Open trial of oral fleroxacin versus amoxicillin/clavulanate in the treatment of infections of skin and soft tissue.

In a multicenter, prospective, randomized trial, fleroxacin was compared with amoxicillin/clavulanate potassium (AMX/CP) for the treatment of infections of skin and soft tissue. Fleroxacin was given at a dosage of 400 mg once daily, and AMX/CP was given at a dosage of 500 mg/125 mg three times a day. Each was administered for 4-21 days. Adult patients with the clinical diagnosis of skin or soft tissue infections were eligible for enrollment. Patients were randomized in a 2:1 ratio. A total of 191 patients were enrolled; 126 took fleroxacin, and 65 took AMX/CP. Of these patients, 42 in the fleroxacin group and 26 in the AMX/CP group were evaluable for both clinical and bacteriologic efficacies. Patients with abscesses comprised the largest single category in each group. Principle reasons for exclusion included: patients lost to follow-up (17 [13%] fleroxacin, 12 [18%] AMX/CP); failure to isolate a causative pathogen (19 [15%] fleroxacin, 9 [14%] AMX/CP); and resistance to study drug (11 [9%] fleroxacin, 2 [3%] AMX/CP). Staphylococcus aureus was the most commonly isolated pathogen. Streptococcus group A, Staphylococcus coagulase-negative, Escherichia coli, and Proteus species, in decreasing order, were the next most common pathogens. Clinical and bacteriologic efficacy was excellent in both groups, with a cure rate of > or = 90%. There were two bacteriologic failures in each group. Patients taking fleroxacin complained of slightly more adverse events, which involved primarily the digestive and central nervous systems. The rate of withdrawal from the study because of adverse events was 4% in both groups. Fleroxacin, 400 mg given once daily, is safe and as effective as AMX/CP in the treatment of skin and soft tissue infections in adults.

Modification of encephalomyocarditis virus-induced diabetes in mice by antiviral agents.

The current study used a murine model of diabetes induced by the D variant of encephalomyocarditis virus (DEMC) to determine the protective effect of exogenous antiviral agents. Antivirals, which were found to inhibit the development of DEMC virus cytopathic effect in L-929 cell monolayers, were administered intraperitoneally beginning 12 h prior to DEMC virus challenge. Arildone (500 mg/kg per day) or murine interferon (3.2 X 10(6) IU/kg per day) significantly reduced the incidence of hyperglycemia at 4 days after virus challenge. The incidences of hyperglycemia were 96% in untreated, 62% in arildone, and 0% in interferon treated mice. In other experiments we found that interferon (1.6 X 10(6) IU/kg per 12 h X 3) significantly protected mice against diabetes when administered at the time of virus infection or beginning 12 h afterwards. This effect was associated with reductions in average viral titers in the heart and pancreas of infected animals relative to untreated, infected mice. The results of these studies suggest that picornavirus induced diabetes may be prevented or ameliorated by the use of antiviral agents.

Ofloxacin versus cephalexin in the treatment of skin, skin structure, and soft-tissue infections in adults.

A multicenter study was conducted to compare the safety and efficacy of oral ofloxacin with that of cephalexin in microbiologic eradication of skin and skin-structure pathogens and the clinical treatment of skin and skin-structure infections. The subjects, 335 adult patients with acute localized infections of the skin, skin structure, or soft tissue, were randomly assigned to receive 400 mg of ofloxacin orally every 12 hours or 500 mg of cephalexin orally every six hours for 10 days. At admission, 398 aerobic pathogens were isolated, the most common being Staphylococcus aureus (160 isolates), Streptococcus pyogenes (49), coagulase-negative staphylococci (30), Staphylococcus epidermidis (25), and Pseudomonas aeruginosa (10). Of 317 isolates tested against ofloxacin, 96% were susceptible, and of 325 tested against cephalexin, 85% were susceptible (P less than 0.001). Microbiologic and clinical outcome were evaluated in 73 ofloxacin-treated patients and in 65 cephalexin-treated patients. The causative pathogens were eradicated in 95% of the ofloxacin group and in 92% of the cephalexin group. In the ofloxacin group, 75% were clinically cured and 23% improved, and in the cephalexin group, 74% and 23%, respectively. Drug-related adverse experiences were reported by 14% of the 161 ofloxacin-treated patients and by 11% of the 162 cephalexin-treated patients; gastrointestinal disturbances were reported by 8% and 7% and nervous system effects by 6% and 1%, respectively (P less than 0.05). It is concluded that both ofloxacin and cephalexin are safe and effective in the treatment of skin and soft-tissue infections.

A multifactorial analysis of the pregnancy outcome in a successful embryo cryopreservation program.

OBJECTIVE: To determine which factor, or factors, may influence the success of an embryo-freezing program. DESIGN: Prospective. SETTING: An established, private IVF clinic. PATIENTS: This study comprises data from 185 consecutive thaw cycles (161 patients) that resulted in embryo replacement. The influence of the following factors, with regard to pregnancy outcome, was specifically addressed: embryo quality, day of the endogenous LH surge, number of thawed embryos replaced, length of time frozen, E2 level at the time of the hCG trigger in the stimulated cycle, and patient age at the time of freezing. RESULTS: An overall pregnancy rate (PR) of 27.6% per ET was achieved in this study. Regardless of the day of the LH surge, patients who had at least one good quality embryo (the "sponsoring embryo") conceived 35% of the time. Patients who lacked a sponsoring embryo frozen conceived 15% of the time. Patients who were 39 years of age or younger had a PR of 31% per transfer. None of the 22 patients who were 40 or older conceived. No other factor examined had any effect on pregnancy outcome. CONCLUSIONS: Good quality frozen/thawed embryos are a major factor in achieving a consistently high PR. Poorer quality embryos are capable of implantation but at a significantly reduced rate. Patient age was also found to be significant in predicting pregnancy. Neither the day of the LH surge, number of embryos transferred, length of time frozen, nor the E2 level appears to have any effect on the establishment of pregnancy.

Sperm morphology and in vitro fertilization outcome: a direct comparison of World Health Organization and strict criteria methodologies.

OBJECTIVE: To perform a direct comparison of two sperm morphology methodologies with regard to IVF outcome. DESIGN: Blinded comparison of two methods of morphology assessment using the same morphology slides. PATIENTS: Data were obtained from 132 couples in a consecutive series of patients undergoing IVF. MAIN OUTCOME MEASURES: Two practical end points were selected for analysis for each couple: the presence of any fertilization and the number of fertilized eggs. Normal traditional morphology was defined as > or = 40% normal forms in a sample and normal strict criteria was defined as > or = 4%. RESULTS: Traditional morphology demonstrated a higher sensitivity and negative predictive value than strict criteria (87% versus 61%, and 68% versus 36%, respectively). Positive predictive value and specificity were also numerically greater but did not reach statistical significance. Abnormal traditional morphology, but not strict criteria, was associated with reduced fertilization even among samples with normal sperm concentration and motility. Samples with normal morphology were associated with a greater number of fertilized eggs per couple than those with abnormal morphology: this difference was 3.2 fertilized eggs for traditional morphology and 1.6 for strict criteria. Overall, for samples with < 40% by traditional morphology only one case yielded more than two fertilized eggs. In contrast, up to five fertilized eggs were noted for the lowest strict criteria scores. CONCLUSIONS: Comparison of traditional morphology and strict criteria with regard to IVF outcome favored traditional morphology in several areas. In particular, low scores were more predictive of poor IVF outcome.

Emergency department use by adult medicaid patients after implementation of managed care.

OBJECTIVE: To determine whether the advent of a mandatory Medicaid managed care (MMC) plan had any effect on emergency department (ED) utilization by adult Medicaid patients at an urban teaching hospital. METHODS: This was a retrospective cohort study using four years of ED records encompassing the year prior to initiation of MMC (1994-95), the enrollment year (1995-96), and two years after the program had matured (1996-98). RESULTS: Total ED census declined slightly, then returned to 1995 levels. Emergency department use by MMC patients declined steadily, with the 1998 figure of 5,888 representing a 40% decline over the pre-MMC volume of 9,849. Visits by MMC patients with acute illness or injury declined by 29%; MMC low-acuity visits decreased by 43%. Medicaid managed care low-acuity after-hours/weekend visits declined by 19%, then leveled off. The MMC enrollment was stable throughout the study period. CONCLUSIONS: Mandatory managed care can be associated with considerable diminution in ED use by Medicaid patients. This decline is most pronounced in low-acuity triage categories, and least evident after hours and on weekends.

The interpretation and use of statistics in assisted reproductive technologies.

This article has discussed some of the uses and limitations of currently available statistics for ART programs. A well-known example from statistics states that flipping a coin will produce "heads" 50% of the time and "tails" 50% of the time, provided that the coin is flipped enough times. Experience also shows that the result of individual flips cannot be predicted. Similarly, in ART, statistics can only give general probabilities and not meaningful predictions of the outcome of any particular cycle. Patients should be aware of the limits of statistical analysis as it applies to their individual treatment.

Pregnancy after gamete intrafallopian transfer in a woman with primary infertility and in utero exposure to diethylstilbestrol. A case report.

In utero exposure to diethylstilbestrol (DES) has an adverse effect on reproductive performance and may be associated with infertility. Gamete intrafallopian transfer (GIFT) is a new reproductive technique that has been advocated as an alternative to in vitro fertilization in women with at least one normally functioning fallopian tube. The process involves the translaparoscopic placement of oocytes and sperm into the fallopian tube. The technique has been successful in treating infertility due to endometriosis, male factors and immunologic factors as well as unexplained infertility. We accomplished the first successful GIFT procedure in a woman with significant uterine effects from prenatal DES exposure. This technique may prove to be an effective treatment for infertile women with DES exposure who have no adequate explanation for their infertility.

Effect of intestinal resection on two juvenile horses with granulomatous enteritis.

Two horses were presented with lethargy, weight loss, anorexia, and swelling of the limbs and ventral body wall. One horse, a 12-month-old American Paso Fino colt, also had acute abdominal pain. The other horse, a seven-month-old Tennessee Walking Horse (TWH) filly passed diarrheic stools during the initial examination. Each horse had low serum protein, neutropenia, and a normal packed cell volume (3.2 g/dl, 1300 cells/ul, and 38%, respectively, for the colt, and 2.4 g/dl, 696 cells/ul, and 44%, respectively for the filly). After intravenously administering plasma, the colt's PCV dropped to 23%, and the filly's dropped to 30%. During exploratory surgery, 3.5 and 2.0 meters of thickened terminal small intestine were removed from the colt and filly respectively, and a jejunocecostomy performed. The results of histologic examination of resected intestine were consistent with a diagnosis of equine granulomatous enteritis (EGE). Both horses showed clinical improvement within two days after surgery. The colt developed a neutrophilia (20,500 cells/ul) within 24 hours of surgery. Serum protein concentrations remained stable and gradually elevated to normal or near normal values of 7.0 g/dl (colt) and 5.8 g/dl (filly) by two weeks. The colt was killed four months after surgery because of signs of abdominal pain. Postmortem examination revealed a small intestinal volvulus associated with an adhesion. The TWH filly remains clinically normal 13 months after surgery.

Medicaid managed care and the emergency department: the first one hundred days.

Spurred by concerns over increasing costs and variable quality, public and private third-party payors are moving their subscribers into managed care plans. A central feature of many of these plans is coordination of patient care through a primary care provider (PCP). In exchange for easy access to the PCP, patients are expected to limit their use of emergency services for episodic, primary, and urgent care problems. The State of Connecticut has begun a transition from a fee-for-service Medicaid plan into a managed care product. Because many Medicaid patients had freely used emergency services under the fee-for-service arrangement, urban teaching hospital emergency departments rapidly became a focus of efforts to control cost and change care-seeking behavior. The Hartford Hospital Emergency Department (ED) began screening, education, and referral of managed Medicaid patients in the fall of 1995 and recorded experiences with patients, administrators, and health care providers involved in the implementation of the managed care program. The first 3 mo following plan implementation were chaotic and frustrating for all parties, with many difficulties due to an unprepared infrastructure. Changes in ED operations and maturation of the payor and health care provider network eventually resulted in a reasonably smooth system accompanied by reductions in ED visit volumes of at least 15%. Continual evolution of role and goals will be necessary if EDs are to maintain an active presence in a health care system dominated by managed care plans.

Conservative therapy of plantar puncture wounds.

In order to define the natural history and complication rate of plantar puncture wounds receiving conservative initial therapy, a prospective, uncontrolled case series study with standardized protocol was conducted in a university hospital emergency department. The eligible patients were between the ages of 18-59 years and presented within 24 hours of sustaining an uncomplicated plantar puncture wound without preexisting impediments to wound healing or wound assessment. Patients were treated with surface cleansing alone and were kept non-weight bearing for 24 hours. Patients were followed by telephone at 48 hours, 1 week, 1 month, and 6 months. Five infections and two retained foreign bodies occurred in 63 patients, for a complication rate of 11.9%. Only the presence of symptoms 48 hours postinjury was associated with a higher risk of complication. No findings at initial presentation predicted a subsequent complication.

Medicare expenditures on unsuccessful out-of-hospital resuscitations.

Numerous studies have shown the futility of continued emergency department (ED) resuscitative efforts for victims of out-of hospital cardiac arrest when prehospital resuscitation has failed. Nevertheless, these patients continue to arrive in the ED, where they create a strain on resources. To assess the economic cost of this, Medicare expenditures were determined for resuscitative efforts on victims of atraumatic, out-of-hospital cardiac arrest subsequently pronounced dead in the ED. Charts of patients pronounced dead in the ED of a 65,000-visit urban teaching hospital during 1995 were reviewed. Selected patients met the following criteria: 1) Medicare recipient age 65 or over; 2) atraumatic, out-of-hospital arrest; 3) transported to the ED by an EMS crew authorized to perform advanced cardiac life support interventions. A total of 105 cases were identified that met inclusion criteria and for which Medicare had claims on file corresponding to the date of death. Ambulance service payments ranged from $105-$391; mean = $263. Physician service payments ranged from $8-$106; mean = $65. Payments for Medicare Part A (hospital facility) ranged from $59-$1,025; mean = $436. The total Medicare reimbursement was $80,197, mean = $764. This annualizes to a national expenditure projection of $58 million. Failed out-of-hospital resuscitation for Medicare patients is associated with poor outcome and high cost. Termination of these efforts in the prehospital arena is unlikely to affect outcome, and would result in considerable cost savings on physician and hospital facility charges. Compassionate protocols that recognize these principles should be developed and implemented.

Epidemiology and prevention of blood and body fluid exposures among emergency department staff.

Emergency Department (ED) staff are vulnerable to occupational exposure to infectious blood and body fluids (BBF). Universal precautions are often ignored in the ED setting. Identification of body locations at high risk of BBF exposure may allow development of site specific protective garments that minimize risk and inconvenience. All permanent staff (92) in a 58,000 visit public university hospital ED with potential for BBF exposure were surveyed. Respondents estimated the number of BBF contacts sustained during the past year, describing their most recent contact in detail. Seventy-eight of 91 (85%) responded, reporting average rates of 54.1 intact skin, 1.5 nonintact skin, and .87 mucous membrane BBF contacts per full-time employee per year. Of the most recent incidents, 94% involved blood, 22% involved vomit or urine, and 11% involved saliva. Eighty-eight percent of BBF contacts were to unprotected skin or mucous membranes, either when no barrier was worn or at the gap between gloves and sleeves. Most (66%) were distal to the elbow; 13% involved the face. Use of long gloves or another continuous protective barrier from the fingers to the elbow, in addition to increased use of face masks or shields, would markedly reduce the rate of ED BBF contacts with a minimum of inconvenience.

Healing of segmental grafts of digital pad skin in dogs.

Pad grafts would be indicated in instances of severe paw trauma when there has been loss of the major weight-bearing pads (ie, metatarsal and metacarpal pads) as well as loss of the digital pads. A practical technique for replacing pad tissue on the remaining paw tissue could avert limb amputation for lack of weight-bearing tissue in the area. Small segmental digital pad grafts were placed in granulation tissue beds in dogs. Although the grafts were from thick pad skin, they healed well. However, intervening wound areas did not become covered with the heavier keratinized epithelium of the pads. The thinner, more rapidly growing, less keratinized epithelium from the wound edges covered most of the wound.

Effects of dexamethasone and surgical hypotension on hepatic morphologic features and enzymes of dogs.

Effects of corticosteroids and surgical stress on hepatic morphologic features and enzymes were studied in 18 mature dogs of mixed breeding: group 1, control (n = 3); group 2, dexamethasone (n = 5); group 3, dexamethasone and surgery (n = 5); and group 4, surgery (n = 5). Dexamethasone (2.2 mg/kg of body weight twice a day subcutaneously) was administered for 8 days in groups 2 and 3 dogs. All dogs were anesthetized with thiopental for 10 minutes on days 0, 2, and 4. On day 2, dogs in groups 3 and 4 were intubated and maintained on methoxyflurane and oxygen, and a liver biopsy, hemilaminectomy (T13-L1), and 15 minutes of hypotension (75/45 mm of Hg) induced by methoxyflurane were done. Serum alkaline phosphatase (ALP) activity, ALP isoenzymes, and alanine aminotransferase (ALT) activity were determined on days 0, 2, 3, 5, and 8. All dogs were euthanatized and necropsied on day 8. Serum hepatic enzyme activity and hepatic morphologic characteristics were normal for group 1 control dogs. The mean ALP and ALT were significantly (P less than 0.05) increased in dogs in groups 2, 3, and 4. In group 2, the mean ALP (days 5 to 8) and ALT (day 8) were significantly (P less than 0.05) increased. In group 3, the mean ALP and ALT activities were significantly increased on days 2 to 8. In group 4, the mean ALP was significantly increased on days 2 to 8 and the mean ALT was significantly increased on days 3 and 5. All other values were normal. A single isoenzyme band (Rf = 0.399 +/- 0.023, mean +/- SD) was identified in all dogs. Hepatic morphologic changes attributed to dexamethasone were mild-to-moderate vacuolation in a diffuse distribution on day 2 (group 3) and aggregates of moderate-to-severe vacuolation in mainly a periportal distribution on day 8 (groups 2 and 3).(ABSTRACT TRUNCATED AT 250 WORDS)

Free segmental paw pad grafts in dogs.

After removal of 1 metatarsal pad and formation of a granulation tissue bed, free segmental 6- x 8-mm grafts from digital pads were sutured into recessed same-size recipient sites in the granulation tissue. In 5 dogs, the grafted area had been denervated by excision of a segment of the tibial nerve at the level of the tarsus. The grafted area was not denervated in the remaining 5 dogs. In both groups of dogs, the grafts placed around the periphery of the wound healed, blocked ingrowth of delicate epithelium from the surrounding skin, and provided a tough keratinized epithelium that covered the wound's center. As healing progressed, the grafts coalesced as the wounds contracted. Weight bearing resulted in graft expansion to provide functional weight-bearing tissue. Dogs of the denervated group had clinical and histologic evidence of collateral sensory reinnervation of the denervated area. However, with the exception of 1 dog, results of sensory nerve action potential tests indicated that reinnervation may not have been by way of regeneration across the excisional gap in the nerve. Evaluation of reinnervation of the tibial autonomous zone in 2 additional dogs revealed clinical evidence that collateral reinnervation began between 19 and 28 days after nerve excision and progressed proximad to distad. Results of sensory nerve action potential tests indicated that reinnervation may not have been via regeneration across the excision site. Results of fluorescent tracer studies did not have positive findings regarding the route of collateral reinnervation. Segmental paw pad grafts can be used effectively to provide weight-bearing tissue on a dog's limb. With local nerve damage on the distal portion of the limb, collateral innervation can grow into the area to reinnervate tissues, including pad grafts.

Effects of dexamethasone and surgical hypotension on the stomach of dogs: clinical, endoscopic, and pathologic evaluations.

Effects of dexamethasone and surgical hypotension on the gastric mucosa of 15 dogs was evaluated by clinical, endoscopic, and pathologic studies. Dexamethasone produced acute reddening of the gastric mucosa with frank hemorrhage, digested blood, and possible gastric erosions, whereas dogs treated by surgical hypotension did not have marked changes in the gastric mucosa. Gastrointestinal disease observed in dogs with spontaneous spinal cord injury that were given dexamethasone and decompressive spinal surgery was not produced. The role of corticosteroids and surgical hypotension in the pathogenesis of gastric lesions and the potential for spinal cord injury to produce gastrointestinal disease is discussed.

Biologic characterization of canine melanoma cell lines.

Eight canine melanoma cell lines were established from tissues from 6 dogs with spontaneous primary or metastatic melanomas. Cell lines were characterized for morphologic features and growth patterns on plastic, pigmentation, ultrastructure, cloning efficiency in soft agar, and tumorigenicity in nude mice. Biologic properties of cell lines were distinct and preserved during 40 to 120 passages in vitro. All cell lines were clonogenic and tumorigenic.

Evaluation of the effects of omega-3 fatty acid-containing diets on the inflammatory stage of wound healing in dogs.

OBJECTIVES: To ascertain the effects of dietary omega-3 (n-3) fatty acids on biochemical and histopathologic components of the inflammatory stage of wound healing. ANIMALS: 30 purpose-bred Beagles. PROCEDURE: Dogs were allotted to 5 groups of 6. Each group was fed a unique dietary fatty acid ratio of omega-6 to n-3--diet A, 5.3:1; diet B, 10.4:1; diet C, 24.1:1; diet D, 51.6:1; and diet E, 95.8:1. Dogs were fed once daily for 12 weeks, then biopsy specimens were taken from 4-day-old wounds of each dog and analyzed by gas chromatography-mass spectrometry for: prostaglandin E2 (PGE2) metabolites, and ratios of omega-6 to n-3 fatty acids, arachidonic acid (AA) to eicosapentaenoic acid (EPA), adrenic acid to docosahexaenoic acid, and PGE2 to prostaglandin E3 (PGE3) metabolites. RESULTS: Qualitative analysis was carried out on AA, EPA, adrenic acid, docosahexaenoic acid, and the major metabolite from the PGE2 and PGE3 pathway. These molecules were further quantified with respect to diet to determine significant differences. By analysis of the AA-to-EPA ratio, diet A was different from diets D and E and diets B and C were different from diet E (P < 0.05). By analysis of the PGE2-to-PGE3 metabolite ratio, diet A was different from diet E (P < 0.05). Though biochemical analysis indicated dietary dependence, histopathologic data indicated no significant difference with respect to diet groups. CONCLUSION: The biochemical component of the inflammatory stage of wound healing can be manipulated by diet. CLINICAL RELEVANCE: Omega-3 fatty acid-enriched diets can be used to control inflammation associated with dermatologic conditions.

Periorchitis after tetramisole treatment in bulls implanted with Setaria labiatopapillos.

Thirteen mixed-breed beef bulls, 1 to 4 years old, were used to determine the effect of live and dead filarial nematodes, Setaria labiatopapillosa, placed in the vaginal cavity of the testes. When dead worms were used, granulomatous lesions developed on the tunica vaginalis parietalis in 7 of 8 testes. The lesions were similar to those seen in some clinical cases of periorchitis. Similar lesions developed in 5 of 6 testes after live worms were implanted in the vaginal cavity of the testes and tetramisole (8 mg/kg) was injected subcutaneously 6 days after implantation. When live worms were implanted and tetramisole was not given, lesions developed in 3 of 6 testes. It was concluded that the granulomatous reaction was a local response to dead or killed S labiatopapillosa.