Abstract
The objective of this prospective multicentre study was to evaluate the efficacy of cefoperazone/sulbactam for monotherapy of patients with bacterial sepsis in different wards of multifield hospitals in Russia. Overall, in 14 study centers 127 patients with sepsis were enrolled, organ dysfunction was diagnosed in 53,5%. All patients received cefoperazone/sulbactam 4–8 g per day for 7–14 days. Clinical examination was performed on 3–5, 7–14 and 28–30 study days. Clinical efficacy of cefoperazone/sulbactam reached 95,8% with 76,5% patients cured and 19,3% – improved. Infection was confirmed microbiologically in 57,5% patients. Pathogens were: Enterobacteriaceae – 44 strains (37%); Pseudomonas aeruginosa – 22 (18,5%) strains; Enterococcus spp. – 22 (18,5%); Staphylococcus aureus – 19 (16%); other nonfermentative gram-negative rods – 12 (10%). The most active against prevalent pathogens (Enterobacteriaceae) were imipenem/cilastatin and cefoperazone/sulbactam with accounting resistance of 2,3% and 6,9% respectively (р > 0,05). Bacteriological efficacy on 7–14 days of treatment in 82 (64,6%) patients was considered as «eradication». In 4 (3,2%) patients a relation of adverse drug events to drug intake was assessed as «probable». Based on the results of the study cefoperazone/sulbactam may be recommended for empirical monotherapy of bacterial sepsis.
-
1.
Brun-Buisson C., Doyon F., Carlet J., et al. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA 1995; 274: 968-74.
-
2.
Angus D.C., Linde-Zwirble W.T., Lidicker J., et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001; 29:1303-10.
-
3.
Martin G.S., Mannino D.M., Eaton S., Moss M. The Epidemiology of Sepsis in the United States from 1979 through 2000. N Engl J Med. 2003; 348: 1546-54.
-
4.
Cross A.S., Opal S.M. A new paradigm for the treatment of sepsis: is it time to consider combination therapy? Ann Intern Med 2003; 138: 502-5.
-
5.
Fish D.N., Piscitelli S.C., Danziger L.H. Development of resistance during antimicrobial therapy: a review of antibiotic classes and patient characteristics in 173 stud- ies. Pharmacotherapy 1995; 15: 279-91.
-
6.
Valles J., Rello J., Ochagavia A., et al Community- acquired bloodstream infection in critically ill adult patients: impact of shock and inappropriate antibiotic therapy on survival. Chest 2003; 123: 1615-24.
-
7.
Williams J.D. β-Lactamase inhibition and in vitro activi- ty of sulbactam and sulbactam/cefoperazone. Clin Infect Dis 1997; 24: 494-7.
-
8.
Bush L.M., Johnson C.C. Ureidopenicillins and β-lac- tam/ β-lactamase inhibitor combinations. Infect Dis Clin North Am 2000; 14: 1-24.
-
9.
Bodey G., Abi-Said D., Rolston K., et al. Imipenem or cef- operazone-sulbactam combined with vancomycin for therapy of presumed or proven infection in neutropenic fever patients. Eur J Clin Microbiol Infect Dis 1996; 15: 625-34.
-
10.
Natanson C. The sirens songs of confirmatory sepsis tri- als: Selection bias and sampling error. Crit Care Med 1998; 26: 1927-32.
-
11.
Интернет-версия Государственного Реестра лекарст- венных средств. Фонд фармацевтической информа- ции. www.drugreg.ru
-
12.
Bone R.C., Balk R.A., Cerra F.B., et al. Definitions for sepsis and organ failure and guidelines for the use of inno- vative therapies in sepsis. Chest 1992; 101: 1644-55.
-
13.
Hantke M., Holzer K., Thone S., et al. The SOFA score in evaluating septic illnesses. Correlations with the MOD and APACHE II score. Chirurg 2000; 71: 1270-6.
-
14.
National Committee for Clinical Laboratory Standards. Performance standards for antimicrobial susceptibility testing. 2002.
-
15.
Solomkin J.S., Hemsell D.L., Sweet R., Tally F., Bart- lett J. Общее руководство по оценке новых противо- инфекционных лекарственных средств. Европейское руководство по клинической оценке противоинфек- ционных лекарственных средств. Пер. с англ. Под ред. T.R. Jr.Beam, D.N. Gilbert, C.M. Kunin. Смоленск: Амипресс; 1996.
-
16.
Rivers E.P., Nguyen H.B., Amponsah D. Sepsis: a land- scape from the emergency department to the intensive care unit. Crit Care Med 2003; 31: 968-9.
-
17.
Rangel-Frausto M.S. The epidemiology of bacterial sep- sis. Infect Dis Clin North Am 1999; 13: 299-312, vii.
-
18.
Vincent J.L., Abraham E., Annane D., et.al. Reducing mortality in sepsis: new directions. Crit Care 2002; 6 (Suppl 3) S1-18.
-
19.
Mouton Y., Deboscker Y., Bazin C., et al. Prospective, randomized, controlled study of imipenem-cilastatin ver- sus cefotaxime-amikacin in the treatment of lower respi- ratory tract infection and septicemia at intensive care units. Presse Med 1990; 19: 607-12.
-
20.
Extermann M., Regamey C., Humair L., et al. Initial treatment of sepsis in non-neutropinic patients: cef- tazidime alone versus "best guess" combined antibiotic therapy. Chemotherapy 1995; 41: 306-15.
-
21.
Solberg C.O., Sjursen H. Safety and efficacy of meropen- em in patients with septicemia: a randomized comparison with ceftazidime, alone or combined with amikacin. J Antimicrob Chemother 1995; 36 (Suppl A): 157-66.
-
22.
Mouton Y.J., Beuscart C. Empirical monotherapy with meropenem in serious bacterial infections. Meropenem Study Group. J Antimicrob Chemother 1995; 36 (Suppl A): 145-56.
-
23.
Яковлев В.П., Крутиков М.Г, Алексеев А.А., Гриши- на И.А., Изотова Г.Н., Кашин Ю.Д. Опыт применения сульперазона (цефоперазон/сульбактам) в комплекс- ном лечении больных с ожоговой инфекцией. Анти- биотики и химиотерапия. 1995; 40: 38-41.
-
24.
Митрохин С.Д. Сульперазон в лечении тяжёлых инфекций у онкологических больных. Антибиотики и химиотерапия. 2003; 48: 26-9.
-
25.
Sattler F.R., Weitekamp M.R., Ballard J.O. Potential for bleeding with the beta-lactam antibiotics. Ann Intern Med 1986; 105: 924.
-
26.
Страчунский Л.С., Решедько Г.К., Рябкова Е.Л. и соавт. Рекомендации по оптимизации антимикробной терапии нозокомиальных инфекций, вызванных гра- мотрицательными бактериями в отделениях реанима- ции и интенсивной терапии. Клин микробиол анти- микроб химиотер 2002;4: 379-90.
-
27.
Stratchounski L., Edelstein I., Narezkina A., et al. In vitro activity of cefoperazone/sulbactam vs amoxicillin/clavu- lanic acid and piperacillin/tazobactam against extended spectrum β-lactamase (ESBL)-producing strains of Escherichia coli and Klebsiella pneumoniae. Clin Microb Infect 2002; 8 (Suppl 1): 329.
-
28.
Hanberger H., Garcia-Rodriguez J.A., Gobernado M., et al. Antibiotic susceptibility among aerobic Gram-nega- tive bacilli in intensive care units in 5 European coun- tries. JAMA 1999; 281: 67-71.
-
29.
Williams J.D. β-lactamases and β-lactamase inhibitors. Int J Antimicrob Agents 1999; 12: S3-7.
-
30.
Zhang Y.L., Li J.T. The in vitro activity of sulbactam com- bined with third generation cephalosporins against third generation cephalosporin-resistant bacteria. Int J Anti- microb Agents 2001; 17: 143-6.
-
31.
Goldstein E.J., Citron D.M. Comparative in vitro activity of cefoperazone/sulbactam and 11 other agents against multidrug resistant Bacteroides fragilis group species. J Antimicrob Chemother 1996; 38: 733-7.
-
32.
Бекетов А.С., Сидоренко С.В., Писарев В.В., Комаров Р.М. Сравнительная клинико-экономическая оценка беталактамных антибиотиков при лечении интрааб- доминальных инфекций. Антибиотики и химиотера- пия. 2003; 48(3): 34-41.
-
33.
Hugonnet S., Harbarth S., Ferriere K., et al. Bacteremic sepsis in intensive care: temporal trends in incidence, organ dysfunction, and prognosis. Crit Care Med. 2003; 31: 390-4. 34 Hotchkiss R.S., Karl I.E. The pathophysiology and treatment of sepsis. N Engl J Med 2003; 348: 138-50. 35 Cross A.S., Opal S.M. A new paradigm for the treatment of sepsis: is it time to consider combination therapy? Ann Intern Med 2003; 138: 502-5.