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PubMed1980

The relationship between active peptic ulcer, endoscopic duodenitis and symptomatic state after treatment with cimetidine.

Fifty patients with active peptic ulcers on endoscopy were randomly allocated for treatment with placebo or cimetidine (1.0 g daily) over a period of four weeks. All patients had free access to antacids to relieve epigastric pain. In the cimetidine group a significantly higher proportion of the ulcers had healed (82.6% of the patients) compared with the placebo group (48.0%). There was poor correlation between the healing of the ulcer and dyspeptic symptoms in the placebo group. The results suggest that the presence of endoscopic duodenitis is to a great extent responsible for the dyspepsia. Cimetidine treatment, besides healing the ulcers, also improved the endoscopic duodenitis and the symptomatic state more than placebo treatment. No significant clinical side effects were observed. Chemical abnormalities were only noted with respect to serum creatinine. In the cimetidine group there was a statistically significant rise in serum creatinine, which was most apparent after two weeks of treatment. However, the increase was slight and not significant among the males, whereas in the case of the females there was a large and highly significant rise. The reason for this sex difference is at present unknown.

Adolescent↗

PubMed1986

A strategy to increase appointment keeping in a pediatric clinic.

This paper reports the results of two related studies. The first, a prospective study, investigated the relationship between appointment keeping at a pediatric clinic and parents' self-perceived time utilization skills as measured by a subscale of Wessman's Temporal Experience Questionnaire (TEQ). Using a logistic regression analysis to adjust for the effect of telephone reminders, low scorers on the time utilization subscale were twice as likely as high scorers to miss their appointments. The second study was a test of the value of using knowledge of parents' subjective time perspectives as part of a strategy to increase appointment keeping. The goal of this study was to achieve equivalent missed appointment rates between high and low scorers on the TEQ. Parents attending the clinic were asked to complete the questionnaire, and they were then stratified into two groups. High scorers, those who initially had a low probability of missing appointments, received a single reminder. Low scorers, those who initially had a high probability of missing appointments, received two reminders. Two alternate forms of reminders were randomly allocated within each scoring strata. Equivalent missed appointment rates were observed between parents who scored low and those who scored high on the TEQ. The study also investigated two other questions. Information on the importance of the visit had no effect. Postcard reminders were as effective as telephone reminders and were more cost efficient.

Adult↗

PubMed1987

A comparison of labetalol plus hospitalization versus hospitalization alone in the management of preeclampsia remote from term.

Two hundred primigravid women with mild preeclampsia at 26-35 weeks' gestation were randomly allocated to treatment with hospitalization alone or combined with labetalol. There were no differences between the two groups in mean systolic or diastolic pressures, mean gestational age, or initial laboratory findings at time of entry. Patients in the labetalol group demonstrated a statistically significant (P less than .005) decrease in blood pressure during treatment. No such decrease occurred in the hospitalization-alone group. Both groups exhibited significant deterioration in proteinuria, creatinine, and uric acid. The average days of pregnancy prolongation (mean +/- SD) were 21.3 +/- 13 and 20.1 +/- 14 days in the hospitalization and labetalol groups, respectively. There were no differences between the groups regarding any of the following: gestational age at delivery, birth weight, number of infants admitted to the special care unit, or cord blood gas measurements. However, the incidence of small-for-gestational-age infants was significantly higher in the labetalol group (19 versus 9%, P less than .05). There were no stillbirths, but one neonatal death in the labetalol group. Treatment of maternal blood pressure in preeclamptic pregnancies with labetalol did not improve perinatal outcome, and was associated with a higher frequency of fetal growth retardation.

Adult↗

PubMed1981

Filtration versus gravity leukapheresis in febrile granulocytopenic patients: a randomized prospective trial.

Forty-eight patients with fever greater than 38.3 degrees C for at least 24 hr despite broad spectrum antibiotics and an absolute granulocyte count less than 1000/microliter were randomly allocated to 4 days of granulocyte transfusions obtained by leukapheresis using filtration (n = 27) or gravity (n = 21) techniques, the latter permitting simultaneous nonmechanical collection of granulocytes and platelets utilizing hydroxyethyl starch as a sedimenting agent. Patient characteristics and dose of granulocytes obtained from both techniques were similar. Complete response to granulocyte transfusions was established by a reduction in temperature to less than 37.2 degrees C sustained for at least 48 hr after the fourth transfusion with sterilization of cultures where previously positive and diminution of measurable infection when present. This occurred in 6/21 (29%) for gravity leukapheresis and 9/27 (33%) for filtration leukapheresis. An additional group had diminution in temperature and clinical improvement during transfusions (6/21 gravity leukapheresis versus 10/27 filtration leukapheresis). Eighty-six percent of patients transfused with gravity leukapheresis cells were alive at day 20 compared with 81% for filtration leukapheresis cells. Transfusion reactions were comparable. Thus, gravity leukapheresis appears to be as efficacious as filtration leukapheresis for treating granulocytopenic febrile patients, with the added advantages of availability to any blood bank without new equipment, of having platelets as by-products, and of not requiring donor heparinization.

Adolescent↗

PubMed1981

Effect of synthetic and natural secretin on the function of the exocrine pancreas in man.

The action of synthetic and natural secretin on the human exocrine pancreas was compared. The trial was an intrasubject crossover comparison with randomized allocation of compounds in 12 healthy male subjects. No significant difference between compounds was found in bicarbonate, amylase and trypsin secretion after bolus injection. However, synthetic secretin evoked a significantly greater volume and amount of bicarbonate after infusion than the natural compound whilst no difference resulted in the other variables. It is concluded that synthetic secretin is suitable for testing the function of the exocrine pancreas.

Adult↗

PubMed1982

Streptokinase of heparin in the treatment of deep vein thrombosis. Follow-up results of a prospective study.

In a previous study on 42 patients with acute deep vein thrombosis, randomly allocated to treatment with streptokinase or heparin, we found that 71.4% of the streptokinase-treated patients achieved phlebographically significant thrombolysis as compared to 23.8% in the heparin group. These patients have been reevaluated after a mean observation period of 6 1/2 years. Seven patients had died and there were no other drop-outs. Thus, 35 patients were subjected to the follow-up study consisting of phlebography and clinical examination. The evaluations were performed without knowledge of the initial therapy. Seven patients had phlebographically normal veins, and all belonged to the streptokinase group. This difference between the treatment groups is statistically highly significant (p less than 0.01). At clinical examination, 13 of the 17 patients in the streptokinase group had normal legs and 4 exhibited moderate postthrombotic changes. In contrast, 3 of the heparin-treated patients showed serious postthrombotic changes with open leg ulcers, and only 6 of 18 patients in this group had normal legs. The present results strongly support the assumption that streptokinase therapy is the best treatment at present in patients with acute deep vein thrombosis. This has been shown for the initial thrombolysis, and now also for the avoidance of late postthrombotic changes.

Adult↗

PubMed1992

Anaesthesia for myocardial revascularisation. A comparison of fentanyl/propofol with fentanyl/enflurane.

We studied the effects on myocardial performance and metabolism of fentanyl/propofol and fentanyl/enflurane anaesthesia in 20 patients before coronary artery bypass grafting. Anaesthesia was induced with fentanyl 20 micrograms.kg-1 and pancuronium 0.15 mg.kg-1. Patients received, by random allocation, either propofol by infusion, 6 mg.kg-1.h-1 reduced by half after 10 min then adjusted as necessary (mean rate 2.8 mg.kg-1.h-1), or enflurane 0.8% inspired concentration for 10 min reduced to 0.6% and adjusted as required (mean 0.7%). Measurements were made before induction, after tracheal intubation, after skin incision and after sternotomy. There were no significant differences between the groups in any haemodynamic variables during the study. Following intubation both groups showed a rise in heart rate (p < 0.01) and cardiac index (p < 0.05). Systemic vascular resistance decreased after intubation (p < 0.05) then returned to baseline during surgery; stroke index was unchanged after intubation but was reduced during surgery (p < 0.01) as systemic vascular resistance increased. Regional and global coronary blood flow were maintained in both groups, as were myocardial oxygen consumption and lactate extraction ratio. However, lactate production did occur in one patient receiving enflurane and Holter monitoring confirmed ischaemia. One patient receiving propofol showed lactate production not accompanied by any ECG changes. This study suggests that propofol may be a suitable alternative to enflurane as an adjunct to opioids in anaesthesia for coronary artery bypass grafting.

Anesthesia, Inhalation↗

PubMed1989

Four-times-a-day dosing frequency is better than a twice-a-day regimen in subjects requiring a high-dose inhaled steroid, budesonide, to control moderate to severe asthma.

Fifty-three adult asthmatic subjects requiring 800 micrograms or more of inhaled beclomethasone dipropionate were enrolled in a double-blind parallel group study of 6-month duration to compare the efficacy and side effects of inhaled budesonide in doses of 800, 1,200, and 1,600 micrograms given two or four times a day (BID or QID). After a two-week observation period to establish baseline, subjects were given the same dose of budesonide as they would be for beclomethasone dipropionate; however, the frequency regimen (BID or QID) was randomly allocated. Subjects were asked to fill in diary cards describing their asthmatic symptoms, need for medication, and throat symptoms. They were assessed by a physician every 4 wk, at which time spirometry was performed. Throat swabs were done at every other monthly visit. Cortisol and response to cortisol after synthetic ACTH injection were assessed at the beginning and end of the trial. Thirty-six subjects, half in each group, completed the study. Those on the BID regimen had almost twice as many days with nocturnal asthma and cough and almost three times as many days with disability due to asthma. There were also twice as many relapses in the BID regimen as judged by the clinician. These relapses mainly occurred toward the end of the study. The maximal daily swings in peak expiratory flow rates were slightly greater in the BID group, although this difference was not physiologically significant. Spirometry, cortisol secretion, and the response after synthetic ACTH injection were not significantly different in either group from the beginning to the end of the study.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗

PubMed1989

Oral versus local treatment of vaginal candidosis.

A comparative study was conducted to compare the results of the use of oral and local vaginal therapy in the treatment of vaginal candidosis. Forty-five patients with clinical and mycological evidence of vaginal candidosis were recruited and were randomly allocated to one of the treatment groups. Twenty-four patients received ketoconazole orally (400 mg/day for 5 days) and 21 patients received nystatin vaginal pessaries (100,000 units twice/day for 7 days). Seven out of 20 rectal swabs (35%) were positive for Candida albicans. Both drugs were significantly effective in relieving patients symptoms and physical signs. The mycological cure rates were 87.5% and 81%, and the relapsing rates were 0% and 5.9% for the ketoconazole and nystatin groups, respectively. Ketoconazole oral therapy had generally slightly higher results than local nystatin therapy in the treatment of vaginal candidosis, yet the difference was statistically insignificant.

Administration, Oral↗

PubMed1988

Comparison of betaxolol with verapamil in hypertensive patients: discrepancy between office and ambulatory blood pressures.

The purpose of this study was to compare in the individual hypertensive patient the blood pressure lowering effect of a beta-blocking agent i.e. betaxolol with that of a calcium entry blocker, i.e. verapamil. The antihypertensive efficacy of the drugs was evaluated both at the physician's office and by monitoring ambulatory daytime blood pressure using a portable blood pressure recorder (Remler M2000). Seventeen patients with uncomplicated essential hypertension (aged 35-67 years) were treated for two consecutive 6-week periods with either betaxolol, 20 mg/day or a slow-release formulation of verapamil, 240-480 mg/day. The sequence of treatment phases was randomly allocated and a 2-week wash-out period preceded each treatment. Both betaxolol and verapamil had a significant blood pressure lowering effect when assessed at the physician's office. However, ambulatory recorded blood pressures were significantly reduced only with betaxolol. In the presence of a physician, the best responders to betaxolol tended to be also the best responders to verapamil, whereas there was no relationship between the fall in ambulatory recorded blood pressure observed during betaxolol and the corresponding fall during verapamil administration. The blood pressure response to both betaxolol and verapamil was not related to age.

Adult↗

PubMed1987

Double-blind comparison of once-daily bopindolol and atenolol for mild-to-moderate hypertension.

In order to compare the medium term antihypertensive effectiveness and tolerability of atenolol with those of bopindolol (LT 31-200), a new non-selective beta-blocker with slight PAA (partial agonist activity), a randomized double-blind study was performed. Thirty-one outpatients with mild-to-moderate essential hypertension (WHO stage I-II) were enrolled and after a placebo run-in randomly allocated to bopindolol (1 to 4 mg/day) or atenolol (50 to 200 mg/day). The dose was titrated according to the individual pressor responses, and thereafter it was kept constant until the end of the treatment (12 weeks). Both drugs induced statistically significant decreases in SBP, DBP and HR, both in resting conditions and during an ergometric test. Accordingly, most patients achieved the main goal of the therapy, i.e., supDBP less than or equal to 90 mmHg, 11/15 (74%) with bopindolol versus 8/13 (62%) with atenolol. There were no significant differences between the effects of the two compounds. Resting airway resistance (expressed as Peak Expiratory Flow) was not influenced by the treatments. The antihypertensive efficacy was still evident after 12 months in 8 patients who were evaluated for non-comparative long-term effectiveness of bopindolol monotherapy, and improvements in plasma lipid profiles were also observed. Side effects were relatively mild and transient, with two patients in the atenolol group discontinuing therapy (one for inefficacy and one because of undesirable reactions) and one dropped out in the bopindolol group (late evidence of not fulfilling inclusion criteria).(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗

PubMed1990

The effect of intravesically applied antibiotic solution in the prophylaxis of infectious complications of renal transplantation.

The effect of intravesically applied antibiotic solution in the prevention of infectious complications of renal transplantation was evaluated in a prospective, randomized study. The bladder was filled preoperatively with saline solution containing cephalotin in the test group, and with saline solution only in the controls. Both groups of patients received IV doses of cephamandole during, and once after, surgery. Two hundred consecutive patients were randomly allocated to the study groups. The overall incidence of urinary tract infection was 10.4% during the first 4 postoperative weeks; that of wound infections was 1.6% and of septicemia 3.3%. The addition of cephalotin to the bladder irrigation fluid did not have any effect on the overall incidence of infectious complications.

Administration, Intravesical↗

PubMed1983

Prospective, randomized comparison of metronidazole and clindamycin, each with gentamicin, for the treatment of serious intra-abdominal infection.

Metronidazole (M) has potent bactericidal activity against anaerobic bacteria. This study was designed to compare its efficacy and safety when combined with gentamicin (M + G) to those of an accepted regimen, clindamycin plus gentamicin (C + G), for the treatment of intra-abdominal infection. Patients were randomly allocated to receive 500 mg of M or 600 to 800 mg of clindamycin (C) each combined with G, 1.5 mg/kg, all administered intravenously every 8 hours. Of 186 patients enrolled, 45 were excluded from analysis (22, M + G). Of the remaining 141 patients, 72 had been allocated to the M + G group. Data refer to M + G and C + G groups, respectively. Infections included abscess in 37 and 30 patients and peritonitis in 30 and 31. Appendicitis was the most common underlying disease, causing intra-abdominal infection in 21 and 22 patients, with diverticulitis occurring next most frequently, seven and 10 patients. Both anaerobic and aerobic bacteria were isolated from abdominal pus in 32 and 27 patients, anaerobes alone in seven and four, and aerobes alone in 24 and 25. In six and seven patients, pus was not cultured. Anaerobic bacteremia occurred in 10/66 and 6/64 patients from whom blood was cultured. Patients were classified as cured, improved, or treatment failures. These ratios were 60:8:4 and 58:8:3. Median trough serum concentrations of M and C were 13.0 and 3.7 micrograms/ml, respectively, and at 15 minutes after infusion, 15 and 10.7 micrograms/ml, respectively. The frequencies of rash, diarrhea, and superinfection were not different in the two treatment groups although abnormal serum tests of liver function occurred more commonly in the C+G group. M+G and C+G are not different in efficacy and acceptability for the therapy of serious intra-abdominal infections in adults.

Abdomen↗

PubMed1987

Prostaglandin E2 vaginal gel--a new formulation for the induction of labour.

In order to evaluate the efficacy of prostaglandin E2 gel in the induction of labour it was compared with a routine method of induction by oxytocin titration. A total of 50 patients were randomly allocated to two groups; 25 patients received intravaginal prostaglandin E2 gel and 25 oxytocin infusion. In both groups amniotomy was performed once the patient was in the active phase of labour. Successful outcome was regarded as established labour within 12 hours of commencement of the trial. In the oxytocin group this was achieved in 88% of multiparas and 75% of primigravidas. In the prostaglandin group the outcome was successful in 82% of multiparas and 75% of primigravidas.

Administration, Intravaginal↗

PubMed1983

A 12-month comparative trial of auranofin and D-penicillamine in rheumatoid arthritis.

The oral gold salt auranofin, 6 mg per day, was compared with oral d-penicillamine, 500 mg per day, in a single-blind trial in 40 patients suffering with definite or classic rheumatoid arthritis. The patients were randomly allocated into the two therapeutic regimens (19 patients auranofin; 21 patients d-penicillamine) and monitored at a minimum of four-week intervals during the first year of treatment. Significant diminution in rheumatoid disease activity, as assessed by numerous clinical and laboratory parameters, was observed in both the auranofin- and penicillamine-treated groups. No significant differences existed for these parameters between the two groups, either initially or at the end of the trial period. Ten patients were lost from the trial over the 52-week period. Three subjects were withdrawn from the auranofin-treated group (increasing severity of rheumatoid arthritis at four weeks; severe diarrhea at four weeks; probable drug-related erosive gastritis at 40 weeks). Seven subjects were permanently withdrawn from the penicillamine-treated group (four, skin rashes four to eight weeks; one, heavy proteinuria at 24 weeks; one, therapeutic failure at 32 weeks; one, compliance failure at eight weeks), and treatment was temporarily withheld in three further patients because of thrombocytopenia (two) and proteinuria (one). We conclude that both drugs are effective in rheumatoid arthritis and that the lesser toxicity with auranofin will make it a valuable addition to our therapeutic armamentarium.

Adult↗

PubMed1987

Bisoprolol versus hydrochlorothiazide plus amiloride in essential hypertension, a randomized double-blind study.

Beta blocker monotherapy is often considered to be inadequate in essential hypertension. It was the aim of this study to compare the antihypertensive activity of the new betablocker bisoprolol with the diuretic combination: hydrochlorothiazide plus amiloride. Forty hypertensive patients (DBP 95-120 mmHg) were enrolled in the study, of which 34 were evaluable for efficacy. The patients were, under double-blind conditions, randomly allocated to receive 10 mg bisoprolol (B) or 50 mg hydrochlorothiazide plus 5 mg amiloride (HA) as single daily doses for 30 days. Patients whose DBP had been normalized (less than or equal to 90 mmHg) after 30 days (D 30) continued the monotherapy for another 30 days. Patients whose DBP remained over 90 mmHg were, under single-blind conditions, kept on their initial treatment but received in addition the alternative drug for another 30 days (D 60). Blood pressure measurements were performed 24 hours after drug intake. The two groups comprising 17 patients each were comparable with regard to the patients' characteristics and baseline blood pressure values. After 30 days of treatment supine SBP, DBP and HR were significantly more reduced with B than with HA. The mean reduction of DBP was 16.8 +/- 8.0 mmHg with B and 8.4 +/- 6.4 mmHg with HA (P less than 0.002). After 30 days of monotherapy, blood pressure was within the normal range in 15/17 (88.2%) patients treated with B but in only 4/17 (23.5%) patients treated with HA (B vs HA: P less than 0.001). In the B group, there was a further slight decrease in SBP, DBP and HR during the second 30 day period.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗

PubMed1985

Factors affecting adenoidectomy for otitis media with effusion (glue ear).

One hundred and fifty-five children suffering bilateral otitis media with effusion (OME) and observed for three months have been followed postoperatively for twelve months. Surgery was randomly allocated into three groups: adenotonsillectomy; adenoidectomy; and no surgery. In all cases unilateral myringotomy and grommet insertion was performed. The contralateral unoperated ear was assessed subsequently for clearance of the effusion. Adenoidectomy produced resolution of the effusion in 31-45% of cases at one year, but tonsillectomy conferred no additional benefit. There was improved resolution in those with longer compared with shorter histories, and in older as opposed to younger children. Assessment of preoperative lateral cephalometric radiographs show improved resolution of the effusion following removal of larger, compared with smaller adenoids, but this effect was only demonstrable for three months. The effect of age was longer-lasting for up to one year postoperatively.

Adenoidectomy↗

PubMed1988

[Reduction using an immunomodulator of the level of respiratory infections in chronic bronchitis].

Fifty-six patients with recurrent bronchopulmonary infections associated with chronic bronchitis were randomly allocated to 2 groups, to assess whether treatment with an immunomodulator, Diribiotin CK, could enhance resistance to infection. The double-blind, placebo-controlled prospective trial over a 9 month period showed that this immunomodulator was well tolerated and significantly reduced the rate of respiratory tract infection. The drug also significantly reduced the prescribing of antibiotic medication and the rate of absenteism from work. These effects have been demonstrated in a rigorously designed clinical study. This is the first time that a clear clinical activity has been attributed to an inducer of soluble mediators of immunity.

Adjuvants, Immunologic↗