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Sustained release hydrodynamically balanced capsules (HBS) of propranolol.HCl have been prepared and evaluated in vitro. Data to support the mechanism of drug release from the HBS capsule are also presented. Floating behaviour of the HBS capsule has also been seen in vivo with the help of endoscopy.
120 patients with upper gastrointestinal symptoms were studied and submitted to gastric secretory tests, upper gastrointestinal X-rays and endoscopy. Gastroesophageal reflux was assessed by means of a Heidelberg telemetric capsule. 60 patients had hiatal hernia. Gastroesophageal reflux was present in 63.33%. 76% of the patients with hiatal hernia had gastroesophageal reflux, especially on those with small hernias and on the 5th and 6th decade of life. Gastric hiperacidity facilitates the incidence and presence of reflux. X-rays and endoscopy allowed us to diagnose diseases at the gastroesophageal junction. The correlation between these 2 methods and the presence or not of reflux, allowed differentiation between patients with organic diseases and patients with "functional" symptoms.
OBJECTIVES: The pattern of reflux in the most distal esophagus of asymptomatic individuals is largely unknown. Using a wireless technique we compared the degree and the pattern of acid reflux just above the squamocolumnar junction (SCJ) with that measured at the conventional level for pH monitoring. METHODS: Fifty-three asymptomatic volunteers underwent endoscopy with transoral placement of two pH recording capsules, one immediately above and one 6 cm above the SCJ. Ambulatory pH monitoring was performed during 48 h. RESULTS: Three subjects were excluded as the distal capsule was inadvertently placed with the pH electrode below the SCJ. The median percent time with pH < 4 and the median number of reflux episodes were significantly higher immediately above the SCJ compared with that found more proximally (1.6%vs 0.9% and 67 vs 26, p < 0.0001). Of all acid reflux events, 69% were isolated episodes immediately above the SCJ. Only 26% of reflux episodes detected at the SCJ extended to the more proximal pH electrode. Reflux events occurring just above the SCJ were more acidic. The number of reflux events with a minimum pH below 2 or 3 was significantly higher at the SCJ compared with that recorded by the upper capsule (16% and 44%vs 6% and 34%, p < 0.0001). CONCLUSIONS: Conventional pH monitoring substantially underestimates the degree of acid exposure in the most distal esophagus. In healthy subjects, acid exposure immediately above the SCJ was considerably higher and was characterized by shorter reflux episodes that had a lower minimum pH compared with that measured at the traditional level for pH monitoring.
We studied the gastrointestinal side effects of three formulations of naproxen in 18 healthy male volunteers. In a Latin-square design crossover study, the subjects received 500 mg naproxen twice daily for 7 days as plain tablets, enteric-coated tablets, or enteric-coated granules in capsules. The 51Cr-EDTA absorption test was performed before and at the end of each drug period, to evaluate changes in the distal gut. The test dose was instilled distally in the duodenum to prevent lesions in the stomach from interfering with the evaluation. Upper endoscopy was performed at the same intervals, scoring changes in the middle and distal duodenum separately from findings in the stomach and duodenal bulb. The nature and severity of adverse effects were recorded for each treatment period. Non-parametric methods were used for statistical evaluation. All drugs induced a significant increase in 51Cr-EDTA absorption, but we did not detect any difference between the three formulations. All formulations were associated with a significant increase in all the endoscopic findings monitored. Enteric-coated tablets induced significantly less lesions than enteric-coated granules in the stomach and duodenal bulb, and an advantage over plain tablets was indicated. No difference was seen in the middle and distal duodenum. The proximal endoscopic scores were not correlated to those found in the middle and distal duodenum. Evaluation of the small and large bowel should probably be included in clinical studies of NSAIDs, but our findings suggest that the importance of transfer of mucosal lesions to the distal gut by enteric coating may have been overemphasized.
A sampling method to collect samples for Helicobacter pylori culture that is easier than endoscopy would be useful. We used a capsule attached to a highly absorbent nylon string, which is swallowed to obtain gastric secretions. Antral biopsy and string specimens, sequentially obtained from 36 adults with clinically suspected ulcer or gastric disease were cultured. 9 (25%) patients were negative in both tests; 18 (50%) were positive by both methods; 6 (17%) were biopsy positive and string-test negative; and 3 (8%) were biopsy negative and string-test positive. The new test is useful, simple, and causes little discomfort.
In the present study we evaluated the efficacy and tolerability of two different therapeutic schedules in eradicating Helicobacter pylori. Forty-six consecutive patients (suffering from either peptic ulcer or non-ulcer dyspepsia) with helicobacter pylori infection were randomly allocated to one of the following two groups: group 1 (n = 23) 2 weeks of treatment with bismuth subcitrate tablets (120 mgx4) + amoxycillin capsules (500 mgx4) + metronidazole tablets (250 mgx4); group 2 (n = 23) 2 weeks of treatment with amoxycillin capsules (500 mgx4) + metronidazole tablets (250 mgx4). Endoscopy, histology and bacterial culture were performed at entry, and 30 and 90 days after treatment. Two group 1 patients and one group 2 patient did not complete the treatment. Successful eradication was obtained in 20/21 (95%) patients treated with triple therapy (group 1) and in 17/22 (77%) patients treated with double therapy (group 2) (p = 0.2). Side-effects occurred in 9/21 (43%) patients of group 1 and in 9/22 (41%) patients of group 2 (p = 0.9). These were all self-limiting and required no specific treatment. These data suggest that combined therapy with amoxycillin and metronidazole, with or without bismuth subcitrate, represents a safe and effective therapeutic approach for the treatment of Helicobacter pylori infection. In our series, triple therapy determined a numerically higher eradication rate than double therapy.
We aimed to assess technical feasibility, clinical applicability, and diagnostic yield of videocapsule endoscopy (VCE) in a large group of unselected patients. VCE was performed with the Given Imaging swallowable capsule. Findings were considered diagnostic if the observed finding could explain the symptomatology of the patient. Findings were considered suspicious if an observed finding failed to completely explain the patient's symptoms. We studied 250 patients. A definite diagnosis was made in 95 patients (38%). Suspicious findings were noted in 80 patients (32%). No diagnosis was obtained in 74 patients (30%). The yield of VCE was higher in patients with suspected Crohn's disease. Mean viewing time decreased significantly from 51 +/- 14 to 30 +/- 7 minutes after reviewing 50 procedures. VCE is an important diagnostic tool, but a definite diagnosis is established in only 38% of the patients. The highest diagnostic yield is obtained in patients with suspected Crohn's disease.
OBJECTIVE: To investigate the incidence of spontaneous detachment of the anterior hyaloid membrane from the posterior lens capsule and to explore the possibility of surgical separation of the anterior hyaloid membrane. DESIGN: Prospective nonrandomized interventional comparative trial and comparative human tissue study. PARTICIPANTS: Thirty-eight eyes of 32 patients undergoing primary pars plana vitrectomy combined with cataract extraction and intraocular lens implantation and 3 eye bank eyes for histopathologic examination. METHODS: The anterior hyaloid membrane and posterior lens capsule were observed with a fiberoptic endoscope. Surgical separation of the anterior hyaloid membrane was attempted by either the hydrodissection method before cataract extraction (18 eyes) or the direct suction method after cataract extraction (20 eyes). In eye bank eyes, histopathologic examination was performed with (one eye) and without (two eyes) surgical separation of the anterior hyaloid membrane. MAIN OUTCOME MEASURES: Incidence of spontaneous detachment and success rate of surgical detachment of the anterior hyaloid membrane. RESULTS: No eye displayed spontaneous detachment of the anterior hyaloid membrane. Using the hydrodissection method, complete detachment of the anterior hyaloid membrane was achieved in 10 eyes (55.6%), partial detachment was attained in 2 eyes (11.1%), and detachment was not induced at all in 6 eyes (33.3%). With the direct suction method, the anterior hyaloid membrane was completely separated from the posterior lens capsule in 10 eyes (50%), partially detached in 10 eyes (50%), and not detached at all in any eye. The direct suction method had a significantly higher success rate than the hydrodissection method (P < 0.001, chi-square test). In eye bank eyes, the surgical manipulation induced complete separation of the anterior hyaloid membrane from the lens capsule. CONCLUSIONS: Spontaneous detachment of the anterior hyaloid membrane from the posterior lens capsule is very rare. Under endoscopic observation, surgical detachment of the anterior hyaloid membrane was possible in half of the patients.
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As from 1983, endoscopy with biopsy in general anesthesia was used instead of the capsule suction method in children with suspected coeliac disease in a county hospital. A study was carried out to evaluate mean endoscopy time, duration of general anesthesia, complications and quality of biopsies. An ordinary Olympus GIF-Q endoscope (diameter 11 mm) was used in 17 patients, eight boys and nine girls. Mean age was 5.9 years (range 11 months-14 years). Mean endoscopy time was 5.3 min. and of duration of general anesthesia 13.6 min. No serious complications such as perforation or bleeding were recorded. All the biopsies that were taken were considered representative. In coeliac disease the method is time-sparing, less harmful to the children, provides representative biopsies and gives fewer complications.
OBJECTIVE: Gastro-oesophageal reflux disease (GORD) is a recurring condition with many patients requiring long-term maintenance therapy. Therefore initial choice of treatment has long-term cost implications. The aim was to compare the costs and effectiveness of treatment of GORD the (unconfirmed by endoscopy) with seven proton pump inhibitors (PPIs: esomeprazole, lansoprazole (capsules and oro-dispersible tablets), omeprazole (generic and branded), pantoprazole and rabeprazole), over one year. DESIGN AND METHODS: A treatment model was developed of 13 interconnected Markov models incorporating acute treatment of symptoms, long-term therapy and subsequent decisions to undertake endoscopy to confirm diagnosis. Patients were allowed to stop treatment or to receive maintenance treatment either continuously or on-demand depending on response to therapy. Long-term dosing schedule (high dose or step-down dose) was based on current market data. Efficacy of treatments was based on clinical trials and follow-up studies, while resource use patterns were determined by a panel of physicians. MAIN OUTCOME MEASURES: The model predicts total expected annual costs, number of symptom-free days and quality-adjusted life-years (QALY). RESULTS: Generic omeprazole and rabeprazole dominated (i.e. cost less and resulted in more symptom-free days and higher QALY gains) the other PPIs. Rabeprazole had a favourable cost-effectiveness ratio of 3.42 pounds per symptom-free day and 8308 pounds/quality-adjusted life-year gained when compared with generic omeprazole. Rabeprazole remained cost-effective independent of choice of maintenance treatment (i.e. proportion of patients remaining on continuous treatment versus on-demand treatment). CONCLUSIONS: Economic models provide a useful framework to evaluate PPIs in realistic clinical scenarios. Our findings show that rabeprazole is cost-effective for the treatment of GORD.
Seventeen patients who were diabetics developed frozen shoulders which failed to respond to conservative management. They had persistent pain, stiffness, and limited function. An arthroscopic release was performed by progressively releasing the anterior structures from superior to inferior. Starting from the interval area we progressed to the anterior superior glenohumeral ligament, the intra-articular portion of the subscapularis, the anterior capsule, and the inferior capsule. Postoperatively physiotherapy was carried out daily to maintain the range of movement. At a follow up of 1 to 5 years the patients were assessed using the American Shoulder Society scheme. In addition the patients were assessed preoperatively and postoperatively on four criteria; pain, external rotation, abduction, and function. We found that the patients were statistically significantly improved in all four categories. Thirteen of the 17 patients had no pain, full range of motion compared with the opposite side, and full function. There was one poor result with no improvement. The remaining three patients had improved but still had residual abnormalities. We consider arthroscopic release to be an effective treatment for the resistant diabetic frozen shoulder.
Most physicians recognize that the ingestion of lye is associated with severe esophageal damage. It is much less widely known that gastric injury is the predominant finding when acid is ingested. We are reporting on five patients who had severe gastric damage after ingestion of diluted sulfuric acid (three cases), capsules of potassium hydroxide, and Clinitest tablets (one case each). Fiberoptic endoscopy was used to localize the extent and severity of injury and to follow the evolution of the damage. The extent and location of injury varied with the amount and type of agent ingested. Acid ingestion resulted in severe gastritis, which eventually led to antral stenosis and gastric outlet obstruction requiring operative intervention in two cases. Potassium hydroxide capsules produced diffuse esophagitis, gastritis, and a non-healing large gastric ulcer. Clinitest tablets produced distal esophagitis and stricture and antral damage leading to gastric outlet obstruction which required operative intervention. These cases demonstrate the natural history of corrosive injury to the stomach and the value of fiberoptic endoscopy in the management of this problem.
Omeprazole, a potent inhibitor of acid secretion, is effective in adults with severe gastroesophageal reflux, but no such data are available on children. We studied 15 children in whom treatment with histamine (type 2) blockers and prokinetic agents had failed; 4 had also had one or more fundoplications. Their ages were 0.8 to 17 years (mean, 8.1 years) and weights were 7.5 to 30.7 kg (mean, 18.6 kg). Of the 15 children, 8 were neurologically handicapped. All patients had endoscopic and histologic evidence of esophagitis; most had esophagitis grade 3 to 4. Patients were initially given omeprazole at 10 to 20 mg; the dose was titrated upward until results of a subsequent 24-hour intraesophageal pH study was normal. Symptoms and signs abated and evidence of esophagitis diminished in all patients. Omeprazole was given for periods of 5.5 to 26 months (mean, 12.2 months). The effective total dose was 20 to 40 mg (0.7 to 3.3 mg/kg) in 11 patients, 10 mg (0.7 mg/kg) in 1 patient, and 60 mg (1.9 to 2.4 mg/kg) in 3 patients. The dosage range was 0.7 to 3.3 to mg/kg per day (mean, 1.9 mg/kg). Mildly elevated transaminase values in 7 patients and elevated fasting gastrin levels in 11 patients were present; in 6 of the 11, gastrin levels were 3 to 5.5 times the upper limit of normal. We found omeprazole to be highly effective in this group of patients with severe esophagitis refractory to other measures. We recommend a starting dose of 0.7 mg/kg as a single morning dose; the adequacy of reflux control is then determined by follow-up 24-hour intraesophageal pH studies. Omeprazole appears to be safe for short-term use, but further studies are needed to assess long-term safety because the significance of chronically elevated gastrin levels in children is unknown.
We investigated possible differences in the rates of mucosal protein synthesis between the proximal and distal regions of the small intestine. We took advantage of access to the gut mucosa available in otherwise healthy patients with ileostomy in whom the terminal ileum was histologically normal. All subjects received primed, continuous intravenous infusions of L-[1-(13)C]leucine after an overnight fast. After 4 h of tracer infusion, jejunal biopsies were obtained using a Crosby-Kugler capsule introduced orally; ileal biopsies were obtained via endoscopy via the ileostomy. Protein synthesis was calculated from protein labeling relative to intracellular leucine enrichment obtained by appropriate mass spectrometric measurements. Rates of jejunal and ileal mucosal protein synthesis were significantly different (P < 0.001) at 2.14 +/- 0.2 and 1.2 +/- 0.2 %/h (means +/- SD). These are lower than rates in normal healthy duodenum (2.53 +/- 0.25 %/h), suggesting a gradation of rates of synthesis along the bowel. Together with other data, these results suggest that mucosae of the bowel contribute not more than 10% to whole body protein turnover.
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The mortality rate in esophageal cancer among male and female is about 7.7 and 2.0, respectively, totaling 4.8 per 100,000 in Japan. This rate is higher in elderly patients over 60 years of age. The progress in esophageal cancer treatment reveals that until 1924, the operative mortality rate was 95% and even in 1932, the rate was still 50%, making this disease difficult to defeat. However, through Nakayama's improvements in operative procedures by Nakayama in 1948, the mortality rate dropped to below 10%. Recent treatment results in Japan show a resectability rate of 56.2%, operative mortality rate of 8.0% and relative 5-year survival rate of 22%. This is due to the fact that the cases were mainly of advanced cancers. For improvement in the treatment results, the detection of early cancer is vital, and practical collaboration on the part of the patient is most important. Besides x-ray and endoscopy, as methods of diagnosis, there is the capsulated brushing cytology and benefit of application of method is highly expected. As factors affecting the operative followed-up results, particularly vascular invasion and existence of lymph node metastasis can be considered and it is desirable that a treatment method with a firm grasp on the degree of advancement in these factors be applied.