In a controlled clinical trial in 488 patients with chronic liver disease treated with prednisone or placebo, survival data were analyzed using Cox's proportional hazards model. A total of 162 variables were screened separately for prognostic and/or therapeutic effect by log-rank analyses, whereby 46 clinical, biochemical, serological, and histological variables were isolated. Another five variables traditionally found to be important in patients with liver disease were included. After extensively checking the assumptions of the model, the 51 variables were, by a step-wise procedure, reduced to a final model. It comprised, besides a treatment indicator, 12 variables with significant (p less than 0.05) prognostic or therapeutic effect. The following eight variables had a significant prognostic effect: sex, age, prothrombin, acetylcholinesterase, eosinophil leucocytes in liver parenchyma, liver cell necrosis, inflammation in liver connective tissue, and efferent veins in parenchymal nodules. A prognostic index based on the final model is formed allowing calculation of 5 years survival probability. The usefulness of the prognostic index was tested by a cross-validation method, and no statistical significant difference was found between the estimated and observed survivorship functions.

Adult↗

PubMedDate not supplied

Conversion of micronodular cirrhosis into macronodular cirrhosis.

The conversion from micro- to macronodular cirrhosis is claimed to be a general phenomenon. In this study, the conversion was quantitated by means of liver needle follow-up biopsies and autopsy in 156 patients followed in a controlled clinical trial of prednisone treatment in cirrhosis. In the initial biopsy, 75 patients were classified as micronodular cirrhosis, and of them, 68 had macronodular cirrhosis at autopsy indicating a conversion ratio of about 0.9 in 10 years. This may overestimate the true conversion ratio slightly since conversion in many cases only was demonstrated at autopsy where the diagnosis of macronodular cirrhosis is made with greater certainty than from a needle biopsy. The median time interval between the diagnosis of micro- and macronodular cirrhosis was 2.25 years which is a maximum estimate of the conversion time due to irregular spacing between biopsies (or biopsy and autopsy). No significant difference was found between the conversion time in females and males. The conversion was faster in patients not drinking alcohol compared to patients drinking alcohol, but the difference was not significant. Prednisone treatment tended to accelerate the conversion, but not significantly.

Autopsy↗

PubMedDate not supplied

Prognostic value of Child-Turcotte criteria in medically treated cirrhosis.

The Child- Turcotte criteria (CTC) (based on serum bilirubin and albumin, ascites, neurological disorder and nutrition) are established prognostic factors in patients with cirrhosis having portacaval shunt surgery. The objective of this study was to evaluate the prognostic value of CTC in conservatively treated cirrhosis. Patients (n = 245) with histologically verified cirrhosis from a control group of a controlled clinical trial were studied. Data at entry into the trial were used to classify patients according to CTC. Survival curves for up to 16 years were made, and survival rates were compared using the log-rank test. Survival decreased significantly with increasing degree of abnormality (A----B----C) of albumin (p less than 0.001), ascites (p less than 0.001), bilirubin (p = 0.02) and nutritional status (p = 0.03). Survival was insignificantly influenced by neurological status (p = 0.11) probably because none of the patients had hepatic coma at entry into the trial. The five variables in CTC were combined to a score. With increasing score, the median survival time decreased from 6.4 years (score 5) to 2 months (scores 12 or more). Furthermore, the mortality from hepatic failure, gastrointestinal bleeding or hepatocellular carcinoma increased significantly with increasing score. CTC provide valuable and easily obtainable prognostic information in cirrhosis. However, CTC are inferior to a prognostic index based on multivariate analysis of prognostic factors.

Actuarial Analysis↗

PubMedDate not supplied

Changes of laboratory variables with time in cirrhosis: prognostic and therapeutic significance.

The time change of laboratory variables in cirrhosis was studied by analysis of data from 488 patients with cirrhosis included in a controlled clinical trial of long-term prednisone vs. placebo. In the placebo group, a marked regression towards normal was seen within 3 months of entry into the trial (increase in serum albumin, acetylcholinesterase, cholesterol, hemoglobin and decrease in erythrocyte sedimentation rate). The subsequent course did not show a clear pattern, except for a slight increase in serum bilirubin and decrease in albumin. When studied in relation to the time of death in patients dying from a "hepatic" cause, marked increase in bilirubin and decrease in prothrombin index, albumin and cholesterol were seen in the year prior to death with little change before that time. In the prednisone group, a more marked decrease in bilirubin, SGOT, alkaline phosphatase, gamma-globulin, sulfobromophthalein retention, erythrocyte sedimentation rate and increase in leukocytes, prothrombin index and cholesterol were seen during the first 3 months. In relation to time of death from a "hepatic" cause, similar changes were seen as in the placebo group except that alkaline phosphatase increased and cholesterol did not decrease. A beneficial effect of prednisone on survival, as expressed by a previously developed therapeutic index, was associated with decrease in SGOT, alkaline phosphatase and gamma-globulin within the first 3 months. An increase in SGOT during prednisone seemed to be associated with harmful effects of therapy.

Acetylcholinesterase↗

PubMedDate not supplied

The significance of the HBe system in an area highly endemic for hepatitis B virus.

A group of 164 consecutive patients with chronic liver disease and 60 healthy HBsAg carriers were investigated in an area highly endemic for hepatitis B virus (HBV). Eighty-two of the 164 patients (50%) were found to be HBsAg-positive and only 39 (24%) had no HBV markers. A statistically significant correlation was found in the HBsAg-positive patients between the HBe system, their age and the time which had elapsed since their acute episode. Thus, the prevalence of HBeAg decreased with increasing age and with increasing time since their acute episodes. Furthermore, a statistically significant correlation was found between the presence of HBeAg and active chronic liver disease. Of the patients with chronic active hepatitis with or without cirrhosis, all patients below the age of 13 years were HBsAg-positive and 72% were also HBeAg-positive. The data suggest that the HBeAg-positivity in HBsAg carriers is of limited duration and that the seroconversion from HBeAg to anti-HBe is related to a histologically less active or inactive stage of the disease.

Adolescent↗

PubMedDate not supplied

Letter: Levodopa as a treatment of obesity.

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Clinical Trials as Topic↗