Лечение тяжелых госпитальных инфекций: новый антибиотик из группы карбапенемов – дорипенем
Лечение тяжелых госпитальных инфекций: новый антибиотик из группы карбапенемов – дорипенем
Петухова И.Н., Дмитриева Н.В. Лечение тяжелых госпитальных инфекций: новый антибиотик из группы карбапенемов – дорипенем. Современная онкология. 2015; 17 (2): 67–73.
________________________________________________
Petukhova I.N., Dmitrieva N.V. Treatment of severe nosocomial infections: doripenem – a new carbapenems antibiotic. Journal of modern oncology. 2015; 17 (2): 67–73.
Лечение тяжелых госпитальных инфекций: новый антибиотик из группы карбапенемов – дорипенем
Петухова И.Н., Дмитриева Н.В. Лечение тяжелых госпитальных инфекций: новый антибиотик из группы карбапенемов – дорипенем. Современная онкология. 2015; 17 (2): 67–73.
________________________________________________
Petukhova I.N., Dmitrieva N.V. Treatment of severe nosocomial infections: doripenem – a new carbapenems antibiotic. Journal of modern oncology. 2015; 17 (2): 67–73.
Дорипенем – новый антибиотик из группы карбапенемов – занимает важное место в лечении тяжелых госпитальных инфекций, а также инфекций, вызванных мультирезистентными микроорганизмами, и может применяться для лечения осложненных интраабдоминальных инфекций, осложненных инфекцией мочевыводящих путей (в том числе с бактериемией), нозокомиальной пневмонии, включая вентиляторассоциированную пневмонию. В обзоре представлены данные международных исследований по определению чувствительности микроорганизмов к дорипенему in vitro, включая синегнойную палочку, ацинетобактер и прочие, результаты фармакокинетических, а также клинических исследований препарата. Обсуждаются подходы к преодолению резистентности микроорганизмов с использованием пролонгированной инфузии дорипенема, а также переносимость антибиотика и фармакоэкономические данные.
Doripenem is a new carbapenems antibiotic and takes an important place in the treatment of severe nosocomial infections, as well as in case of infections caused by multi-drug resistant microorganisms; and can be used for the treatment of complicated intraabdominal infection, complicated urinary tract infections (including bacteraemia), nosocomial pneumonia, including ventilator-associated pneumonia. The review presents the data of international studies concerning the determining the susceptibility of microorganisms to doripenem in vitro, including Pseudomonas aeruginosa, Acinetobacter and others, the results of pharmacokinetic and clinical studies with the drug. We discuss the approaches to overcome the microorganism resistance using prolonged infusion of doripenem, as well as antibiotic tolerance and pharmacoeconomic data.
1. Livermore DM. Doripenem: Antimicrobial profile and clinical potential. Microb Inf Dis 2009: 63: 455–8.
2. Schwaber MJ, Carmely Y. Mortality and delay in effective therapy associated with extended-spectrum b-lactamase production in Enterobacteriaceae bacteraemia: a systematic review and meta-analysis. J Antimicrob Chemother 2007; 60: 913–20.
3. Fritsche TR, Sader HS, Stillwell MG, Jones RN. Antimicrobial activity of doripenem tested against prevalent gram-positive pathogens: results from a global surveillance study (2003–2007). Diagn Microbiol Infect Dis 2009; 63: 440–6.
4. Jones RN, Bell JM, Sader HS et al. In vitro potency of doripenem tested against an international collection of rarely isolated bacterial pathogens. Diagn Microbiol Infect Dis 2009, 63: 434–9.
5. Mendes RE, Rhomberg PR, Turnidge J, Sader HS. Doripenem activity against a global collection of Enterobacteriaceae, including isolates resistant to other extended-spectrum agents. Diagn Microbiol Infect Dis 2009; 63: 415–25.
6. Сastanheira M, Jones RN, Livermore DM. Antimicrobial activities of doripenem and other carbapenems against Pseudomonas aeruginosa, other nonfermentative bacilli, and Aeromonas spp. Diagn Microbiol Infect Dis, 2009; 63: 426–33.
7. Goldstein EJC, Citron DM. Activity of a novel carbapenem, doripenem, against anaerobic pathogens. Diagn Microbiol Infect Dis 2009; 63: 447–54.
8. Kallen AJ, Hidron AI, Patel J, Srinivasan A. Multidrug resistance among gram-negative pathogens that caused healthcare-associated infections reported to the National Healthcare Safety Network, 2006–2008. Infect Control Hosp Epidemiol 2010; 31: 528–31.
9. Gales AC, Azevedo HD, Cereda RF et al for INVITA-A-DORI Brazilian Study Group. Antimicrobial activity of doripenem against gram-negative pathogens: results from INVITA-A-DORI Brazilian Study. Braz J Infect Dis 2011; 15 (6): 513–20.
10. Mushtaq S, Ge Y, Livermore DM. Doripenem versus Pseudomonas aeruginosa in vitro: activity against characterized isolates, mutants and transconjugants and resistance selection potential. Antimicrob Agents Chemother 2004; 48: 3086–92.
11. Fujimura T, Anan N, Sugimori G et al. Susceptibility of Pseudomonas aeruginosa clinical isolates in Japan to doripenem and other antipseudomonal strains. Int J Antimicrob Agents 2009; 34: 523–8.
12. Sakyo S, Tomita H, Tanimoto K et al. Potency of carbapenems for the prevention of carbapenem-resistant mutants of Pseudomonas aeruginosa: a high potency of a new carbapenem doripenem. J Antibiot 2006; 59: 220–8.
13. Davies TA, Shang W, Redman R et al. Genotyping of gramnegative uropathogens isolated pre- and post-treatment from subjects in a doripenem clinical trial for complicated urinary tract infections, 2008. WPCCID, Taipei, Taiwan.
14. Jones TN, Pfaller MA, SENTRY Antimicrobial Surveillance Program Participants Group (USA) (2001). Can antimicrobial susceptibility testing results for ciprofloxacin or levofloxacin predict susceptibility to a newer fluorquinolone, gatifloxacin? Report from The SENTRY Antimicrobial Surveillance Program (1997-99). Diagn Microbiol Infect Dis 39: 237–43.
15. Hagihara M, Kuti JL. Nicolau DP. Predicting doripenem susceptibility based on meropenem and imipenem interpretation for Pseudomonas aerginosa. Diagn Microbiol Infect Dis 2012; 72: 258–62.
16. Григорьевская З.В., Дмитриева Н.В., Петухова И.Н., Дьякова С.А. Особенности течения инфекционных осложнений, вызванных панрезистентными Acinetobacter baumannii, у онкологических больных. Сиб. онкологический журн. 2011; 6: 14–8. / Grigor'evskaia Z.V., Dmitrieva N.V., Petukhova I.N., D'iakova S.A. Osobennosti techeniia infektsionnykh oslozhnenii, vyzvannykh panrezistentnymi Acinetobacter baumannii, u onkologicheskikh bol'nykh. Sib. onkologicheskii zhurn. 2011; 6: 14–8. [in Russian]
17. Chaudhary M, Payasi A. Incidence, prevalence and control of multidrug resistant (MDR) carbapenemase producing Acinetobacter baumannii in Indian intensive care units. J Pharm Res 2013, 7: 175–80.
18. Dong S-X, Wang J-T, Chang S-C. Activities of doripenem against nosocomial bacteremic drug-resistant Gram-negative bacteria in a medical center in Taiwan. J Microbiol Immunol Infection 2012; 45: 459–64.
19. Somily AM, Absar MM, Arshad MZ et al. Antimicrobial susceptibility patterns of multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii against carbapenems, colistin, and tigecycline. Saudi Med J 2012; 33 (7): 750–5.
20. Marti S, Sanchez-Cespedes J, Alba V, Vila J. In vitro activity of doripenem against Acinetobacter baumannii clinical isolates. Int J Antimicrob Agents 2009; 33: 181–2.
21. Clock SA, Tabibi S, Alba L et al. In vitro activity of doripenem alone and in multi-agent combinations against extensively drug-resistant Acinetobacter baumannii and Klebsiella pneumoniae. Diagn Microbiol Infect Dis 2013, 76: 343–6.
22. Van Wart SA, Andes DR, Ambrose PG, Bhavnani SM. Pharmacokinetic-pharmacodynamic modeling to support doripenem dose regimen optimization for critically ill patients. Diagn Microbiol Infect Dis 2009, 63: 409–14.
23. Jaruratanasirikul S, Wongpoowarak W, Kositpantawong N et al. Pharmacodynamics of doripenem in critically ill patients with ventilator-associated gram-negative bacilli pneumonia. Int J Antimicrob Agents 2012; 40: 434–9.
24. Ariano RE, Nyhlen A, Donnelly JP et al. Pharmacokinetics and pharmacodynamics of meropenem in febrile neutropenic patients with bacteriemia. Ann Pharmacother 2005; 39: 32–8.
25. He W, Kaniga K, Lynch AS et al. In vitro Etest synergy of doripenem with amikacin, colistin, and levofloxacin against Pseudomonas aeruginosa with defined carbapenem resistance mechanisms as determined by the Etest method. Diagn Microbiol Infect Dis 2012; 74: 417–9.
26. Wiskirchen DE, Crandon JL, Nicolau DP. Impact of various conditions on the efficacy of dual carbapenem therapy against KPC-producing Klebsiella pneumoniae. Int J Antimicrob Agents 2013; 41: 582–5.
27. Lucasti C, Jasovich A, Umeh O et al. Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, non-inferiority study. Clin Therapeutics 2008; 30 (5): 868–83.
28. Malafaia O, Umeh O, Jiang J. Doripenem versus meropenem for the treatment of complicated intra-abdominal infections. Presented at: 46th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 27–30, 2006; San Francisco, California. Poster L-15640-b.
29. Naber KG, Llorens L, Kaniga K et al. Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infections and pyelonephritis. Antimicrob Agents Chemother 2009; 53: 3782–92.
30. Rea-Neto A, Niederman M, Lobo SM et al. Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized open-label, multicenter study. Curr Med Res Opin 2008; 24: 2113–26.
31. Chastre J, Wunderink R, Prokocimer P et al. Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study. Crit Care Med 2008; 36 (4): 1089–96.
32. Tazuma S, Igarashi Y, Inui K et al. Clinical efficacy of intravenous doripenem in patients with acute biliary tract infection: a multicenter, randomized, controlled trial with imipenem/сilastatin as comparator. J Gastroenterol 2015; 50 (2): 221–9.
33. Mustafa M, Chang WM, Lee C et al. PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study). Int J Antimicrob Agents 2014; 43 (4): 353–60.
34. Kollef MH, Chastre J, Clavel M et al. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care 2012; 16: R218.
35. Jenkins SG, Fisher AC, Peterson JA et al. Meta-analysis of doripenem vs comparators in patients with pseudomonas infections enrolled in four phase III efficacy and safety trials. Curr Med Res Opin 2009; 25 (12): 3029–36.
36. Qu X-Y, Hu TT, Zhou W. A meta-analysis of efficacy and safety of doripenem for treating bacterial infections. Braz J Infect Dis 2015; 19 (2): 156–2.
37. Merchant S, Gast C, Nathwani D et al. Hospital resource utilization with doripenem versus imipenem in the treatment of ventilator-associated pneumonia. Clin Therapeutics 2008; 30 (4): 717–33.
38. Matthews SJ, Lancaster JW. Doripenem monohydrate, a broad-spectrum carbapenem antibiotic. Clin Ther 2009; 31 (1): 42–63.
39. Horiuchi M, Kimura M, Tokumura M et al. Absence of convulsive liability of doripenem, a new carbapenem antibiotic, in comparison with b-lactam antibiotics. Toxicology 2006; 222: 114–24.
40. Questions and answers on the review of Doribax (doripenem). Outcome of a procedure under Article 20 of Regulation (EC) No 726/2004. 21 June 2012. EMA/CHMP/411815/2012. www.ema.europa.eu
41. Kongnakorn T, Mwamburi M, Merchant S et al. Economic evaluation of doripenem for the treatment of nosocomial pneumonia in the US: discrete event simulation. Curr Med Res Opin 2010; 26: 17–24.
42. Rello J, Ollendorf DA, Oster J et al. For the CAP Outcomes Scientific Advisory Group. Epidemiology and outcomes of ventilator-associated pneumonia in a large U.S.database. Chest 2002; 122: 2115–21.
43. Белоусов Ю.Б., Зырянов С.К., Штейнберг Л.Л. Фармакоэкономические аспекты применения различных карбапенемов (имипенем/циластатин, меропенем, дорипенем) в лечении нозокомиальной пневмонии. Земский врач. 2013; 1 (18): 15–20. / Belousov Iu.B., Zyrianov S.K., Shteinberg L.L. Farmakoekonomicheskie aspekty primeneniia razlichnykh karbapenemov (imipenem/tsilastatin, meropenem, doripenem) v lechenii nozokomial'noi pnevmonii. Zemskii vrach. 2013; 1 (18): 15–20. [in Russian]
________________________________________________
1. Livermore DM. Doripenem: Antimicrobial profile and clinical potential. Microb Inf Dis 2009: 63: 455–8.
2. Schwaber MJ, Carmely Y. Mortality and delay in effective therapy associated with extended-spectrum b-lactamase production in Enterobacteriaceae bacteraemia: a systematic review and meta-analysis. J Antimicrob Chemother 2007; 60: 913–20.
3. Fritsche TR, Sader HS, Stillwell MG, Jones RN. Antimicrobial activity of doripenem tested against prevalent gram-positive pathogens: results from a global surveillance study (2003–2007). Diagn Microbiol Infect Dis 2009; 63: 440–6.
4. Jones RN, Bell JM, Sader HS et al. In vitro potency of doripenem tested against an international collection of rarely isolated bacterial pathogens. Diagn Microbiol Infect Dis 2009, 63: 434–9.
5. Mendes RE, Rhomberg PR, Turnidge J, Sader HS. Doripenem activity against a global collection of Enterobacteriaceae, including isolates resistant to other extended-spectrum agents. Diagn Microbiol Infect Dis 2009; 63: 415–25.
6. Сastanheira M, Jones RN, Livermore DM. Antimicrobial activities of doripenem and other carbapenems against Pseudomonas aeruginosa, other nonfermentative bacilli, and Aeromonas spp. Diagn Microbiol Infect Dis, 2009; 63: 426–33.
7. Goldstein EJC, Citron DM. Activity of a novel carbapenem, doripenem, against anaerobic pathogens. Diagn Microbiol Infect Dis 2009; 63: 447–54.
8. Kallen AJ, Hidron AI, Patel J, Srinivasan A. Multidrug resistance among gram-negative pathogens that caused healthcare-associated infections reported to the National Healthcare Safety Network, 2006–2008. Infect Control Hosp Epidemiol 2010; 31: 528–31.
9. Gales AC, Azevedo HD, Cereda RF et al for INVITA-A-DORI Brazilian Study Group. Antimicrobial activity of doripenem against gram-negative pathogens: results from INVITA-A-DORI Brazilian Study. Braz J Infect Dis 2011; 15 (6): 513–20.
10. Mushtaq S, Ge Y, Livermore DM. Doripenem versus Pseudomonas aeruginosa in vitro: activity against characterized isolates, mutants and transconjugants and resistance selection potential. Antimicrob Agents Chemother 2004; 48: 3086–92.
11. Fujimura T, Anan N, Sugimori G et al. Susceptibility of Pseudomonas aeruginosa clinical isolates in Japan to doripenem and other antipseudomonal strains. Int J Antimicrob Agents 2009; 34: 523–8.
12. Sakyo S, Tomita H, Tanimoto K et al. Potency of carbapenems for the prevention of carbapenem-resistant mutants of Pseudomonas aeruginosa: a high potency of a new carbapenem doripenem. J Antibiot 2006; 59: 220–8.
13. Davies TA, Shang W, Redman R et al. Genotyping of gramnegative uropathogens isolated pre- and post-treatment from subjects in a doripenem clinical trial for complicated urinary tract infections, 2008. WPCCID, Taipei, Taiwan.
14. Jones TN, Pfaller MA, SENTRY Antimicrobial Surveillance Program Participants Group (USA) (2001). Can antimicrobial susceptibility testing results for ciprofloxacin or levofloxacin predict susceptibility to a newer fluorquinolone, gatifloxacin? Report from The SENTRY Antimicrobial Surveillance Program (1997-99). Diagn Microbiol Infect Dis 39: 237–43.
15. Hagihara M, Kuti JL. Nicolau DP. Predicting doripenem susceptibility based on meropenem and imipenem interpretation for Pseudomonas aerginosa. Diagn Microbiol Infect Dis 2012; 72: 258–62.
16. Grigor'evskaia Z.V., Dmitrieva N.V., Petukhova I.N., D'iakova S.A. Osobennosti techeniia infektsionnykh oslozhnenii, vyzvannykh panrezistentnymi Acinetobacter baumannii, u onkologicheskikh bol'nykh. Sib. onkologicheskii zhurn. 2011; 6: 14–8. [in Russian]
17. Chaudhary M, Payasi A. Incidence, prevalence and control of multidrug resistant (MDR) carbapenemase producing Acinetobacter baumannii in Indian intensive care units. J Pharm Res 2013, 7: 175–80.
18. Dong S-X, Wang J-T, Chang S-C. Activities of doripenem against nosocomial bacteremic drug-resistant Gram-negative bacteria in a medical center in Taiwan. J Microbiol Immunol Infection 2012; 45: 459–64.
19. Somily AM, Absar MM, Arshad MZ et al. Antimicrobial susceptibility patterns of multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii against carbapenems, colistin, and tigecycline. Saudi Med J 2012; 33 (7): 750–5.
20. Marti S, Sanchez-Cespedes J, Alba V, Vila J. In vitro activity of doripenem against Acinetobacter baumannii clinical isolates. Int J Antimicrob Agents 2009; 33: 181–2.
21. Clock SA, Tabibi S, Alba L et al. In vitro activity of doripenem alone and in multi-agent combinations against extensively drug-resistant Acinetobacter baumannii and Klebsiella pneumoniae. Diagn Microbiol Infect Dis 2013, 76: 343–6.
22. Van Wart SA, Andes DR, Ambrose PG, Bhavnani SM. Pharmacokinetic-pharmacodynamic modeling to support doripenem dose regimen optimization for critically ill patients. Diagn Microbiol Infect Dis 2009, 63: 409–14.
23. Jaruratanasirikul S, Wongpoowarak W, Kositpantawong N et al. Pharmacodynamics of doripenem in critically ill patients with ventilator-associated gram-negative bacilli pneumonia. Int J Antimicrob Agents 2012; 40: 434–9.
24. Ariano RE, Nyhlen A, Donnelly JP et al. Pharmacokinetics and pharmacodynamics of meropenem in febrile neutropenic patients with bacteriemia. Ann Pharmacother 2005; 39: 32–8.
25. He W, Kaniga K, Lynch AS et al. In vitro Etest synergy of doripenem with amikacin, colistin, and levofloxacin against Pseudomonas aeruginosa with defined carbapenem resistance mechanisms as determined by the Etest method. Diagn Microbiol Infect Dis 2012; 74: 417–9.
26. Wiskirchen DE, Crandon JL, Nicolau DP. Impact of various conditions on the efficacy of dual carbapenem therapy against KPC-producing Klebsiella pneumoniae. Int J Antimicrob Agents 2013; 41: 582–5.
27. Lucasti C, Jasovich A, Umeh O et al. Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, non-inferiority study. Clin Therapeutics 2008; 30 (5): 868–83.
28. Malafaia O, Umeh O, Jiang J. Doripenem versus meropenem for the treatment of complicated intra-abdominal infections. Presented at: 46th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 27–30, 2006; San Francisco, California. Poster L-15640-b.
29. Naber KG, Llorens L, Kaniga K et al. Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infections and pyelonephritis. Antimicrob Agents Chemother 2009; 53: 3782–92.
30. Rea-Neto A, Niederman M, Lobo SM et al. Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized open-label, multicenter study. Curr Med Res Opin 2008; 24: 2113–26.
31. Chastre J, Wunderink R, Prokocimer P et al. Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study. Crit Care Med 2008; 36 (4): 1089–96.
32. Tazuma S, Igarashi Y, Inui K et al. Clinical efficacy of intravenous doripenem in patients with acute biliary tract infection: a multicenter, randomized, controlled trial with imipenem/сilastatin as comparator. J Gastroenterol 2015; 50 (2): 221–9.
33. Mustafa M, Chang WM, Lee C et al. PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study). Int J Antimicrob Agents 2014; 43 (4): 353–60.
34. Kollef MH, Chastre J, Clavel M et al. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care 2012; 16: R218.
35. Jenkins SG, Fisher AC, Peterson JA et al. Meta-analysis of doripenem vs comparators in patients with pseudomonas infections enrolled in four phase III efficacy and safety trials. Curr Med Res Opin 2009; 25 (12): 3029–36.
36. Qu X-Y, Hu TT, Zhou W. A meta-analysis of efficacy and safety of doripenem for treating bacterial infections. Braz J Infect Dis 2015; 19 (2): 156–2.
37. Merchant S, Gast C, Nathwani D et al. Hospital resource utilization with doripenem versus imipenem in the treatment of ventilator-associated pneumonia. Clin Therapeutics 2008; 30 (4): 717–33.
38. Matthews SJ, Lancaster JW. Doripenem monohydrate, a broad-spectrum carbapenem antibiotic. Clin Ther 2009; 31 (1): 42–63.
39. Horiuchi M, Kimura M, Tokumura M et al. Absence of convulsive liability of doripenem, a new carbapenem antibiotic, in comparison with b-lactam antibiotics. Toxicology 2006; 222: 114–24.
40. Questions and answers on the review of Doribax (doripenem). Outcome of a procedure under Article 20 of Regulation (EC) No 726/2004. 21 June 2012. EMA/CHMP/411815/2012. www.ema.europa.eu
41. Kongnakorn T, Mwamburi M, Merchant S et al. Economic evaluation of doripenem for the treatment of nosocomial pneumonia in the US: discrete event simulation. Curr Med Res Opin 2010; 26: 17–24.
42. Rello J, Ollendorf DA, Oster J et al. For the CAP Outcomes Scientific Advisory Group. Epidemiology and outcomes of ventilator-associated pneumonia in a large U.S.database. Chest 2002; 122: 2115–21.
43. Belousov Iu.B., Zyrianov S.K., Shteinberg L.L. Farmakoekonomicheskie aspekty primeneniia razlichnykh karbapenemov (imipenem/tsilastatin, meropenem, doripenem) v lechenii nozokomial'noi pnevmonii. Zemskii vrach. 2013; 1 (18): 15–20. [in Russian]
Авторы
И.Н.Петухова*, Н.В.Дмитриева
ФГБНУ Российский онкологический научный центр им. Н.Н.Блохина. 115478, Россия, Москва, Каширское ш., д. 23
*irinapet@list.ru
________________________________________________
I.N.Petukhova*, N.V.Dmitrieva
N.N.Blokhin Russian Cancer Research Center. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*irinapet@list.ru