Quinolones for uncomplicated acute cystitis in women.

BACKGROUND: Uncomplicated acute cystitis is one of the most common bacterial infections in adults. The percentage of women who have at least one episode of acute cystitis is estimated to be between 40% to 50%. Quinolones are recommended for acute cystitis in regions where the level of resistance to other antimicrobials namely co-trimoxazole is high. However the efficacy, safety and tolerance of quinolones needs investigation. OBJECTIVES: To compare the efficacy, safety and tolerance of different quinolones in women with uncomplicated acute cystitis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library Issue 3, 2003), MEDLINE (1966 - September 2003), EMBASE (1988 - September 2003), reference lists of articles and abstracts from conference proceedings without language restriction. Reference lists of urology, infectious diseases and nephrology textbooks, review articles and relevant studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing two or more different quinolones in women (>/= 16 years) with uncomplicated acute cystitis were selected. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Statistical analyses were performed using the random effects model and the results expressed as relative risk (RR) for dichotomous outcomes with 95% confidence intervals (CI). MAIN RESULTS: We identified 11 studies enrolling 7535 women. There were no significant differences in clinical or microbiological efficacy between quinolones. Photosensitivity reactions were more frequently observed for sparfloxacin when compared to ofloxacin. Any adverse event, adverse events causing withdrawal, skin adverse events, photosensitivity reactions were more common for lomefloxacin when compared to norfloxacin. Any adverse event, adverse drug reactions, CNS adverse events were more common for ofloxacin when compared to ciprofloxacin. CNS adverse events and insomnia were more often reported for rufloxacin when compared to pefloxacin. Adverse drug reactions occurred frequently for ofloxacin than levofloxacin. Insomnia was reported more frequently for enoxacin than ciprofloxacin. AUTHORS' CONCLUSIONS: We found no significant differences in clinical or microbiological efficacy between quinolones but some differences in occurrence and spectrum of quinolone safety.

[On fluoroquinolones treatment safety in children (clinical, morphological and catamnesis data)]. / O bezopasnosti primeneniia ftorkhinolonov u detei (kliniko-morfologicheskie i katamnesticheskie dannye).

Results of prospective comparative investigation of monofluoroquinolones (ciprofloxacin, ofloxacin, pefloxacin) arthropathy are presented. The trial was performed at 144 children with mucoviscidosis (aged 0.5-16) and at 37 children with aplastic anemia (aged 1.75-15). Two groups differ by necessary antibacterials regimes and hence by different abilities for arthropathy development: patients with mucoviscidosis were treated with fluoroquinolones followed by repeated short courses in combination with other antibacterials; patients with aplastic anemia--were treated permanently for a long time with low doses as monotherapy for autoinfection prophylaxis. Analysis was performed on the base of catamnesis, year growth rate, postmortal morphological investigation of the right knee joint. It was shown that quinolone arthropathy development didn't depend on treatment duration, as it developed during the first three weeks of the fluoroquinolone use, but depended on the drug, patient age and nosology. Arthropathy has favourable prognosis and was fully resolved at the period from 7 days to 3 month according to the arthropathy form (arthrologic, arthritic). Quinolones arthropathy at the children has specific features, the main one is absence of cartilage damage confirmed by morphological analysis.

[Comparative efficacy and safety of ciprofloxacin, ofloxacin, and pefloxacin in treatment of respiratory infections in children with cystic fibrosis]. / Sravnitel'naia éffektivnost' i bezopasnost' tsiprofloksatsina, ofloksatsina i pefloksatsina pri lechenii infektsii dykhatel'nykh putei u detei s mukovitsidozom.

Data on comparative investigation of the clinical and bacteriological efficacy and tolerability of monofluoroquinolones ciprofloxacin, ofloxacin and pefloxacin are given. The results confirm good clinical efficacy of all three monofluoroquinolones and high antistaphylococcal activity of pefloxacin. Efficacy of monofluoroquinolones against P. aeruginosa and S. maltophilia was moderate--only isolation of bacteria from spetrum became lower. Tolerability of monofluoroquinolones was good. Only at 5 patients the drugs use was stopped (4 in the ciprofloxacin group and 1--in the pefloxacin group). At 2 patients it was caused by arthropathy which was drug- and age-dependent. Quinolone-arthropathy was more often in the pefloxacin group and was registered only at the children elder than 10 years old with arthrological anamnesis. This arthropathy differed from experimental one by positive outcome and full recovery in the period from 7 days to 3 months. Results of morphological investigation confirmed clinical data--no invalidizing cartilage damage was revealed.

Eradicative effect of cotrimoxazole and quinolones on non-typhoid salmonellae.

Opinions on antibiotic treatment of salmonella gastroenteritis are still different. Many authors support an opinion that antimicrobial treatment has no effect on salmonella elimination. The authors of the study have tried to prove that fluoroquinolones shorten the elimination of salmonellae and therefore they are useful not only for the treatment of salmonella gastroenteritis in immunocompromised patients to prevent sepsis and extraintestinal manifestations of the infection, but also for eradication of salmonellae in food industry workers, whose carrier state might exclude them from their work. (Tab. 3, Ref. 10.)

[The pharmacodynamics and pharmacokinetics of fluoroquinolones in the evaluation of antibacterial therapy regimens]. / Farmakodinamika i farmakokinetika ftorkhinolonov pri otsenke rezhimov antibakterial'noi terapii.

Sensitivity of 505 strains of gram-negative and gram-positive microorganisms to II generation fluoroquinolones (ciprofloxacin, pefloxacin) was determined. Strains of Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus with different level of sensitivity were selected. Pharmacokinetics of the drugs was investigated after their administration per os in one dose. The resulting indices were used for calculation of the following parameters--Cmax/MIC and AUC/MIC. These parameters may be used in evaluation of the drugs efficacy and for dosing corrections.

Efficacy of amikacin, ofloxacin, pefloxacin, ciprofloxacin, enoxacin and fleroxacin in experimental left-sided Pseudomonas aeruginosa endocarditis.

The efficacies of amikacin, ofloxacin, pefloxacin, ciprofloxacin, enoxacin and fleroxacin, each as monotherapy, were evaluated in a rabbit model of induced left-sided Pseudomonas aeruginosa endocarditis. Therapy started 48 h after infection and lasted 5 days. All agents were given intramuscularly; amikacin at 7 mg/kg/12 h, and each quinolone at 35 mg/kg/12 h. All animals survived except for 1 of the group that received amikacin, and 2 of the untreated control group. No sterile vegetations were found in the untreated group and the group of fleroxacin, while 3 animals from the amikacin, ofloxacin, and enoxacin groups, and 2 from the ciprofloxacin and pefloxacin groups had sterile vegetations. All agents used significantly reduced the number of CFU per gram of vegetation versus untreated controls. Enoxacin and ciprofloxacin were equipotent and more effective than pefloxacin, ofloxacin and amikacin. Fleroxacin had a weaker activity.

[Use of pefloxacin in the treatment of patients with purulent wounds of soft tissues]. / Primenenie pefloksatsina dlia lecheniia bol'nykh s gnoinymi ranami miagkikh tkanei.

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.

Efficacy of pefloxacin in the treatment of postoperative sepsis in gynaecology.

Twenty four women with postoperative sepsis following gynaecological surgery were recruited into a study designed to determine the efficacy of Pefloxacin. With the standard oral dose of Pefloxacin, clinical cure or improvement occurred in 98% of the patients. In-vitro, 90% of bacterial isolates were sensitive to Pefloxacin. No adverse effect was encountered in any of the patients. We concluded that Pefloxacin is effective in the treatment of postoperative bacterial infections following gynaecological surgery.

Perioperative antibiotic prophylaxis in abdominal surgery for hernia repair: retrospective study of 1,524 consecutive patients.

In the surgical units of our Division, from January 1979 to December 1989, the infection rate in surgical groin hernia repair was much higher than expected, in comparison to other reports in the literature. In order to evaluate if correct preoperative antibiotic prophylaxis could decrease the incidence of postoperative infections (wound, urinary and respiratory tract) after abdominal wall hernia repair surgery, a total of 1,524 consecutive patients undergoing this type of procedure were reviewed between January 1990 and December 1996. The patients were divided in three different groups, according to the antibiotic prophylaxis regimen: i) group A: 606 patients (39.8%) treated with ceftriaxone; ii) group B: 408 patients (26.8%) treated with pefloxacin; and iii) group C: 510 patients (33.4%) treated with different regimens using either cephalosporins or quinolones other than ceftriaxone and pefloxacin. Only 1 surgical wound infection was observed (0.06%). The tolerability was good: no significant side effects related to antibiotic prophylaxis were recorded in our experience. In this study, even though retrospective, single-dose ceftriaxone proved to be a valid and cost-effective choice in antibiotic prophylaxis.

Increased burn patient survival with once-a-day high dose teicoplanin and netilmicin. An Italian multicenter study.

This is the final report of a large, controlled, multicenter Italian study on immuno- and chemotherapy in adult patients with burns affecting 20 to 95% of total body surface area (mean 35%). The antibiotic treatment of burn patients consisted of topical silver sulfadiazine, short-term antimicrobial chemoprophylaxis with pefloxacin (800 mg i.v. qd) for the first 4 days and polychemotherapy with teicoplanin (800 mg i.v. qd) together with netilmicin (300 mg i.m. qd) in one or more cycles of 5-12 days. At random, half of the patients received thymostimulin, 70 mg i.m. qd for the first month and every other day thereafter. The analysis at completion of 634 valid cases showed that when the results are stratified by means of the Roi risk index, 396 of the 530 patients who contracted wound infection (84%) after chemoprophylaxis were in the first three categories and a mean of 95% survived. Of the remaining 134 patients (Roi index 4-5) only 50% survived. There was no difference in survival of the immunotherapy group in comparison with the parallel group without thymostimulin. The short-term antimicrobial prophylaxis prevented wound infection in only 104 of 634 patients (16%) and they were at low risk (84% Roi index 1). Of the bacterial pathogens involved in septic complications Staphylococcus aureus and Pseudomonas aeruginosa were prevalent (86%): eradication was achieved in 43% of patients and clinical cure or improvement were seen with combination chemotherapy in 64% of all patients, mainly with only one treatment cycle. This value increased to 79% for the 395 protocol-complying patients and went down to 20% in the 135 non-compliers. The total survival of complier and non-complier patients was 447 of the 530 valid patients (84%). The overall mortality of the 634 evaluable patients was 13.1%, ranging from less than 2% to 68%. Burn mortality was directly proportional to the percentage of burned body surface area, to increasing age and other variables of the Roi index, a 50% mortality being associated with a 72.5% total body surface area burned. Normoergic burn patients had a mortality rate of 9.1% versus 35.7% in anergic patients.

[Yersinia pseudotuberculosis sensitivity to fluoroquinolones and the efficacy of pefloxacin in experimental pseudotuberculosis]. / Izuchenie chuvstvitel'nosti Yersinia pseudotuberculosis k ftorkhinolonam i éffektivnosti pefloksatsina pri éksperimental'nom psevdotuberkuleze.

The sensitivity of Y. pseudotuberculosis of different origin and plasmid profile to Russian preparations of the ftoroquinolones group (cyprofloxacin, pefloxacin, norfloxacin) was studied. Of the 3 preparations under study, pefloxacin was found to be most active with respect to Y. pseudotuberculosis. The absence of relationship between antibiotic resistance in 4 Y. pseudotuberculosis strains to cyprofloxacin, pefloxacin and norfloxacin and their additional conjugative R-plasmid with molecular weights of 32 and 38 mD was noted. Pefloxacin was shown to give a good sanitation and protective effect in experimental pseudotuberculosis.

Efficacy of pefloxacin in acute gonococcal urethritis.

A clinical trial of pefloxacin as a single oral regimen in the treatment of acute uncomplicated gonococcal infection was evaluated in sixty-four male patients with clinical and laboratory diagnosis of gonococcal urethritis using a single dose of 800 mg pefloxacin. Of the 64 men, 59 (92.2%) were infected by (penicillinase producing Neisseria gonorrhoeae (PPNG) strains, while 5 (7.8%) had non-PPNG strains. The cumulative percentage cure for all infections was 84.4%. Pefloxacin is effective as a single dose therapy for acute gonococcal urethritis in males infected by penicillinase producing and non-penicillinase producing Neisseria gonorrhea in our area of study.

Efficacy of sparfloxacin and autoradiographic diffusion pattern of [14C]Sparfloxacin in experimental Staphylococcus aureus joint prosthesis infection.

Using a new rabbit model of methicillin-susceptible Staphylococcus aureus knee prosthesis infection, we compared the efficacies of sparfloxacin (50 mg/kg of body weight subcutaneously, twice a day) and pefloxacin (50 mg/kg subcutaneously, twice a day). A partial knee replacement was performed with a silicone implant fitted into the intramedullary canal of the tibia, and 5 x 10(7) CFU of methicillin-susceptible S. aureus was injected into the knee. The 7-day treatment regimen was started 15 days later. The MICs and MBCs of sparfloxacin and pefloxacin were, respectively, 0.06 and 0.25 microgram/ml (MIC) and 0.25 and 1 microgram/ml (MBC). The peak levels of sparfloxacin and pefloxacin in serum were 3.6 and 21 micrograms/ml, respectively. Three weeks after the end of treatment, animals were sacrificed and tibias were removed, pulverized, and quantitatively cultured. In contrast to pefloxacin (3.61 +/- 1.64 log10 CFU/g of bone), sparfloxacin significantly reduced the bacterial density (2.12 +/- 1.1 log10 CFU/g of bone) (P = 0.01) in comparison with the level in controls (4.59 +/- 1.21 log10 CFU/g of bone), without selection of resistant variants. Sparfloxacin was significantly more effective than pefloxacin (P = 0.025). The autoradiographic pattern of [14C]sparfloxacin diffusion was studied in noninfected animals with prostheses and in infected animals 15 days after inoculation. Sixty minutes after completion of infusion of 250 microCi of [14C]sparfloxacin, in infected animals the highest levels of radioactivity were detected around the prosthesis, in femoral cartilage, and in articular ligaments. Radioactivity was slightly less intense in bone marrow and muscles and was very weak in compact bone. The distribution of sparfloxacin in uninfected rabbits was similar. Thus, sparfloxacin may represent a valid alternative therapy in these infections provided that it is carefully monitored for potential side effects.

[Use of pefloxacin in the treatment of infected burn wounds]. / Primenenie pefloksatsina dlia lecheniia infitsirovannykh ozhogovykh ran.

The efficacy of a home-made pefloxacin was estimated in clinico-laboratory trials including 25 patients with wound infection. The fluoroquinolone was used in a dose of 400 mg administered orally twice a day for 4-16 days. Good and satisfactory results were stated in 24 patients (96 per cent). The isolates from the patients were mainly susceptible to the drug (86.2 per cent). The bacteriological efficacy amounted to 92 per cent. No side effects to the use of pefloxacin were observed.

The influence of pefloxacine on experimental adriamycin-induced nephrotic syndrome in rats.

Initial reports on antiproteinuric effect of pefloxacine in small groups of patients with minimal-change nephropathy (MCN) and focal and segmental glomerulosclerosis (FSGS) have not been confirmed in other papers. To assess its antiproteinuric effect in experimental animals we administered pefloxacine to rats with adriamycin nephropathy showing morphological changes resembling human minimal-change disease or focal segmental glomerulosclerosis, and clinically with full-blown nephrotic syndrome. Pefloxacine treatment was at least partially effective in preventing further increase of proteinuria in rats with adriamycin nephropathy. The mechanism of this effect remains unclear and deserves further studies concentrating on the glomerular cytokine network and glomerular production of reactive oxygen species.

[Comparative study of the antimicrobial activity of pefloxacin, ciprofloxacin, norfloxacin and azithromycin with respect to Strains of Yersinia pseudotuberculosis]. / Sravnitel'noe izuchenie antimikrobnoi aktivnosti pefloksatsina, tsiprofloksatsina, norfloksatsina i zitromitsina v otnoshenii shtammov Yersinia pseudotuberculosis.

Ciprofloxacin (C), pefloxacin (P) and norfloxacin (N) had a marked effect on Yersinia pseudotuberculosis strains isolated from the infected humans and animals. The activity of C (MIC 0.0312-0.125 microgram/ml) was higher than that of P and N (MIC 0.0625-2.0 micrograms/ml). The isolates were resistant to azithromycin (MIC 3.1-100 micrograms/ml). The susceptibility of the strains did not depend on the source of their isolation. The polyresistant strains carrying the R plasmids preserved the susceptibility to the fluoroquinolones.

[Use of fluoroquinolones in rheumatology]. / Primenenie ftorkhinolonov v revmatologii.

The efficacy and tolerance of 3 fluoroquinolones (ciprofloxacin, pefloxacin, lomefloxacin) were studied in 157 patients with rheumatic diseases concurrent with infection-induced abnormalities. Infection cure was achieved in 123 (78.6%) patients, as evidenced by clinical, microbiological, and serological studies. The tolerance of fluoroquinolones was regarded as good, satisfactory, and poor in 114 (72.6%), 37 (23.6%), and 6 (3.8%) patients, respectively. All representative drugs of the fluoroquinolones series produced typical adverse reactions. The authors consider it expedient to make further clinical studies to test the optimal treatment regimens and to expand indications for the use of fluoroquinolones in this group of patients.

[Effectiveness of pefloxacin in the surgical clinic]. / Effektivnost' pefloksatsina v khirurichesko i klinike.

Pefloxacin (Rhone-Poulenc, France) was used prophylactically and therapeutically in 8 and 21 surgical inpatients respectively. The majority of the Enterobacteriaceae isolates were susceptible to pefloxacin (91 to 100 per cent). The isolates of Acinetobacter spp. and Pseudomonas aeruginosa were less susceptible (77 and 33.3 per cent respectively). The isolates of Staphylococcus aureus and S. epidermidis were mainly susceptible to the drug. The high antimicrobial activity of pefloxacin used therapeutically well correlated with the favourable time course of the main disease. When pefloxacin was used prophylactically the results were positive in all the cases. The drug tolerance in the majority of the cases was good. Only 2 patients developed allergic reactions as multiple minipunctate rash. After discontinuation of the drug use and short-term course of the desensitization the clinical sings of the allergic reactions disappeared in 3 days.

Comparing the efficacy of pefloxacin and ciprofloxacin in the treatment of acute uncomplicated gonococcal urethritis in males.

The aim of this study was to compare the efficacy of single-dose pefloxacin 400 mg and ciprofloxacin 250 mg in the treatment of acute uncomplicated gonococcal urethritis in males. One hundred and twenty male patients with uncomplicated gonococcal urethritis were assigned alternately to receive single oral doses of either pefloxacin 400 mg or ciprofloxacin 250 mg. Forty-one out of 43 patients (95.3%) of the pefloxacin group and 46 of 47 (97.9%) of the ciprofloxacin group were cured of gonorrhoeae. The rates of post-gonococcal urethritis were 57.7% and 53.3% in the pefloxacin and ciprofloxacin groups respectively. There was a high incidence of penicillinase-producing gonococci (34.2%). High level resistance to pefloxacin (minimum inhibitory concentration [MIC] >1.0 mg/l) resulting in clinical failure on 400 mg stat dose was noted in 1 isolate. It also showed decreased susceptibility to ciprofloxacin (MIC 0.25 mg/l). Another isolate showed high-level resistance (MIC 0.06 mg/l) to ciprofloxacin 250 mg stat dose with concomitant decreased susceptibility to pefloxacin (MIC >1.0 mg/l). Ciprofloxacin 250 mg stat dose is still useful for the treatment of uncomplicated gonococcal urethritis in males. The cure rate of 95.3% with pefloxacin at 400 mg stat dose is acceptable, but needs to be monitored with caution. The emergence of a more resistant strain of Neisseria gonorrhoeae to fluoroquinolones calls for vigilance in the monitoring of antimicrobial susceptibility.