The effect of dietary glutamine and dietary RNA on ileal flora, ileal histology, and bacterial translocation in mice.
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Biomedical subjects
Publications and source records attributed to P T Lavin.
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The subjects of this multicenter study were 160 patients with endoscopically confirmed active duodenal ulcers, randomly assigned to receive 40 mg of famotidine or 300 mg of ranitidine nightly for four to eight weeks. During a subsequent six-month maintenance treatment phase, the patients received 20 mg of famotidine or 150 mg of ranitidine nightly. After eight weeks of treatment, ulcer healing was endoscopically confirmed in 94% of the 81 famotidine-treated patients and in 80% of the 79 ranitidine-treated patients (P less than 0.01). During the first week of treatment, daytime and nighttime pain scores were significantly lower in the famotidine-treated than ranitidine-treated patients. During the maintenance treatment phase, the ulcer in 79% of 58 famotidine-treated patients and in 81% of 52 ranitidine-treated patients remained healed. Multivariate analysis of factors such as age, sex, smoking, alcohol and coffee consumption, use of nonsteroidal anti-inflammatory drugs (NSAIDs), history of ulcer, and ulcer size and number showed that they had no significant effects on the differences in healing rates between the two treatment groups. The ulcers were all healed in the famotidine-treated patients whose ulcers were associated with the prior use of NSAIDs. The results of this and many other studies indicate that, unless ulcer healing is confirmed by endoscopy, treatment of active duodenal ulcers should continue for six to eight weeks.
The subjects of this multicenter study were 159 patients aged 21 to 76 years with mild to moderate uncomplicated essential hypertension. The patients were randomly assigned to receive up to 40 mg of enalapril daily or 360 mg of sustained-release diltiazem daily for a titration period of eight weeks and then maintenance doses for four weeks. The treatment goal was a supine diastolic blood pressure of less than 90 mmHg or a fall of at least 10 mmHg from baseline. During titration, 62% of the enalapril-treated patients and 51% of the diltiazem-treated patients reached the treatment goal after two weeks, 82% and 74% after four weeks, 87% and 84% after six weeks, and 92% and 87% after eight weeks. During the maintenance period, 85% of the enalapril-treated and 87% of the diltiazem-treated patients maintained the goal blood pressure. Treatment side effects were reported by 21% of the enalapril-treated patients and 29% of the diltiazem-treated patients; treatment was discontinued in two patients from each group because of side effects. It is concluded that both drugs were generally well tolerated and effective in the treatment of adult mild to moderate essential hypertension.
The study involved 113 patients over age 50 years with mild to moderate essential hypertension, randomly assigned to treatment with enalapril (n = 54) or sustained-release verapamil (n = 59). During an eight-week titration period, doses were adjusted to achieve supine diastolic blood pressures (DBP) below 90 mmHg; patients were then given maintenance doses for eight weeks. Mean blood pressures were reduced significantly from 147.7/93.9 mmHg at baseline to 137.7/84.5 mmHg at the end of the maintenance period in the enalapril group and from 155.1/95.1 to 142.4/86.2 mmHg in the verapamil group. In the patients who completed treatment, the mean daily doses required to maintain DBP below 90 mmHg were 9.6 mg of enalapril and 244.9 mg of verapamil. There were 11 treatment failures in the enalapril group and 22 in the verapamil group: eight of the enalapril and 17 of the verapamil patients did not attain goal blood pressures and three and five were withdrawn because of side effects. It is concluded that both enalapril and sustained-release verapamil were generally effective and well tolerated in the treatment of mild to moderate hypertension in the middle-aged and older patients.
In this study, 139 eligible and evaluable patients with advanced gastric cancer, measurable disease, and no prior chemotherapy were randomized between treatment with Adriamycin alone, 5-fluorouracil (5-FU) plus mitomycin C, and 5-FU plus methyl-CCNU. Objective responses were seen in eight of 37 patients (22%) receiving Adriamycin, in 17 of 53 (32%) receiving 5-FU plus mitomycin C, and in 12 of 49 (24%) receiving 5-FU plus methyl-CCNU. Median durations of response were 4, 3 1/2, and 8 1/2 months, respectively. Sixty-one patients were treated after previous failure to other chemotherapy regimens. Response rates were seen in seven of 47 patients (15%) receiving Adriamycin, in two of nine receiving 5-FU plus mitomycin C, and in one of five receiving 5-FU plus methyl-CCNU. Complete responses were observed more frequently with Adriamycin and with 5-FU plus methyl-CCNU than with 5-FU plus mitomycin C. Although 5-FU plus methyl-CCNU had a slight advantage in interval to disease progression, this was not statistically significant. Median survival for all previously untreated patients was slightly greater than 17 weeks, and there was no meaningful or significant survival difference between the three treatment groups.
The Gastrointestinal Tumor Study Group conducted a carcinoembryonic antigen standardization experiment to address the issue of reproducibility of assays performed at participating institutions and a central laboratory. Samples were drawn in quadruplicate from 37 patients, representing five participating institutions. Systematic biases were observed in four of the five institutions: two series were consistently higher and another two series were consistently lower than the corresponding central laboratory determinations. Significantly higher variations were found in three of the five series, comparing the sample variances associated with the matching assay series. Overall, the standard deviation associated with the central laboratory was one third that of the participating institutions. These results point toward the limitation of pooling multi-institutional carcinoembryonic antigen data. The use of multivariate models with parameters for institution comparison is proposed as a solution to this problem.
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The efficacy and tolerability of an enalapril maleate-hydrochlorothiazide combination (EM-HCTZ) were evaluated in a prospective, open-label study in 26 patients with uncomplicated essential hypertension (mean baseline sitting systolic/diastolic blood pressure: 153/103 mmHg) requiring two agents to reduce sitting diastolic blood pressure (SDBP) below 90 mmHg. Their mean age was 52 years. Patients received enalapril 5 mg daily, which was increased to 10 mg if SDBP was not reduced to < 90 mmHg during a 5-week titration period following washout. If blood pressure did not reach that goal, 25 mg hydrochlorothiazide was added. Only patients who required enalapril 10 mg and hydrochlorothiazide 25 mg for control (SDBP < 90 mmHg) at the end of titration received open-label EM-HCTZ as maintenance therapy for 6 weeks. The SDBP of 19 of the 26 patients (73%) who began titration was controlled at the end of titration, and they received maintenance therapy. During maintenance, the mean SDBP decreased from baseline 13.2 mmHg at week 2, 13.3 mmHg at week 4, and 10.1 mmHg at week 6. All changes from baseline were significant. At the end of the maintenance period, SDBP was controlled in 8 (42%) of 19 patients enrolled. One patient was withdrawn from the study because blood pressure was poorly controlled. Ambulatory blood pressure (ABP) was monitored, average outcome was computed for each patient during the 24-hour interval, and with a paired comparison, baseline and follow-up data were compared with the data measured manually. The mean baseline ABP was 9 mmHg lower than the baseline SDBP measured manually (r = 0.58, P = 0.01). Following treatment with EM-HCTZ, mean diastolic blood pressure fell 10 mmHg and mean systolic blood pressure fell 15 mmHg. In summary, EM-HCTZ was highly effective and generally well-tolerated in a substantial proportion of participants whose SDBP remained > 90 mmHg on enalapril 10 mg. Important differences between blood pressure measured manually and with a monitor were also demonstrated.
Seventy-one of 85 consecutive patients with endoscopically confirmed active benign gastric ulcers completed an 8-week study to evaluate the effects on healing of famotidine 40 mg given as a single dose at night. The healing rate in the 48 patients in whom the ulcers were associated with nonsteroidal anti-inflammatory drug (NSAID) or aspirin (ASA) use was compared with that in the 23 patients with idiopathic ulcers. Endoscopy, symptom assessments, antacid use, hematology, and serum chemistry were performed at weeks 4 and 8 of treatment. Famotidine 40 mg at bedtime healed 63 (89%) of the 71 ulcers at 8 weeks; the healing rate for NSAID/ASA-associated ulcers was 46 (96%) of 48, which was significantly greater than that for idiopathic ulcers (17 of 23; 74%) (P = 0.0119). Of the 54 patients who returned a questionnaire 1 to 2 years after completing the study, 20% were still taking an NSAID/ASA (mainly for cardiovascular prophylaxis). About half of the patients surveyed were taking anti-ulcer medication. None of these patients had experienced any serious ulcer complication. The results of this study suggest that differentiating NSAID/ASA-induced ulcers from idiopathic ulcers may be important with regard to healing rates and duration of therapy.