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Strategies abound for the setting of analytical goals in clinical chemistry. Many, especially those more recently proposed for particular clinical situations, are concerned with tests used in diagnosis. We suggest a general theory for the setting of goals in situations that specifically involve the monitoring of individuals. Goals are calculated from the formula CVA less than [(delta c 2/2Z2)-CVB2]1/2, where CVA is the analytical imprecision (as coefficient of variation, CV); delta c is the percentage change in serial results that is considered clinically significant; Z is the Z-statistic, which depends only on the probability selected for statistical significance; and CVB is the average inherent within-subject biological variation (as CV). Examples given show applications in hematology and in monitoring diabetes mellitus, chronic renal failure, and hepatitis. The derived goals are for total random analytical error (imprecision and intermittent systematic variation), and provide objective criteria that should be achieved in practice. The effect of analytical variability on both variability in test results and the probability that a stated change can be considered significant should be calculated whether or not the goals are attained.
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PMID:Setting analytical goals for random analytical error in specific clinical monitoring situations. 201 90

Changes of the functional indices of central and intracardiac hemodynamics during treatment with hemodialysis or peritoneal dialysis, as well as after cadaver kidney transplantation, were studied in 44 patients with the terminal stage of chronic renal failure by means of radiocardiography with 131I-albumin. The signs of cardiac insufficiency were evaluated according to the classes of the cardiologists' New York classification accepted in 1964. Four groups of patients were distinguished during the analysis: group 1-10 patients given intravenous detoxification therapy; group 2-19 patients treated by chronic programmed hemodialysis; group 3-4 patients kept on peritoneal dialysis; group 4-11 patients after allotransplantation of cadaver kidney. It was found that in group 1 patients the indices of central (mean arterial pressure, cardiac and stroke indices, total peripheral vascular resistance, work of the left ventricle) and intracardiac (time of circulation of blood in the heart cavities and lungs) hemodynamics were on the upper normal values and in occasional cases exceeded it. In patients of group 2 the indices of intracardiac hemodynamics grew worse and required an individual approach to the hemodialysis regimens with due account for the volemic disorders. In group 3 some indices of central and intracardiac hemodynamics corresponded to those in group 2, but the circulation volume, and mean arterial pressure were normal, which was reflected by better subjective tolerance to peritoneal dialysis. Analysis of indices in group 4 patients showed improvement of normalization of most parameters of central and intracardiac hemodynamics with gradual increase of diuresis, and abatement of the clinical signs of cardiac insufficiency after successful transplantation.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[A comparative evaluation of the central hemodynamic indices in patients with the terminal stage of kidney failure during dialysis therapy and allografting]. 226 5

The peptide, 7B2, originally isolated from pituitary, has been shown to be present in endocrine tumors of high concentrations in pancreatic islet tumors. Plasma from most of these patients showed very high 7B2 immunoreactivity (IR-7B2) though there is a lack of knowledge concerning physiological and pathological changes in plasma IR-7B2 levels in other conditions. To assess whether or not there is any alteration in circulating IR-7B2 levels due to age, sex or any specific condition, plasma levels of IR-7B2 were measured in the fasting state in 106 healthy subjects aged 3 months to 91 years, 101 diabetics, 28 patients with hyperthyroidism. 7 patients with primary hypothyroidism, 13 patients with liver cirrhosis, 43 patients with chronic renal failure, 35 patients with cerebral vascular accident, and 26 pregnant subjects. Twenty-four cord bloods were also included. The responses of circulating IR-7B2 to oral glucose, intravenous arginine infusion, volus thyrotropin (TRH) or volus luteinizing hormone-releasing hormone (LH-RH) injection were also evaluated. Particularly high IR-7B2 levels were found to exist in cord blood. Postnatally the concentrations decreased gradually with age to adult values (15.6 +/- 2.9pmol/liter (mean +/- SE) in 20's-60's), though plasma IR-7B2 levels again increased significantly in over 70's (37.1 +/- 3.2pmol/liter; P less than 0.01). There was no significant difference in plasma 7B2 levels in either sex. Among the pathological conditions studied, significantly high IR-7B2 levels were observed in patients with chronic renal failure (175.1 +/- 35.9pmol/liter). Some of the pregnant patients in their third trimester also showed high plasma IR-7B2 levels. A small but significant rise in plasma IR-7B2 was observed after a glucose load in control subjects and diabetics. Intravenous LH-RH exerted a rise in plasma 7B2 concentrations though arginine and TRH showed no significant effect on plasma IR-7B2 concentrations. Compared with the plasma concentrations, ten to fifty-fold high levels of IR-7B2 were observed in cerebrospinal fluid (CSF) from patients with cerebrovascular accidents or multiple sclerosis. These results suggested that the kidney plays a major role in 7B2 degradation and that LH-RH simulates IR-7B2 release from the pituitary gland. Whether reduced clearance or increased production was responsible for the IR-7B2 elevation in subjects under 10 years or over 70 years requires investigation. Furthermore, high levels of IR-7B2 in CSF might indicate its specific role for the central nervous system.
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PMID:[Immunoreactive 7B2 concentrations in plasma and cerebrospinal fluid in pathophysiological conditions and the responses to oral glucose load, intravenous LH-RH, TRH and arginine infusion]. 251 84

Left ventricular systolic and diastolic performance was examined using Doppler and M-mode echocardiography in 42 patients with chronic renal failure before and after hemodialysis. Twenty patients with left ventricular hypertrophy, 22 without hypertrophy and 30 normal subjects were studied. Chronic renal failure patients showed significantly larger chamber diameters of the left ventricle, left atrium and right ventricle than did normal subjects. This group also exhibited greater fractional shortening, stroke volume and cardiac output. Before hemodialysis, patients with left ventricular hypertrophy had a significantly higher cardiac output and the greater ratio of late to early diastolic peak flow velocities (A/R) than did patients without hypertrophy. After hemodialysis, there were significant reductions in blood pressure, ventricular and atrial dimensions, stroke volume and cardiac output. The velocities of early and late diastolic left ventricular filling and the deceleration rate were also significantly reduced. The heart rate, A/R, deceleration half time, and the ratio of deceleration half time to acceleration half time (DHT/AHT) were significantly increased. The greater the amount of fluid removed, the greater the changes in the above values. Patients with left ventricular hypertrophy exhibited significant reductions in fractional shortening, ejection fraction, stroke volume and cardiac output, compared to those without hypertrophy. However, patients without hypertrophy showed more significant decrease in the acceleration half time and increase in DHT/AHT than did patients with hypertrophy. These findings demonstrated normal systolic function and impaired diastolic properties in patients with chronic renal failure, who had left ventricular hypertrophy unaccompanied by dilatation.
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PMID:[Effects of hemodialysis on left ventricular performance: a Doppler echocardiographic study]. 253 21

Since March 1986, coronary artery bypass grafting (CABG) by utilizing the right gastroepiploic artery (GEA) has been performed in 60 patients during 3 year period. There were 52 males and 8 females, and age ranged from 34 to 73 year old with the mean of 56.2 year old. Triple vessel disease and the left main disease involved 90% of the patients. There were two patients under hemodialysis for chronic renal failure, one patient with idiopathic thrombocytopenic purpura, one patient with aneurysm of the abdominal aorta, and two patients with arteriosclerosis obliterance, preoperatively. Five patients were second CABG. GEA was used as an in-situ graft in 57 patients and as a free graft in 3 patients and was anastomosed to 3 left anterior descending, 3 diagonal (all "free" graft), 5 circumflex, and 49 right coronary arteries. To bypass the other coronary arteries, the internal mammary artery graft (unilateral 38, bilateral 20, sequential 5) with or without saphenous vein graft was used. The mean number of distal anastomoses was 3.3 (1-5) and the mean number of arterial graft anastomoses was 2.4 (1-4) per patient with the mean aortic cross clamp time of 62.4 minutes (23-137 minutes) and the mean cardiopulmonary bypass time of 120.8 minutes (69-210 minutes). Splenectomy, Y graft replacement of the abdominal aorta, and ascending aorta-bifemoral bypass were concomitantly carried out in each one patient. Two patients (3.3%) died of renal and cardiac failure within 30 postoperative days. One patient (1.7%) died of stroke lately. New Q wave was noted in 2 patients.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Coronary artery bypass grafting using gastroepiploic artery]. 260 5

Evaluation of cardiac function during hemopurification was performed in 26 patients with chronic renal failure. Cardiac function was measured with a Swan-Ganz thermodilution catheter prior to and every hour after starting the procedure. The effects of hemodialysis (HD) and hemofiltration (HF) on cardiac function were compared by crossover study. The variation in the left ventricular stroke work index (SWI) associated with the reduction in the pulmonary capillary wedge pressure (PCWP) was smaller (p less than 0.05) during HF than during HD. The reduction in PCWP and the variation in SWI associated with the increase in the rate of water elimination were smaller (p less than 0.05) during HF than during HD. These findings suggested that in terms of left ventricular contractility, HF had less effect on cardiac function than did HD. In the second part of the study, 12 diabetic patients (DN group) were compared with 14 non-diabetic (non-DN group) in terms of cardiac function during HD. The rise in the variation in SWI associated with the increase in the variation in the double product tended to be smaller in the DN group than in the non-DN group. The regression coefficient of the variation in the systemic vascular resistance index (SVRI) to the variation in SWI for the DN group was positive, and different (p less than 0.05) from the negative coefficient obtained for the non-DN group. These results suggested that during HD the DN group had less effective utilization of oxygen in cardiac muscle and an impaired compensatory mechanism for decreases in cardiac function associated with increased water elimination than did the non-DN group.
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PMID:[Evaluation of cardiac function during hemopurification in patients with chronic renal failure]. 280 44

Recombinant human erythropoietin is a major advance in the management of patients with chronic renal failure. The sustained dose-dependent rise in haematocrit which it produces effectively abolishes symptoms of anaemia, but at the cost of an increase in blood viscosity. This in turn predisposes to increased vascular resistance and the development of hypertension. Over half of all deaths of patients with end-stage renal failure are from cardiovascular disease, notably myocardial infarction, heart failure, and stroke, for which hypertension is a known risk factor. Erythropoietin-related increases in blood pressure are therefore of particular concern, and seem to be most severe in previously hypertensive patients. There is now a need to establish the optimum rate and extent of rise of haematocrit required to alleviate symptoms without incurring undue risk.
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PMID:Hypertension, blood viscosity, and cardiovascular morbidity in renal failure: implications of erythropoietin therapy. 289 90

The case histories of the 49 patients who died in a series of 165 patients admitted to the Medical Unit between 1958 and 1984 with polyarteritis nodosa (PAN) were reviewed. The causes of death of the 29 men and 20 women, mean age 51.44 +/- 7.4 years, were classified into 6 groups. Infection accounted for 26.5% (13/49) of deaths, the initial site of infection being pulmonary, complicated by septicaemia in 6 cases. Cardiovascular events were responsible for death in 24.4% (11/49): terminal cardiac failure (4 cases), myocardial infarction (1 case), ventricular tachycardia (1 case), stroke (1 case), pulmonary embolism (2 cases), fulminant hemoptysis (1 case). Gastrointestinal complications were the cause of death in 16.3% (8/49): ischemic necrosis (5 cases), acute pancreatitis (2 cases), oesophageal ulceration (1 case). Renal failure was observed in 10.2% (5/49), all occurring before 1972: acute renal failure (3 cases), chronic renal failure (2 cases). Cancer was the cause of death in 10.2% (5/49): primary bronchial carcinoma (2 cases), laryngeal carcinoma (1 case), carcinoma of the vulva (1 case), bone metastases (1 case). Finally, 14.2% (7/49) could not be classified in the preceding groups. Sudden death occurred in 3 patients, shock in 1 patient, multivisceral PAN in 2 patients and anaphylactic shock in 1 patient. Three of the 12 patients who had post-mortem studies had signs of progressive vasculitis. The results are compared with other reports in the literature and the pathogenic mechanisms are discussed. The infections and cardiovascular deaths occurred early or late and were not related to the state of the activity of the vasculitis. Immunosuppressive treatment seems to play an important role in their pathogenesis.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Causes of death in systemic vasculitis of polyarteritis nodosa. Analysis of a series of 165 patients]. 290 28

The long-term clinical courses of 212 "cured" (normocalcemic) patients were analyzed for 1 to 25 years (mean, 6.8 +/- 5.4 years). Preoperatively, 181 patients (85%) were classified as having typical symptoms, 22 patients (11%) as having minimal symptoms, and nine patients (4%) as having no symptoms of primary hyperparathyroidism (PHP). Although the formation of urinary calculi was stopped in 91% of patients, deteriorated renal function and hypertension were seen in patients with symptoms (14% and 8%, respectively) and patients with minimal symptoms of PHP (6% and 15%, respectively). Renal function changes and hypertension were unpredictable despite normalization of the hyperactive parathyroid metabolism and had decisive results: 7% of the patients died of uremia or of the consequences of hypertension (stroke). Large, multiple bone lesions healed functionally and were of no prognostic significance. In the majority of patients with symptoms of PHP, gastrointestinal manifestations healed postoperatively, but two patients who had no preoperative gastrointestinal complaints died of acute pancreatitis. Almost all symptoms of the hypercalcemia syndrome disappeared immediately and permanently in patients with symptoms and patients with minimal symptoms of PHP. Neither deterioration of renal function nor elevation of blood pressure were observed postoperatively in "cured" patients who showed no symptoms of PHP preoperatively. Even in these patients, immediate surgical treatment may have avoided the complications of chronic renal failure or hypertension. As soon as organic manifestations, even in mild form, have been established, it seems impossible to predict the course and to prevent an unfavorable clinical outcome.
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PMID:Successful parathyroidectomy in primary hyperparathyroidism: a clinical follow-up study of 212 consecutive patients. 368 53

The incidences of cerebral hemorrhage (CH), cerebral infarction (CI) and subarachnoid hemorrhage (SAH) were examined retrospectively in patients with chronic renal failure on maintenance hemodialysis, followed for 13 years in our 26 satellite dialysis centers. During 10,364 patient-years of experience (PYE), CH developed in 66, CI in 16, SAH in 3 and unclassified stroke in 5 cases. The incidence was 637 per 10(5) PYE for CH and 154 for CI, the former being approximately 5 times and the latter one third of the incidence of CH or CI in the general population in Japan. Forty-six percent of fatal CH cases died within 24 hours and 73% within 3 days after the onset, while 13% of CI deaths died within 24 hours and 26% within 3 days. These data suggest that factors such as the regular use of heparin as an anticoagulant in hemodialysis patients or other inherent factors in these patients may increase vulnerability to CH and decrease the probability of CI.
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PMID:Incidence of strokes and its prognosis in patients on maintenance hemodialysis. 382 May 79


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