[Efficacy of cefotiam hexetil in acute maxillary sinusitis, with a short five day vs ten day treatment]. / Efficacité du céfotiam hexétil en cure courte dans le traitement des sinusites maxillaires aiguës. Comparaison de l'efficacité d'un traitement de cinq vs dix jours.

OBJECTIVE: The aim of this multicentric, randomized, double blind study with direct individual benefit, was to compare two therapeutic regimens of cefotiam hexetil administration, 5 days vs 10 days, in acute maxillary sinusitis. METHOD: The study was conducted in ambulatory patients treated by general practitioners according to AFSAPS (French agency for sanitary safety) guidelines for treatment of acute maxillary sinusitis. Five hundred and fifty three GPs included 1042 patients presenting with acute maxillary sinusitis in the study from December 2000 to July 2001. Patients were randomly treated with cefotiam hexetil 200 mg bid over a 5 day period followed by 5 days of placebo, or with cefotiam hexetil 200 mg bid over a 10 day period. RESULTS: No significant difference was noted in each treatment group. Radiography performed in 72.2% of included patients confirmed the diagnosis in 78.8% of the cases. No significant difference occurred in the number and percentage of cured patients. In the ITT analysis (1018 patients) the clinical cure rates were respectively 85.5% and 85.3% in the 5 day and in the 10 day treatment groups, In the PP analysis (800 patients) the clinical cure rates were respectively 88.6% in each group. The low incidence of adverse effects (3.36%) was confirmed in both groups. CONCLUSION: A 5 day course of cefotiam hexetil 200 mg bid is as effective as a 10 day course in the treatment of acute maxillary sinusitis in adults.

[Continuous nocturnal automassage of an acupuncture point modifies sleep in healthy subjects]. / L'automassage nocturne continu d'un point d'acupuncture modifie le sommeil de sujets sains.

To test the somnogenic properties of the automassage of point 7 heart of acupuncture, polygraphic night sleep was studied in six healthy volunteers (age: 27.8 +/- 1.6 years) from 23:00 h to 07:00 h. After one night of adaptation, two PEBA cones (Polyether Block Amides; Isocones) were fixed bilaterally at both points 7 heart (active application, AA) or on the back of hand (placebo application, AP). The alternate application was used 2 weeks later, using a randomized, double-blind, and cross-over protocol. Cyclic alternating patterns (CAP) were also analysed on the electroencephalogram during non-REM sleep. Sleep efficiency increased in AA, due to a decrease in wakefulness, and an increase in total sleep time due to an increase in non-REM sleep. The number of CAP decreased in AA, as did the number of CAP sequences and the ratio of CAP duration to total sleep time (CAP rate) and to the duration of slow-wave sleep. In conclusion, the application of Isocones at point 7 heart during the night induced a decrease in wakefulness and an increase in non-REM sleep during night sleep in healthy subjects.

Pharmcokinetics in healthy volunteers and patients of NAc-SDKP (seraspenide), a negative regulator of hematopoiesis.

NAc-SDKP is a peptide being tested as a bone marrow hematopoiesis protector in chemotherapy trials in cancer patients. We studied the pharmacokinetics of NAc-SDKP in six healthy human volunteers and in five patients undergoing chemotherapy. Plasma concentrations of NAc-SDKP were monitored using a specific enzyme immunoassay. Because NAc-SDKP is an endogenous compound, a preliminary study was undertaken to determine intra- and interday baseline variations in healthy subjects. The baseline value (range 1.7-3.2 nM) differed between subjects, but was constant over time. The influence of the route of administration was studied in six healthy volunteers with 128 nmol/kg given as a 12-hr intravenous infusion or as a single subcutaneous or intramuscular injection. After cessation of intravenous infusion in healthy volunteers, NAc-SDKP was characterized by a quick elimination phase, with a mean half-life of 4.5 min. The volume distribution was 117 ml/kg and the area under the curve was 117 nM hr. After subcutaneous and intramuscular administrations, peak plasma drug concentrations occurred at 0.26 and 0.28 hr, with Cmax values of 156 and 110 nM, respectively. The bioavailabilities determined after subcutaneous and intramuscular administrations were 100 and 81%, respectively. NAc-SDKP pharmacokinetics was studied in patients after intravenous infusion over 48 hr of a dose of between 51.3 and 513 nmol/kg. Area under the curve values increased proportionately with the dose. Mean clearance was lower in patients than in healthy volunteers: 524 vs. 1120 ml/hr/kg, respectively.