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Biomedical subjects

J W Singleton

Publications and source records attributed to J W Singleton.

33 records · Page 2Linked to original sources
PubMed1979

National Cooperative Crohn's Disease Study: adverse reactions to study drugs.

Adverse reactions to the drugs employed in the National Cooperative Crohn's Disease Study were sought prospectively at each patient visit and by retrospective review of all patient charts. Prednisone caused evident side effects in over 50% of patients on high-dose suppressive therapy and in approximately one-third of patients on prophylactic dose. Thirty-two percent of patients on high-dose, and 26% on prophylactic-dose prednisone required dose reduction or withdrawal because of side effects. Comparable figures for sulfasalazine were 14% and 12%, and for azathioprine 32% and 20%. The incidence of nausea, vomiting, or anorexia among patients taking sulfasalazine was 46% and 34%, on high and low dose respectively; however, this incidence was no different than that observed among patients taking placebo. These symptoms occasioned withdrawal from the study of only 4% and 3% of patients on high and low doses of sulfasalazine, respectively. Azathioprine produced leukopenia at a dose of 2.5 mg/kg body weight in 15% of patients and the mean white cell count, lymphocyte count, granulocyte count, and hematocrit all fell significantly in patients on this dose. Pancreatitis occurred in 5% of patients taking azathioprine but in no other patients. Sulfasalazine proved to be the safest effective suppressive drug for Crohn's disease. Prednisone toxicity, though substantial, is acceptable in view of its demonstrated suppressive efficacy. Azathioprine was approximately as toxic as prednisone but no more effective than placebo in suppressing active disease. None of the drugs was effective prophylactically, and all showed appreciable long-term toxicity.

Adult↗
PubMed1979

Azathioprine-related pancreatitis in patients with Crohn's disease.

Pancreatitis developed in 6 patients in the National Cooperative Crohn's Disease Study. In five of these the diagnosis was confirmed by elevated levels of seum amylase or lipase. All cases were in the 113 patients who received azathioprine and occurred within the first 21 days of treatment. This incidence of pancreatitis was significantly greater than in the patients treated with sulfasalazine, prednisone, or placebo (P less than 0.01).

Adult↗
PubMed1979

A trial of sulfasalazine as adjunctive therapy in Crohn's disease.

The effect of the combination of sulfasalazine and prednisone has been compared with that of prednisone and placebo in 89 actively symptomatic patients with Crohn's disease in a double-blind, randomized, multicenter controlled trial. The combination was less effective than prednisone alone in treatment of active symptomatic disease. The probability of obtaining this result, if sulfasalazine truly has a clinically useful effect equal to or greater than that specified in the calculation, is less than 1%. Patients who were in remission at the end of 8 wk were rerandomized to receive either the two drugs together or prednisone plus placebo while repeated systematic attempts to withdraw prednisone were made over the next 6 mo. Sulfasalazine showed no prednisone-sparing effect as judged either by outcome ranking or total dose of prednisone consmed by the two treatment groups. However, in this comparison the probability is greater than 5% that, given the results observed, a clinically useful effect of sulfasalazine of specified minimum degree truly exists. It was possible to withdraw prednisone from 25% of patients at the first attempt and ultimately in 37%.

Adult↗
PubMed1979

Radiographic findings of the National Cooperative Crohn's Disease Study.

On-study barium radiographs of 535 patients in the National Cooperative Crohn's Disease Study have been analyzed for the pattern of distribution of bowel disease and the individual features that characterized bowel involvement. On-study and off-study radiographs of 403 of these patients were compared under code to judge radiographic response to drug treatment and discover correlations of radiographic findings with clinical response. Patients with more clinically active disease had more colonic disease on x-ray. Duodenal abnormalities were recognized in 22% of the patients and radiographically typicaly Crohn's disease of the duodenum in 8%. Recurrent Crohn's disease and that characterized by small bowel obstruction each displayed a characteristic appearance. Overall there was little evidence of radiographic improvement during the study, and little correlation between clinical response and evidence of radiologic improvement. Only patients treated with prednisone for more than 6 mo showed statistically significant radiologic improvement. Patients with definite radiographic progression or regression were found in each treatment group. Both fistula and stricture with obstruction were associated with a poor clinical response to all therapies. In view of the evidence from this study that radiographic findings do not correlate with clinical symptoms or response, the ritual use of x-ray to follow patients with Crohn's disease is unnecessary.

Adult↗
PubMed1979

Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI).

A previous paper reported derivation of the Crohn's Disease Activity Index (CDAI) from data on 112 patients. We have now rederived the values of the eight coefficients of the CDAI using data from 1058 visits of patients enrolled in the National Cooperative Crohn's Disease Study and the Trial of Adjunctive Sulfasalazine in Crohn's Disease. The rederived coefficients are similar to the original ones. New and original index values calculated on the same data from patient visits correlated very highly. Because there is so little difference between the original and the rederived versions, continued use of the original version is suggested in order to maintain comparability of new studies employing this tool with those previously accomplished.

Crohn Disease↗
PubMed1976

Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study.

Needing a single index of degree of illness in Crohn's disease, the National Cooperative Crohn's Disease Study group collected data prospectively from 187 visits of 112 patients with Crohn's disease of the small bowel, colon, or both. Information on 18 predictor variables was gathered at each visit. In addition, the attending physician rated his over-all evaluation of how well the patient was doing and compared the patient's status with that at the previous visit. A multiple regression computer program was utilized to derive an equation for prediction of the physician's over-all ratings from a subset of the predictor variables fulfilling a combination of constraints. This equation, numerically simplified and utilizing eight selected variables, is the Crohn's Disease Activity Index. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease, and values above 450 are seen with extremely severe disease.

Adult↗
PubMed1975

Thymus-derived lymphocytes in type B acute viral hepatitis and healthy carriers of hepatitis B surface antigen (HBsAg).

To assess thymus-derived (T) lymphocyte function in hepatitis B infection, lymphocytes from patients with type B acute viral hepatitis and healthy carriers of the hepatitis B surface antigen, were compared to normal controlss using phytohemagglutinin (PHA) -induced blast cell transformation and sheep-cell rosette formation. Overall cell (T lymphocyte) -mediated immune function was similar with these in vitro assays in all three groups, except for decreases in total T cells in isolated patients with acute disease. Consequently, if a defect in cellular immunity exists in normal controls with persistent hepatitis B infection, it is probably specific for the antigens of the hepatitis B virus and not related to a generalized impairment of T-lymphocyte function.

Carrier State↗