Prospective evaluation of venous access difficulty and a near-infrared vein visualizer at four French haemophilia treatment centres.

Although a serious impediment in haemophilia patients, difficulty accessing peripheral veins has received little attention in clinical studies. New peripheral vein visualization devices could potentially ameliorate difficult venous access (DVA), but their utility remains unproved. The study aim was to survey the frequency, causes and clinical manifestations of DVA and evaluate the clinical utility of a near-infrared (NIR) vein visualizer. In this multicentre prospective study, methods, difficulties and outcomes of venous access were assessed for a single venipuncture in consecutive patients. The impact of an NIR vein visualizer on vein localization, the number of venipuncture attempts and patient stress and pain was determined. Among 450 total patients enrolled, venous access was judged to be difficult in 165 (36.7%), most often because of poor vein condition, young patient age, overweight and difficulty in finding veins. Of the patients with DVA, difficulty in locating veins was encountered in 82.4%, and more than one venipuncture attempt was required in 24.8%. Veins were difficult to locate in significantly fewer DVA patients (P = 0.002) when the NIR vein visualizer was used (76.0%) than not used (92.3%). Pain during venipuncture in DVA patients was also significantly less common (P = 0.019) with use of the NIR vein visualizer (34.0% vs. 55.4%). No effect was observed on venipuncture attempts. DVA affects more than one-third of patients at haemophilia treatment centres. An NIR vein visualizer showed significant promise for facilitating vein location and mitigating patient pain in those patients.

FEIBA in the treatment of acquired haemophilia A: results from the prospective multicentre French 'FEIBA dans l'hémophilie A acquise' (FEIBHAC) registry.

Factor VIII inhibitor bypass activity (FEIBA) is a recommended first-line bypassing agent for bleeding episodes in patients with acquired haemophilia A (AHA). Due to the low incidence of AHA, available clinical data on FEIBA treatment are limited. The study aim was to delineate practice patterns in FEIBA treatment of AHA patients, the haemostatic efficacy of FEIBA, including criteria for its assessment, and safety. A prospective registry was established of AHA patients receiving FEIBA for bleeding episodes or prophylaxis at the time of invasive procedures. Data were collected at 16 participating centres in France. Patients were followed up for 3 months. Haemostatic efficacy, FEIBA regimen and FEIBA-related adverse events were documented. Thirty-four patients averaging 81.8 years old with standard deviation (SD) 8.1 years were included in the study: 33 for acute bleeding and one for haematoma evacuation. The mean initial dose of FEIBA for acute bleeding was 75.4 U kg(-1) (SD, 7.7 U kg(-1) ), most often administered twice daily, and the median duration of FEIBA treatment was 4.0 days (interquartile range, 2.2-8.0 days). FEIBA was effective in managing 88.0% of bleeding episodes (95% confidence interval, 75.8-94.5%). No baseline variables influencing treatment response could be identified. The sensitivity and specificity of an objective haemostatic efficacy scale in predicting sequential investigator assessments of haemostatic efficacy were 45.3% and 84.1% respectively. Four patients experienced a total of six serious adverse events possibly related to FEIBA. In the first prospective study specifically focused on FEIBA treatment of patients with AHA, 88.0% of bleeding episodes were effectively managed.

A multicenter study of lomefloxacin and trimethoprim/sulfamethoxazole in the treatment of uncomplicated acute pyelonephritis.

A total of 63 adult patients with uncomplicated acute pyelonephritis were enrolled in a multicenter, randomized comparison of lomefloxacin (400 mg orally once daily for 14 days) and trimethoprim/sulfamethoxazole (TMP/SMX, 160/800 mg orally twice daily for 14 days). Study participants were predominantly female (70% in the lomefloxacin group and 80% in the TMP/SMX group). Escherichia coli was isolated from pretreatment urine cultures in 87.5% of the lomefloxacin group and 80.0% of the TMP/SMX group. Baseline pathogens were eradicated in 100% of evaluable patients in the lomefloxacin group 5-9 days after the end of therapy and in 88.9% of patients in the TMP/SMX group (p = 0.05). The clinical cure rate 5-9 days after therapy with lomefloxacin was 65.0% and for TMP/SMX was 68.4%. At the 4-6 week follow-up in the lomefloxacin group, nine pathogens remained eradicated, one E. coli was isolated, and the results for 14 pathogens were unknown or unevaluable. In the TMP/SMX group, 12 pathogens remained eradicated, three E. coli and one Group D Streptococcus were isolated, and the results for nine pathogens were unknown or unevaluable. Both treatment regimens were well tolerated; adverse events occurred in 12% of patients in the lomefloxacin group and in 17% in the TMP/SMX group. Events considered by the investigators to be probably related to treatment occurred in three patients in each group. In conclusion, once-daily lomefloxacin (400 mg) was a well tolerated and effective alternative to twice-daily TMP/SMX (160/800 mg) for the treatment of adults with uncomplicated acute pyelonephritis.

A French controlled multicenter study of intraarticular orgotein versus intraarticular corticosteroids in the treatment of knee osteoarthritis: a one-year followup.

The efficacy of injection of orgotein was compared with that of betamethasone over a one-year period in 419 patients with osteoarthritis of the knee. The criteria for efficacy were the number of recurrences, the rate of persistence in the trial and, secondarily, Lequesne index and the visual analogue scale. Though betamethasone was quicker-acting, the efficacy of orgotein at low doses (4 or 8 mg) was comparable with that of the corticosteroid from Week 4 and up to a year after the beginning of the study, at the cost of a greater number of injections and more numerous local side effects.

[Antibacterial activity of lomefloxacin in the urine during the 4 days following a single 400 mg oral dose]. / Activité antibactérienne de la loméfloxacine dans l'urine durant quatre jours après prise orale unique de 400 mg.

Antibacterial activity of lomefloxacin was studied in the urine after single dose of 400 mg in ten healthy female volunteers. Urine was collected in 7 periods: 0-3 h, 3-6 h, 6-12 h, 12-24 h, 24-48 h, 48-72 h, 72-96 h. Lomefloxacin concentration were assayed in all samples by microbiological method. Urine antibacterial activity was determined towards five strains isolated in urine: 2 E. Coli strains one sensitive and the other resistant to nalidixic acid (Nal-A), 1 Klebsiella pneumoniae resistant to nalidixic acid (Nal-B), 1 Staphylococcus saprophyticus and 1 Streptococcus faecalis. MIC's of lomefloxacin against these strains were respectively 0.06, 0.50, 0.50, 0.25 and 4 micrograms/ml. Lomefloxacin mean concentrations were 208.5 +/- 44.2, 104.3 +/- 15.2, 100.5 +/- 17.9, 36.8 +/- 8.2, 9.6 +/- 2.2 micrograms/ml in the five first urine samples. Low levels were present in urine the 4th day. Mean urine elimination percentage was 62.2 +/- 4.2% for the four days, with extreme values from 91.2 to 41.8%. Urine bacteriostatic activity against enterobacteriacae was greater than or equal to 32 the first day reaching 8,192 for the Nal-S E. Coli, it was greater than or equal to 4 the second day. Against staphylococcus it was greater than or equal to 64 the first day, greater than or equal to 16 the second day. Against enterococcus it was greater than or equal to 4 the first day. Against the strains implicated in UTI a bacteriostatic activity was present during 2 days in all subjects.