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At least 1,333 records · Page 74Linked to original sources

PubMed1989

The effect of six months of daily treatment with the beta-2 agonist oral pirbuterol on pulmonary hemodynamics in patients with chronic hypoxic cor pulmonale receiving long-term oxygen therapy.

We studied the acute and long-term effect of the oral beta-2 agonist pirbuterol on pulmonary hemodynamics and right and left ventricular ejection fractions in 11 patients with stable hypoxic chronic bronchitis and emphysema who were maintained on long-term oxygen therapy. We have used a double-blind study with random allocation of patients to receive either pirbuterol or an identical-appearing placebo. Six patients received 15 mg pirbuterol thrice daily, and five patients received a similar placebo thrice daily, over a 6-month period. The first 15-mg dose of pirbuterol by mouth at the beginning of the study raised the heart rate from 84 +/- 13 to 100 +/- 16 beats/min (mean +/- SD) (p less than 0.01), and cardiac output from 5.2 +/- 0.9 to 6.4 +/- 0.8 L/min (p less than 0.01) and right ventricular ejection fraction (RVEF) from 0.28 +/- 0.10 to 0.33 +/- 0.12 (p less than 0.01) within 120 min after receiving the drug, but without significant change in the mean pulmonary arterial pressure. None of these variables changed significantly after an acute dose of placebo in another four patients. Repeated measurements after 6 months of chronic oral therapy with either pirbuterol or placebo showed that 16 h after the last 15-mg oral dose of pirbuterol or placebo, the heart rate, mean pulmonary arterial pressure, cardiac output, total pulmonary vascular resistance, and RVEF were all not significantly different from the values 6 months previously, before receiving either pirbuterol or the placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Agonists↗

PubMed1991

Reduction of colonization and infection rate during pediatric intensive care by selective decontamination of the digestive tract.

OBJECTIVE: To compare the effects of two different antibiotic regimes on the colonization and infection rates of critically ill pediatric patients. DESIGN: A prospective randomized trial. SETTING: A pediatric ICU in a university hospital. PATIENTS: Fifty critically ill pediatric patients who required intensive care for at least 4 days were randomly allocated to either the selective parenteral and enteral antisepsis regimen (treatment group, n = 25) or the control group (n = 25). INTERVENTIONS: The treatment group received oral nonabsorbable antimicrobial agents (polymyxin E, gentamicin, and amphotericin B) and parenteral cefotaxime, whereas the control group received either perioperative antibiotic prophylaxis or antibiotic therapy according to clinical or microbiological evidence of infection. RESULTS: Both groups were comparable for age, body weight, sex, and severity of illness. Colonization with Gram-negative microorganisms and yeasts in the oropharynx, and digestive and respiratory tracts increased rapidly up to 52% in the control group, whereas there was no colonization with these microorganisms in the treatment group. The occurrence rates of acquired secondary infections in the control and treatment groups were 36% and 8%, respectively (p less than .025). There were no differences between groups in the duration of intensive care or mortality rate. CONCLUSION: Selective oropharyngeal and gastrointestinal decontamination combined with systemic cefotaxime application allows for a significant reduction of the colonization rate with Gram-negative bacteria and yeasts in critically ill pediatric patients undergoing prolonged intensive care. In addition, it significantly reduces the Gram-negative infection rate of the respiratory system. However, this therapeutic approach does not alter ICU length of stay or mortality rate.

Anti-Bacterial Agents↗

PubMed1989

Advantages of the paramedian approach for lumbar epidural analgesia with catheter technique. A clinical comparison between midline and paramedian approaches.

Forty-nine patients, scheduled for transurethral resection of the prostate or a bladder neoplasm on 50 occasions, were studied. The patients were randomly allocated to one of the two methods of puncture, midline or paramedian. Technical difficulties and the occurrence of complications were recorded. The extent of sensory and motor blockade was also compared. The paramedian approach was associated with a lower frequency of technical problems compared to the midline approach. Statistically significant differences were demonstrated between the two techniques for the following factors: repeated attempts at needle insertion; difficulty in identification of the epidural space; resistance to introduction of the catheter; resistance to injection through the epidural catheter; and the production of paraesthesiae (nine patients in the midline group compared to only one patient in the paramedian group, p less than 0.01). The catheter entered a vessel at first in two patients in each group. No significant differences were demonstrated between the groups in the extent of sensory and motor blockade. The study supports the view that the paramedian approach has technical advantages over the midline approach for lumbar epidural analgesia with catheter technique.

Aged↗

PubMed1990

Haemodynamic and neurohumoral effects of xenon anaesthesia. A comparison with nitrous oxide.

Thirty-two patients were randomly allocated to be anaesthetised either with nitrous oxide or xenon. Those who received nitrous oxide required significantly more fentanyl peroperatively. Arterial blood pressure and heart rate were adequately controlled during surgery in both groups. Plasma noradrenaline and prolactin increased peroperatively in both groups, but plasma adrenaline and cortisol, which increased in the nitrous oxide group, did not change in the xenon group. Growth hormone was below control in those given xenon, but not in the nitrous oxide group, while dopamine remained unchanged in both groups. Postoperative plasma concentrations of noradrenaline, adrenaline, cortisol and prolactin (in both groups) and dopamine (in the nitrous oxide group) were elevated, and slowly returned to control. No differences were seen between the two gases in effects on plasma sodium and potassium. Xenon, because of its favourable haemodynamic, neurohumoral and antinociceptive properties, deserves a more prominent place in anaesthetic practice than it has so far occupied.

Adult↗

PubMed1988

A comparison of fluconazole and ketoconazole in the oral treatment of vaginal candidiasis; report of a double-blind multicentre trial.

One hundred and eighty three patients with vaginal candidiasis were randomly allocated to treatment with either fluconazole in a single oral 150 mg dose, or ketoconazole, 200 mg twice daily for 5 days. Favourable clinical responses were obtained in 92% of the patients in the fluconazole group and in 89% of those in the ketoconazole group after 5-16 days. Long-term evaluation at 27-62 days showed favourable clinical responses in 86 and 88%, respectively. Candida was eradicated from the vagina in 77% of both treatment groups at the long-term evaluation. The relapse or reinfection rate was similar for both groups, ranging between 4-8%. One hundred and thirty two of the 160 patients who had rectal swabs cultured for yeast at baseline, gave positive results. Of the 27 patients in the fluconazole group whose rectal cultures remained negative at the long-term evaluation, 26 maintained mycological cure of their vaginal candidiasis. In contrast, patients with positive rectal cultures at this time were much less frequently associated with mycological cure. The results were similar for the patients in the ketoconazole group. Treatment-related side effects in both groups were few and minor. This double-blind multicentre study showed that a single oral 150 mg dose of fluconazole was as effective as 5 days of oral ketoconazole medication in the treatment of vaginal candidiasis.

Administration, Oral↗

PubMed1992

A randomized phase II study of a new tick-borne encephalitis vaccine using three different doses and two immunization regimens.

A new, highly purified inactivated tick-borne encephalitis (TBE) vaccine (FSME-Vaccine Behring, BI 71.061) was recently registered in Germany. A multinational phase II study was performed in seven centres located in areas endemic for TBE. A total of 379 healthy adults were randomly allocated into three dosage groups (1.0, 1.5 and 2.0 micrograms antigen per dose, respectively) and into two immunization schedules [vaccination with one dose of 0.5 ml intramuscularly on days 0, 7 and 21 (abbreviated schedule), or on days 0, 28 and 300 (conventional schedule)]. Antibody response to vaccination was assayed by enzyme-linked immunosorbent assay (ELISA), haemagglutination inhibition test (HIT) and neutralization test (NT). Seroconversion rates in the different groups 28 days after one single dose were 75.3-83.5% in ELISA, 35.8-50.6% in HIT, and 100% in NT. All vaccinees showed seroconversion in all tests on day 42 in the conventional schedule and on day 35 in the abbreviated schedule, with the exception of one subject, who remained seronegative in HIT only. Geometric mean titres (GMT) of about 3000 in ELISA were achieved by two vaccinations in the conventional schedule and showed a booster increase to 5500-8000 GMT after revaccination on day 300. Overall frequency of adverse events (related and unrelated) was 37% (conventional schedule) and 46% (abbreviated schedule) after the first, 9% and 21% after the second, and 5% and 15% after the third vaccination, respectively. Generally, side effects were mild and transient, including mainly headache, fever, malaise and local irritation. Serious, vaccine-related side effects did not occur.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1989

Comparison of intravenous and intranasal sufentanil absorption and sedation.

The absorption and sedation following an intranasal dose of sufentanil were evaluated and compared with those of the same dose given intravenously. Sixteen adult patients scheduled for elective surgery were randomly allocated to receive as premedication 15 micrograms sufentanil either intravenously or intranasally. Before administration and at fixed time intervals thereafter, the degree of sedation was assessed, vital signs were recorded and venous blood samples were taken for the determination of sufentanil plasma concentrations. Peroperative sedation of rapid onset and limited duration was seen in both groups. However, the onset of sedation was more rapid after intravenous injection. At 10 min, all patients in the IV group were sedated versus only two in the intranasal group (P less than 0.01). No significant intergroup differences in sedation were seen at 20 to 60 min. This clinical effect is in agreement with the measured plasma levels, which were significantly lower after intranasal application at 5 and 10 min, being 36 and 56 per cent of those after IV dosing, respectively. From 30 min, plasma concentrations were virtually identical for the two routes of administration. The AUC0-120 min after intranasal dosing was 78 per cent of that after intravenous injection. Intranasal dosing induced no clinically significant changes in vital signs, whereas after IV sufentanil, a clinically significant decrease in PaO2 was seen at 5 min. The results of this study show that sufentanil, when administered intranasally, is rapidly and effectively absorbed from the human nasal mucosa, so that this route may be an attractive alternative for a premedicant, avoiding the discomfort of an intravenous or intramuscular injection.

Absorption↗

PubMed1987

Prospectively randomized clinical trial to compare in situ and reversed saphenous vein grafts for femoropopliteal bypass.

Two hundred and fifteen femoropopliteal bypass procedures using autologous saphenous vein grafts were randomly allocated to either the reversed or in situ technique. Eleven veins (5 per cent) were rejected at operation on the basis of their small size, nine in the reversed group and two in the in situ group, and there were two (2 per cent) perioperative deaths in each group, leaving 102 reversed and 98 in situ grafts for further study. The cumulative patency at 3 years of the reversed grafts was 77 per cent and that of the in situ grafts was 68 per cent (n.s.). The patency of all grafts was affected adversely by small veins (P less than 0.005), long grafts (P less than 0.05), low volume of blood flow in the grafts (P less than 0.001) and poor run-off (P less than 0.05). These factors influenced the outcome of the in situ and reversed operations to a similar degree and there was no statistically significant difference between them within any subgroup. The mean compliance of the in situ grafts measured 3 months or more after operation with an ultrasonic echo-tracking system was 0.024 +/- 0.01 per cent/mmHg (+/- s.d.) compared with 0.017 +/- 0.01 per cent/mmHg for the reversed grafts (t = 2.43, P less than 0.02). The incidence of fibrous stricture formation as shown by intravenous digital subtraction angiography was 29 per cent in both the reversed and the in situ grafts. The results of the study to date indicate that reversed and in situ vein grafts are equally effective for femoropopliteal bypass.

Adult↗

PubMed1986

[Clinical and instrumental evaluation by multiple colonic manometry of tiropramide, trimebutine and octylonium bromide in irritable colon. II. Repeated oral administration].

Sixty out-patients with acute or sub-acute irritable colon were randomly allocated to receive 3 daily doses of 100 mg tiropramide, 150 mg trimebutine maleate or 20 mg octilonium bromide, orally during 5 consecutive days. Before and after treatment, multiple colonic manometry was performed, monitoring tonus, intensity and frequency of sinusoid contraction waves, transitories and vibrations, as well as the voluntary contraction capacity. Before treatment and after 2 and 5 days, the specific symptoms were also monitored, scored and recorded. Significant variations in tonus were not observed with any drug, but while tiropramide left unmodified the voluntary contractile ability, a significant inhibition was observed with trimebutine and, mainly, with octilonium. The overall power of spontaneous colonic contractions did not vary significantly with any drug. However, while with tiropramide a significant redistribution of muscular power was observed so as to increase propulsion waves and to decrease the ineffective transitory and vibrational contractions, with octilonium and trimebutine no clinically relevant redistribution of the power wasted in transient spasms was observed. Based on these observations, tiropramide was considered to be at least as effective an antispasmodic as octilonium and at least as effective a synchronizer as trimebutine, but was different from both reference drugs because it was the only one to act simultanously as both an antispasmodic and a synchronizer. The three drugs produced an improvement in each and all monitored symptoms as well as in the overall symptom intensity. Tiropramide, however, produced an improvement significantly faster, more progressively and to a greater extent than either reference drug.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

PubMed1986

Combined vaccination with live oral polio vaccine and the bovine rotavirus RIT 4237 strain.

A clinical trial was carried out in 3-month-old infants to assess whether concomitant oral administration of live polio and rotavirus RIT 4237 vaccines would reduce their immunogenicities as a result of mutual interference. One hundred and sixty breast-fed male and female infants were randomly allocated to four study groups to receive in a blind fashion the poliovirus vaccine, the RIT 4237 vaccine, a combination of both vaccines or a placebo preparation. Antibody titres were measured in pre- and postvaccination serum samples by the ELISA test and the neutralizing antibody test (NT) for rotavirus and by the NT for polioviruses types 1 and 3. The percentage of subjects with immune responses to rotavirus in the placebo group was low, indicating the absence of wild rotavirus circulation in the population. Antibody responses against polio types 1 and 3 were found in about a quarter of the infants receiving a placebo because the study was performed during a polio vaccination campaign when vaccine viruses are known to circulate. The results showed that 73% of seroconversion was obtained when RIT 4237 was administered alone and that the responses to polioviruses types 1 and 3 were good. However, simultaneous administration of polio and RIT 4237 vaccines caused a significant reduction of the antibody response to rotavirus but not to polioviruses types 1 and 3.

Antibodies, Viral↗

PubMed1989

A comparative study of Japanese and British BCG vaccine strains in newborn infants.

A prospective study on the British and Japanese BCG vaccines in newborn infants was carried out in which 317 and 285 infants were randomly allocated and vaccinated with the British and Japanese BCG vaccines, respectively. Four follow-up examinations were carried out with an average of 98% of the study cohort attending all sessions. About half the infants did not produce any visible response at the end of the first week. All, by the end of the third month, had characteristic BCG scars with an average diameter of 4.6 mm. A Mantoux test was carried out at six months. A mean skin induration of 7.2 mm (SD 5.3 mm) was recorded. Significantly higher proportions of infants given Japanese BCG were found to be tuberculin convertors (74.7%) when compared to those given British BCG (51.4%). Breast-feeding practices and the mothers' tuberculin status did not influence markedly their infants response to tuberculin.

BCG Vaccine↗

PubMed1989

A clinical and urodynamic study comparing the Stamey bladder neck suspension and suburethral sling procedures in the treatment of genuine stress incontinence.

Twenty women with urodynamically proven genuine stress incontinence were randomly allocated to treatment by suburethral sling or Stamey endoscopic bladder neck suspension. Urodynamic assessment was performed before and 3 months after surgery; clinical follow-up is reported up to 2 years. Blood loss was greater, and there were significantly more postoperative complications associated with the sling procedures. The subjective and objective cure rates at 3 months and 2 years were not significantly different between the two procedures. No significant changes in the resting urethral pressure profile were evident, although with both procedures, cure was associated with an enhancement in pressure transmission ratios in the proximal urethra. Detrusor instability occurring for the first time after operation was associated with both procedures; the sling, in addition, induced a significant degree of outflow obstruction, although this was not evident after the Stamey procedure.

Adult↗

PubMed1986

[Value of short prophylactic antibiotherapy in thoracic and vascular surgery. Comparative randomized double-blind study of 3 and 8 injections of cefamandole].

The subject of whether an optimal duration of prophylactic antibiotic therapy exists was evaluated by comparing results of short and medium-term treatment in aseptic surgery during a double-blind, randomized, prospective trial in 507 patients undergoing vascular or thoracic operations. Patients were randomly allocated to receive either 3 injections of cefamandole: at induction of anesthesia and after 4 and 10 hours (251 cases) or 8 injections of the same antibiotic: at induction of anesthesia, after 4 hours and then every 6 hours up to 40 hours (256 cases). Evaluation on discharge showed that among the 251 patients receiving 3 injections, 21 (8.33%) were infected while in the group treated with 8 injections (256 cases) 25 (9.8%) were infected. The X2 was 0.25 and there is a lack of statistically significant difference between treatments. Duration of prophylactic antibiotic therapy can be shortened, without loss of efficacy in thoracic or vascular aseptic surgery, to reduce selection of resistant germs and to lower costs.

Bacterial Infections↗

PubMed1993

A double-blind comparative study of soluble aspirin and diclofenac dispersible in the control of postextraction pain after removal of impacted third molars.

The analgesic efficacy and patient acceptability of soluble aspirin and diclofenac dispersible were compared in patients with postoperative pain after removal of impacted third molars. A total of 136 patients were randomly allocated to receive soluble aspirin 600 mg tds or diclofenac dispersible 50 mg tds after extraction under local anaesthesia of impacted third molars on one side of the mouth. The medication, which was both patient and operator blind, was reversed after extraction of the contralateral third molars 3 weeks later, the patients acting as their own controls in assessing postoperative pain, pain relief, and interincisal opening. Patients receiving diclofenac dispersible recorded significantly lower pain levels; pain relief was significantly greater and the patients' assessment significantly favoured diclofenac dispersible. Interincisal opening throughout the study period was significantly increased in the diclofenac dispersible group. The surgeons' postoperative assessment of extraction sites showed no significant difference between the two treatment groups in rate of healing. Two patients reported side-effects while taking soluble aspirin, and eight while taking diclofenac dispersible, two of whom discontinued treatment.

Adolescent↗

PubMedDate not supplied

Clinical study of oral administration of DN-1417, a TRH analog, in patients with intractable epilepsy.

An open dose-finding trial of orally administered DN-1417 was undertaken to investigate dose, efficacy, and adverse reactions. One hundred ninety patients, with epilepsy resistant to conventional drug treatment, were randomly allocated to two treatment groups of low dose (20 mg/day for adult) and high dose (80 mg/day for adult). Medication was given while fasting, once a day, for 8 weeks. If at the end of the first 4-week treatment period the patient had a satisfactory response, the dose was doubled. Patient response was assessed by global improvement rating (GIR) based on changes in seizure frequency, EEG findings, and nonparoxysmal clinical manifestations. The responses assessed by GIR was "slightly to markedly improved" in 48% of the patients with low-dose treatment and 55% with high-dose treatment. There was no clear dose-related difference between the two treatments. In patients with Lennox-Gastaut syndrome having no history of West syndrome, the rate of response assessed by GIR was found to be slightly dose-related (low dose, 61%; high dose, 73%).

Administration, Oral↗

PubMed1989

Randomized, double-blind comparison of famotidine with ranitidine in treatment of acute, benign gastric ulcer disease. Community-based study coupled with a patient registry.

A multicenter, double-blind, randomized controlled trial comparing the efficacy and safety of famotidine with ranitidine in the treatment of acute, benign gastric ulcer disease was coupled with a community-based gastric ulcer disease registry. One hundred ninety-five patients with endoscopically documented gastric ulcer disease were enrolled in the trial and randomly allocated to treatment with either famotidine 40 mg at bedtime or ranitidine 150 mg twice a day. Healing rates were similar in both groups: at four weeks 49% vs 48%, at six weeks 71% vs 69%, and at eight weeks 83% vs 81% for famotidine and for ranitidine, respectively. Pain relief, antacid tablet use, and adverse experiences were also similar in the two groups. Only 25% of patients entered in the gastric ulcer registry were enrolled in the trial. Given that patients with more severe or complicated gastric ulcer disease should be excluded from controlled trials of new drugs, the screening criteria used in the present study be excluded from findings being representative of a quarter of the patients seen in these practices. Therefore, coupling a patient registry with a clinical trial helps determine the applicability of its results. Famotidine 40 mg at bedtime is an effective and well-tolerated treatment of acute, benign gastric ulcer disease and is comparable in efficacy and safety to ranitidine 150 mg twice a day.

Clinical Trials as Topic↗

PubMed1984

Treatment of chronic obstructive pulmonary disease with corticosteroids. Comparison of daily vs alternate-day therapy.

We compared the efficacy of corticosteroid therapy initiated as an alternate-day regimen to that of a four-times-daily regimen in patients with stable chronic obstructive pulmonary disease. In this double-blind study, 44 patients with moderate to severe COPD (mean FEV1 740 +/- 310 ml) were hospitalized and randomly allocated to receive methylprednisolone, 8 mg qid, 64 mg qod, or placebo for a ten-day period. The mean FEV1 and FVC improved significantly to a comparable degree in both steroid-treated groups, but not in the placebo-treated group. Eight of the 29 steroid-treated patients (28 percent) had improved FEV1 of more than 25 percent compared with only one of the 15 placebo-treated patients. Those in the qod group also had notable improvement in SaO2. Although the correlation between the improvement after the administration of nebulized bronchodilators and that after corticosteroid therapy was significant, some patients had more than a 25 percent improvement in their FEV1 with corticosteroids, but less than a 10 percent improvement after nebulized bronchodilators. We conclude that a substantial proportion of all patients with stable COPD will have a greater than 25 percent improvement in their flow rates with corticosteroid administration. Since the response to a qod regimen is comparable to that of a qid regimen, and since the qod regimen is associated with fewer side effects, we recommend that a qod regimen be tried initially.

Adrenal Cortex Hormones↗

PubMed1980

Long-term results of internal mammary artery implantation for coronary artery disease: a controlled trial by the participants of the Veterans Administration Coronary Bypass Surgery Cooperative Study Group.

One hundred forty-six adult men from sixteen Veterans Administration hospitals were entered in a controlled prospective clinical trial. Seventy-one patients were randomly allocated to receive implantation of the internal mammary artery into the left ventricular myocardium for chronic ischemic heart disease with angina pectoris, and 75 were assigned to the control group. The two treatment groups were similar at baseline with respect to sixteen clinical and angiographic factors thought to have prognostic importance. Most of the patients were operated on before 1970. Operative mortality was 12%, and implant patency in 52% of eligible patients studied 1 year after operation was 67%. At the end of follow-up extending up to 12 years (mean, 9.3 years), cumulative survival for both groups was similar. Over half of the patients (58%) had died at the end of 10 years (5% per year). While the hypothesis on which the operation was based appears to be valid, the degree of revascularization achievable in most patients did not affect longevity.

Adult↗