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Biomedical subjects

E Garbe

Publications and source records attributed to E Garbe.

At least 37 records · Page 2Linked to original sources
PubMed1997

Risk of ocular hypertension or open-angle glaucoma in elderly patients on oral glucocorticoids.

BACKGROUND: Ocular hypertension and open-angle glaucoma are well-known side-effects of treatment with topical ophthalmic glucocorticoids. There is uncertainty about the risk of these disorders with oral glucocorticoid therapy. METHODS: Data from the Quebec universal health insurance programme for the elderly were used to identify 9793 patients with a new diagnosis of ocular hypertension or open-angle glaucoma, or on newly prescribed treatment for these disorders (cases). 38,325 controls were randomly selected from ophthalmology patients seen in the same month and year as the case (index date). Current use of oral glucocorticoids was defined as that within 14 days of the index date. All glucocorticoid doses were converted to the equivalent amount of hydrocortisone. The case-control analysis was done by conditional logistic regression and adjusted for age, sex, systemic hypertension, diabetes mellitus, ophthalmic glucocorticoids, glucocorticoid injections, and variables related to general health. FINDINGS: The mean ages of cases and controls were similar (74.9 [SD 6.3] vs 74.7 [6.4]). The adjusted odds ratio of ocular hypertension or open-angle glaucoma for current users of oral glucocorticoids compared with non-users was 1.41 (95% CI 1.22-1.63). There was a dose-related increase in the adjusted odds ratios for current users: 1.26 (1.01-1.56) for less than 40 mg per day of hydrocortisone, 1.37 (1.06-1.76) for patients on 40-79 mg per day, and 1.88 (1.40-2.53) for patients on 80 mg or more per day. The odds ratios also increased with the duration of treatment over the first 11 months of exposure. INTERPRETATION: The use of oral glucocorticoids increases the risk of ocular hypertension or open-angle glaucoma in elderly patients. In patients in this age-group who need long-term treatment with high doses of oral glucocorticoids, monitoring of intraocular pressure may be justified.

Administration, Oral↗
PubMed1997

Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma.

OBJECTIVE: To determine whether the use of inhaled and nasal glucocorticoids is associated with an increased risk of ocular hypertension or open-angle glaucoma. DESIGN: Case-control study. SETTING: Québec universal health insurance program for all elderly (registered in the Régie de l'assurance maladie du Québec [RAMQ] database). PATIENTS: Enrollees in the RAMQ database aged 66 years and older. The 9793 case patients were ophthalmology patients with a new diagnosis of borderline glaucoma or open-angle glaucoma or were newly started on treatment for ocular hypertension or glaucoma between 1988 and 1994. The 38,325 control patients were randomly selected among noncases with ophthalmologist visits in the same month and year as the case event (index date). MAIN OUTCOME MEASURES: The odds ratio (OR) of ocular hypertension or open-angle glaucoma was determined in patients using inhaled or nasal glucocorticoids relative to nonusers, using conditional logistic regression analysis. The OR was adjusted for age, sex, diabetes mellitus, systemic hypertension, use of ophthalmic and oral glucocorticoids, and characteristics of health care system use in the year before the index date. RESULTS: Overall, current use of inhaled and nasal glucocorticoids was not associated with an increased risk of ocular hypertension or open-angle glaucoma. Current users of high doses of inhaled steroids prescribed regularly for 3 or more months were at an increased risk with an OR of 1.44 (95% confidence interval, 1.01-2.06). CONCLUSION: Prolonged administration of high doses of inhaled glucocorticoids increases the risk of ocular hypertension or open-angle glaucoma. This finding suggests that in these patients intraocular pressure monitoring may be warranted.

Administration, Inhalation↗
PubMed1993

Clinical and statistical issues in therapeutic equivalence trials.

Absolute proof of efficacy can only be given by placebo controlled trials. It is, however, important to classify a drug within the spectrum of existing therapeutic alternatives and, where effective treatment is available, it may be imperative due to ethical considerations to demonstrate that one drug is as effective as another. The issue of therapeutic equivalence trials is discussed along the lines of the important items which should be defined in the protocol: a) the target parameter, which is the primary endpoint of the trial, b) the reference drug, which should be selected with respect to efficacy (superior to others), and safety (largest amount of data), c) the acceptance range, which depends on the primary endpoint, and its implication for the clinical endpoints of morbidity and mortality (the conventional acceptance range for bioequivalence trials does not apply), and d) the statistical procedures, which must take into consideration the unsuitability of the conventional power approach for confirming equivalence. In an equivalence trial, compared to those that are placebo-controlled, the proof that one drug is as effective as another relies much more upon the quality of conduct of the study according to Good Clinical Practice.

Clinical Trials as Topic↗
PubMed1990

Adrenomedullary hyperplasia and phaeochromocytoma. DNA cytophotometric findings in 47 cases.

Fifty adrenalectomy specimens containing normal (n = 3), hyperplastic (n = 4) or neoplastic (n = 43) medullary tissue were subjected to quantitative cytophotometric measurements of DNA content. Differing evaluation schemes were applied for interpretation of DNA distribution patterns. Of the 43 phaeochromocytomas (PCC), 16 were inherited as part of the syndrome of multiple endocrine neoplasia type 2a (MEN 2a). Five of 27 sporadic PCCs followed a malignant course. Three benign and three malignant PCCs lacked endocrine activity. In normal medulla and in adrenomedullary hyperplasia, diploid or euploid DNA distributions were found. In contrast, 87% (33/38) of the benign and all 5 malignant PCCs exhibited non-diploid or aneuploid DNA histograms. No differences in DNA content existed between functioning and non-functioning PCCs or between sporadic and hereditary tumours. In this study, in contrast to earlier communications, DNA cytophotometry did not discriminate between benign and malignant adrenomedullary tumours. In addition, as opposed to the findings in a variety of other endocrine tumours, DNA measurements did not appear to be a useful tool to assess the prognosis of an individual malignant PCC.

Adrenal Gland Neoplasms↗
PubMed1990

[Histology, immunocytochemistry and DNA cytophotometry of adrenal glandpheochromocytoma (PCC)--a morphologic clinal study of 64 tumors].

Surgical specimens of 64 adrenal PCCs were investigated by conventional histology, immunocytochemistry and DNA-cytophotometry. Tumour weights of more than 200 g were recorded for each of the 6 malignant, but for only one of the 58 clinically benign neoplasms. Increased mitotic activity (greater than 5 mitoses/10 HPF) was, apart from one benign lesion, only seen among malignomas. Immunocytochemically, all malignomas were entirely devoid of S100-positive sustentacular cells and, as compared to benign PCCs, showed reduced expression rates of different neuropeptides. Upon cytophotometry, only 5/43 tumours exhibited euploid DNA histograms, all these cases belonging to the group of benign PCC. According to these findings, morphology does not enable a definite prediction of the clinical course of individual PCC cases, but renders the definition of risk groups possible. A benign diagnosis can be made in multihormonal euploid tumours weighing less than 200 g. In larger neoplasms and in cases lacking sustentacular cells and showing increased mitotic activity, an unfavourable prognosis is to be suspected and the same therapeutic procedures should be applied as for tumours in which malignancy is evident in metastatic growth.

Adrenal Gland Neoplasms↗
PubMed1990

Prevention by aluminium phosphate of gastric lesions induced by ethanol in the rat: role of endogenous prostaglandins and sulfhydryls.

This study was designed to demonstrate the cytoprotective effect of an antacid containing aluminium phosphate (Phosphalugel) against ethanol-induced gastric injury in the rat and to determine whether this cytoprotective effect is mediated by endogenous prostaglandins and sulfhydryls. We have quantitatively evaluated gastric mucosal lesions using macroscopic and histological techniques one hour after ethanol administration. Two ml of aluminium phosphate given orally one hour before administration of 2 ml of 100% ethanol significantly (p less than 0.01) reduced the area of macroscopic lesions induced by ethanol (3.3 +/- 0.9%) when compared to distilled water (20 +/- 4.8%). The histological study showed that aluminium phosphate prevented deep tissue necrosis. However, it did not protect surface epithelial cells against ethanol injury. Pretreatment with indomethacin, 5 mg/kg sc one hour before aluminium phosphate, slightly but significantly (p less than 0.05) reduced the cytoprotective effect of aluminium phosphate. Macroscopic lesions occupied 4.3 +/- 0.94% and 1.88 +/- 0.41% of total mucosal area in indomethacin group and in vehicle group, respectively. On the other hand, the sulfhydryl blocker, N-ethyl-maleimide, 10 mg/kg sc, given one hour before aluminium phosphate, completely abolished the cytoprotective effect of aluminium phosphate (32.92 +/- 4.85% in N-ethyl-maleimide group versus 3.78 +/- 1.41% in vehicle group; p less than 0.01). These results show that aluminium phosphate has a cytoprotective effect against ethanol injury in the rat. This property appears to be mediated by both endogenous prostaglandins and sulfhydryls.

Aluminum↗
PubMed1989

Protective effect of low dose of enprostil against gastric blood loss induced by aspirin in man.

This study tested the efficacy of enprostil given both at potent antisecretory (35 micrograms twice daily) and weak antisecretory (7 micrograms twice daily) doses in preventing aspirin-induced gastric blood loss measured chemically in gastric washings in 10 volunteers. Aspirin (500 mg four times a day) increased gastric blood loss compared with placebo (p less than 0.001). When enprostil was given in addition to aspirin, gastric blood loss was not significantly different from basal value. The pH of gastric washings was significantly increased by the large but not by the low dose of enprostil compared with placebo. The two doses of enprostil were equally efficacious, suggesting a mucosal protective effect of enprostil independent of acid inhibition.

Adult↗
PubMed1989

DNA cytophotometric findings in pheochromocytoma.

Fifty adrenalectomy specimens containing normal (n = 3), hyperplastic (n = 4), or neoplastic (n = 43) medullary tissue were subjected to quantitative measurements of DNA content. Of the 43 pheochromocytomas, 16 were neoplasms inherited in the setting of multiple endocrine neoplasia type 2A. Five of 27 sporadic pheochromocytomas followed a malignant clinical course. Follow-up data were available in 25 patients. In normal medulla and adrenomedullary hyperplasia either diploid or euploid DNA distributions were found. In contrast, 87% (33 of 38) of the benign and all five malignant pheochromocytomas exhibited nondiploid or aneuploid DNA histograms. No differences in DNA content existed between sporadic and hereditary tumors. In contrast to earlier reports, in this study DNA cytophotometry was not suitable to discriminate benign from malignant adrenomedullary tumors. In addition, DNA measurements appeared not to be a useful tool to assess the prognosis of an individual malignant pheochromocytoma.

Adolescent↗
PubMed1988

Sequential trial of initial chemotherapy for advanced cancer of the head and neck. DDP versus DDP + 5-fluorouracil.

The study, which compares DDP to DDP + FU, was planned to detect an increase by 60% in efficacy and by 5% in toxicity (2a = B = 5%) for DDP + FU. In a previous trial DDP produced 15% of responders and 5% of high-level toxic manifestations. The eligible patients with an advanced head and neck cancer were paired off successively on the basis of the tumour site and the UICC stage. DDP (100 mg/m2; day 1) was administered with hyperhydration, alone in the first protocol and followed by a 5-day continuous infusion of 5-FU (1 g/m2) in the second one. Courses were repeated every three weeks. Assessment was carried out after three courses or two, in cases of toxic manifestations. Seventy-four patients, who were paired off, entered the trial. The median age was 55 years and the median Karnofsky index was 90. The tumor site was as follows: 28 hypopharynx, 28 oropharynx, 8 oral cavity, and 10 multiple primary cancers. According to the UICC stage, there were 14 T1/T2 N3, 60 T3/T4 with among them 45 N3, and they were all MO. Comparisons were made through sequential closed plans. The combination chemotherapy was more efficacious than DDP with a difference that could be appreciated by the sequential analysis as high as 60% (95% confidence interval, 38% to 82%). The high-level toxicity appeared more significant (+25%) for the association. After radiation therapy 11 of 37 patients (30%) achieved a complete response in the arm with DDP versus 18 of 37 (49%) in that with DDP + FU. The median survival times were 9 and 11.5 months, respectively, and were not statistically different.

Adult↗
PubMed1982

Phase I study of SOAz.

SOAz, an inorganic cyclic derivative, was given as a single iv injection through one cycle in a phase I trial. Dose-limiting toxic effects noted were neutropenia and thrombocytopenia occurring at doses greater than or equal to 220 mg/M2 in patients with prior myelosuppressive treatment. The time to nadir for blood cell counts was long, as well as the time to recovery, so cumulative toxicity could be suspected. No other significant toxicity was noted. In patients with measurable volume, no significant antitumor responses were seen. For further study, the dose of 220 mg/m2 every 6-8 weeks according to hematologic restoration is recommended.

Adult↗
PubMed1981

Thioproline toxicity.

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Carcinoma, Squamous Cell↗
PubMed1980

[The application in cancerology of continuous pump-tube enteric alimentation (author's transl)].

Malnutrition and cachexia are major consequences of neoplastic diseases. When a response to one or more forms of oncologic therapy is expected, simultaneous application of artificial nutrition is often needed. Continuous pump-tube enteric alimentation is an efficient, well tolerated method which is easy to perform in a medical ward. We fed 29 patients with this technique during a mean of 43,6 days and a daily intake of more than 3500 Kcal. We noticed the following observations: -- when out of the impact of any therapy directed against the tumor the 21 patients with advanced cancers demonstrated an ability to gain weight and to achieve a positive nitrogen balance equivalent to that performed by the 8 non tumor-bearing patients; -- radiation therapy, administered to the head, neck and thorax resulted in an increase of energetic expenditure; -- chemotherapy impairs for a few days the benefits of the enteric alimentation. This paper underlines the possibility of nutritional rehabilitation of patients with a cancer cachexia. The metabolic injury produced by chemotherapy and radiation therapy increases the need for an afficient treatment of the malnutrition in cancer.

Body Weight↗