Biomedical subjects
E Sundal
Publications and source records attributed to E Sundal.
[Cerebral hemorrhage after diving].
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Epoetin alpha prevents anaemia and reduces transfusion requirements in patients undergoing primarily platinum-based chemotherapy for small cell lung cancer.
Anaemia commonly occurs in cancer patients receiving chemotherapy, often necessitating blood transfusion. This multicentre study was designed to evaluate the efficacy and safety of epoetin alpha in preventing the decline in haemoglobin (Hb) level, and to determine whether the transfusion requirement could be reduced, in patients receiving 4-6 cycles of primarily platinum-based combination cyclic chemotherapy for small cell lung cancer (SCLC). A total of 130 non-anaemic SCLC patients were randomized to receive no additional treatment (n = 44), epoetin alpha 150 IU kg(-1) subcutaneously (s.c.) three times a week (n = 42) or 300 IU kg(-1) s.c. three times a week (n = 44). Reductions in epoetin alpha dosage were made during the study if Hb level increased to >15 g dl(-1). The mean weekly dosage was 335 and 612 IU kg(-1), respectively, in the two active treatment groups. Significantly fewer (P < 0.05) epoetin alpha-treated patients experienced anaemia (Hb < 10 g dl(-1)) during the course of chemotherapy (300 IU kg(-1), 39%; 150 IU kg(-1), 48%; untreated, 66%). This was reflected in the significantly lower number of treated patients transfused [300 IU kg(-1), 20% (P< 0.001); 150 IU kg(-1), 45% (P< 0.05); untreated, 59%]. Epoetin alpha was well-tolerated, and there was no evidence of sustained, clinically significant, hypertension. In summary, epoetin alpha is effective and well-tolerated in maintaining Hb level and reducing transfusion requirement in patients undergoing cyclic chemotherapy for SCLC.
Effect of low and moderate doses of recombinant human erythropoietin on the haematological response in premature infants on a high protein and iron intake.
UNLABELLED: There is no consensus regarding protein intake and the doses of recombinant human erythropoietin (r-HuEpo) and iron in the treatment of anaemia of prematurity (AOP). This open, randomized study has compared the effectiveness of 50 IU r-HuEpo/kg with that of 100 IU/kg, both given subcutaneously thrice weekly. In addition, two different protein supplements have been compared; lyophilized human milk protein and a commercial cow's milk product. Total protein intake was 3 g/kg per day. Daily iron dose was 18-36 mg. "Healthy" preterm infants (n = 32, birth weight: 800-1400 g, gestational age < or = 31 weeks) were studied from age 3 to 8 weeks. The two protein regimens yielded no differences in body growth, reticulocyte count or Hb concentration. In both r-HuEpo dose groups increased number of reticulocytes followed start of treatment; higher levels were, however, found in the group receiving 100 IU/kg. Mean Hb concentration plateaued at 12 g/dl for infants receiving 100 IU/kg, at 11 g/dl in the 50 IU/kg group. Even though serum levels of ferritin and transferrin saturation indicated no iron deficiency, soluble transferrin receptor increased in both groups, more rapidly and to higher levels in the 100 IU/kg group. In addition, the number of infants having more than 8% hypochromic red cells increased in both groups. CONCLUSIONS: Commercial cow's milk protein added to human milk was as good as human milk protein supplementation in supporting growth and erythropoiesis. Fifty IU/kg r-HuEpo thrice weekly during AOP stimulated erythropoiesis significantly, but less so than 100 IU/kg. Even when using high oral doses of iron to preterms receiving r-HuEpo, our data suggested a certain degree of iron deficient erythropoiesis.
Epoetin alfa facilitates presurgical autologous blood donation in non-anaemic patients scheduled for orthopaedic or cardiovascular surgery.
Patients expected to need at least three units of blood for their elective cardiovascular or orthopaedic surgery, were allocated randomly to receive intravenous (i.v.) Epoetin alfa 600 IU kg-1 (n = 27), 300 IU kg-1 (n = 30) or placebo (n = 23), on days 1, 4 and 7. Provided haemoglobin > or = 11 g dL-1, one unit of blood was collected on days 1, 4, 7, 11 and 14. Iron supplementation was given throughout the study. Surgery was scheduled between days 18 and 21. Significantly more patients treated with Epoetin alfa (100% for 600 IU kg-1; 97% for 300 IU kg-1) were able to donate > or = 4 units of blood compared with placebo (78%) (P = 0.011 and P = 0.032). No significant differences were seen in total patient exposure to homologous blood (7.4%, 3.3% and 17.4%, respectively). Mean red cell volume donated (P = 0.005 for 600 IU kg-1; P = 0.158 for 300 IU kg-1 both vs. placebo) and production (P < 0.001 and P = 0.012, respectively) were dose related. Twenty-four patients became iron deficient. No differences in the incidence of adverse events were seen between the groups.
Recombinant human erythropoietin for the correction of cancer associated anemia with and without concomitant cytotoxic chemotherapy.
BACKGROUND: Chronic anemia is a common complication in patients with cancer, especially in those with advanced disease or who are under intensive chemotherapy. Because homologous blood transfusions involve some hazards, the safety and efficacy of recombinant human erythropoietin (r-HuEPO) in the treatment of anemic patients with cancer with and without concomitant chemotherapy were studied. METHODS: One-hundred two cancer patients with hemoglobin less than 11 g/dl, ferritin greater than 30 micrograms/l, and creatinine < 220 mumol/l were enrolled in the study, 94 were eligible for efficacy evaluation. Sixty-eight patients received chemotherapy (CT group) and 26 had no cytotoxic cancer treatment (NT group). Recombinant human erythropoietin was administered subcutaneously at a dose of 150 U/kg three times per week for 6 weeks; in nonresponders the dose was doubled for the subsequent 6 weeks. Response was defined as the achievement of a hemoglobin increase of 2g/dl. Clinical and laboratory parameters, including serum erythropoietin (EPO) levels, performance status, and quality of life, were investigated at baseline and monitored at regular intervals thereafter. RESULTS: Response was achieved by 52% and 62% of CT and NT patients, respectively. The highest response rates were observed in patients with lung cancer or with a histology of squamous cell carcinoma (both 80%). In responding patients, the symptoms of anemia subsided. They no longer needed blood transfusions after 4 weeks of therapy; and both their performance status and quality of life improved significantly. The NT patients achieved slightly more favorable results on lower weekly doses: 450 U/kg/week in NT versus 570 U/kg/week in CT patients. Serum EPO levels were higher in nonresponders at baseline and further increased during the course of treatment. Recombinant human erythropoietin was well tolerated by all patients. CONCLUSION: This multicenter study in a large patient collective shows that r-HuEPO treatment represents a safe and effective means to increase the red cell mass and eliminate the need for blood transfusions in approximately 50% of the patients with chronic anemia of cancer. Responding patients not only have increased levels of hemoglobin, but their performance status also improves significantly, and they enjoy a significantly enhanced quality of life.
Thymopentin treatment of rheumatoid arthritis.
Although the etiology of rheumatoid arthritis (RA) is unknown, there is solid evidence that immunological factors play a pivotal role in its pathogenesis. It seems that a hyporeactivity of local (intraarticular) T-suppressor cells would permit an excessive immune response that ultimately leads to the classical symptoms and signs of inflammation and cartilage damage. Thymopentin is a synthetic pentapeptide (Arg-Lys-Asp-Val-Tyr) which represents the active biologic site (sequence 32-36) of the native thymic hormone thymopoietin, containing 49 amino acids. Thymopoietin and thymopentin have been shown to possess immuno-normalizing properties in a number of animal model systems. Low concentrations of the hormone characteristically stimulate the OKT4-positive cells, whereas higher concentrations additionally induce stimulation of OKT8-positive cells. This report summarizes the clinical experience collected by Italian investigators, and discusses the results with a view to previously published papers.
Management of viral infections with thymopentin.
Recurrent herpes simplex-, herpes zoster- and human papilloma virus infections are sometimes difficult to control by traditional antiviral therapy. Although detectable immune disturbances are not regularly associated with the clinical presentation, a compromised cellular immunity has been found to play an important role in the pathogenesis of those diseases. Thymopentin (Arg-Lys-Asp-Val-Tyr) is a synthetic pentapeptide corresponding to the active structure of the natural 49 amino acids containing thymic hormone thymopoietin, which has shown impressive immunoregulatory activity in many animal model systems and human in-vitro tests. Cumulative clinical experience with this drug has suggested that it would be of particular value in certain recurrent viral diseases. This report summarizes some of the individual studies performed so far, and discusses the mechanisms of action within the context of relevant published articles in this field. Contrary to antiviral drugs, thymopentin's effect appears to be long-lasting also after discontinuation of treatment. The drug seems to be extremely safe and no serious adverse reactions have been reported to date.
Treatment of transfusion-dependent anaemia of chronic renal failure with recombinant human erythropoietin. A European multicentre study in 142 patients to define dose regimen and safety profile.
This multicentre study in 142 transfusion-dependent patients with chronic renal failure maintained by haemodialysis was performed to establish the appropriate dose regimen of rHuEpo and define its long-term safety profile. Only one of 132 patients eligible for efficacy analysis did not achieve the haemoglobin target of greater than or equal to 10 g/dl; this particular patient had folate deficiency and overt hyperparathyroidism. Regular blood transfusions were no longer necessary in any patients, however five patients needed blood transfusions only once, not due to rHuEpo failure: two for iron deficiency and three for intercurrent disease. In parallel with the haemoglobin increase a statistically significant improvement in quality of life scores was observed. The weekly dose required to maintain median haemoglobin between 10 and 10.5 g/dl for 1 year (n = 79) was 200-225 U/kg, applied as two or three i.v. injections. Mean serum ferritin decreased from 1900 to 1300 ng/ml and transferrin saturation from 60% to 30%; this feature was associated with statistically significant decrease of pre-study elevated liver enzymes. The treatment had no untoward effect on the outcome of renal transplantation (n = 24). Of the 56 patients who experienced hypertensive episodes during rHuEpo therapy, 47 had a history of hypertension and nine had not. The patient incidence during the first 3 months was 28.9% and fell markedly to 4% after 1 year. Only two hypertensive episodes could not be controlled and the patients dropped out. Seizures occurred in 11 patients, most of them during early treatment; annualised incidence during the first 3 months was 7.78 per year vs 2.07 per year for seizures beyond 3 months treatment. Clinical presentation, patients' history, haemoglobin pattern, BP recordings, brain scan, and EEG indicated that the pathophysiology is multifactorial, with emphasis on rate of haemoglobin increase. Therefore a smooth haemoglobin increase rate, induced by a conservative starting dose regimen (50 U/kg thrice weekly) is recommended, to allow the circulation to adapt to changes in haematocrit/viscosity and O2 delivery. The majority of the observed adverse reactions were related to rHuEpo's therapeutic effect, i.e. increase the haematocrit. The side-effects are therefore largely predictable and can be successfully managed.
[Blood transfusion in cancer of the colon and rectum. Blood transfusion and immunology].
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Correction of anaemia of chronic renal failure with recombinant human erythropoietin: safety and efficacy of one year's treatment in a European multicentre study of 150 haemodialysis-dependent patients.
One hundred and fifty patients undergoing regular haemodialysis for end-stage renal failure entered a trial of treatment for anaemia with recombinant human erythropoietin (r-HuEPO). At data cut-off 37 patients (24.6%) had dropped out for various reasons; most of them (n = 22) discontinued because of kidney transplantation (after 3-17 months of treatment). The initial dose was 24 U/kg i.v. thrice weekly, with subsequent dose escalations after a minimum of 2 weeks if the haemoglobin (Hb) was less than 10% above the pretreatment baseline. One hundred and forty-three patients who were eligible for efficacy analysis achieved an Hb increase of greater than or equal to 2 g/dl, and all 139 patients eligible for 'full response' analysis (Hb between 10 and 12 g/dl) were dose titrated to reach this arbitrarily defined optimal range. Patients' response to r-HuEPO treatment was independent of age, weight, nephric state or duration of dialysis treatment. To maintain the Hb within the range of 10-12 g/dl during 1 year's treatment (n = 96) a median weekly r-HuEPO dose of 200 U/kg (range 150-300) divided into one, two, or three administrations appeared to be adequate. This maintenance dose depends slightly on the patient's baseline Hb. The study provides evidence that long-term treatment with r-HuEPO is safe. In 48 patients (of whom 12 had no history of hypertension) elevation of blood pressure required additional treatment, which was effective in all but one who was withdrawn from the study. Four patients had seizures and one suffered hypertensive encephalopathy without convulsions.(ABSTRACT TRUNCATED AT 250 WORDS)
Human recombinant erythropoietin does not induce bone marrow fibrosis in haemodialysed patients.
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Thymopentin treatment in patients with chemotherapy-resistant lepromatous leprosy.
Leprosy is a chronic infectious disease caused by Mycobacterium leprae; it is chiefly involving the skin and peripheral nerves. In lepromatous leprosy there are widespread loose infiltrates with M. leprae multiplying extensively in the skin macrophages and Schwann cells of peripheral nerves. Such patients reveal a decrease of circulating T helper cells, which is still more pronounced in the cutaneous lesions. Due to the ever increasing bacterial resistance to classical dapsone and combined chemotherapy as well, an immunomodulatory approach seemed reasonable: Eight patients with long-lasting (5-40 years) disease who had become resistant to combined chemotherapy were treated with thymopentin, 50 mg s.c., 3 times weekly for 5 weeks and thereafter combined with dapsone and clofazimine for 5 months. During the trial a statistically significant increase in E-rosette-forming cells (p less than 0.05) was observed, along with a steady improvement of the bacterial status of the nasal mucus. Although the skin lesions did not disappear within the observation period of the study, it is important to realize that long-term improvement of such lesions is always initiated by clearance of bacilli from the nasal mucus, hence, thymopentin treatment appears to be a promising approach to chemotherapy-resistant lepromatous lepra.
Peritoneoscopy in abdominal emergencies--a valuable diagnostic tool.
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[Can we do without the bromsulphthalein-(BSP-)test in diagnosis of liver disease? (author's transl)].
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[Gonorrhoic perihepatitis. Fitz-Hugh-Curtis syndrome].
The Fitz-Hugh--Curtis syndrome is an extragenital manifestation of gonorrhea, characterized by fibrinous inflammation of the subphrenic area with violinstring-like adhesions between the liver surface and the parietal peritoneum. When such patients present with acute upper right quadrant pain, the differential diagnosis to other abdominal emergencies (cholecystitis, peptic ulcer disease etc.) may be difficult, because it will not always be possible to isolate the causative agent from the external genitals. In such cases only a laparoscopic approach will allow a correct diagnosis. Two case reports are discussed in the light of the literature.
[Causes and consequences of small intestine bacterial contamination].
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[Emergencies with old people (author's transl)].
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