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The objective of the study was to evaluate the phosphate-binding efficacy, side effects, and cost of therapy of calcium ketoglutarate granulate as compared with calcium carbonate tablets in patients on chronic hemodialysis. The study design used was a randomized, crossover open trial, and the main outcome measurements were plasma ionized calcium levels, plasma phosphate levels, plasma intact parathyroid hormone (PTH) levels, requirements for supplemental aluminum-aminoacetate therapy, patient tolerance, and cost of therapy. Nineteen patients on chronic hemodialysis were treated with a dialysate calcium concentration of 1.25 mmol/L and a fixed alfacalcidol dose for at least 2 months. All had previously tolerated therapy with calcium carbonate. Of the 19 patients included, 10 completed both treatment arms. After 12 weeks of therapy, the mean (+/-SEM) plasma ionized calcium level was significantly lower in the ketoglutarate arm compared with the calcium carbonate arm (4.8+/-0.1 mg/dL v 5.2+/-0.1 mg/dL; P = 0.004), whereas the mean plasma phosphate (4.5+/-0.3 mg/dL v 5.1+/-0.1 mg/dL) and PTH levels (266+/-125 pg/mL v 301+/-148 pg/mL) did not differ significantly between the two treatment arms. Supplemental aluminum-aminoacetate was not required during calcium ketoglutarate treatment, while two patients needed this supplement when treated with calcium carbonate. Five of 17 (29%) patients were withdrawn from calcium ketoglutarate therapy within 1 to 2 weeks due to intolerance (anorexia, vomiting, diarrhea, general uneasiness), whereas the remaining 12 patients did not experience any side effects at all. The five patients with calcium ketoglutarate intolerance all had pre-existing gastrointestinal symptoms; four of them had received treatment with cimetidine or omeprazol before inclusion into the study. Calculations based on median doses after 12 weeks showed that the cost of the therapy in Denmark was 10 times higher for calcium ketoglutarate compared with calcium carbonate (US$6.00/d v US$0.65/d). Calcium ketoglutarate may be an effective and safe alternative to treatment with aluminum-containing phosphate binders in patients on hemodialysis who are intolerant of calcium carbonate or acetate because of hypercalcemia. However, care must be exercised when dealing with patients with pre-existing gastrointestinal discomfort. Due to the high cost of the therapy, calcium ketoglutarate should be used only for selected patients.
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PMID:Randomized crossover study comparing the phosphate-binding efficacy of calcium ketoglutarate versus calcium carbonate in patients on chronic hemodialysis. 946 96

The toxicity and outcome after high-dose ara-C/daunorubicin (HDara-C/DNR) consolidation therapy in de novo AML was compared in 11 patients who received an idarubicin-containing induction therapy (IDA; from June 1995 to March 1997) and 16 patients pretreated with daunorubicin (DNR; from July 1990 to May 1995) for induction. The DNR group consisted of two cohorts, one (n = 6) of patients who had received, as had the IDA group, two induction and one intermediate-dose ara-C consolidation courses, and another (n = 10) of patients who had been pretreated with one induction and one consolidation course prior to HDara-C/DNR. There was no difference in the relative dose between the three cohorts. Following HDara-C/DNR, the IDA-pretreated patients experienced a more prolonged myelosuppression during consolidation therapy compared with the DNR group. Duration of neutropenia (< 500 neutrophils/microl) following HDara-C/DNR was 31.2 +/- 16 days (mean +/- SEM) in the IDA group compared with 18.7 +/- 5 days in the DNR group (p < .001 Mann-Whitney U-test). The duration 'of thrombocytopenia (platelets < 25000/microl) was 34.8 +/- 20 days in the IDA group vs. 18.5 +/- 6 days in the DNR group (p < .005). The more prolonged myelosupression was associated with a longer duration of fever (18.9 +/- 24 vs. 6.9 +/- 5.2 days). A greater incidence, length (11 +/- 8 vs. 1.2 +/- 2 days), and severity of diarrhea were observed in the IDA-pretreated group. Three of 11 IDA patients experienced WHO grade III-IV diarrhea. In the IDA group two patients developed severe enterocolitis with Candida septicemia, and one of these patients died. One patient in the IDA group died during prolonged aplasia. In the DNR group 6/16 patients experienced grade I-II diarrhea. Two patients in each group died during consolidation therapy. The CR rate was 87% in the IDA group and 79% in the DNR group. Relapse-free survival after HDara-C is 50% at a median follow-up of 60 months in the DNR group and 45% after a median follow-up of 17 months in the IDA group. Whether the advantage of the superior response rate in the IDA-treated patients may be lost during HDara-C consolidation treatment due to increased toxicity remains to be proven in larger trials.
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PMID:Comparison of toxicity and outcome in patients with acute myeloid leukemia treated with high-dose cytosine arabinoside consolidation after induction with a regimen containing idarubicin or daunorubicin. 961 32

To compare the clinical outcome of treatment of cholera in children with ampicillin, erythromycin or tetracycline, a double-'blind' randomized four-cell trial was carried out in Bangladesh. Ampicillin was chosen as additional therapy for acute respiratory tract infection, present in many subjects with diarrhoea. One hundred and eighty-four children aged 1-5 years who were not wasted, with diarrhoea of duration < 48 h, signs of some or severe dehydration, dark-field stool microscopy demonstrating Vibrio cholerae, and a baseline purging rate > 4 mL/kg/h over 6 h were enrolled in the study. Ampicillin, tetracycline, erythromycin or placebo were given orally every 6 h for 3 d. After 3 d of antibiotic treatment, diarrhoeal stool volume was significantly reduced in all antibiotic groups, with mean volumes per kg body weight as follows: tetracycline, 318 mL (SEM = 50), ampicillin, 335 mL (SEM = 30); erythromycin, 323 mL (SEM = 25); placebo, 498 mL (SEM = 37). Compared to tetracycline, the clinical recovery rates by 96 h were 75% with placebo, 91.3% with ampicillin, and 95.7% with eythromycin. Compared to tetracycline, the total mean times to recovery were increased by 66% with placebo (P < 0.001), 25% with ampicillin (P < 0.017), and 9% with erythromycin (P = 0.37). These results indicated comparable clinical efficacy of tetracycline, ampicillin and erythromycin. We therefore recommend that, unless V. cholerae is resistant, ampicillin should be used as a cost-effective alternative to erythromycin for paediatric cholera, especially in children with concomitant acute respiratory infection.
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PMID:A randomized clinical trial to compare the efficacy of erythromycin, ampicillin and tetracycline for the treatment of cholera in children. 985 Apr 10

Acromegaly is a disorder caused by excessive secretion of human growth hormone (GH). Somatostatin and its analogue-prolonged release formulation, lanreotide (Somatuline PR), inhibit the secretion of growth hormone. The aim of this open Phase III study was to investigate the clinical efficacy of lanreotide in the treatment of six acromegalic patients with a mean age of 44 +/- 13 yr including two patients with diabetes mellitus. All the patients previously received transsphenoidal or transcranial hypophysectomy. Lanreotide was given intramuscularly every 2 weeks at a fixed dose of 30 mg for 12 weeks. Serum GH and insulin-like growth factor-I (IGF-I) levels were evaluated before, 2, 6 and 12 weeks after treatment. After 12 weeks of treatment, mean (+/- SEM) GH levels decreased from 24.8 +/- 12.5 to 6.9 +/- 3.3 ng/ml and mean serum IGF-I levels decreased from 689 +/- 282 to 430 +/- 216 ng/ml. Abdominal ultrasonographic examinations showed no gallbladder stone or bile sand formation before or after the treatment. Three of the patients who did not receive octreotide presented with manifestations of mild gastrointestinal adverse effect such as mild abdominal pain and diarrhea. In conclusion, lanreotide is effective in the treatment of active postoperative acromegaly.
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PMID:An open, phase III study of lanreotide (Somatuline PR) in the treatment of acromegaly. 1042 87

Among the poor in developing countries, up to 20% of an infant's life experience may include diarrhea. This problem is spatially related to the lack of potable water at different sites. This project used risk analysis (RA) methods and geographic information system (GIS) technologies to evaluate the health impact of water source. Maps of Imo State, Nigeria were converted into digital form using ARC/INFO GIS software, and the resulting coverages included geology, hydrology, towns, and villages. A total of 11,537 diarrheal cases were reported. Thirty-nine water sources were evaluated. A computer modeling approach called probabilistic layer analysis (PLA) spatially displayed the water source at layers of geology, hydrology, population, environmental pollution, and electricity according to a color-coded five-point ranking. The water sources were categorized into A, B, and C based on the cumulative scores < 10 for A, 10-19 for B, and > 19 for C. T-test showed revealed significant differences in diarrheal disease incidence between categories A, B, and C with mean +/- SEM values of 1.612 +/- 0.325, 6.257 +/- 0.408, and 15.608 +/- 2.151, respectively. The differences were significant between categories A and B (P = 0.0000022), A and C (P = 0.0000188), and B and C (P = 0.0011348). The PLA enabled estimation of the probability of the risk of diarrheal diseases occurring at each layer and solutions to eliminate these risks.
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PMID:Application of risk analysis and geographic information system technologies to the prevention of diarrheal diseases in Nigeria. 1049 70

Somatostatin analogs have been shown to be effective for the treatment of TSH-secreting pituitary adenomas. However, their use in this indication is limited by the fact that available analogs require several daily sc injections. The present study was performed to evaluate the effects of a slow release formulation of the somatostatin analog lanreotide (SR-L) on both hormone secretion and tumor size and to assess the tolerance in a series of thyrotropinomas treated for 6 months. Eighteen patients with hyperthyroidism related to a TSH-secreting pituitary adenoma, evidenced by pituitary magnetic resonance imaging, were studied. After a basal assessment, each patient received 30 mg SR-L, im, every 14 days for 1 month. Then, according to the free T3 (fT3) plasma level measured, 9 of 18 patients were injected twice monthly, and 7 of 18 patients received SR-L every 10 days for 5 additional months. One patient was dismissed from the study in month 1 of the study for side-effects and another in month 3 for noncompliance to the protocol. Clinical and biological evaluations (plasma TSH, free alpha-subunit, fT4, fT3, and lanreotide levels) were performed before and in months 1, 3, and 6 of treatment. Pituitary magnetic resonance imaging and gallbladder ultrasonography were performed both at entry and at the end of the study. Clinical signs of hyperthyroidism improved within 1 month in all 16 evaluable patients. Mean (+/- SEM) plasma lanreotide levels reached 1.11 +/- 0.43 and 1.69 +/- 0.65 ng/mL in month 3 using 2 and 3 injections/month, respectively, then remained stable until the end of the study. During therapy, the plasma TSH level decreased from 2.72 +/- 0.32 to 1.89 +/-0.27 mU/L (P < 0.01), with parallel significant changes in free alpha-subunit. During the same period, plasma fT4 and fT3 levels decreased from 37.9 +/- 2.9 to 19.7 +/- 2.3 pmol/L (P < 0.01) and from 14.6 +/- 1.1 to 8.3 +/- 0.8 pmol/L (P < 0.01), respectively. No statistically significant change in mean adenoma size was observed after 6 months of treatment. Side-effects, including pain at the injection point, abdominal cramps, and diarrhea, were mild and transient and did not lead to interruption of the treatment. No gallstones occurred during the study. SR-L appears to be able to suppress clinical signs of hyperthyroidism in our series of patients with TSH-secreting pituitary adenomas. The analog also reduces plasma TSH and thyroid hormone levels, which were normalized in 13 of 16 cases. The effect was maintained throughout the treatment using 2 or 3 SR-L injections monthly without any problem of tolerance. We conclude that SR-L is a safe and effective treatment of thyrotropinomas and avoids the drawbacks of the modes of administration of other somatostatin analogs, given three times daily.
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PMID:Evaluation of the treatment of thyrotropin-secreting pituitary adenomas with a slow release formulation of the somatostatin analog lanreotide. 1077 Jan 86

A gastric restrictive procedure is usually performed simultaneous with takedown of a jejunoileal bypass (JIB) to prevent weight regain. However, the preferred gastric restrictive procedure has not been established. Currently, we combine JIB takedown with silastic ring vertical gastroplasty (SRVG), and report our experience with 36 patients treated over a 5-year period. Indications for JIB takedown were diarrhea (69%), arthralgias (53%), liver disease (34%), nephrolithiasis (25%), and increasing weight (33%). Mean weight at the time of JIB takedown was 232+/-12 (SEM) lb (105 +/- 5 kg) (77 +/- 8% EBW (excess body weight)). Follow-up was complete in 33 (92%) patients. Post-reversal weight was 202 +/- 14 lb (92 +/- 6 kg) (55 +/- 8% EBW) at 1 year and 218 +/- 12 lb (99 +/- 5 kg) (67 +/- 8% EBW) (not significant) at a mean follow-up of 2.9 years. Twenty-one (64%) patients lost weight or were stable (+/-% EBW), while 12 (36%) gained a mean of 39 +/- 7 lb (18 +/- 3 kg) (range 16-80 lb (7 +/- 36 kg)). Resolution of preoperative complaints was noted in all patients with diarrhea and 53% with migratory arthralgias. Major early postoperative morbidity occurred in 11%, with no mortality. We conclude that SRVG is a safe and effective procedure to combine with JIB takedown.
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PMID:Conversion of Jejunoileal Bypass to Silastic Ring Vertical Gastroplasty. 1077 36

Conventional milk feeding for calves (by bucket twice daily at a total of 10% of body weight) was compared with feeding milk for ad libitum consumption from a nipple. Calves were weaned gradually between d 37 and 42 by diluting the milk with water, and body weight and feed consumption were followed until d 63. Calves fed ad libitum drank 89% more milk than calves fed conventionally during the preweaning period, but the ad libitum-fed calves ate only 16% as much calf starter and 17% as much hay. Consumption of starter and hay increased rapidly after weaning, and treatment differences disappeared. Probably as a result of the much higher intake of milk, the ad libitum-fed calves gained 63% more weight than the conventionally fed calves before weaning, resulting in a 10.5-kg weight advantage on d 35. During and immediately after weaning, the rate of weight gain slowed for both treatment groups, but recovered by approximaely d 49. There were no treatment differences in weight gains over the weaning or postweaning periods, and at the end of the experiment on d 63, the calves fed ad libitum maintained an advantage in mean (+/- SEM) body weight (89.07 +/- 2.47 kg vs 81.07 +/- 2.47 kg for the conventionally fed calves). Incidence of diarrhea was low and did not differ between treatment groups. We conclude that ad libitum nipple feeding of milk to dairy calves can allow for increased milk intake and weight gain with no detrimental effects on intake of solid food after weaning.
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PMID:Effects of ad libitum milk intake on dairy calves. 1248 71

Acorus calamus Linn. (Araceae) is a native of Central Asia and Eastern Europe and has widespread use in the traditional system of medicine for gastrointestinal disorders such as colic pain and diarrhoea. This study was aimed at providing a possible pharmacological basis to the use of this plant as an antispasmodic and antidiarrhoeal. In the isolated rabbit jejunum preparation the crude extract (Ac.Cr), which tested positive for the presence of alkaloid, saponins and tannins, caused inhibition of spontaneous and high K(+) (80 mm)-induced contractions, with respective EC(50) values of 0.42 +/- 0.06 and 0.13 +/- 0.04 mg/mL (mean +/- SEM; n = 6-8), thus showing spasmolytic activity, mediated possibly through calcium channel blockade (CCB). The CCB activity was confirmed when pre-treatment of the tissue with Ac.Cr (0.3-1.0 mg/mL) caused a rightward shift in the Ca(++) dose-response curves similar to that caused by verapamil, a standard calcium channel blocker. Activity-directed fractionation revealed that the CCB activity was concentrated in the n-hexane fraction while the ethylacetate fraction was less potent. These results suggest that the spasmolytic effect of the plant extract is mediated through the presence of CCB-like constituent(s) which is concentrated in the n-hexane fraction and this study provides a strong mechanistic base for its traditional use in gastrointestinal disorders such as colic pain and diarrhoea.
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PMID:Antispasmodic effect of Acorus calamus Linn. is mediated through calcium channel blockade. 1700 6

An experiment was conducted to determine whether adding oat hulls to weaner pig diets based on extruded rice or unprocessed wheat influenced post-weaning diarrhoea (PWD) and protein fermentation in the large intestine. Ninety-six male piglets (5.16 (SEM 0.08) kg) were allocated to (i) extruded rice plus animal proteins (RAP); (ii) RAP with added oat hulls (20 g/kg); (iii) wheat plus animal proteins (WAP); (iv) WAP with added oat hulls (20 g/kg). Blood and faecal samples were collected on days 7 and 14 after weaning at about age 21 d. Pigs fed RAP had more PWD than pigs fed WAP (P < 0.05). Oat hull supplementation to diet RAP decreased the incidence of PWD (P < 0.05). The total-tract digestibility of DM, starch and energy was higher in rice-based diets than in wheat-based diets (P < 0.001); however, oat hulls decreased digestibility of DM and gross energy (P < 0.001). Pigs fed RAP had higher plasma creatinine concentrations (P < 0.01), which were positively correlated to cumulative beta-haemolytic Escherichia coli scores after weaning (R2 0.928; P = 0.015). Addition of oat hulls decreased plasma urea concentrations only in pigs fed RAP (interaction; P < 0.05). Pigs fed RAP had lower faecal total biogenic amine concentrations than pigs fed WAP (P < 0.001). Oat hull supplementation tended to decrease total biogenic amine concentrations (P = 0.103). These data indirectly suggest that a mostly insoluble dietary fibre source such as oat hulls can decrease PWD in dietary situations where there may be a misbalance of carbohydrate to protein entering the hindgut.
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PMID:Addition of oat hulls to an extruded rice-based diet for weaner pigs ameliorates the incidence of diarrhoea and reduces indices of protein fermentation in the gastrointestinal tract. 1804 8


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