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Comparison between ranitidine 150 mg b.d. and ranitidine 300 mg nocte in the treatment of duodenal ulcer.

A multicenter trial was undertaken to assess the clinical usefulness of a single night-time dose of ranitidine in the short-term healing of duodenal ulcer. 384 patients with endoscopically diagnosed duodenal ulcer were randomly allocated to treatment with ranitidine either 150 mg b.d. or 300 mg as a single night-time dose for four weeks. The patients not healed after four weeks were again treated for four weeks. Of the 356 patients who completed the study, according to the protocol, 148 of 176 (84.1%) recovered on ranitidine 150 mg b.d. and 147 of 180 (81.7%) recovered on 300 mg nocte after four weeks. The healing rates increased to 95.8% and 94.8% respectively after four more weeks. Ulcer symptoms were rapidly reduced with no significant differences between the two treatment groups. There were no unwanted effects in either group and no significant abnormal biochemical or hematological changes. The results of this study support the hypothesis that ranitidine 300 mg given as one night-time dose and ranitidine 150 mg b.d. are equally effective. Ranitidine 300 mg once daily in a clinical practice may be advantageous to the patient.

Adult↗

Short time prophylaxis with ornidazole in elective colo-rectal surgery.

A study of 100 patients given short time prophylaxis against anaerobic infections in association with colo-rectal surgery is presented. The patients were randomly allocated into two groups receiving either ornidazole (Tiberal) or doxycycline (Vibramycin) for 3 days. Ornidazole concentrations in serum, subcutaneous fat, and intestinal wall were measured in 10 patients. No infection of anaerobic etiology was noticed in the ornidazole group, in contrast to 5 anaerobic infections in the doxycycline group. This difference is statistically significant (p less than 0.05). The pharmacokinetic results indicate that a 3-day treatment with ornidazole gives a sufficient plasma steady state concentration, while the preoperative loading dose should be given less than 24 h prior to operation. The necessity of prophylaxis against both aerobic and anaerobic infections in colo-rectal surgery is emphasized.

Adipose Tissue↗

[Total intravenous anesthesia with propofol-fentanyl. Is it necessary to supply nitrous oxide?].

Forty patients admitted for elective hemilaminectomy were randomly allocated in two groups: Group I: intravenous anaesthesia with propofol-fentanyl and Group II: Propofol-fentanyl anaesthesia with a supplement of nitrous oxide. The purpose of the study was to investigate whether this supplement involved any advantages or disadvantages for the patients. Mean arterial pressures, awakening times, complications immediately postoperatively and total doses of fentanyl showed no statistically significant differences. In group I (-N2O), the median dose of supplementation with fentanyl was significantly greater, 0.89 micrograms/kg versus 0 in group II (p less than 0.05). We conclude that total intravenous anaesthesia is preferable, because pollution of the air in the operating theatre is avoided.

Adult↗

Can normal saline be used to fill the balloon of a Foley catheter? The experience of a prospective randomized study in China.

BACKGROUND: Despite the lack of evidence, using normal saline for inflating the balloon of a Foley urethral catheter is frequently regarded as a cause for deflation failure. We have investigated the issue by comparing the rate of deflation failure of Foley catheter balloon, using either sterile water or normal saline as the filling solution. METHODS: Four thousand latex Foley urethral catheters (14 Fr) were randomly assigned to one of two groups: sterile water or normal saline. Each of the catheter balloons would then be inflated with 10 mL of the corresponding fluid. They were subsequently put in water baths at 37 degrees C for 4 weeks. At the end of 4 weeks, all the balloons were deflated by people who were blind to the assignment of fluid inflated. Failure of deflation was defined as the balloon not being able to be deflated completely. The number of deflation failures was recorded and the amount of fluid aspirated from each balloon was also noted. RESULTS: Of the 4000 catheters, 17 (0.43%) were found to be defective and could not be used for the study. The remaining 3983 catheters were randomly allocated into the sterile water (2011) and normal saline (1972) groups. The failure rate of deflation for the sterile water group and normal saline group were 185 (9.2%) and 157 (8.0%), respectively, which was not statistically significant (P = 0.162). CONCLUSION: There was no difference in the rate of deflation failure of latex Foley balloons by using either sterile water or normal saline as the filling solution.

Catheterization↗

Comparison of Bricanyl Turbuhaler and Berotec dry powder inhaler.

Terbutaline (Bricanyl) 0.5 mg t.i.d. administered via Turbuhaler was compared with fenoterol (Berotec) 0.2 mg t.i.d. administered via Inhalator Ingelheim in 36 asthmatic children aged 7-12 years. The study was of an open crossover design with two randomly allocated treatment periods, each lasting 2 weeks. Forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) were measured at clinic visits before study start and at the end of each treatment period. The patients recorded peak expiratory flow (PEF) before and after inhaler use, morning and evening. They also recorded asthma symptoms and number of extra inhalations. At the end of the study, children and parents were asked for inhaler preference. No differences between the treatments were found concerning the results of the lung function measurements at the clinic or at the PEF measurements at home. No differences were found between the treatments as regards asthma symptoms or number of extra inhalations. Two patients experienced mild side effects during fenoterol treatment, none during terbutaline treatment. Treatment with terbutaline in Turbuhaler was preferred by a majority of children and parents. In conclusion, in this group of asthmatic children, treatment with terbutaline administered via Turbuhaler was as efficacious as treatment with fenoterol administered via Inhalator Ingelheim. There was a clear preference in favour of the Turbuhaler.

Asthma↗

Ranitidine versus cimetidine in the management of acute upper gastrointestinal tract bleeding.

Ranitidine and cimetidine were compared with respect to their effect on preventing the continuation or recurrence of acute upper gastrointestinal bleeding secondary to peptic ulcer disease. Fifty patients were randomly allocated to treatment with either ranitidine or with cimetidine. The two groups were comparable for age, sex, and severity of hemorrhage. There was no statistically significant difference in outcome between the groups when assessing need for surgery, total number of units in blood required, days in hospital, incidence of rebleeding, or deaths. However, there was a trend in favor of ranitidine: only one ranitidine-treated patient went to operation versus four of the cimetidine group. In addition, the number of rebleeds was higher in the cimetidine group (14) compared to the ranitidine group (1). Two patients in each group died. Therefore, ranitidine appears to be comparable to cimetidine in the management of patients with acute upper gastrointestinal tract bleeding. However, this study did not include a placebo group, and thus the generalized use of H2-receptor blockers in all patients with acute upper gastrointestinal tract bleeding has not been proven.

Acute Disease↗

The clinical significance of the gastro-oral pathway of intestinal bacteria after head and neck cancer surgery.

Intestinal aerobic gram-negative bacilli (IAGB) are considered to be important in the pathogenesis of wound infection following major head and neck surgery. These micro-organisms have been shown to originate endogenously from the stomach, in spite of broad spectrum chemoprophylaxis. We have attempted to interrupt this gastro-oral pathway by instilling an antiseptic (40% ethanol) into the stomach after surgery. We studied 16 patients who were randomly allocated to an 'alcohol' or control group. Alcohol was administered to 8 patients regularly via the nasogastric tube until the 5th postoperative day. The mouth, tracheostomy site and gastric aspirates were sampled on the 1st, 5th, and 10th days after surgery. No patients had IAGB grown from the mouth before surgery, but after surgery coliforms were prolific in all sites in both patient groups, and the administration of alcohol did not have any noticeable affect. However, even though coliforms were ubiquitous during the recovery period, wound complications were few, and their importance in the pathogenesis of wound sepsis is reconsidered.

Adult↗

Placebo substitution for methyldopa in geriatric hypertensive patients.

The aim of this study was to obtain an objective evaluation of the possibly inappropriate antihypertensive therapy of elderly patients; this was done by means of placebo substitution for methyldopa, one of the drugs taken by all the participating patients. Forty patients were recruited from a hospital outpatient clinic and randomly allocated to two groups. One group remained on treatment which included methyldopa, while a matching placebo tablet was substituted in the other group. The study was conducted over a period of 6 months in a single-blind manner. Methyldopa was reintroduced in the placebo group when one of the evaluation clauses was recorded. Only 2 patients in the placebo group required reintroduction of methyldopa tablets. In the rest of this group there was no significant difference between systolic and diastolic pressures before and after 6 months of placebo substitution. Withdrawal of unnecessary antihypertensive therapy in the elderly should be considered. Patients must be observed carefully and therapy reintroduced when blood pressures rise.

Aged↗

[Comparison of the efficacy and tolerance of Kabi 2165 and standard heparin in the prevention of deep venous thrombosis in total hip prosthesis].

A series of 80 patients operated for total hip prosthesis under epidural anesthesia was randomly allocated to treatment with Kabi 2165 (n = 40): 2,500 U anti-Xa preoperatively and evening of operation and 2,500 U anti-Xa morning and evening daily up to the 9th or 10th day postoperatively, or standard heparin (n = 40): 3,750 U preoperatively and then 8 hourly, at a dose adjusted with thrombin time and cephalin + activator time, daily up to the 9th or 10th day. Phlebography was performed routinely on the 9th or 10th day. Venous thrombosis occurred in 7 patients (17.5%) in the Kabi 2165 group, including two high, potentially emboligenic, localizations (5%), and in 4 patients (10%) in the standard heparin group, including 2 potentially emboligenic clots (5%). The difference is not statistically significant (total number: p = 0.5; potentially emboligenic: p = 0.33). Pulmonary embolism did not occur. Overall tolerance, evaluated from hemoglobin and hematocrit values, intra- and post-operative bleeding and operation wound hematoma and at injection site was comparable in the two groups.

Aged↗

The serotonin uptake inhibitor citalopram attenuates ethanol intake.

No effective drug for decreasing ethanol intake is available for clinical use. Our previous studies showed that zimeldine decreased ethanol intake in rats and nondepressed alcohol abusers. However, zimeldine was withdrawn from the market because of serious toxicity. We tested citalopram, a selective serotonin uptake inhibitor, in 39 male nondepressed early-stage problem drinkers (aged 19 to 61 years). Subjects were randomly allocated to receive either citalopram, 20 (n = 20) or 40 (n = 19) mg/day orally, or placebo in a double-blind, crossover trial. Citalopram administration and ethanol intake were assessed by self-report and objectively. Citalopram, 20 mg/day, did not show an effect. However, citalopram, 40 mg/day, decreased the number of drinks consumed (F1,17 = 5.27; P less than 0.05) and increased the number of abstinent days (F1,17 = 13.18; P less than 0.005). The effect is probably through modulation of the neurobiologic mechanisms regulating ethanol intake. Our results suggest a new pharmacologic approach to decrease ethanol intake.

Adult↗

Prevention of deep venous thrombosis and thrombo-embolism by dipyridamole and acetylsalicylic acid after reconstructive arterial surgery.

A series of 400 consecutive patients subjected to reconstructive arterial surgery were randomly allocated into four equal groups in order to study the effect of dipyridamole and acetylsalicylic acid (ASA) in the prevention of deep venous thrombosis and pulmonary embolism. There were 11 drop-outs. In the dipyridamole-ASA group there were no thrombotic complications while in the control group without antithrombotic therapy five cases of deep venous thrombosis and two cases of fatal pulmonary embolism were encountered (p < 0.05). In the groups receiving either dipyridamole or ASA alone two and four cases of deep venous thrombosis, respectively, were found. It is concluded that treatment with dipyridamole and ASA combined is useful in preventing postoperative thrombotic complication after peripheral vascular reconstructive surgery.

Adolescent↗

Prospective randomized controlled trial of urethral versus suprapubic catheterization.

Sixty-six patients requiring catheterization in the course of general surgical operations were randomly allocated into two groups. Of the 34 patients catheterized urethrally 16 developed urinary tract infections whereas of the 32 suprapubically catheterized patients only 2 developed an infection (P less than 0.001). Five patients required recatheterization after removal of their urethral catheters. There were no major complications associated with the use of suprapubic catheters. We propose that, when catheterization is required during a general surgical procedure, the suprapubic route is to be preferred.

Catheters, Indwelling↗

Relationship between the venoconstrictor activity of dihydroergotamine and its pharmacokinetics during acute and chronic oral dosing.

In a double-blind, interindividual comparative study 30 healthy volunteers were randomly allocated to oral treatment with 5 or 10 mg of dihydroergotamine (DHE) or placebo once daily for 16 days. Regional basic venous blood volume (BBV), pressure dependent venous capacitance (CV) of the calf, resting heart rate and blood pressure were determined on Days 1 and 15 of treatment. Plasma concentrations of DHE were monitored on Days 2 and 16. Due to spontaneous vasodilation BBV varied considerably, showing that it is an inappropriate parameter for investigating the venoconstrictor activity of DHE. CV remained unchanged after the first dose of DHE but it had declined significantly on both dosage regimens at the end of the treatment phase. In contrast, the blood concentration profiles of DHE were comparable at the beginning and the end of the trial. The discrepancy can best be explained by the existence of an effect compartment, e.g. smooth vascular musculature, which slowly becomes filled with DHE and/or its active metabolites. The venoconstrictor activity of DHE exhibited a significant dose-response relationship.

Administration, Oral↗

Randomized trial comparing two short courses of moderate-dose metoclopramide for moderate-dose cisplatin-induced emesis.

To better define the dose-response relationship of moderate-dose (MD) metoclopramide (MCP), 42 patients receiving their first course of cisplatin (50 mg/m2) were randomly allocated to receive a short-course regimen of MCP, either at 1 mg/kg X 1 dose, 30 min before cisplatin (regimen A) or 1 mg/kg X 2 doses, 30 min before and 1 h after cisplatin (regimen B). The antiemetic response was assessed only by objective means (duration and volume of emesis over a 6-hour period). The results obtained in the two groups show a significantly better antiemetic effect (p = 0.03) employing the higher dose of this short-course regimen, with as much as 76% of the patients experiencing no vomiting or only a low degree of emesis. Furthermore, the lower-dose MCP regimen seems to be inadequate for preventing emesis, especially in the subgroups at higher emetic risk (patients with prior chemotherapy exposure and those concurrently receiving adriamycin. No significant side effects were present with either treatment. Further studies are required to define the best short-course regimen of MCP for patients receiving MD cisplatin.

Adult↗

Influence of neostigmine on postoperative vomiting.

Thirty-eight patients undergoing elective hip or knee surgery were randomly allocated to two groups. Neuromuscular blockade in group A was antagonized with neostigmine 2.5 mg and atropine 1.2 mg, while group B received no drugs to facilitate antagonism of blockade. The incidence and severity of postoperative nausea and vomiting were assessed 24 h after operation. Nausea and vomiting were significantly reduced in group B. The incidence of nausea in group A was 68%, compared with 32% in group B (P less than 0.01). The incidence of vomiting was 47% in group A, compared with 11% in group B (P less than 0.02). A significant relationship was shown between postoperative emetic symptoms and the antagonism of neuromuscular blockade by neostigmine and atropine.

Aged↗

Cardiovascular response during cerebral angiography under general and local anaesthesia.

Nineteen patients with subarachnoid haemorrhage who had cerebral angiography with the new contrast medium iohexol, were randomly allocated to receive either local anaesthesia plus sedation, or general anaesthesia. Arterial blood pressure, PaO2, PaCO2 and patient acceptability were examined. Significant fluctuations in arterial blood pressure occurred in the patients who received general anaesthesia. Local anaesthesia was associated with a stable blood blood pressure, adequate spontaneous ventilation and good patient acceptability. The quality of films obtained was examined and found to be of good or very good diagnostic quality in all cases in both groups of patients. Greater use of local anaesthesia with sedation for angiography is recommended.

Adolescent↗

Cryotherapy compared with trichloroacetic acid in treating genital warts.

In an observer blind comparative study, 130 men with penile warts were randomly allocated to treatment with either cryotherapy or trichloroacetic acid (TCAA). There was no significant difference in response to treatment, side effects, or recurrence rates between the two treatments. Warts resolved in 81% of patients treated with TCAA compared with 88% of those treated with cryotherapy. Early recurrence occurred in 36% of patients treated with TCAA and in 39% of those treated with cryotherapy.

Adolescent↗

Evaluation of antisecretory activity of misoprostol in duodenal ulcer patients using long-term intragastric pH monitoring.

The effect of the new synthetic prostaglandin E1 analog, misoprostol, on intragastric acidity was evaluated by means of 24-hr intraluminal pH monitoring of 16 duodenal ulcer patients. They were randomly allocated into two groups: eight received no medication and misoprostol 400 micrograms bid and eight received ranitidine 150 mg and misoprostol 400 micrograms bid not less than one week apart. The comparison of the 24-hr areas under the curve related to the median pH values showed that no difference existed between misoprostol and untreated patients in the first group, while ranitidine was significantly more effective (P = 0.00003) than misoprostol in the second group. The analysis of arithmetic differences between the 24-hr median pH values showed that misoprostol increased pH values by at least one unit compared to the untreated subgroup for about 3.5 hr, while the antisecretory action of ranitidine was far superior to that of misoprostol throughout the whole 24-hr period. It can be concluded that the effect of twice daily doses of misoprostol 400 micrograms on 24-hr intragastric pH is small and not at all comparable to that of the well-known potent H2 blocker ranitidine.

Alprostadil↗