Publication: Sefepim ve metronidazol kombinasyonunun intraabdominal enfeksiyonlarda etkinliği ve güvenilirliği
Abstract
Günümüzde çeşitli enfeksiyonların tedavisinde karşılaşı¬lan en sık sorun kullanılan antibiyotiklere karşı etken bak-terilerce direnç geliştirilmesidir. Hem bakteri direncini önlemek hem de daha önceki kuşak sefalosporinlerin dar bir spektrumda etken olmaları dezavantajını ortadan kal¬dırma amaçlı olarak bir dördüncü kuşak sefalosporin olan sefepim geliştirilmiştir. Gram pozitif ve negatif aerob bak¬terilere karşı etkin olduğu bilinen sefepime ek olarak ana-eroblara karşı etkinliği bilinen metronidazolun beraberce tüm bakteri spekturumunu kapsayacak şekilde kullanılma¬sı ağır intraabdominal enfeksiyonlarda bir seçenek olarak düşünülmüştür. Çok merkezli, non-komperatif, prospektif olarak yapılan bu çalışmada sefepim (Maxipim® 2x1-2 gr IV infüzyon; 10 gün) ve metronidazol (Flagyl®, 15 mglkg dozunu takiben 4x7 mglkg IV infüzyon; 10 gün) kombi¬nasyonunun intraabdominal enfeksiyonlardaki etkinliği ve güvenilirliği araştırıldı. Tedavinin öncesi, sonrası ve teda¬vi süresince kan biyokimyası ölçümleri, tam kan sayımı ile intraoperatif olarak karından veya ameliyat sonrası dren¬ler aracılığı ile elde edilen enfekte materyal ile kan kültür/ antibiyogram incelemeleri yapıldı. Tüm değerlendirmeler 250 hasta üzerinden yapıldı. İntraabdominal enfeksiyonun nedeni en sık akut apandisit (% 41) idi. 68 hastanın (% 27) kontamine kirli, 182 hastanın (%~73) ise kirli enfeksi¬yonu bulunmakta idi. Hastalardan alınan kültürlerde en sık olarak E.coli (% 67) izole edildi. Klinik olarak hasta¬ların % 96'sı sefepime 72 saatte olumlu yanıt verirken, % 4 hastada yanıt alınamadı. Son klinik değerlendirmede % 92 hastada tam iyileşme sağlanırken, % 7 hastada düzel¬me saptandı. Bulantı, diyare ve cilt reaksiyonu gibi yan etkiler yalnız % 3 hastada görüldü. Bu çalışma ile her iki ilacın belirtilen dozda beraberce kullanılmasının intraab¬dominal enfeksiyonların tedavisinde etkin olmasının yanı-sıra düşük yan etki oranı ile de güvenilir olduğu sonucuna varılmıştır.
Efficiency and Safety of Cefepime and Metronidazole Combination on intraabdominal Infections Bacterial resistance to common antibiotics used for vari¬ous kinds of infections is one of the leading causes of con¬cern in clinics. Although third generation cephalosporines are among the prefered drugs used for intraabdominal in¬fections, their bacterial coverage is still limited for bacte¬ria other than gram negative rods. Recently, cefepime-a fourth generation cephalosporine-has been emerged as a solution for overcoming bacterial resistance and lack of broad spectrum coverage of earlier generations. In the present study, cefapime (Maxipime®, 1-2 grs every 12 hrs; 10 days, BristolMyers Squibb) and metronidazole (Flagyl®, induction dose of 15 mglkg followed by 7.5 mgl kg eveiy 6 hrs; 10 days, Eczacıbaşı) are delivered to pa¬tients with intraabdominal suppuration in order to assess their safety and effectiveness in severe circumstances. Measurement of blood biochemistry values and whole blood count were carried out as routine in patients and also intraabdominal infectious material was collected both intra and postoperatively for evaluation of bacterial culture and antibiogram before commencing, during and after completition of the therapy as possible. Totally 250 patients with intraabdominal infection were in¬cluded in the study from various centers in Turkey. Acute apandicitis (41 %) was the leading cause for the suppura¬tion in patients. The operative wound infection classifica¬tion was found to be as contaminated in 27 % and dirty I infected in 73 % of patients. E.coli (67 %) was the isolated organism in most patients. Complete clinical response to the regimen was obtained in 96 % of patients whereas in 4 % of patients, the response was inadequate within the first 72 hours. At the completition of the therapy, we observed full recovery in 92 % and limited in 7 % of patients. Ad¬verse reactions due to the regimen (i.e. nausea, skin reac¬tions, diarrhea) were experienced in only 3 % of patients. In this multicenter, prospective but noncomperative study, the combined regimen of cefepime and metronidazol was found to be effective and safe to overcome the infection in patients with intraabdominal suppuration.
Efficiency and Safety of Cefepime and Metronidazole Combination on intraabdominal Infections Bacterial resistance to common antibiotics used for vari¬ous kinds of infections is one of the leading causes of con¬cern in clinics. Although third generation cephalosporines are among the prefered drugs used for intraabdominal in¬fections, their bacterial coverage is still limited for bacte¬ria other than gram negative rods. Recently, cefepime-a fourth generation cephalosporine-has been emerged as a solution for overcoming bacterial resistance and lack of broad spectrum coverage of earlier generations. In the present study, cefapime (Maxipime®, 1-2 grs every 12 hrs; 10 days, BristolMyers Squibb) and metronidazole (Flagyl®, induction dose of 15 mglkg followed by 7.5 mgl kg eveiy 6 hrs; 10 days, Eczacıbaşı) are delivered to pa¬tients with intraabdominal suppuration in order to assess their safety and effectiveness in severe circumstances. Measurement of blood biochemistry values and whole blood count were carried out as routine in patients and also intraabdominal infectious material was collected both intra and postoperatively for evaluation of bacterial culture and antibiogram before commencing, during and after completition of the therapy as possible. Totally 250 patients with intraabdominal infection were in¬cluded in the study from various centers in Turkey. Acute apandicitis (41 %) was the leading cause for the suppura¬tion in patients. The operative wound infection classifica¬tion was found to be as contaminated in 27 % and dirty I infected in 73 % of patients. E.coli (67 %) was the isolated organism in most patients. Complete clinical response to the regimen was obtained in 96 % of patients whereas in 4 % of patients, the response was inadequate within the first 72 hours. At the completition of the therapy, we observed full recovery in 92 % and limited in 7 % of patients. Ad¬verse reactions due to the regimen (i.e. nausea, skin reac¬tions, diarrhea) were experienced in only 3 % of patients. In this multicenter, prospective but noncomperative study, the combined regimen of cefepime and metronidazol was found to be effective and safe to overcome the infection in patients with intraabdominal suppuration.