Ointments containing Ceratothoa oestroides extract: Evaluation of their healing potential in the treatment of diabetic foot ulcers.

Diabetic foot ulceration is a common and severe complication of diabetes, causing substantial social, medical, and economic burdens. Treatment of foot ulcers remains challenging, thus requiring increasing awareness and more efficient management. This study investigates the efficacy of ointments, containing as main active ingredient the olive oil extract of the marine isopod Ceratothoa oestroides, in the treatment of patients with diabetic foot ulcers. Fifty-two patients were allocated into four treatment groups either receiving therapy with an ointment containing extract of C. oestroides or extract of C. oestroides and eosin or extract of C. oestroides and cefaclor or no treatment. Patients were monitored for a period of 135 days by evaluation of transepidermal water loss, skin hydration, planimetry, photo-documentation, and clinical condition. Treatment with the extract of C. oestroides demonstrated significant healing properties that became evident after 45 days of treatment and resulted in complete ulcer healing in 61% of the patients. A significant improvement in transepidermal water loss (p < 0.001), skin hydration levels (p < 0.001), and wound area (p < 0.001) was observed in all patients. Similar efficacy was demonstrated for the combination of C. oestroides extract with eosin treatment (p < 0.001). On the contrary, the combination of C. oestroides extract with cefaclor antibiotic agent completely inhibited the healing properties of the isopod extract and did not improve water loss, skin hydration, or wound area. An important factor for C. oestroides extract healing properties is its selective activity against Gram negative bacteria. Ointments containing C. oestroides extract alone or combined with the antimicrobial agent eosin emerges as an effective regimen for the treatment of diabetic foot ulcers.

Cefaclor as a first-line treatment for acute uncomplicated cystitis: a retrospective single-center study.

BACKGROUND: Wide-spectrum antibiotics have been favored to treat acute uncomplicated cystitis (AUC) for a long time, leading to the emergence of multi-drug resistant bacteria. We hypothesize that narrow-spectrum antibiotics might mitigate the issue and aim to investigate the clinical efficacy of cefaclor in patients with AUC. METHODS: We retrospectively reviewed the clinical data of female outpatients with AUC treated with cefaclor and evaluated the safety and clinical efficacy. Clinical cure was defined as the elimination of clinical symptom under 4 white blood cells (WBCs) per high power field on microscopy. RESULTS: Overall, 223 women with AUC were enrolled. Escherichia coli was the dominant pathogen (n = 160; 68.6%), followed by Klebsiella species and E. coli-extended spectrum ß-lactamase (ESBL) (n = 19; 8.1% and n = 18; 7.7%). Overall success rate was 94.0% (n = 219) and susceptibility rate of cefazolin was 84.1%, which was close to that of levofloxacin (82.9%). Ampicillin showed the lowest rate of 63.7% with a significantly greater resistance rate of 35.3% among all antibiotics (P < 0.001). In the subgroup analysis, the success rate in patients with resistance to levofloxacin or cefazolin was 100% (n = 24) or 93.3% (n = 14). The rate in patients with resistance to both antibiotics was 60.0% (n = 9), and the pathogens in the other 40.0% (n = 6) of patients with treatment failure were E. coli-ESBL. CONCLUSION: Cefaclor showed excellent efficacy in AUC patients, even in those with in vitro resistance to cefazolin or levofloxacin. Cefaclor may be considered as a first-line option in patients with AUC and a second-line option for those with levofloxacin treatment failure.

Spectrophotometric analysis of discoloration and internal bleaching after use of different antibiotic pastes.

OBJECTIVES: To investigate teeth's antibiotic-induced color differences after bleaching using two different techniques. MATERIALS AND METHODS: One hundred twenty extracted maxillar human incisors were examined. The specimens were randomly divided into six groups, each receiving one of six antibiotic paste fillings: (1) triple antibiotic paste (TAP) with minocycline, (2) double antibiotic paste (DAP), (3) TAP with amoxicillin, (4) TAP with cefaclor, (5) TAP with doxycycline, and (6) no filling (control group). Spectrophotometric measurements were obtained at baseline and then during the first, second, and third weeks after paste placement. The specimens discolored by antibiotics pastes were randomly divided into two subgroups: (1) internal bleaching with hydrogen peroxide (H2O2) and (2) internal bleaching with H2O2 plus Nd-YAG laser irradiation. The ∆E value was calculated and analyzed using a two-way analysis of variance and post-hoc Tukey's test (α = 0.05). RESULTS: The ∆E for all groups showed color differences exceeding the perceptibility threshold (∆E Ëƒ 3.7) at all time points except in the control and DAP groups. Minocycline-induced TAP showed the most severe coronal discoloration (32.42). When the ∆E was examined, thermo/photo bleaching (22.01 ± 8.23) caused more bleaching than walking bleaching (19.73 ± 5.73) at every time point (P = 0.19). No group returned to the original color after bleaching (P < 0.05). CONCLUSIONS: Except for DAP, all antibiotic pastes caused discoloration. Internal bleaching with Nd-YAG laser can be useful for bleaching/removing this discoloration. CLINICAL RELEVANCE: For clinically successful final appearances, understanding the effects of bleaching procedures on antibiotic paste discoloration is important.

Nitrofurantoin vs other prophylactic agents in reducing recurrent urinary tract infections in adult women: a systematic review and meta-analysis.

BACKGROUND: The clinical and financial burden from bladder infections is significant. Daily antibiotic use is the recommended strategy for recurrent urinary tract infection prevention. Increasing antibiotic resistance rates, however, require immediate identification of innovative alternative prophylactic therapies. This systematic review aims to provide guidance on gaps in evidence to guide future research. OBJECTIVE: The objective of this review was to provide current pooled estimates of randomized control trials comparing the effects of nitrofurantoin vs other agents in reducing recurrent urinary tract infections in adult, nonpregnant women and assess relative adverse side effects. DATA SOURCES: Data sources included the following: MEDLINE, Jan. 1, 1946, to Jan. 31, 2015; Cochrane Central Register of Controlled Trials the Cochrane Database of Systematic Reviews, and web sites of the National Institute for Clinical Excellence, and the National Guideline Clearinghouse from 2000 to 2015. Randomized control trials of women with recurrent urinary tract infections comparing nitrofurantoin with any other treatment were included. STUDY DESIGN: A protocol for the study was developed a priori. Published guidance was followed for assessment of study quality. All meta-analyses were performed using random-effects models with Stats Direct Software. Dual review was used for all decisions and data abstraction. RESULTS: Twelve randomized control trials involving 1063 patients were included. One study that had a serious flaw was rated poor in quality, one study rated good, and the remainder fair. No significant differences in prophylactic antibiotic treatment with nitrofurantoin and norfloxacin, trimethoprim, sulfamethoxazole/trimethoprim, methamine hippurate, estriol, or cefaclor were found in clinical or microbiological cure in adult nonpregnant women with recurrent urinary tract infections (9 randomized control trials, 673 patients, relative risk ratio, 1.06; 95% confidence interval, 0.89-1.27; I2, 65%; and 12 randomized control trials, 1063 patients, relative risk ratio, 1.06; 95% confidence interval, 0.90-1.26; I2, 76%, respectively). Duration of prophylaxis also did not have a significant impact on outcomes. There was a statistically significant difference in overall adverse effects, with nitrofurantoin resulting in greater risk than other prophylactic treatments (10 randomized control trials, 948 patients, relative risk ratio, 2.17; 95% confidence interval, 1.34-3.50; I2, 61%). Overall, the majority of nitrofurantoin adverse effects were gastrointestinal, with a significant difference for withdrawals (12 randomized control trials, 1063 patients, relative risk ratio, 2.14; 95% confidence interval, 1.28-3.56; I2, 8%). CONCLUSION: Nitrofurantoin had similar efficacy but a greater risk of adverse events than other prophylactic treatments. Balancing the risks of adverse events, particularly gastrointestinal symptoms, with potential benefits of decreasing collateral ecological damage should be considered if selecting nitrofurantoin.

Application of Cefaclor in Orthodontics through Micro-Implant Anchorage in Patients with Periodontitis.

AIM: Chronic periodontitis leads to gingival swelling, hyperplasia, and tooth mobility, which affects orthodontic treatment. The aim of this study was to investigate the application of cefaclor in orthodontics through micro-implant anchorage in patients with periodontitis. METHODS: A retrospective study was conducted on patients with periodontitis who received micro-implant anchorage treatment in the department of orthodontics at the First People's Hospital of Yongkang City from July 2019 to January 2022. According to different treatment regimens, these patients were divided into the test group (patients receiving cefaclor and micro-implant anchorage treatment) and the control group (patients receiving micro-implant anchorage treatment only). The plaque index (PLI), gingival index (GI), sulcus bleeding index (SBI), and serum inflammatory factor levels were compared between the two groups after treatment. RESULTS: One hundred and five patients were included in the study, (44 males and 61 females, median age 21 [15-25] years), 51 in the cefaclor group and 54 in the no cefaclor group. After treatment, the PLI, GI, and SBI scores in the two groups were higher than those before treatment, and the levels of serum inflammatory markers significantly increased (p < 0.05). After treatment, the PLI, GI, and SBI scores in the test group were significantly lower than those in the control group (p < 0.001). The levels of serum interleukin-1ß, interleukin-6, interleukin-8, and tumor necrosis factor-α were significantly lower in the test group, and the interleukin-2 level was higher in the test group (p < 0.001). There was no significant difference in the incidence of complications between the two groups (p > 0.05). CONCLUSIONS: Cefaclor and micro-implant anchorage have a good clinical effect on orthodontics in patients with periodontitis, improving periodontal health and reducing inflammatory response.

Efficacy of antimicrobials or placebo compared to amoxicillin-clavulanate in children with acute otitis media: a systematic review.

BACKGROUND: Acute otitis media (AOM) is the inflammation of the middle ear. It constitutes one of the most frequent infections which affects children and usually occurs between 6 to 24 months of age. AOM can emerge due to viruses and/or bacteria. The aim of the current systematic review is to assess in children between 6 months and 12 years of age with AOM, the efficacy of any antimicrobial agent or placebo compared with amoxicillinclavulanate, to measure the resolution of AOM or symptoms. METHODS: The medical databases PubMed (MEDLINE) and Web of Science were used. Data extraction and analysis were performed by two independent reviewers. Eligibility criteria were set, and only randomised control trials (RCTs) were included. Critical appraisal of the eligible studies was performed. Pooled analysis was conducted using the Review Manager v. 5.4.1 software (RevMan). RESULTS: Twelve RCTs were totally included. Three (25.0%) RCTs studied the impact of azithromycin, two (16.7%) investigated the impact of cefdinir, two (16.7%) investigated placebo, three (25.0%) studied quinolones, one (8.3%) investigated cefaclor and one (8.3%) studied penicillin V, compared to amoxicillin-clavulanate. In five (41.7%) RCTs, amoxicillin-clavulanate proved to be superior to azithromycin, cefdinir, placebo, cefaclor and penicillin V, while in seven (58.3%) RCTs its efficacy was comparable with other antimicrobials or placebo. The rates of AOM relapse after treatment with amoxicillin-clavulanate were comparable to those of other antimicrobials or placebo. However, amoxicillin-clavulanate was more effective in eradicating Streptococcus pneumoniae from the culture, when compared to cefdinir. The results of the meta-analysis were not evaluated due to substantial heterogeneity between studies. CONCLUSIONS: Amoxicillin-clavulanate should be the treatment of choice for children between 6 months and 12 years of age with AOM.

Cefaclor Monohydrate-Loaded Colon-Targeted Nanoparticles for Use in COVID-19 Dependent Coinfections and Intestinal Symptoms: Formulation, Characterization, Release Kinetics, and Antimicrobial Activity.

Corona virus disease-2019 (COVID-19) emerged in Wuhan, China in December 2019 and was declared as a pandemic by the World Health Organization in March 2020. Although there is no complete treatment protocol for COVID-19, studies on this topic are ongoing, and it is known that broad-spectrum antibiotics such as cephalosporins are used for coinfections and symptoms in COVID-19 patients. Studies have shown that Staphylococcus aureus and Escherichia coli bacteria can cause symptoms such as diarrhea and coinfections accompanying COVID-19. Therefore, in this study, colon-targeted cefaclor monohydrate (CEF)-loaded poly(lactic-co-glycolic acid) (PLGA)-Eudragit S100 nanoparticles (NPs) were prepared using a nanoprecipitation technique. The particle sizes of the CEF-loaded NPs were between 171.4 and 198.8 nm. The encapsulation efficiency was in the range of 58.4%-81.2%. With dissolution studies, it has been concluded that formulations prepared with Eudragit S100 (E-coded) and Eudragit S100+PLGA (EP-coded) are pH-sensitive formulations and they are targetable to the colon, whereas the formulation prepared only with PLGA (P-coded) can release a higher CEF rate in the colon owing to the slow release properties of PLGA. The release kinetics were fitted to the Korsmeyer-Peppas and Weibull models. The antibacterial activity of E-, EP-, and P-coded formulations was 16-fold, 16-fold, and 2-fold higher than CEF, respectively, for S. aureus and E. coli according to the microdilution results. As a result of the time killing experiment, all formulations prepared were found to be more effective than the antibiotic itself for long periods. Consequently, all formulations prepared in this study hope to guide researchers/clinicians in treating both gram-positive and gram-negative bacteria-induced infections, as well as COVID-19 associated coinfections and symptoms.

Common risk difference test and interval estimation of risk difference for stratified bilateral correlated data.

Bilateral correlated data are often encountered in medical researches such as ophthalmologic (or otolaryngologic) studies, in which each unit contributes information from paired organs to the data analysis, and the measurements from such paired organs are generally highly correlated. Various statistical methods have been developed to tackle intra-class correlation on bilateral correlated data analysis. In practice, it is very important to adjust the effect of confounder on statistical inferences, since either ignoring the intra-class correlation or confounding effect may lead to biased results. In this article, we propose three approaches for testing common risk difference for stratified bilateral correlated data under the assumption of equal correlation. Five confidence intervals of common difference of two proportions are derived. The performance of the proposed test methods and confidence interval estimations is evaluated by Monte Carlo simulations. The simulation results show that the score test statistic outperforms other statistics in the sense that the former has robust type I error rates with high powers. The score confidence interval induced from the score test statistic performs satisfactorily in terms of coverage probabilities with reasonable interval widths. A real data set from an otolaryngologic study is used to illustrate the proposed methodologies.

Hyper IgE syndrome associated with novel and recurrent STAT3 mutations: Two case reports.

RATIONALE: Hyper-IgE syndrome (HIES) is a rare primary immunodeficiency presenting as two forms including autosomal dominant HIES (AD-HIES) and autosomal recessive HIES (AR-HIES), which are mainly caused by mutations in STAT3 and DOCK8, respectively. To date, only about 500 cases have been reported worldwide including 37 cases in China. The spectrum and prevalence of mutations and molecular pathogenesis in HIES remain poorly understood. PATIENT CONCERNS: Here we reported two Chinese children presenting clinical manifestations of HIES. DIAGNOSIS: Based on medical history, clinical manifestations, and laboratory findings, a diagnosis of HIES was made for both children. Targeted next-generation sequencing (NGS) identified a novel heterozygous deletion of 15 bp (c.1960_1974del, p.G654_D658del or alternatively c.1966_1980del, and p.G656_D660del), and a recurrent missense mutation (c.1144C>T, p.R382W) in STAT3 in the two patients, respectively. INTERVENTIONS: The two patients have been given the successful treatment of skin infections with cefaclor. OUTCOMES: Both patients have been under follow-up for more than 6 months, with no signs of recurrent infections. LESSONS: Our results extend the spectrum of STAT3 mutations associated with ADHIES and highlight the value of targeted NGS in confirming diagnosis of genetic disorders.

Pulp revascularization of a necrotic infected immature permanent tooth: case report and review of the literature.

The purpose of this report was to present the case of a patient wherein revascularization of the necrotic infected pulp space of an immature permanent maxillary central incisor tooth was induced in vivo by stimulation of a blood clot from the periapical tissues into the canal space. This was achieved after disinfection of the canal space with a topical antibiotic paste followed by a blood clot scaffold induced from the periapical tissues. This treatment approach offers clinicians great potential to avoid the need for traditional apexification with calcium hydroxide or the need to achieve an artificial apical barrier with mineral trioxide aggregate. Furthermore, this treatment approach can help rescue infected immature teeth by physiologically strengthening the root walls.

[Management of acute pyelonephritis in patients older than 3 months: survey conducted in 39 paediatric emergency departments of the Ile de France Region in 2004]. / Prise en charge des pyélonéphrites aiguës du nourrisson de plus de 3 mois et de l'enfant: enquête effectuée parmi les services d'urgences pédiatriques d'Ile de France en 2004.

OBJECTIVES: To describe the different modalities of ambulatory management of acute pyelonephritis in patients older than 3 months of age in paediatric emergency units of the Ile de France region in 2004. METHODS: Between October 2003 and April 2004, referents of 39 paediatric emergency units of the Ile de France region were questioned through a written questionnaire concerning the management of acute pyelonephritis: in or outpatient modalities, antibiotic regimen (molecule and route of administration), investigations and follow-up. RESULTS: Thirty-one questionnaires (79.5%) were returned and analysed. A written protocol was available in 60% of the units. Outpatient management was performed in 24/31 centres. Young age, poor clinical tolerance, urological abnormalities and social difficulties were the major contra-indications for such management. Ultrasonic echography at diagnosis (within 24 h) was performed in 50% of the units. Antibiotics were started using IV route in 18/24 units (75%) and ceftriaxone and aminoside were respectively prescribed in 100% and 29.4% of the units for a duration of 1 to 5 days before switching to the oral route. Antibiotherapy was started orally in 6 units and cefixime was chosen by 5 of them. Follow-up consultations were scheduled in 100% of the units but with various delay after initiation of the treatment. The total duration of treatment was mostly 10 days and oral prophylactic antibiotherapy was prescribed by 10/24 centres after completion of the treatment. Cystoureterography was systematically realized by 83.3% of the units. CONCLUSIONS: Despite important differences in the management of acute pyelonephritis in Ile-de-France, a majority of the units follows similar therapeutic modalities. In the absence of consensus, new recommendations are necessary concerning the management of pyelonephritis in infants and children in France.

Blinded comparison of cefuroxime to cefaclor for lower respiratory tract infections.

Cefuroxime axetil was compared with cefaclor for the therapy for lower respiratory tract infections. Sixty-one patients were randomized to receive the following drug dosages: (1) cefuroxime axetil, 250 mg orally every 12 hours (21 patients); (2) cefuroxime axetil, 500 mg orally every 12 hours (21 patients); and (3) cefaclor, 500 mg orally every eight hours (19 patients). Of these 61 patients, 80% were male, with a mean age of 59.5 years; 56% had acute pneumonia, and the remainder had an acute bronchitis. Causative pathogens included typical respiratory tract pathogens. Overall, 23 of 27 patients with bronchitis were clinically cured at the end of therapy. Thirty-one of 34 pneumonias were clinically cured or improved at the end of therapy; the three pneumonia treatment failures occurred in the lower dose cefuroxime (n = 2) and cefaclor (n = 1) treatment groups. Overall, bacteriologic cure occurred in 86% of patients treated with 500 mg of cefuroxime axetil compared with 60% of cefaclor-treated patients. Adverse clinical effects were uncommon. From this study, it was concluded that cefuroxime given every 12 hours is at least as clinically efficacious as cefaclor; it is a new oral cephalosporin with pharmacologic and bacterial spectrum advantages over many older agents.

Efficacy of prophylaxis in women with sex induced cystitis.

UNLABELLED: Sexual intercourse has been established as one of the most important risk factors for both isolated and recurrent uncomplicated infections of the urinary tract. Prophylactic therapy requires only a small dose of an antimicrobial agent, which is generally given at bedtime for 6 to 12 months. An alternative method is to give an antimicrobial agent for six months post-intercourse. It is still unknown which of the two methods is most effective. A total of 123 women with suspected sexually induced recurrent cystitis (mean age 28 years, range 15 to 65) and a history of recurrent urinary tract infection (UTI) (the last one within the last six months) were subjected to prophylactic therapy for six months. Half of them were treated with low-dose trimethoprim-cotrimoxazole (TMP-SMX) and cefaclor given orally post-intercourse (spontaneous usage), while the other half were treated with low-dose TMP-SMX and cefaclor given at bedtime. The response to the prophylactic therapy was classified as continued cure in 106 cases (86.17%), failure in 13 cases (10.56%), and unknown in four cases (3.25%). TMP-SMX administered in continuous nightly prophylaxis showed similar efficacy and tolerability as cefaclor post-intercourse. OBJECTIVE: To determine the efficacy of prophylaxis in women with recurrent sex induced cystitis and compare the post-intercourse versus the conventional bedtime given long-term, low-dose use of prophylactic antimicrobials.

Evaluation of the clinical efficacy of Qingqiao capsule in treating patients with secretory otitis media.

OBJECTIVE: To observe the clinical efficacy of Qingqiao Capsule (QQC) in treating patients with secretory otitis media (SOM). METHODS: A total of 90 patients were randomly assigned into the treated group (n = 45) and the control group (n = 45). Patients in the treated group were administrated with QQC, 5 capsules each time, 3 times a day for totally 10-14 days, and those in the control group were given per os cefaclor capsules 0.5 g each time for adult, 3 times a day, or 20 mg/(kg.d) for children, for 10-14 days. The therapeutic efficacy of treatment on the patients was observed and compared after treatment and followed up for 3-6 months. RESULTS: (1) The clinical efficacy in the treated group was superior to that in the control group with significant statistical difference (P < 0.01); (2) Comparison of the efficacies in patients of three different TCM syndrome types (the external pathogenic wind invasion caused auditory orifice stuffiness type, the Gan-Dan damp-heat steaming up auditory orifice type and the Pi-deficiency dysfunction induced dirty dampness blocking ear type) showed no statistically significant difference (P > 0.05); (3) The vanishing rate and time needed of the main symptoms and signs in the treated group were superior to those in the control group on ear muffle, tinnitus, hearing impairment, hydrotypanum, pure tone threshold and abnormal tongue figure, and the difference was statistically significant (P < 0.05 or P < 0.01), only those of earache, otopiesis and abnormal pulse figure were insignificantly different between the two groups (P > 0.05). CONCLUSION: QQC is an effective Chinese composite medicine on patients with SOM, and shows no obvious adverse reaction.

[Treatment of acute bacterial tonsillopharyngitis in pediatrics: a meta-analysis]. / Trattamento della faringotonsillite acuta batterica in età pediatrica: una metanalisi.

Pharyngo-tonsillitis represents the most common infection of the upper respiratory tract, its treatment being the most common cause for prescribing antibiotics. Efficacy, safety and compliance of cefaclor were compared with those of other antibiotics in the treatment of paediatric acute bacterial tonsillo-pharyngitis in a meta-analysis of randomized controlled trials published between 1979 and 2003. Overall, evaluations were performed on 16 studies (Medline/PubMed, keywords "Cefaclor and tonsillo-pharyngitis) which proved eligible (Jadad score > or = 1); twelve out of 16 studies were multicentre ones, only one was a double-blind study. Mostly, the comparator agent was a beta-lactam, in four cases it was a macrolide. Efficacy and safety were end-points of all studies whereas only 13 and 4 studies evaluated adverse events and compliance, respectively. The analysis was based on a 2 x 2 contingency table with classification by treatment and number of improvements/cures, side-effects, and compliance of the individual studies. The global estimate of the effective treatment was obtained with the weighted mean of the log OR (Odds Ratio) according to Mantel-Haenszel and associated confidence intervals (CI) at 95%. Chi-square test was performed. All the calculations were performed using SAS v.8. Clinical efficacy evaluation, number of improvements/cures, did not evidence a statistically significant difference among cefaclor and comparators (93.8% vs 92.3%; Odds Ratio 1.21, IC 0.95/1.48). In the cefaclor-treated patients, adverse events were observed in a statistically significant lower percentage compared to other antibiotics: 8.5% vs 15.5% (Odds Ratio 0.49, IC 0.22/0.76; P < 0.0001). Compliance was observed in a similar proportion in both the two groups, cefaclor and comparators (Cefaclor, mean 100%; comparators, mean 98.3%). The present meta-analysis proves that in the treatment of paediatric acute bacterial tonsillo-pharyngitis cefaclor exhibits a clinical efficacy equal to other antibiotics usually employed in this setting, similar compliance but superior safety.

Antibiotic therapy for urinary tract infections.

Loracarbef, a member of the carbacephem class of beta-lactam antibiotics, was tested in randomized, double-blind, parallel studies for the treatment of uncomplicated urinary tract infections (UTIs). In one study conducted in the United States, a 7-day course of once-daily doses of loracarbef (200 mg) was compared with a 7-day course of multiple daily doses of cefaclor (250 mg three times a day). Analysis of data from a small, homogeneous patient population of 108 college-aged women showed that loracarbef produced clinical and bacteriologic responses similar to those produced by cefaclor. At 5-9 days posttherapy, bacteriologic cure was observed in 96% of patients in the loracarbef group and 90% of patients in the cefaclor group (p = 0.614); at 4-6 weeks post-therapy, the same cure rate (81%) was observed in both groups. Analysis of the larger (333 patients) and more heterogeneous study population containing several male and elderly female patients showed that loracarbef again produced responses similar to those produced by cefaclor, with no statistically significant differences seen between the groups at 5-9 days or at 4-6 weeks posttherapy. The adverse events reported by the loracarbef and cefaclor groups were also comparable in both the small and large patient populations analyzed. Similarly favorable results were seen when a 7-day regimen of loracarbef (200 mg once a day) was compared with a 7-day regimen of norfloxacin (400 mg twice a day) in a large European study of approximately 300 patients with uncomplicated cystitis. These studies demonstrate that the safety and efficacy of once-daily loracarbef are comparable to the safety and efficacy of multiple-dose/day therapy with other antimicrobial agents commonly used in the treatment of uncomplicated UTIs.

Single-dose cefaclor therapy of urinary tract infection. Evaluation of antibody-coated bacteria test and C-reactive protein assay as predictors of cure.

The efficacy of single-dose (cefaclor, 2 g orally) and multidose (cefaclor, 250 mg orally three times a day for 10 days) antibiotic regimens in the therapy of acute uncomplicated urinary tract infections (UTI) in nonpregnant women were compared. The patient's clinical status and results of urine cultures were compared in retrospect with the results of the antibody-coated bacteria (ACB) test and C-reactive protein (CRP) test in order to determine if either test would predict the patient's response. Overall, 10 of 30 patients (33 percent) and 18 of 22 patients (81 percent) given single doses and multidoses, respectively, had negative urine cultures four weeks after completion of therapy. A negative urine culture at four weeks correlated with a negative ACB test utilizing the less inclusive criteria for negativity (less than 5 bacteria with fluorescence in 5 minutes of search) but not with a negative ACB test utilizing the more inclusive criteria (less than 10 percent bacteria with fluorescence) or with a negative CRP test. The cure rate in the ACB-negative single-dose group (7 of 9 patients) utilizing the less inclusive criteria for negativity was similar to the cure rate in the ACB-negative multidose group (8 of 10 patients). This study suggests that the ACB test, if properly standardized, might permit identification of a population of patients with UTI who would respond to single-dose cefaclor therapy.

Emergence and persistence of beta-lactamase-producing bacteria in the upper respiratory tract in children treated with beta-lactam antibiotics.

PURPOSE: To assess the ecologic impact, in terms of selection of beta-lactamase-producing respiratory tract bacteria, of a single course of peroral beta-lactam antibiotics. PATIENTS AND METHODS: One-hundred fifty consecutive children with clinical signs of bacterial respiratory tract infection were randomly assigned to a seven-day course of treatment with either penicillin V, amoxicillin, or cefaclor. Bacteriologic specimens were collected before treatment, at its termination, and at follow-up four weeks later. RESULTS: All three drugs investigated caused a similar increase in beta-lactamase-producing bacteria, both in absolute and relative terms, an increase that persisted over a period of at least one month after completion of treatment. CONCLUSION: Penicillin V, amoxicillin, and cefaclor all act as selective agents for beta-lactamase-producing bacteria in the upper respiratory tract. Treatment with a peroral beta-lactam antibiotic puts patients at risk of becoming persistent carriers of beta-lactamase-producing bacteria.

Safety and efficacy of lomefloxacin versus cefaclor in the treatment of acute exacerbations of chronic bronchitis.

In two multicenter trials, lomefloxacin and cefaclor were compared as treatments for acute bacterial exacerbations of chronic bronchitis. In total, 522 adult outpatients were enrolled at 50 centers in the United States. Patients were randomized to treatment groups receiving either 400 mg lomefloxacin orally once daily (n = 259) or 250 mg cefaclor every 8 hours (n = 263) for 7-10 days. Both groups were comparable in terms of age, severity of exacerbation, smoking history, theophylline use, and baseline pathogens. The most common baseline pathogens were Haemophilus influenzae, found in 32% of patients in the lomefloxacin group and in 29% in the cefaclor group, Pseudomonas aeruginosa (13% and 16%, respectively), Moraxella (Branhamella) catarrhalis (12% and 13%), and Streptococcus pneumoniae (10% in both groups). Bacterial eradication rates 1-4 days after the completion of treatment for all patients with baseline pathogens were 81.8% in the lomefloxacin group and 62.7% in the cefaclor group (p less than 0.001). Clinical success (disappearance or improvement of presenting signs and symptoms) was noted in 80.0% of patients in the lomefloxacin group and 64.7% in the cefaclor group (p = 0.002). Eradication rates for the subgroup of patients who had pathogens susceptible in vitro to both study drugs and who completed treatment were 97.1% for lomefloxacin and 84.6% for cefaclor (p = 0.002). Clinical success rates in this subgroup were 92.4% for lomefloxacin and 90.1 for cefaclor (p = 0.585). Treatment-related adverse events were reported for 7% of patients in the lomefloxacin group and 5% in the cefaclor group. The most common adverse events in both groups were nausea and diarrhea. Six patients were withdrawn from treatment with lomefloxacin and four from the cefaclor group because of adverse events. There was no clinical or laboratory evidence of theophylline interaction with either treatment. Once-daily oral administration of 400 mg lomefloxacin was an effective, well-tolerated alternative to 250 mg of cefaclor three times daily in the treatment of acute exacerbations of chronic bronchitis.