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Biomedical subjects

G Leber

Publications and source records attributed to G Leber.

10 recordsLinked to original sources

Phase I clinical and pharmacokinetics study of high-dose toremifene in postmenopausal patients with advanced breast cancer.

Toremifene is an antiestrogen that binds strongly to estrogen receptors (ER). A total of 19 previously treated postmenopausal women with metastatic breast cancer whose performance status was good and whose ER status was positive or unknown were studied to determine the maximum tolerated dose of toremifene. Cohorts of patients received 200, 300, or 400 mg/m2 p.o. daily until relapse or unacceptable toxicity had occurred. Nausea, vomiting, and dizziness were dose-related. Three of five patients receiving 400 mg/m2 experienced moderate or severe vomiting and another developed reversible disorientation and hallucinations. Mild sweating, peripheral edema, vaginal discharge, and hot flushes were encountered at all doses. Reversible corneal pigmentation was identified in seven cases but was not of clinical importance. The pharmacokinetics of toremifene was studied weekly and in detail on day 42 using a high-performance liquid chromatographic (HPLC) assay that identified the parent compound and three active metabolites, N-desmethyltoremifene, (deaminohydroxy)toremifene, and didemethyltoremifene. Steady state was achieved at 1-3 weeks. The toremifene area under the curve and the maximal concentration were dose-dependent at high doses. The recommended phase II dose is 300 mg/m2 p.o. daily.

Adult↗

Ofloxacin compared with chloramphenicol in the management of external ocular infection.

The safety and efficacy of 0.3% ofloxacin in treating bacterial ocular infections was compared with that of 0.5% chloramphenicol in a parallel-group, randomised clinical trial at five sites. Clinical and microbiological improvement rates were studied in 84 culture-positive patients. Patients with suspected bacterial ocular infections were evaluated for clinical improvement and were included in drug safety and comfort analyses. Clinical improvement did not differ significantly between drug treatments. All patients completing the study (79 assigned ofloxacin, and 74 chloramphenicol) showed clinical improvement. Clinical improvement in the culture-positive groups was 100% (41/41) after ofloxacin treatment, and 95% (41/43) after chloramphenicol treatment. Microbiological improvement rates were similar for the two drugs: 85% (33/39) improved with ofloxacin, and 88% (38/43) improved with chloramphenicol. Both drugs were well tolerated. Adverse reactions possibly due to the study medication occurred in 1% (1/89) of those who received ofloxacin, and in 4% (4/93) of those who received chloramphenicol.

Adult↗

Long term anticoagulation with low molecular weight heparin in outpatients with side effects on oral anticoagulants.

A total of 70 outpatients with previous severe haemorrhages and other side effects on conventional oral anticoagulants given for prophylaxis of tromboembolism, were treated with low molecular weight (LMW) heparin fraction Kabi 2165. Anticoagulation was necessary in all patients because of recurrent venous thromboembolism (n = 39), artificial heart valve replacement (n = 12), atrial fibrillation with peripheral embolism (n = 10), and cardiomyopathy (n = 9). LMW heparin was injected sc at doses ranging from 2,500 to 15,000 antifactor Xa (aXa) units once daily by the patients themselves. The dose was adjusted on the basis of body weight, of bleeding risk, and risk of developing thromboembolism. Five of 70 patients with poor compliance, 3 experienced non fatal embolism during the treatment period. Two of 65 patients with good compliance experienced repeat embolism. No fatal embolism occurred. One major episode of gastrointestinal bleeding occurred in a patient with an undetected colon carcinoma. Nine minor hemorrhages were observed in all patients. The present experience suggests that LMW heparin may be used safely and effectively as an alternative anticoagulant in patients who have experienced bleeding and other complications with oral anticoagulants or conventional heparin.

Adult↗

Primary and secondary long-term prophylaxis of thromboembolism in outpatients with the low-molecular-weight heparin Kabi 2165.

Bleeding episodes and other side effects may complicate the treatment with oral anticoagulants. We report on the results of 66 patients who were treated with a low molecular weight heparin fraction for up to 19 months. The data of the study demonstrate the effective long-term anticoagulation with low-molecular-weight heparin and the reduced incidence of hemorrhages compared with conventional anticoagulants. Thus, low-molecular-weight heparin may be effectively and safely used for long-term anticoagulation in patients with bleeding problems on conventional anticoagulants.

Clinical Trials as Topic↗

[Ambulatory long-term prevention of thromboembolism with low-molecular weight heparin].

Patients with severe bleeding complications and other side effects on conventional anticoagulants and strong indication for further anticoagulation were treated with a low molecular weight heparin fragment (Tedelparin). In this paper we report the experiences in 30 patients, who were anticoagulated 1-11 months with this compound. All patients injected themselves a dose ranging from 1 X 2,500 to 1 X 20,000 anti factor Xa units per day. Within 132 months of treatment one patient with good compliance developed thromboembolism. Four patients had bad compliance. Two of them experienced rethrombosis 1 and 8 weeks after starting therapy. Severe haemorrhages did not occur. Two patients had one minor bleeding complication each. Both patients developed several times per year severe haemorrhages with conventional anticoagulants. All excessive subcutaneous haematomas and indurations of the adipose tissue at the injection site of conventional heparin disappeared completely. Low molecular weight heparin can be regarded as an alternative anticoagulant in patients with severe bleeding and other complications on oral anticoagulants and conventional heparin.

Adult↗

[Prevention of thromboembolism with low-molecular weight heparin in pregnancy].

Two patients were anticoagulated during pregnancy with the low molecular weight heparin Kabi 2165 because of side effects on conventional heparin. One patient had to be treated because of deep vein thrombosis in the first pregnancy and the other patient because of a Björk Shiley mitral valve prosthesis. The first patient had developed cutaneous allergic reactions to different conventional heparins and the second patient suffered from extensive local haematomas because of subcutaneous injection of heparin. The doses of the low molecular heparin were 1 X 5000 (patient 1) and 1 X 10,000 (patient 2) anti factor Xa units. The treatment period was 27 and 20 weeks, respectively. No thromboembolism or bleeding occurred. The low molecular weight heparin could not be detected in the umbilical vein or in the breast milk.

Adult↗

[Anticoagulation with low molecular-weight heparin in patients with prosthetic heart valve replacements].

In six patients with prosthetic heart valve replacement anticoagulation was performed with low molecular weight heparin for 4-58 weeks. The treatment was indicated because of one or more severe cerebral or gastrointestinal bleeding complications during therapy with oral anticoagulants or conventional heparin. The dose of the low molecular weight heparin ranged individually from 2,500 to 12,000 units once a day subcutaneously and was adjusted on the basis of the general bleeding tendency of the patient and the specific anticoagulant effect on factor Xa. Under this treatment no heart valve thrombosis occurred. Two minor bleeding complications were observed in two patients. All patients suffered previously from severe bleeding complications with conventional anticoagulants. One additional patient, who had been treated one year earlier with the low molecular weight heparin, again experienced embolism during treatment with only 1 X 5,000 anti factor Xa units per day. We conclude that anticoagulation with low molecular weight heparin may be recommended for patients with prosthetic heart valve replacement and severe bleeding problems with conventional anticoagulants. In patients with recurrent embolism higher doses should be administered.

Adult↗

Peritonitis in patients with liver disease and ascites. Use of Candida albicans as a microbiological clue in differential diagnosis.

Peritonitis in patients with pre-existing liver disease and ascites may be secondary to a local abdominal condition which potentially requires surgery for cure, or alternatively, may be spontaneous in origin. For the latter, antimicrobials are therapeutic while surgery is contraindicated. An easily accessible and important clue for distinguishing these forms of peritonitis may be found in the microbiology of ascitic fluid. Visualization on gram stain smear or recovery on culture of multiple organisms and/or anaerobes favors local abdominal disease over spontaneous peritonitis. The presence of Candida species in the ascitic fluid of such patients, although less common, is highly significant. In the absence of peritoneal dialysis, recent abdominal surgery, or risk factors for disseminated candidiasis, the isolation of Candida suggests specifically gastrointestinal perforation.

Aged↗

We must rescue them.

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Abortion, Legal↗