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Biomedical subjects

M Kummer

Publications and source records attributed to M Kummer.

At least 19 recordsLinked to original sources

Comparison of the efficacy and tolerability of a paracetamol/codeine fixed-dose combination with tramadol in patients with refractory chronic back pain.

Fifty-five patients suffering from refractory chronic back pain took part in a double-blind, multiple-dose, randomised, cross-over study to compare the efficacy and tolerability of a fixed-dose capsule preparation containing 500 mg paracetamol (CAS 103-90-2) and 30 mg codeine phosphate 1/2 H2O (CAS 41444-62-6) (talvosilen forte, test preparation) with a reference capsule preparation containing 50 mg tramadol hydrochloride (CAS 22204-88-2), in a regimen of two capsules 8-hourly. There were two treatment periods of up to 7 days each. Cross-over took place, without washout, at the end of 7 days, or sooner if patients were unable to tolerate the first treatment. The test preparation was at least as efficacious as the reference in the treatment of back pain (81% of patients experienced good or satisfactory pain relief). 81% of patients tolerated the test well compared to only 69% receiving the reference, as per protocol analysis. The results of this study suggest that the test product is at least as efficacious as tramadol in the treatment of patients with refractory chronic back pain, whilst being better tolerated.

Acetaminophen

Pharmacokinetics and metabolic pattern after intravenous infusion and oral administration to healthy subjects.

Meloxicam [4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H- 1,2-benzothiazine-3-carboxamide-1,1-dioxide] is a new nonsteroidal antiinflammatory drug belonging to the enolic acid group. In a crossover study, 30 mg 14C-labeled meloxicam was administered to four male healthy volunteers as a short-term infusion and as an oral solution. The objectives of the study were to determine the mode of elimination, the excretion balance, the in vivo binding characteristics to serum proteins, and to investigate the metabolic pattern in plasma, urine, and feces. A comparison of plasma concentration measurements of unchanged drug by a specific HPLC assay and total radioactivity by liquid scintillation counting revealed a very close conformity. Over 90% of the plasma radioactivity was represented by unchanged drug. Its terminal and dominant half-life of elimination from plasma, as determined from plasma and urinary data in this study, ranged from 12 to 17 hr in the volunteers. The serum protein binding of the radioactivity from in vivo samples was very high (99.1-99.7%). The excretion balance was complete after 6 days. Average urinary excretion of 14C-radioactivity accounted for 43% of the dose, with the remainder appearing with the feces. Meloxicam was extensively metabolized, with only traces of the drug appearing unchanged in urine and feces. The main metabolites were formed by hydroxylation and further oxidation of the methyl group of the thiazolyl moiety. In addition, two further metabolites were found, particularly in urine. Altogether, > 95% of the dose excreted could be accounted for by the metabolites identified or the parent compound itself.

Administration, Oral

Spontaneous perforation of the ureter: a rare complication of urolithiasis.

The spontaneous rupture of the ureter is a rare condition. A case of a girl is reported with a spontaneous perforation caused by ureteral and renal calculi. The concomitant urinoma was drained and the ureter splinted with a double-J catheter. The calculi were destroyed by extracorporal piezoelectric lithotripsy without anesthesia.

Child

ADHD and the thyroid.

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Attention Deficit Disorder with Hyperactivity

Congenital intracranial cysts: clinical findings, diagnosis, treatment and follow-up. A multicenter, retrospective long-term evaluation of 72 children.

A multicenter, retrospective evaluation of 72 children born between 1973 and 1987 with intracranial cysts was performed: 37 had an arachnoid cyst, 25 a Dandy-Walker malformation and 10 a porencephalic cyst. The following criteria were evaluated: history, clinical findings, diagnostic work-up (neuroradiology, CSF and intracystic pressures), surgical therapy and follow-up (outcome and cyst volumes).

Adolescent

[Liposomal amphotericin B in the treatment of candida infection in a 3-month-old infant].

Amphotericin B (Amph-B) is the treatment of choice for systemic fungal infections. The application of high doses is limited due to the high incidence of acute side effects (fever, chills) and organ toxicity (reduction in glomerular filtration rate, renal tubular damage). Amph-B was applied without success in a three months old infant, who suffered from systemic candidiasis. After a change to high doses (3-5 mg/kg/day) of liposomal Amph-B (Amph-lip) rapid improvement of the patient's condition occurred and the pulmonary lesions disappeared during six weeks of treatment (total dose 185.5 mg/kg). Acute side effects or renal function abnormalities did not occur. The reported case indicates that the application of high doses of Amph-lip is an alternative to conventional Amph-B in treatment of systemic fungal infections.

Amphotericin B

Regulation of insulin-like growth factor I messenger ribonucleic acid levels by serum in cultured rat fibroblasts.

Fibroblasts represent one of the in vivo sites of extrahepatic insulin-like growth factor I (IGF-I) production. In this study, cultured fibroblasts prepared from the skin of neonatal rats were used as a model to assess the role of serum in regulating IGF-I messenger RNA (mRNA) levels. IGF-I mRNA, as demonstrated by Northern blot analysis, was present in the cultured fibroblasts, and serum free media which was conditioned by fibroblasts for 20 h contained 108 pg/ml of immunoreactive IGF-I. Fetal calf serum (FCS) decreased steady state IGF-I mRNA levels, as measured by solution hybridization/RNase protection assay, in fibroblasts in a time- and dose-dependent fashion. Incubation of fibroblasts for 18 h in the presence of 0.3%, 0.6%, or 1% FCS decreased IGF-I mRNA levels to 76%, 56%, and 46% of the levels present in control cells which were maintained in serum free media with 0.25% BSA. Maximal inhibition to approximately 20% of control levels was seen with 4-10% FCS. In contrast, basic fibroblast growth factor and beta-actin mRNA levels increased 2- and 4-fold, respectively, with increasing concentrations of FCS. Treatment of the cells with 10 micrograms/ml cycloheximide resulted in partial abrogation of the inhibitory effect of FCS while protein synthesis in the cells was decreased to 6% of control levels. The addition of 2 micrograms/ml of insulin or 15-100 ng/ml of IGF-I to the fibroblasts did not reproduce the inhibitory effect of FCS. Finally, the inhibitory factor(s) present in the FCS was partially removed/inactivated by charcoal stripping or heat inactivating the serum, but delipidation of the FCS by chloroform extraction had no effect on the inhibitory effect of FCS. In summary, FCS contains a factor(s) that decreases IGF-I mRNA levels in cultured fibroblasts in a time- and dose-dependent fashion. The partial abrogation of the inhibitory effect of FCS with cycloheximide treatment suggests that this effect is at least partially dependent upon new protein synthesis. Furthermore, the studies using delipidated, heat-inactivated, and charcoal-stripped serum suggest that the inhibitory factor(s) is a peptide.

Actins

[Congenital hydrocephalus--an analysis of the course of pregnancy, prenatal studies and labor].

An analysis of the pool of our patients revealed few disturbances during pregnancy. In two cases the malformations were possibly due to drugs. Prenatal sonographic diagnostics were performed in one-third of the cases or documented: in 60% of the investigated cases a hydrocephalus was found, this being only 20% of the whole pool. The major part of the births were performed by Caesarean section, mainly because of a prolongation of the birth directly or indirectly due to the large circumference of the head. The hereditary trait of associated malformations and malformations of the central nervous system was frequent. Therefore, we advocate a better prenatal work-up and a birth by planned Caesarean section.

Abnormalities, Multiple

[Bioequivalence of piracetam following acute administration of an oral solution or two tablet formulations in volunteers].

In an open, non-randomized 3-way cross-over study, the bioavailability of 2-oxo-pyrrolidine-1-acetamide (piracetam, Encetrop) from two solid oral formulations and one liquid formulation was tested in 8 healthy male volunteers. The area under the concentration time curve, which is defined to be a measurement for bioequivalence among the three tested galenic formulations correlated very well with the area under the effect intensity-time curve, which was estimated in the same volunteers using electro-physiological methods. The different methods of estimation of bioequivalence show similarity between both solid galenic formulations, while the liquid form exhibits superiority in respect to the oral solid formulations.

Adult

[Cooperative studies in the treatment of acute lymphoblastic leukemia in children in Austria--report of 10 years' experience].

437 children with acute lymphoblastic leukaemia (ALL) have been treated at 9 different institutions in Austria utilizing common protocols and central registration between 1974 and 1984. 227 patients (132 boys and 95 girls, group I) were treated between 1974 and 1980 using 3 consecutive protocols (KMK, O 76, A 78), which were essentially derived from the Memphis studies VII and VIII. Patients with a high risk of relapse were treated according to the LSA 2-L2 protocol. 210 patients (112 boys and 98 girls, group II) were consecutively treated following the BFM protocols 76/79 and 81/83. In this group, treatment intensity was adjusted to the initially determined individual risk of relapse (BFM risk score or risk factor). To date, the life table analysis demonstrates that the probability of continuous complete remission for patients in group II is 60% after 5 and 3 years (BFM 76/79 and BFM 81/83, respectively), whereas group I reaches a level of 37.3%. The prognostic difference between risk and non-risk patients in both studies of group II was eliminated. Despite a higher morbidity and non-leukaemia-related mortality in group II, the therapeutic success can be attributed to the intensification of induction therapy.

Asparaginase

[Bioavailability of codeine and paracetamol in a combination preparation following oral and rectal administration].

The plasma concentrations of acetaminophen (paracetamol) and codeine were determined in a cross-over study in twelve healthy volunteers after oral and rectal application of a compound preparation. The relative bioavailability from the two forms of application was also computed. The two active substances showed almost parallel plasma concentration paths, and thus were systemically available at the same time. The maximum levels in plasma were already reached after one to two hours. In both active substances the suppositories displayed a classical retardation effect. In contrast to acetaminophen the rectal absorption of codeine was almost as effective as the oral absorption. Thus this application form shows almost bioequivalency vis-à-vis the capsule form. Based on these results the rectal form of administration of codeine as well as the combination of this substance with acetaminophen can be regarded, from the pharmacokinetic point of view, as a rational enhancement of the treatment of various forms of pain.

Acetaminophen