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Инфекции мочевыводящих путей: доказанные возможности растительной фармакотерапии
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Urinary tract infections: proven potentials of plant pharmacotherapy. Consilium Medicum. 2019; 21 (7): 75–80. DOI: 10.26442/20751753.2019.7.190181
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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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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.
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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/
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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.
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[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/
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1. Wagenlehner FM, Weidner W, Naber KG. An update on uncomplicated urinary tract infections in women. Curr Opin Urol 2009; 19: 368–74.
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. 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. 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).