Oral pantoprazole in the form of granules or tablets are pharmacodynamically equivalent in suppressing acid output in patients with gastro-oesophageal reflux disease and a history of erosive oesophagitis.

AIM: To demonstrate the pharmacodynamic comparability between oral 40 mg pantoprazole delayed-release granules and tablets. METHODS: This was a multicentre, randomized, open-label, 2-period, 2-sequence, 9-week crossover study in patients aged 18-65 years with gastro-oesophageal reflux disease and documented erosive oesophagitis. The primary endpoint was a comparison of the inhibition of pentagastrin-stimulated maximum acid output (MAO) at steady state after once daily dosing for 1 week and 23 h after the last dose of pantoprazole granules and tablets. Basal acid output was measured prior to MAO. Standard safety evaluations were performed. The one-sided t-test was used to test the null hypothesis that granules - 1.2 x tablet >/= 0 against the alternative hypothesis that this difference was <0 for both MAO and basal acid output values. RESULTS: Sixty patients completed the study. The mean MAO values were 7.11 +/- 4.98 and 7.29 +/- 4.77 mmol/h, while the mean basal acid output values were 0.74 +/- 0.91 and 0.58 +/- 0.63 mmol/h for the granules and tablets, respectively. The two formulations were shown statistically to be pharmacodynamically equivalent in suppressing MAO (P = 0.006), safe and well tolerated. CONCLUSION: Patients with gastro-oesophageal reflux disease who are unable to swallow the tablet may safely be prescribed the pantoprazole sodium granules.

Three-year oral pantoprazole administration is effective for patients with Zollinger-Ellison syndrome and other hypersecretory conditions.

BACKGROUND: Zollinger-Ellison syndrome and idiopathic hypersecretion are gastrointestinal hypersecretory conditions requiring long-term maintenance. AIMS: The safety and efficacy data for short-term (6-month) treatment of Zollinger-Ellison syndrome and idiopathic hypersecretion with oral pantoprazole were previously published. This study extends the initial observations to 3 years. METHODS: The primary efficacy end point for this report was the control of gastric acid secretion in the last hour before the next dose of oral pantoprazole (acid output of <10 mmol/h; <5 mmol/h in subjects with prior acid-reducing surgery). Dose titration was permitted to a maximum of 240 mg per 24 h. RESULTS: Twenty-four subjects completed the study. The acid output of 28 of 34 subjects was controlled at initial enrolment. The mean acid output rates were <10 mmol/h throughout the 36 months of treatment for 90-100% of the patients. The majority of the patients were controlled with b.d. doses of 40 or 80 mg pantoprazole at 36 months (acid output was controlled in 24 of 24 subjects). Pantoprazole was generally well tolerated with minimal adverse events reported. CONCLUSIONS: Maintenance oral pantoprazole therapy up to 3 years at dosages of 40-120 mg b.d. was effective and well tolerated in patients with Zollinger-Ellison syndrome and other hypersecretory conditions.

Benefits of oral supplementation with and without synbiotics in young children with acute bacterial infections.

Acutely ill children (n = 129) aged 1-6 years receiving antibiotic therapy were randomized to receive a nutritional supplement with (PS) or without (P) synbiotics or a fruit-flavored drink (D) with their medications. Group PS had significantly greater weight gains (versus D) following antibiotic therapy. The percentages of subjects without bacterial illnesses 14 days following antibiotic therapy were as follows: 94.3% (PS), 87.8% (D), and 80.6% (P). PS (vs D) significantly increased fecal Lactobacillus in a subset of subjects. Oral supplements increase energy intake and promote weight gain in acutely ill children receiving antibiotics; synbiotics may confer additional benefits by increasing bifidobacteria levels.

Bacterial contamination of blenderized whole food and commercial enteral tube feedings in the Philippines.

Hospital-prepared tube feedings from four Philippine acute-care hospitals were analysed for microbial contamination. Two feedings were prepared on three separate days at each hospital. The tube feedings were either blended natural whole foods or a reconstituted commercial powdered nutritional product. Samples of each feeding were collected for coliform count and standard plate count at the time of preparation and at 1, 2 and 4 h after preparation after maintenance at room temperature (26-31 degrees C). At the time of preparation, mean coliform and standard plate counts for all samples were 10.3 most probable number per gram (MPN/g) and 7.4x10(4)colony-forming units per gram (cfu/g), respectively. Nine of 24 samples (38%) had coliform counts greater than 10 MPN/g, and 22/24 (92%) samples had standard plate counts greater than 10(3) cfu/g. There were significant increases in mean coliform and standard plate counts over 4 h (P=0.0005 and P=0.008, respectively). At 4 h after preparation, the mean coliform and standard plate counts were 18.2 MPN/g and 2.1x10(5) cfu/g, respectively. At this time, 18/24 (75%) samples had coliform counts greater than 10 MPN/g and 20/24 (83%) samples had standard plate counts greater than 10(5) cfu/g. The results of this study show that the microbial quality of the majority of the hospital-prepared enteral tube feedings analysed were not within published guidelines for safety.

A prospective randomized placebo-controlled double-blinded pilot study of misoprostol rectal suppositories in the prevention of acute and chronic radiation proctitis symptoms in prostate cancer patients.

OBJECTIVE: Radiation proctitis is a known complication of radiation therapy for prostate cancer. Available medical treatment is usually ineffective and has focused on relieving symptoms after damage has occurred. Our study aimed at evaluating the use of misoprostol rectal suppositories in the prevention of acute as well as chronic radiation proctitis symptoms. METHODS: A prospective, randomized, placebo-controlled, double-blinded trial was conducted in patients with recently diagnosed stages B and C prostate cancer who underwent external beam irradiation. Patients received either a misoprostol or a placebo suppository 1 h before each radiation session. Misoprostol suppositories were made from two 200-microg tablets (Cytotec, Searle Pharmaceuticals, Skokie, IL), whereas the placebo was made from cocoa butter. A 12-point radiation proctitis symptom score was obtained from each patient at 4, 8, 12, and 36 wk after radiation therapy. RESULTS: A total of 16 patients were enrolled. Seven patients received placebo, and nine patients received misoprostol. Mean radiation proctitis symptom scores in the placebo group were 4.86, 5.86, 5.71, and 3.83 at 4, 8, 12, and 36 wk, respectively. The mean scores in the misoprostol group were 0.78, 0.67, 0.33, and 0.37 at 4, 8, 12, and 36 wk, respectively. The difference between the two groups was statistically significant (p < 0.05) at 4, 8, 12, and 36 wk. CONCLUSION: Misoprostol rectal suppositories significantly reduce acute and chronic radiation proctitis symptoms in patients receiving radiation therapy for prostate cancer.

Effect of high ambient temperature on contamination and physical stability of one-liter ready-to-hang enteral delivery systems.

The effect of high ambient temperature on the physical stability and bacterial contamination of 1-L, prefilled, closed enteral feeding systems was examined under simulated clinical conditions. One hundred Jevity Ready-to-Hang enteral feeding systems (Abbott Park, IL, USA) were placed in a 37 degrees C incubator for 24 h. The Ready-to-Hang formula containers were visually inspected at 0 and 24 h. Formula samples were collected from the containers at 24 h and plated on trypticase soy agar. Two samples had insignificant bacterial growth of one colony-forming unit per milliliter that was not demonstrated in repeat culture. No growth was observed for any other sample. Additional samples collected from the two apparently contaminated delivery sets showed no growth. No set showed signs of formula instability, such as coagulation, clumping, or curdling. These findings suggest that, even at a high ambient temperature of 37 degrees C, the risk of bacterial contamination or compromised physical integrity is very low with the use of 1-L, prefilled, closed enteral feeding systems.

Hydrogen peroxide 3% exposures.

OBJECTIVE: To present a child who developed gastric ulcers and duodenal erosions after ingestion of hydrogen peroxide 3% and delineate the epidemiology, medical outcomes, and toxicity of exposures to this agent managed by a poison control center. METHODS: A retrospective chart review of exposures to hydrogen peroxide 3% reported to the Long Island Regional Poison Control Center from January 1992 to April 1995 was conducted. Data extracted included age, route of exposure, amount of agent, symptoms, therapy, and medical outcome. RESULTS: There were 670 exposures to hydrogen peroxide 3% of 81,126 total exposures reported during the 40 months. Most exposures were by oral route (77%), occurred in children < 17 years old (67%), and were asymptomatic (85.6%). All but one exposure resulted in a benign outcome. One child, who presented with bloody emesis, developed multiple gastric ulcers and duodenal erosions after ingestion of hydrogen peroxide 2-4 oz. CONCLUSIONS: Exposure to hydrogen peroxide 3% is usually benign, however, severe gastric injury may occur following small ingestions in children. Patients who report persistent vomiting or bloody emesis require medical evaluation and consideration of endoscopy to evaluate gastrointestinal injury.

Hepatotoxicity from isoniazid and rifampin in inner-city AIDS patients.

OBJECTIVE: To determine the incidence of hepatotoxicity due to isoniazid and rifampin in inner-city patients with active tuberculosis. DESIGN: A hospital-based review of 70 consecutive in-patients in a 770-bed, inner-city hospital. The patient population is primarily African-American and Hispanic. METHODS: Fifty-eight men and 12 women were followed from 2-12 wk (median 4 wk). Patients had to be treated for at least 2 wk to be eligible for the study. Patients were excluded if they had been on any anti-tuberculous or any other hepatotoxic drug during the 2-month period before their hospitalization. Aminotransferases, alkaline phosphatase, bilirubin, and albumin were obtained at least every 2 wk. RESULTS: Hepatocellular toxicity, defined as AST and/or ALT greater than 200 IU/L, occurred in eight out of 70 (11.4%) patients. The mean age of these patients was 38.9 yr (22-58 yr). Patients with AIDS were significantly more likely to develop hepatotoxicity than those with any other risk factor (p < 0.01). CONCLUSIONS: Baseline aminotransferases followed by monitoring may be necessary in AIDS patients.

Nutritional support during liver failure.

Critically ill patients in varying degrees of liver failure are catabolic and consequently require expeditious caloric support. Unique problems in this group of patients essentially revolve around the diagnosis and management of hepatic encephalopathy. From the overview provided in this text, it can be concluded that, only in overt hepatic coma, should all nitrogen products be withheld while precipitating causes are evaluated. Protein should be reintroduced as rapidly as possible to avoid the consequences of protein deprivation. Once the acute intercurrent illness has resolved, the cirrhotic patient returns to baseline energy and protein requirements indistinguishable from the population at large.

AIDS-related cholangiopancreatographic changes.

The cholangiographic and pancreatographic appearances of the acquired immunodeficiency syndrome (AIDS) associated cholangitis were evaluated in 26 patients. Twenty-four patients were diagnosed by retrograde cholangiography or endoscopic cholangiopancreatography (ERC or ERCP). One patient was diagnosed by T-tube cholangiography and another patient by transhepatic cholangiography. The radiographic findings ranged from intrahepatic ductal abnormalities with or without involvement of the extrahepatic biliary tree (eight patients) to irregularities and strictures involving the ampulla of Vater or the intrapancreatic portion of the common bile duct (CBD) with proximal dilatation (18 patients). Significant strictures involving the juxta-ampullary pancreatic duct were identified in six of 12 patients. Twenty-one of the 26 patients had associated infections which included: Cryptosporidium (CS), Mycobacterium avium intracellulare (MAI), cytomegalovirus (CMV), Microsporidium (MSP), and Isospora (ISP). Three patients were operated upon for acute acalculous cholecystitis. In each instance, organisms were identified in both the bile duct and the inflamed gallbladder.

Hepatic amyloidosis in intravenous drug abusers and AIDS patients.

The clinical and pathological features of four liver biopsies and 12 autopsies from 1981-1990 with hepatic amyloidosis were reviewed. All of the patients had a history of both intravenous and subcutaneous cocaine and heroin use with chronic suppurative skin ulcers. Five patients were proven to have the acquired immunodeficiency syndrome at autopsy. Systemic amyloidosis was diagnosed in only five out of the 16 patients prior to death. Hepatomegaly was present in 12 patients. The amyloid protein was AA in 14 and AL in one case. Definitive characterization of the amyloid substance was not possible in one case. There was no evidence of multiple myeloma or a plasma cell dyscrasia in the one patient with AL amyloid. The amyloid distribution in the liver was both parenchymal and vascular in 12 cases. Cholestasis, which appeared to occur preterminally, was the only histological finding that correlated with the patient's clinical condition. The histological pattern of amyloid in the liver could not predict the type of amyloid protein that was identified. Amyloidosis should be considered in the differential diagnosis of unexplained hepatomegaly in the acquired immunodeficiency syndrome with chronic suppurative infections.

Transfusion-related chronic liver disease in sickle cell anemia.

The medical records and liver biopsies of nine sickle cell patients with chronically elevated liver function tests were retrospectively reviewed to determine the etiology of chronic liver disease. There were eight women and one man with a mean age of 30 yr. All patients had hemoglobin SS. Eight patients were referred for elevated aminotransferases and one for an elevated alkaline phosphatase. Hemosiderosis was present in all of the biopsies. Two patients had cirrhosis. Chronic hepatitis was noted in two patients, and five patients had cholestasis. Two patients had serologic markers demonstrating HBV exposure but no patients were HBsAg positive. Erythrophagocytosis, sinusoidal dilatation, and Kupffer cell hyperplasia were present in all of the liver biopsies. Transfusion-related causes were the most common significant pathologic findings in our patients, and appeared to be the etiologies of chronic liver disease in sickle cell patients.

Cluster of fulminant hepatitis B in crack users.

Fulminant hepatitis occurs in only 1% of acute hepatitis B patients, requiring hospitalization, but coinfection with delta virus increases the incidence. Hepatitis B and D infection are commonly associated with intravenous drug abuse, but there have been no previous reports of an association with nonparenteral cocaine. Crack use, via sexual promiscuity, is associated with an increased risk for human immunodeficiency virus infection, but has never been associated with viral hepatitis. We report four fatal cases of fulminant hepatitis B including, one with delta virus coinfection and one with human immunodeficiency virus (HIV) infection, in young, sexually active, heterosexual crack users. These patients denied a history of intravenous drug abuse. Our patients probably contracted hepatitis B infection via heterosexual contact. Chronic cocaine exposure may or may not have contributed to the fulminant outcome. Crack users may be at increased risk of developing hepatitis B and D infection. Epidemiological studies are needed to evaluate their risk of viral hepatitis and the effect of cocaine on its outcome.

Streptococcus bovis brain abscess associated with an occult colonic villous adenoma.

Streptococcus bovis is now recognized as a common cause of bacterial endocarditis. However, infection of the central nervous system by this organism is very rare. Recent studies have demonstrated the association between Streptococcus bovis infections and colonic neoplasms.

Liver biopsies in the acquired immune deficiency syndrome: influence of endemic disease and drug abuse.

A retrospective review of 48 liver biopsies in 34 patients with acquired immune deficiency syndrome (AIDS) and 10 patients with AIDS-related complex (ARC) was performed at Harlem Hospital Center to assess the diagnostic yield of liver biopsies in this distinct patient population. Among the patients, 93.2% were black and 32 were males, with a mean age of 36.7 yr. Intravenous drug abuse was a risk factor for AIDS in 81.8% of patients. Liver biopsies were particularly useful in patients with fever of unclear origin, which was positively correlated with the presence of granulomas (p = 0.01). Granulomas due to mycobacteria were present in 16 (33.3%) of the biopsies. Liver biopsy proved to be clinically significant in 14 of 17 patients (82.3%) with mycobacterial disease, or 29.3% of the liver biopsies. Chronic active hepatitis was present in 12 (29.2%) of the biopsies, and in all but one was due to non-A non-B hepatitis viruses. All patients with chronic active hepatitis were intravenous drug abusers or the sexual partners of intravenous drug abusers. Liver biopsy can provide important diagnostic information in AIDS patients. The pathological findings in this series reflect the high risk of exposure to tuberculosis and hepatitis in the intravenous drug abusers in Harlem.

Dilated cardiomyopathy associated with chylous ascites.

Chylous ascites is a well-documented sequelae of traumatic rupture of the thoracic duct and mechanical obstruction of the lymphatic system due to neoplastic, inflammatory, or congenital anomalies. Less commonly, chylous ascites results from altered hemodynamics and lymphatic flow, as seen in cirrhosis and constrictive pericarditis. Rarely, severe right-sided heart failure from a variety of causes has also resulted in chylous ascites or a protein-losing enteropathy. We report a case of chylous ascites due to dilated cardiomyopathy with autopsy findings. The pathophysiology of chylous ascites formation in right heart failure will be discussed, with a review of the literature.

Cardiolipin-fluorescent (M1) antimitochondrial antibody and cholestatic hepatitis in secondary syphilis.

A 27-year-old black male with secondary syphilis and cholestatic jaundice is presented. The liver biopsy was believed to be most consistent with large bile duct obstruction, but both the ultrasound and endoscopic retrograde cholangiography were normal. Prior to treatment with penicillin, his serum was positive for antimitochondrial antibody. After treatment, the antibody was no longer detectable and the jaundice gradually resolved. The patient's pretreatment serum was, after further analysis, found to be positive for the antibody to the M1 antimitochondrial antigen subtype, which is identical to cardiolipin, the antigen in both the VDRL and Wasserman tests. A review of hepatic involvement in secondary syphilis is presented.

Isolation of intestinal mononuclear cells from colonoscopic biopsies for immunofluorescence analysis by flow cytometry.

A method for isolating and characterizing intestinal lymphoid cells from colonoscopic biopsies is presented. Intraepithelial lymphocytes were separated from the lamina propria by incubation in edetic acid (EDTA) and lamina propria lymphoid cells isolated by incubation in collagenase followed by Ficoll-Hypaque density flotation. Quantitation of T lymphocyte helper (OKT4) and suppressor (OKT8) cells was performed using monoclonal antibodies to cell surface markers and analyzed on a flow cytometer. The isolation procedure yielded approximately 400,000 lamina propria cells and 100,000 intraepithelial cells per sample, with better than 90% viability. Surface marker analysis demonstrated significant differences in the ratios of helper to suppressor cells between the intraepithelial lymphocytes and the lamina propria lymphocytes. These demonstrate the feasibility of lymphoid cell isolation from colonoscopic biopsy specimens for surface marker analysis by flow cytofluorimetry. These techniques could prove important in the study of immune mechanisms in inflammatory bowel diseases.