Biomechanical evaluation of scapular girdle in patients with chronic arm lymphedema.

The presence of arm lymphedema can induce alterations in motor functions and posture. Using an optoelectronic system (ELITE 2002), we evaluated these alterations during a set of tests involving walking, resting and fatigue. The results of our biomechanical analysis demonstrated a limited range of motion of the affected arm, particularly a reduction in swinging during walking tests, and in shoulder retroposition and abduction movements for all patients. After repeated cyclical movements, premature fatigue appeared in the pathological arm. Lymphedema does not appear to cause alterations to the posture of the spine in our study, but drooping of the shoulder homolateral to the lymphedema can occur. This kind of investigation, which is quick, easy, and comfortable for patients with lymphedema, can be a useful method to evaluate functional capacity, thus allowing a quantitative assessment of the loss of function and the optimizing of the rehabilitative protocol.

Treatment of venous leg ulcers with 5% amikacin gel: phase IV trial.

A phase IV trial with 5% amikacin gel was carried out on 100 adult in patients of both sexes suffering from venous infected leg ulcers. After 2 weeks' therapy the microbiological culture tests were negative for more than 80% of the patients. The mean ulcer surface area was reduced by 34% and the accompanying symptoms of erythema, inflammation and pain were improved. Only very mild unwanted local effects were reported by four out of the 100 patients. Five percent amikacin gel was judged a safe and effective topical treatment for curing infected venous leg ulcers.

Metabolic fate of exogenous chondroitin sulfate in man.

Chondroitin sulfate is administered as a drug to man by intravenous, intramuscular or oral route. However, few data are available on the metabolic fate of exogenous chondroitin sulfate in man. After intravenous administration of 0.5 g of chondroitin sulfate to healthy volunteers, the plasma level decreases according to a two-compartmental open model. The half-lives of distribution and elimination are 25.5 +/- 6.6 and 281 +/- 32 min, respectively. The volumes of central and tissue compartments are 6.0 +/- 1.0 and 22.9 +/- 7.7 l, respectively. More than 50% of the administered chondroitin sulfate is excreted with urine during the first 24 h as high and low molecular weight derivatives. After oral administration of 3 g of chondroitin sulfate to 12 healthy volunteers, a main peak (11.4 +/- 3.7 micrograms/ml) preceded by a lower peak is observed after 190 +/- 21 min. The elimination half-life is 363 +/- 109 min. The absolute bioavailability following oral administration calculated from AUC of plasma concentration is 13.2%. A peak of oligo- and polysaccharides with a molecular weight lower than 5000 Daltons derived from partial digestion of exogenous chondroitin sulfate is also present in plasma. These observations indicate that the metabolic fate of exogenous chondroitin sulfate is similar in man and in experimental animals.

Diclofenac delays healing of gastroduodenal mucosal lesions. Double-blind, placebo-controlled endoscopic study in healthy volunteers.

The effects of the water-soluble and delayed-release formulations of a nonsteroidal antiinflammatory drug, diclofenac, on the healing of gastroduodenal mucosal lesions were compared in a double-blind, double cross-over, placebo-controlled endoscopic study conducted in 14 healthy volunteers. Severe endoscopic lesions (petechiae, erosions, ulcers, and esophageal candidiasis) were found only in the group taking the soluble formulation of diclofenac (P less than 0.05 vs placebo). The endoscopic healing of biopsies at one week was delayed by both preparations in comparison to placebo (P less than 0.05 vs placebo). Neither formulation produced significantly more histological inflammation or minor endoscopic lesions (erythema, red striae) than placebo. Both formulations were equally well tolerated and produced no more symptoms than placebo. This study suggests that soluble diclofenac acts topically to delay gastroduodenal healing and produce gastroduodenal injury; it thus provides a model for future studies of the production, perpetuation, and healing of peptic lesions.

Metabolic fate of exogenous chondroitin sulfate in the experimental animal.

After the administration of tritiated chondroitin sulfate (CS) by oral and intramuscular route, the distribution of radioactivity was investigated in two opportunist omnivorous animals, namely the rat and the dog. More than 70% of the orally administered radioactivity was absorbed. Independently of the administration route, radioactivity was mainly excreted through the urine. Plasma levels showed a rapid increase after oral administration, followed by a large plateau with a maximum at the 14th and 28th h in the rat and in the dog, respectively. A tropism of the radioactivity was observed towards glycosaminoglycan-rich tissues, such as joint cartilage. The analysis of the molecular weight of the radioactive material showed that compounds with a molecular weight corresponding to those of CS, poly-, oligo- and monosaccharides as well as of tritiated water, were present in the plasma, urine, synovial fluid and cartilage. The level of radioactive low molecular weight material, derived from the metabolism of CS and from the exchange reaction, increased with the time after administration. The high molecular weight fraction represented at least 10% of the orally administered CS.

Comparative bioavailability of diclofenac hydroxyethylpyrrolidine vs diclofenac sodium in man.

A phamacokinetic study in man has been made of a new dosage form of diclofenac hydroxyethylpyrrolidine (DIEP); soluble salt packed in sachets was compared with diclofenac sodium as enteric coated tablets. Oral DIEP 2 X 50 mg showed a significant difference in absorption kinetics (ka, lag time and tmax) as compared to oral diclofenac sodium 2 X 50 mg. A relevant plasma concentration of diclofenac was detected just 15 min after DIEP, while diclofenac sodium produced a measurable plasma concentration only 0.5-1 h after the treatment. Cmax and t1/2 after DIEP and diclofenac sodium were comparable. Comparison of the two AUC values showed that DIEP was bioequivalent to diclofenac sodium (Q = 100%).

Bioavailability of suckable tablets of oral N-acetylcysteine in man.

The pharmacokinetics and bioavailability of suckable tablets and granules of N-acetylcysteine (NAC) have been compared after oral administration of 400 mg doses to 10 healthy volunteers. The oral bioavailability of the NAC tablets was 103%. In a multiple dosing study of the same tablets in the same subjects, a high maintenance plasma level of NAC was revealed.

[Thiamphenicol versus trimethoprim-sulfamethoxazole in bacterial exacerbations of chronic unspecific respiratory tract diseases. A controlled study]. / Thiamphenicol versus Trimethoprim-Sulfamethoxazol bei bakteriellen Exazerbationen chronischer unspezifischer Atemwegerkrankungen. Eine kontrollierte Studie.

To document the efficacy of trimethoprim-sulfamethoxazole (TMP-SMZ) in treating bacterial exacerbations of chronic bronchitis, and to evaluate the efficacy of thiamphenicol (TAP), 29 patients with chronic bronchial disease were treated for two separate bacterial exacerbations, once with 0.48 g of TMP and 2.4 g SMZ daily, and once with 1.5 g of TAP daily, for 14 days. Patients were evaluated weekly and different measurements, including graded clinical observations, ventilatory tests, sputum measurements, quantitative bacterial counts and blood studies were performed. Side effects were closely monitored. Of the 29 patients entered, 20 finished the trial and hence 40 exacerbations were evaluated. All graded clinical observations were improved by the antimicrobials, whereas no marked change in the ventilatory tests was seen. Of the sputum measurements the daily volume, purulence, numbers of neutrophils and bronchial epithelial cells decreased, as did the numbers of Haemophilus influenzae and pneumococci. Of the blood studies the red blood cell count fell by more than 20% of the pretreatment value in 2 patients on TAP and 2 on TMP-SMZ. Using the same criterion, the hemoglobin level fell in 4 patients on TAP and in the hemoglobin level fell in 4 patients on TAP and in 2 patients on TAP-SMZ, while the hematocrit fell in 4 patients on TAP and in 1 on TMP-SMZ. However, all these changes were completely reversible. Minor gastrointestinal side effects were observed in 11 patients receiving TAP, compared to 3 patients on TMP-SMZ. 1 patient on the latter drug experienced a rash at the end of therapy. From the viewpoint of overall clinical assessment, 16 patients improved and 4 remained unchanged during therapy with TAP. The corresponding figures for TMP-SMZ were 17 patients improved, 2 the same and 1 worse at the end of therapy. The average relapse time after TAP was 184 days and after TMP-SMZ 180 days. In conclusion, 80% or more of exacerbations were improved by the two drugs. For all the variables measured, no significant differences were statistically detectable between the two antimicrobials, whether given in the sequence TAP first and TMP-SMZ second, or vice versa.