Patient-reported experience with Velosulin human insulin in continuous subcutaneous insulin infusion.

A multicenter, retrospective survey of 339 patients with insulin-dependent diabetes mellitus was done to evaluate patient experience with Velosulin Human insulin, a regular insulin in a phosphate buffer, used in continuous subcutaneous insulin infusion. Patients had used this insulin exclusively for 3 months preceding the survey. Responses were elicited through interviews conducted by physicians or nurses. Patients were queried as to the occurrence of specific complications associated with pump therapy that occurred while using Velosulin Human insulin, including hypoglycemia, diabetic ketoacidosis, unexplained hyperglycemia, tubing obstruction, and infection or abscess at the infusion site. Most patients reported that they did not experience any of these complications during the preceding 3 months. The most frequently cited complication was hyperglycemia unexplained by dosage, exercise, or dietary changes, reported by 110 (32%) patients. The second most frequently reported complication was tubing obstruction, reported by 99 (29%) patients. The reported frequencies of the other complications were: severe hypoglycemia, 45 (13%) patients; diabetic ketoacidosis, 28 (8%) patients; and infection or abscess at the infusion site, 26 (8%) patients. The low morbidity reported by the patients in this survey probably was due in large part to careful patient selection, a high level of motivation on the part of the patients, and experience and education on the part of the health care team, as well as to the use of buffered regular human insulin.

Effect of chenodeoxycholic acid on liver structure and function in man: a stereological and biochemical study.

Chenodeoxycholic acid (CDCA) is an effective treatment for dissolving gallstones but experimental studies have suggested that it might be hepatotoxic. The present study is concerned with a group of patients undergoing medical therapy for gallstones for periods of 30 days up to 14 months with CDCA (15 mg/kg/day). Routine functional tests, determination of some liver microsomal enzymes and stereological studies of the liver tissue have been performed and the data have been compared with those obtained before treatment. No significant changes were observed in the functional tests throughout the study. Also the microsomal mixed function oxidase system seemed unaffected by CDCA therapy. The histological features of the liver biopsies were not appreciably different from those observed prior to treatment. Although there were large interindividual variations, the volume density of parenchymal steatosis and of the lipocytes remained comparable in the ssme individual. The ultrastructural features noted in untreated subjects such as curled mitochondrial cristae, slight intracellular bile retention, increased surface density of the rough endoplasmic reticulum were still evident after 14 months of treatment. No additional changes were noted. These results show that no evidence of hepatotoxicity seems to develop in man under therapy with CDCA at the dose considered. But the structural abnormalities observed before treatment appear to persist even in subjects under long-term therapy.

A stereological and biochemical study of the human liver in uncomplicated cholelithiasis.

A quantitative analysis of needle liver biopsies of patients with untreated, uncomplicated cholelithiasis has been performed to better evaluate eventual changes occurring under medical therapy of gallstones. With the light microscope, the intensity of parenchymal steatosis was variable among the patients but the mean volume density of lipid droplets was significantly increased as compared to normal subjects. In addition, there was a significant increase in the volume density of lipocytes (fat-storing cells) without an increase in the number per square area, suggesting a hypertrophy of individual cells. The data obtained by ultrastructural morphometry show a significant increase in the surface density of the rough endoplasmic reticulum in the hepatocytes, a significant increase of the mitochondrial volume density together with the presence of curled mitochondrial cristae and a slight, inconstant intracellular and intracanalicular bile retention. No qualitative or quantitative changes were observed at the level of the smooth endoplasmic reticulum. The activity of the microsomal enzyme NADPH-cytochrome c reductase as evaluated on liver biopsy material was in the normal range. Some of the features observed in this group of patients are reminiscent of alterations previously described in human or experimental cholestasis and suggest that they might depend on a common underlying disturbance in cholesterol and bile salt metabolism.