Efficacy of pefoxacin (abactal) in the complex treatment of patients with pancreonecrosis]

The efficacy of pefloxacin in the complex treatment of 28 patients with pancreatonecrosis of various etiology was estimated in a prospective trial. The diagnosis of pancreatonecrosis was verified by the data of the disease clinical progress, laboratory findings and instrumental examination. Pefloxacin (Abactal; LEK) was administered intravenously in a dose of 400 mg every 8 hours (1200 mg) in combination with metronidazole in a dose of 1.5-2.0 g a day intravenously. When indicated 3 days after the start of the pefloxacin therapy, the treatment was switched to the oral use of the drug in the same dosage. The positive clinical effect (cure and improvement) at the end of the treatment with pefloxacin was stated in 78 per cent of the patients in spite of the initial severity state of above 15 APACHE II. It was shown that in the treatment of patients with pancreatonecrosis when the severity state was not above 12 APACHE II the antibacterial therapy with pefloxacin in combination with metronidazole was optimal.     

Sulperazone in the treatment of severe infections in patients with cancer]

For the evaluation of rational sulperazone position in oncological hospital and elaboration of its implementation criteria investigation was performed. The trial included 193 patients (88 patients with injuries, 66 with hospital pneumonia, 39 with urinary track infection). From different clinical material of the patients were isolated 136 straines of Gram-negative bacteria. Suseptibile to sulperazone were 67 per cent of P. aeruginosa, 78-86 per cent of P. vulgaris, Klebsiella and E. coli isolates, 66 [symbol: see text] 60 per cent of Enterobacter and Serratia isolates subsequently. Comparative results of treatment with sulperazone as monotherapy and for combination with aminoglycosides (gentamycin or amicacin) in the case of P. aeruginosa infection demonstrated high sulperazone efficacy not lower than imipenem/cilsatatin and cefepime efficacy in the case of hospital infections treatment at critical care units. Low price of the sulperazone treatment when compared to imipenem/cilastatine is emphasized. Another advantage of sulperazone when compared to cefepime is anaerobic infection treatment--cefepime is administered in combination with metronidazole while sulperazone is used in monotherapy.     

The role of cefepime, a 4th-generation cephalosporin, in treating patients with surgical sepsis]

Cefepime (Maxipime) was used in the management of 22 patients at the age of 18 to 73 years with the surgical sepsis syndrome (SAPS > 15). In 16 patients surgical sepsis was due to pancreatitis, appendititis, abdominal wound or trauma or complications after planned surgical interventions on the organs of the abdominal cavity. In the other 6 patients surgical sepsis was due to inflammatory processes in soft tissues after minor trauma. In 10 patients (group 1) cefepime was used after the pathogen verification and antibioticogram examination. In 12 patients (group 2) the antibiotic was used in the empirical therapy as the first line drug after the patients acceptance from another unit when the pathogen nature was obscure. Cefepime was administered intravenously in a dose of 2.0 g twice daily for 7 to 10 days in combination with metronidazole in a dose of 0.5 g thrice daily. After 5-6 days of the treatment the patients of group 1 were switched to the cefepime intramuscular regimen. The lethality totaled 18 per cent (4 patients). Three of them were from group 2. The patients died of progressive polyorgan insufficiency. It is characteristic that in no cases cefepime induced septic shock due to the endotoxin escape. No septicopyemia was as well observed even in the patients with verified bacteremia due to Staphylococcus aureus.     

Comparative clinical and epidemiological evaluation of beta-lactam antibiotics in the treatment of intraabdominal infections]

We performed a retrospective, comparative study to evaluate efficacy, safety and economic outcomes of empiric cefoperazone/sulbactam monotherapy compared with the meropenem, imipenem/cilastatine and combination of cefepime plus metroindazol in patients with intra-abdominal infection. A total of 468 patients diagnosed with intra-abdominal abscess, peritonitis, pancreatitis were included in the study (the severity of infection according to scale APACHE II was less than 15). Patients were randomized to be treated with either 500 mg meropemen i.v. every 8 hours or 500 mg imipenem/cilastatine i.v. every 8 hours or 2 g cefepime i.v. every 12 hours plus 500 mg metronidazol twice daily or cefoperazone/sulbactam 2 g daily administered every 12 hours. Overall positive clinical responses (cure or improvement) were achieved at the end of treatment for 87.5 patients in meropenem group, 86.6% in the imipenem/cilastatin group, 85.3% in the cefepime group and 86.8% in cefoperazone/sulbactam group. Total cost of the treatment per 100 patients with intra-abdominal infections for cefoperazone/sulbactam was 1957031 roubles, for combinations of cefepime with metronidazol--2497815 roubles. For carbapenem group cost achieved for meropenem--3085291 rub., for imipenem/cilastatin--2653388 roubles. Rate "cost-effectiveness" in total: 784.47$ for cefepime, and 834.39$ for imipenem/cilastatine, 970.21$ for meropenem and 615.4$ for cefoperazone/sulbactam. The most expensive treatment was considered to be with meropenem and imipenem/cilastatine, main share is determined by initial cost of preparations. Less expensive was treatment by cefoperazone/sulbactam with cefepime and by metronidazol.     

The use of ampicillin/sulbactam (Unasyn) in treating inflammatory urological diseases

Unasyn is a combination of ampicillin, a bactericidal antibiotic, and sulbactam, an inhibitor of beta-lactamases. It was used in treatment of 36 patients with urogenital infections. The combination was administered intravenously and in the main intramuscularly. The treatment course amounted to 7-10 days. The average daily dose was 6 to 9 g. 22 patients with acute nonocclusive pyelonephritis were treated with the combination and its clinical and bacteriological efficacy was stated in 95 per cent of the cases. An excellent clinical effect of the combination was observed in 6 patients with acute epididymitis. A clinical improvement was also observed in the treatment of the patients with acute prostatitis and chronic renal infections. Unasyn proved to be a highly efficient antibacterial combination with regard to gram-positive flora and colon bacilli as representatives of gram-negative organisms. Satisfactory results were also stated in the treatment of infections caused by Proteus spp. Complete elimination of the pathogen was achieved in 57.7 per cent of the cases. No adverse reactions to Unasyn except pain in the site of the injection were recorded.     

Efficacy of meropenem in the treatment of severe complicated urinary tract infections]

The clinical and bacteriological efficacies of meropenem in the treatment of 12 patients with urinary tract infection were studied. In 8 patients the drug was administered intravenously in a dose of 1 g every 8 hours and in 4 patients with the creatinine clearance below 50 ml/min it was administered in a dose of 1 g every 12 hours (the treatment course of 7 to 10 days). Meropenem was used in the monotherapy. Severe complicated urinary tract infections were mainly observed in the patients with long-term urolithiasis, subjected to repeated surgical interventions and isolating as a rule polyresistant strains of Pseudomonas aeruginosa and E.agglomerans as the pyelonephritis pathogens at a titre of 5 x 10(5)-5 x 10(8) microbial cells per 1 ml of the urine susceptible to meropenem in 80 to 96 per cent of the cases. The clinical efficacy of the drug was stated in all the patients while the bacteriological efficacy amounted to 88.9 per cent.     

Multicentre study of comparative efficacy of meropenem and combined regimens for empirical antibacterial therapy of severe nosocomial infections: results of clinical and pharmacoeconomic analysis]

Adequacy and effectiveness of empirical antibacterial therapy of severe nosocomial infections with meropenem vs. combined regimens of antibacterial therapy were investigated and the ratio of the cost and effectiveness of the compared regimens was evaluated. A prospective, randomized, open, comparative study of two initiative regimens of empirical antibacterial therapy of severe nosocomial infections was performed: meropenem in a daily dose of 1.5-3 g and the standard regimen with the use of betalactams and fluoroquinolones in combination with aminoglycosides and/or metronidazole. Patients with recorded diagnosis of nosocomial pneumonia (including the ventilator-associated one) or abdominal infection with the signs of severe sepsis and severity of APACHE II > 14 were enrolled. The patients were stratified into 2 groups subject to the disease severity, i.e. APACHE II 15-20 and APACHE II 21-25. One hundred thirty five out of 166 patients with recorded nosocomial infection were included into the final estimate of the therapy adequacy and effectiveness (Protocol Analysis): 62 patients were treated with meropenem and in the treatment of 73 patients the standard antibacterial therapy was used. In the group of the patients treated with meropenem there were stated significantly higher clinical effectiveness (recovery in 80.6% of the patients vs. the control of 46.6%, p < 0.01) and pathogen eradication (89.6 and 48.1% respectively, p < 0.01). The difference in the clinical and bacteriological effectiveness of meropenem and the standard therapy was more evident in the subgroups of more severe patients (APACHE > 20). With the use of meropenem the probability of recovery from nosocomial infection was significantly higher (RR 1.73-1.94, p < 0.001) vs. the control. Meropenem provided significantly higher eradication of the pathogens: P. aeruginosa (88 and 40% respectively, p = 0.007), E. coli (100 and 46.7%, p = 0.003), Acinetobacter spp. (90.9 and 40%, p = 0.02). The antibacterial therapy with the use of meropenem was assessed as adequate in 51 out of 56 patients (91.1%), that was 3 times as frequent as with the use of the standard antibacterial therapy (33.9%). The cost-effectiveness coefficient with the use of meropenem was 2.2 times lower vs. the control. Therefore, the empirical therapy of severe nosocomial infections with meropenem proved to be more adequate and from the economic viewpoint more advantageous vs. the standard combined regimens of antibacterial therapy, that was evident from significantly higher clinical and bacteriological efficacy of the treatment and decrease of the terms of the patients hospitalization in intensive care units (on the average by 5 days).     

A trial of using augmentin (amoxicillin/clavulanate) in surgical practice]

The experience with the use of augmentin (amoxycillin/clavulane) in abdominal surgery for prophylaxis of postoperative purulent complications was analyzed. The drug was used in 44 patients after relatively pure operations, 37 of them having various risk factors. In 2 patients (4.5 per cent) of that group postoperative pyoinflammatory complications were recorded. For comparison the results of the prophylactic use of cefoperazone, cefamandole or ceftazidime in the group of 78 patients after relatively pure operations on the abdominal cavity organs were analyzed. Postoperative complications in the latter group amounted to 7.4 per cent (4 patients). The results of the treatment of patients in two groups after contaminated operations were also compared. The patients of one group (41 patients) were treated prophylactically with augmentin in a dose of 1200 mg intraoperatively followed by the drug use in a dose of 600 mg thrice daily for 1 to 2 days after the operation. Postoperative pyoinflammatory complications were recorded in 4 patients of that group (9.7 per cent). 78 patients of the other group were treated prophylactically with ceftazidime or cefoperazone in a dose of 2 g and metronidazole intraoperatively or cefoperazone in a dose of 2 g twice daily and metronidazole in a dose of 500 mg twice daily for 1 to 2 days after the operation. Postoperative infectious complications were recorded in 8 patients of that group (10 per cent). In the group of patients with acute cholecystitis treated with ciprofloxacin in a dose of 400 mg in combination, with metronidazole before the operation and for 1 to 2 days after the operation postoperative complications were recorded in 4 patients (17 per cent).     

The clinical and economic efficacies of short courses of azithromycin in acute sinusitis]

A randomized study of a 3-day course of azithromycin therapy (500 mg once daily) vs. a 10-day course of co-amoxiclav therapy (625 mg thrice daily) in patients with acute sinusitis was performed with an account of the GCP criteria. One hundred patients in 2 groups each of 50 persons were enrolled. The estimates of the patient body temperature, headache, pain on palpation in the area of the accessory nasal sinuses, nasal cavity stuffing, nasal discharge nature and the nose mucous membrane appearance were recorded prior to the treatment, in 72 hours and on the 10th-12th and 26th-30th days of the treatment. The microbiological analysis of the punctate from the accessory nasal sinuses was undertaken before the antibiotic therapy and 72 hours after its start. The economic analysis included the cost of the antibiotic therapy course, hospitalization term, medical manipulations and laboratory tests as well as the cost/efficacy index. The frequency of the relapses within 6 months after the cure was estimated in the two groups compared. In 72 hours and on the 10th-12th days after the treatment start the efficacy of azithromycin was significantly higher than that of co-amoxiclav. The cure was stated in 41 (82 per cent) and 26 (52 per cent) patients on the 10th-12th days, in 6 (12 per cent) and 21 (42 per cent) patients the improvement was stated and the fail was stated in 3 (6 per cent) and 2 (4 per cent) patients respectively. The efficacy of the drugs on the 26th-30th days after the treatment start did not differ. The isolates of Staphylococcus aureus and Streptococcus pyogenes were the main pathogens. The bacteriologic eradication was recorded in 29 (90.6 per cent) patients treated with azithromycin and only in 18 (69.2 per cent) patients treated with co-amoxiclav. Adverse reactions and relapses of the disease within 6 months after the cure were more frequent in the patients treated with co-amoxiclav. The cost of the azithromycin therapy was significantly lower. It was shown that the shortened course of the azithromycin therapy provided earlier cure of the patients with acute sinusitis, better tolerance of the drug, less frequent adverse reactions, lower cost as compared to the use of co-amoxiclav and no relapses.     

Cefepime/amikacin in the empirical antibacterial therapy for patients with hemoblastosis of different forms]

The results of the use of cefepime (Maxipime) combination with amikacin vs ceftriaxon combination with amikacin in the treatment of 80 patients with different forms of hemoblastosis are presented. Severe infectious complications in the patients were associated with prolonged and deep neutropenia during inductive or antirelapsing chemotherapy. All the patients in the trial were from the group of high risk of infectious complications with the blood neutrophil count under 100 cells/microliter. The duration of neutropenia averaged 12 days (7 to 15). The average period of the treatment with cefepime and amikacin equaled to 13 days (8 to 16). The treatment with cefepime + amikacin was successful in 38 out of 40 patients (95%). The average period of the treatment with ceftriaxon and amikacin equaled to 14 days (7 to 18). The efficacy of the treatment with ceftriaxon + amikacin was 60% (24 patients out of 40).     

Use of pefloxacin in the treatment of patients with purulent wounds of soft tissues]

Pefloxacin was used in the treatment of 25 patients with wound infection in a dose of 400 mg orally twice a day for 10-12 days. As the monotherapy it was applied to 15 patients. 7 patients with clinical signs of non-clostridial anaerobic infection were treated with pefloxacin in combination with intravenous metronidazole. Pefloxacin was highly efficient in 96 per cent of the cases with extensive posttraumatic purulent wounds with and without bone affection, acute purulent wounds of the soft tissue, purulent wounds of the soft tissues in diabetic patients, trophic or decubitus ulcer. 266 clinical isolates of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Proteus mirabilis, Enterobacter spp. and Acinetobacter spp, were tested and 75 to 100 per cent of them was shown to be susceptible to pefloxacin and ciprofloxacin. At the same time the isolates of Pseudomonas aeruginosa and Klebsiella spp. were more susceptible to ciprofloxacin. The pathogen eradication and eradication with superinfection in the cases treated with pefloxacin amounted to 92 per cent. The drug tolerance was good. No clinically significant adverse events were recorded.     

The clinical efficacy of ticarcillin/clavulanate in severe pneumonia]

Efficacy of ticarcillin/clavulanate was studied in the treatment of 11 patients with severe community- and hospital-acquired pneumonia in an open controlled trial. The drug was administered in a dose of 3.1 g every 4 or 6 hours depending on the infection severity. When pneumonia was due to Pseudomonas aeruginosa, amikacin was additionally used. The positive clinical effect of ticarcillin/clavulanate was stated in 73 per cent of the patients. The pathogen eradication was stated in all the patients. However, in 2 cases superinfection due to P.aeruginosa developed. Mild adverse effects were observed in 2 cases. It is concluded that ticarcillin/clavulanate is highly efficient in the treatment of patients with severe or complicated pneumonia. In cases with ventilator-associated pneumonia it is advisable to use ticarcillin/clavulanate in combination with an aminoglycoside.     

Cefepime in the treatment of infection in neutropenic patients]

Cefepime, a fourth-generation cephalosporin, was used in the treatment of 11 febrile episodes in 8 patients with profound neutropenia. The patients were neutropenic because of high-dose chemotherapy with stem-cell rescue or second-line salvage chemotherapy for malignant lymphomas (5 patients) or solid tumors (3 patients). The median duration of grade-IV neutropenia (according to the WHO classification) was 11 days (7 to 14). Cefepime was used as the monotherapy in a dose of 2 g thrice daily. Disappearance of the infection signs was recorded in 8 episodes (73 per cent). In 3 episodes (23 per cent) cefepime was replaced by another drug. The tolerability of cefepime was good and no adverse events were observed with the exception of 1 event of an allergic reaction.     

Use of 5-fluorouracil, bleomycetin and platidiam in combined treatment of localized cancer of the larynx]

Preliminary results of chemoradiotherapy in 30 patients with the larynx cancer T3T4N0M0 are presented. Two treatment schemes were applied. According to scheme I, the treatment was started with chemotherapy with 5-fluorouracil in doses of 1000 mg on days 1, 2 and 3, bleomycetin in doses of 15 mg on days 1, 2 and 3 and platidiam in doses of 120 mg/m2 on day 4 followed by radiotherapy to the total dose of 66 to 70 Gy. Scheme II included two analogous courses of the chemotherapy, one prior to the radiotherapy and the other after irradiation in a dose of 38 to 40 Gy, after a two-week interval the radiotherapy was continued to doses of 66 to 70 Gy. 15 patients were treated in accordance with each scheme. Complete resorption of the tumor was observed in 66.6 and 83.3 per cent of the patients treated according to schemes I and II, respectively. The results showed that the use of 5-fluorouracil, bleomycetin and platidiam in combination with radiotherapy was promising in treatment of patients with local cancer of the larynx.     

Detoxifying effect of antibiotics and their effectiveness in experimental plague at the stage of explicit intoxication]

The effect of antibiotics such as amikacin, rifampicin, doxycycline, polymyxin B and cefotaxime on the toxins of the plague microbe (lipopolysaccharide + fraction II according to Beiker) was studied in vitro and in vivo. The study on the antibiotic neutralization of plague toxins revealed that only polymyxin had toxin neutralizing capacity which depended on the dose. Investigation of the polymyxin effect at various stages of plague infection showed that when polymyxin in a dose of 1250 units and a mixture of plague toxins in lethal doses were administered simultaneously to albino mice, the positive effect amounted to 100 per cent. When the antibiotic was administered 30 or 60 minutes later, the antibiotic efficacy proved to be lower by 90 or 76.6 per cent, respectively. The intoxication in later periods (in 90-120 minutes) resulted in a decrease in animal survival up to 40-15 per cent. It was demonstrated on the model of the plague infection in albino mice that the use of amikacin, cefotaxime, rifampicin or doxycycline during polymyxin therapy at the stage of marked generalization of the infection provided a significant increase in the animal survival (60 to 80 per cent) as compared to that after the use of the same drugs alone (0 to 20 per cent).     

Clinical and microbiological efficacy of metronidazole and ornidazole in the treatment of urogenital trichomoniasis in men]

The aim of the study was to compare the efficacy of metronidazole and ornidazole in the treatment of urogenital trichomoniasis in men. The drugs were used randomly in usual doses as monotherapy: 210 patients, metronidazole and 217 patients, ornidazole. The clinical efficacy of metronidazole and ornidazole was stated in 57.6 and 94.5% of the patients and the microbiological efficacy was stated in 77.1 and 98.2% of the patients respectively. The side effects were recorded in 59.0 and 3.7% of the patients respectively. Thus, ornidazole proved to be a more efficient and safe agent vs. metronidazole in the treatment of urogenital trichomoniasis.     

The comparative activity of cefepime and other current antibiotics against microorganisms isolated from patients in pediatric intensive therapy units]

Comparative activity of cefepime, ceftazidime, ceftriaxone, ciprofloxacin, imipenem and piperacillin/tazobactam against isolates from patients of pediatric intensive care units within October-December 1998 was studied. The isolates were identified with the Walkaway-40 System. The antibiotic susceptibility was evaluated by the E-test on the Mueller-Hinton II agar. The data were interpreted in accordance with the NCCLS. The number of the isolates totaled 100. Among them not more than 10 to 12 strains belonged to the same species. 92 per cent of the isolates was susceptible to cefepime and 70 to 75 per cent of the isolates were susceptible to the third generation cephalosporins. Piperacillin/tazobactam proved to be highly susceptible, the number of the isolates resistant and moderately resistant to it being 6 and 1 per cent respectively. The results showed that cefepime was intermediate between the third generation cephalosporins and carbapenems.     

Quality of use of parenteral metronidazole therapy in a teaching hospital

The recent release, relatively high cost and potential adverse effects of parenterally administered metronidazole prompted a quality-of-use audit at a 1000-bed teaching hospital. Ninety-two courses of treatment in 81 inpatients during a 6-week period were studied. Appropriateness of therapy was assessed on the basis of published indications. Parenterally administered metronidazole was prescribed primarily in anaerobic and anaerobic-aerobic infections. It was used as frequently for prophylaxis as for therapy. Surgical services accounted for 95% of the treatment courses. Inappropriate use was noted in 27 (29%) of the courses: agents other than parenterally administered metronidazole were indicated in 12 (13%), while the dose, dosing interval or duration of treatment was suboptimal in 15 (16%). Substantial savings would be achieved if oral or rectal metronidazole therapy were substituted for intravenous therapy for perioperative prophylaxis in elective colorectal surgery. Written justification for use and automatic stop orders are recommended to improve the cost effectiveness of both prophylactic and therapeutic use of selected antimicrobial agents.     

TRICHOMONIASIS—Clinical Trial of Metronidazole (Flagyl?)

Metronidazole was given in various dosage regimens to 97 patients having microscopically diagnosed trichomoniasis.At the first examination after treatment all 97, including 76 to whom metronidazole had been given orally only, were found by culture and wet smear to be free of trichomonads.Reexamination of the 65 patients followed up for periods ranging from two weeks to 14 months revealed reappearance of trichomonads in eight cases.Nineteen husbands were treated. No patient had a recurrence after treatment of the husband.No effect of metronidazole on pregnancy or on fetal development was seen. Side effects, noted in 19 cases (20 per cent), generally were mild and transient and in no case were severe enough to terminate therapy before cure was effected.     

Cefepime treatment efficacy in surgical patients]

Clinical and bacteriologial efficacies of cefepime were studied in the treatment of 20 surgical patients. Intraoperative prophylaxis is with the use of cefepime alone and postoperative prophylaxis with the use of cefepime in combination with some other drugs were applied to 10 patients. No postoperative complications in the group of the 10 patients were stated. The other 10 patients were subjected to intraoperative and postoperative combined prophylaxis with some other antibiotics. In 6 patients of the latter group postoperative complications developed. Obvious clinical advantages of cefepime were demonstrated.