection in women – a pilot study. Planta Med 2013; 79: PB1.
20. Alidjanov JF, Abduffattaev UA, Makhsudov SA et al. New self-reporting questionnaire to assess urinary tract infections and differential diagnosis: acute cystitis symptom score. Urol Int 2013; 92: 230–6.
21. Alidjanov JF, Abdufattaev UA, Makhsudov SA et al. The acute cystitis symptom score for patient-reported outcome assessment. Urol Int 2016; 97: 402–9.
22. Kranz J, Schmidt S, Lebert C et al. The 2017 update of the German clinical guideline on epidemiology, diagnostics, therapy, prevention, and management of uncomplicated urinary tract infections in adult patients. Part II: therapy and prevention. Urol Int 2018; 100: 263–70.
23. Christiaens TC, De Meyere M, Verschraegen G et al. Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women. Br J Gen Pract 2002; 52: 729734.
24. Ferry SA, Holm SE, Stenlund H et al. The natural course of uncomplicated lower urinary tract infection in women illustrated by a randomized placebo controlled study. Scand J Infect Dis 2004; 36: 296–301.
25. Stamm WE, Counts GW, Running KR et al. Diagnosis of coliform infection in acutely dysuric women. N Engl J Med 1982; 307: 463–8.
26. Hooton TM, Roberts PL, Cox ME, Stapleton AE. Voided midstream urine culture and acute cystitis in premenopausal women. N Engl J Med 2013; 369: 1883–91.
27. Ferry SA, Holm SE, Stenlund H et al. Clinical and bacteriological outcome of different doses and duration of pivmecillinam compared with placebo therapy of uncomplicated lower urinary tract infection in women: the LUTIW project. Scand J Prim Health Care 2007; 25: 49–57.
28. LaRocco MT, Franek J, Leibach EK et al. Effectiveness of preanalytic practices on contamination and diagnostic accuracy of urine cultures: a laboratory medicine best practices systematic review and meta-analysis. Clin Microbiol Rev 2016; 29: 105–47.
29. Набер К.Г., Коган М.И., Вагенленер Ф. и др. Как терапия урологических заболеваний влияет на микробиом: стандартные подходы в сравнении с альтернативными. Clin Phytosci 2017; 3 (8). DOI. org/10.1186/s40816-017-0045-8
[Naber K.G., Kogan M.I., Vagenlener F. et al. Kak terapiia urologicheskikh zabolevanii vliiaet na mikrobiom: standartnye podkhody v sravnenii s al'ternativnymi. Clin Phytosci 2017; 3 (8). DOI. org/10.1186/s40816-017-0045-8 (in Russian).]
30. EAU Guidelines on Urological Infections 2015 EAU website: http://www.uroweb.org/guidelines/online-guidelines/
31. Wagenlehner FM, Bartoletti R, Cek M et al. Antibiotic stewardship: a call for action by the urologic community. Eur Urol 013; 64: 358–60.
32. Guarner F, Malagelada J-R. Gut flora in health and disease. Lancet 2003; 361: 512–9. DOI: 10.1016/S0140–6736 (03) 12489–0
33. Захарова И.Н., Османов И.М., Касьянова А.Н. и др. Протективные факторы слизистой оболочки мочевого пузыря – ключ к новым подходам к терапии инфекции мочевых путей. Рос. вестн. перинатол. и педиатр. 2018; 63 (2): 16–21. DOI: 10.21508/1027-4065-2018-63-2-16-21
[Zakharova I.N., Osmanov I.M., Kas'ianova A.N. et al. Protektivnye faktory slizistoi obolochki mochevogo puzyria – kliuch k novym podkhodam k terapii infektsii mochevykh putei. Ros. vestn. perinatol. i pediatr. 2018; 63 (2): 16–21. DOI: 10.21508/1027-4065-2018-63-2-16-21 (in Russian).]
________________________________________________
2. Foxman B. The epidemiology of urinary tract infection. Nat Rev Urol 2010; 7: 653–60.
3. Loew D, Dieter D, Habs M et al. Erkrankungen der ableitenden Harnwege; in Loew D, Habs M, Klimm H-D, Trunzler G (eds): Phytopharmaka-Report: Rationale Therapie mit pflanzlichen Arzneimitteln. Heidelberg, Steinkopff-Verlag Heidelberg, 2013.
4. EAU Guidelines. Edn. presented at the EAU Annual Congress Copenhagen 2018. ISBN 978-94-92671-01-1. www.http://uroweb.org/ guideline/urological-infections/
5. Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med 2016; 8: 39.
6. Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. Pharm Ther 2015; 40: 277–83.
7. Tandogdu Z, Cek M, Wagenlehner F et al. Resistance patterns of nosocomial urinary tract infections in urology departments: 8-year results of the global prevalence of infections in urology study. World J Urol 2014; 32: 791–801.
8. Bleidorn J, Hummers-Pradier E, Schmiemann G et al. Recurrent urinary tract infections and complications after symptomatic versus antibiotic treatment: follow-up of a randomised controlled trial. Ger Med Sci 2016; 14: Doc01.
9. Gagyor I, Bleidorn J, Kochen MM et al. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ 2015; 351: h6544.
10. Kronenberg A, Butikofer L, Odutayo A et al. Symptomatic treatment of uncomplicated lower urinary tract infections in the ambulatory setting: randomised, double blind trial. BMJ 2017; 359: j4784.
11. Stange R, Schneider B, Albrecht U et al. Results of a randomized, prospective, double-dummy, double-blind trial to compare efficacy and safety of a herbal combination containing Tropaeoli majoris herba and Armoraciae rusticanae radix with co-trimoxazole in patients with acute and uncomplicated cystitis. Res Rep Urol 2017; 9: 43–50.
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