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At least 829 records · Page 46Linked to original sources
PubMed1993

The effects of a chlorhexidine toothpaste on the development of plaque, gingivitis and tooth staining.

Chlorhexidine has found many uses in clinical dentistry as an antiplaque agent. To date, effective chlorhexidine-containing toothpastes have not been made available. This study was the first phase in the evaluation of a 1% chlorhexidine toothpaste, formulated to ensure a high availability of the contained antiseptic. The study was a 19-day, randomised double-blind placebo-controlled, crossover experiment al gingivitis clinical trial employing 14 healthy human volunteers. From a zero plaque and low gingivitis baseline, the development of plaque, gingivitis and dental staining was measured on days 12 and 19 of the 2 study periods. The toothpaste was used 2x a day as a slurry rinse with no other form of oral hygiene. The washout period was 21 days. The development of plaque and gingivitis was statistically and clinically highly significantly reduced during the use of the active compared to the placebo product. Conversely, dental staining was statistically and clinically significantly increased. The product deserves further evaluation for potential clinical use.

Adult↗
PubMed1989

The effects of cefmetazole and latamoxef on platelet function in healthy human volunteers.

This study has compared the effects of normal saline (placebo), cefmetazole, and latamoxef (moxalactam) on platelet function in healthy human volunteers. Twenty-nine volunteers were randomized to receive placebo (n = 10), cefmetazole 2 g (n = 9) or latamoxef 2 g (n = 10) intravenously every 6 h for six days. Under double-blind conditions template bleeding time and ex-vivo adenosine diphosphate (ADP) induced platelet aggregation were measured before drug dosing, after the first, ninth, and last drug doses and one and three days after the last drug dose. Latamoxef caused progressive impairment of platelet function with statistically significant increases in the mean bleeding time to 7.4 +/- 3.7 min (P = 0.02) and the amount of ADP (0.2 mM) required to induce 50% platelet aggregation to 77.3 +/- 91.1 microliters (P = 0.03) on day 6 of treatment compared with values before drug administration (4.2 +/- 0.7 min; 3.7 +/- 22 microliters, respectively). These changes were reversible following discontinuation of drug dosing. Cefmetazole and placebo had no significant effects on either measure of platelet function at any time during the study.

Adenosine Diphosphate↗
PubMed1997

Treatment of high-grade, high-stage prostate cancer with estramustine phosphate or diethylstilbestrol. A double-blind study. The SPCG-1 Study Group. Scandinavian Prostate Cancer Group.

Between 1984 and 1989, 197 patients with T1-4, NX, M1, G2-3 or G3 prostate cancer were randomized to treatment with 560 mg estramustine phosphate (EMP, Estracyt, Emcyt) or 3 mg diethylstilbestrol (DES) per day in a double blind study with stratification on presence or absence of cancer pain at start. A total of 194 patients were evaluated for efficacy of therapy. Time to progression (p = 0.054), to treatment failure (p = 0.036), cancer-specific survival (p = 0.068) as well as overall survival (p = 0.021) were longer in the DES group. There were more patients with prognostic parameters indicating bad prognosis in the EMP group. This trial was designed to study whether EMP had better effect than DES as the primary treatment of high-grade, disseminated prostate cancer. The results did not confirm this hypothesis. On the contrary, treatment with DES had relatively good effect on this very aggressive form of prostate cancer.

Antineoplastic Agents, Hormonal↗
PubMed1997

Comparison of low-molecular-weight heparin with unfractionated heparin acutely and with placebo for 6 weeks in the management of unstable coronary artery disease. Fragmin in unstable coronary artery disease study (FRIC)

BACKGROUND: Low-molecular-weight heparin has a number of pharmacological and pharmacokinetic advantages over unfractionated heparin that make it potentially suitable, when used in combination with aspirin, for the treatment of unstable coronary artery disease. METHOD AND RESULTS: Patients with unstable angina or non-Q-wave myocardial infarction (1482) were included in the study, which had two phases. In an open, acute phase (days 1 to 6), patients were assigned either twice-daily weight-adjusted subcutaneous injections of dalteparin (120 i.u./kg) or dose-adjusted intravenous infusion of unfractionated heparin. In the double-blind, prolonged treatment phase (days 6 to 45), patients received subcutaneously either dalteparin (7500 i.u. once daily) or placebo. During the first 6 days, the rate of death, myocardial infarction, or recurrence of angina was 7.6% in the unfractionated heparin-treated patients and 9.3% in the dalteparin-treated patients (relative risk, 1.18; 95% confidence interval [CI], 0.84 to 1.66). The corresponding rates in the two treatment groups for the composite end point of death or myocardial infarction were 3.6% and 3.9%, respectively (relative risk, 1.07; 95% CI, 0.63 to 1.80). Revascularization procedures were undertaken in 5.3% and 4.8% of patients in unfractionated heparin and dalteparin groups, respectively (relative risk, 0.88; 95% CI, 0.57 to 1.35). Between days 6 and 45, the rate of death, myocardial infarction, or recurrence of angina was 12.3% in both the placebo and dalteparin groups (relative risk, 1.01; 95% CI, 0.74 to 1.38). The corresponding rates for death or myocardial infarction were 4.7% and 4.3% (relative risk, 0.92; 95% CI, 0.54 to 1.57). Revascularization procedures were undertaken in 14.2% and 14.3% of patients in the placebo and dalteparin groups, respectively. CONCLUSIONS: Our results add to previous evidence suggesting that the low-molecular-weight heparin dalteparin administered by twice-daily subcutaneous injection may be an alternative to unfractionated heparin in the acute treatment of unstable angina or non-Q-wave myocardial infarction. Prolonged treatment with dalteparin at a lower once-daily dose in our study did not confer any additional benefit over aspirin (75 to 165 mg) alone.

Adult↗
PubMed1983

[Objectification of the efficacy of an ointment for joint injuries using a volumetric method].

Distorsions of the upper ankle joint in 27 sport students were treated with an ointment dressing once daily in a double-blind test over 8 days. 14 cases were treated with Hepathrombin-50,000-Salbe Adenylchemie (100 g contain 50,000 I.E. heparin, 300 mg allantoin and 400 mg dexpanthenol) and 13 cases with the ointment base. The therapeutic effect was objectified based on measurements taken after 1, 2, 4, and 8 days of the foot volume (weight of displaced water by overflow at 23 cm height) and mobility of the joint. Moreover, resting, movement and pressure pain were individually assessed and compiled as a pain score (0-12). In the Hepathrombin group, swelling subsided continuously from 100 to 42% and the pain score decreased from 12 to 3. With application of the ointment base, swelling increased at first to 114% after 2 days, then decreased until Day 8 to 86% of the initial value. The pain score decreased from 12 to 7. The superiority of Hepathrombin-Salbe over the ointment base could be statistically demonstrated; the difference between the two groups was significant with respect to swelling after just one day, and with respect to joint mobility after just 2 days of treatment.

Administration, Topical↗
PubMed2000

Randomized, placebo-controlled pilot study of divalproex sodium in the treatment of acute exacerbations of chronic schizophrenia.

Experimental and clinical data suggest that GABA-ergic drugs such as valproate may have a potential role in the treatment of schizophrenia. The authors designed a 21-day prospective, double-blind, randomized, placebo-controlled pilot study of divalproex sodium as add-on treatment to haloperidol in 12 hospitalized patients with acute exacerbations of chronic schizophrenia. All patients received haloperidol 10 mg/day for 3 days and 15 mg/day for the remaining 18 days. In addition, five patients were randomly assigned to receive divalproex augmentation and seven to receive placebo. The divalproex dose was adjusted to a target serum concentration of 75 microg/mL for 2 weeks; placebo replaced divalproex during the third and last weeks to determine any carryover effect. Psychiatric rating scales were administered at baseline and on days 7, 14, and 21. Although the placebo group improved with haloperidol treatment, the divalproex group demonstrated greater improvement. On day 21, the divalproex group had greater improvement from baseline on the Clinical Global Impression Scale (p < or = 0.04), Brief Psychiatric Rating Scale (p < or = 0.13), and Schedule for Assessment of Negative Symptoms scores (p < or = 0.007). After divalproex withdrawal on day 15, a carryover effect was observed during week 3. The authors concluded that the addition of divalproex sodium to standard antipsychotic drugs may prove effective in relieving the symptoms of acute schizophrenia. Future studies may benefit from the design of this pilot study. However, it is premature to apply this augmentation strategy in the clinical setting just yet because of the small sample size and the likely heterogeneity of the disorder.

Acute Disease↗
PubMedDate not supplied

Effect of levothyroxine administration on hemostatic analytes in Doberman Pinschers with von Willebrand disease.

Levothyroxine administration has been suggested to be an effective treatment for canine von Willebrand disease (vWd), but evidence supporting this treatment is lacking. Effects of levothyroxine administration were evaluated in 8 euthyroid Doberman Pinschers with plasma von Willebrand factor (vWf) concentrations < 15%, characteristic of type 1 vWd. Levothyroxine (0.04 mg/kg PO q12h) and placebo were administered for 30 days in a 2-period, 2-treatment, double-blinded, crossover design with a 30-day washout period between treatments. Buccal mucosal bleeding time (BMBT), plasma vWf concentration (vWf: Ag), vWf collagen binding activity (vWf:CBA), factor VIII coagulant activity (FVIII:C), and serum concentrations of total thyroxine (T4), free thyroxine (fT4), 3,5,3'-triiodothyronine (T3), and thyroid-stimulating hormone (TSH) were measured on days 0, 2, and 30 of each treatment period. The 8 dogs (1 male, 7 females) had markedly low plasma vWf:Ag (mean, 8.9%; reference range, 70-180%) and vWf:CBA (mean, 11.1%; reference range, >70%). Response to placebo versus levothyroxine treatment was not significantly different between groups at day 0, 2, or 30 for BMBT, vWf:Ag, vWf:CBA, and FVIII:C. Serum T4, fT4, and T3 concentrations were significantly higher and serum TSH significantly lower in the levothyroxine-treated group than in the placebo group at days 2 and 30. Administration of levothyroxine at 0.04 mg/kg caused laboratory evidence of hyperthyroidism but did not affect plasma FVIII:C and vWf:Ag concentrations or vWf-dependent collagen binding and BMBT. The results of this study failed to identify a direct action of levothyroxine supplementation on plasma vWf concentration or activity in euthyroid Doberman Pinschers with vWd.

Animals↗
PubMed1984

Naproxen and aspirin in acute musculoskeletal disorders: a double-blind, parallel study in patients with sports injuries.

Seventy-nine patients with injuries of less than 14-days' duration were treated with either 750 mg naproxen or 2 g acetylsalicylic acid daily for 7 days in a double-blind trial. A statistically significant improvement (p less than 0.001) was noted in both treatment groups in respect of tenderness on palpation, pain on movement and functional capacity. However, there were no significant differences between the groups. Fresh injuries were over-represented in the acetylsalicylic acid group (p less than 0.01), and when all patients were analyzed together, a significantly better treatment result was obtained the shorter the interval between injury and start of treatment. This might have influenced the results from this study. Fifteen side-effects were reported by 11 patients, 5 in the naproxen group and 6 in the acetylsalicylic acid group. None was serious, and only 2 patients interrupted the treatment for this reason. It is suggested that treatment with analgesics or anti-inflammatory drugs should start as early as possible after the injury.

Adolescent↗
PubMed2005

Oral direct thrombin inhibitor ximelagatran compared with warfarin for the prevention of venous thromboembolism after total knee arthroplasty.

BACKGROUND: Warfarin, which requires coagulation monitoring, is associated with relatively high rates of thromboembolism despite providing adequate prophylaxis. This study compared an oral direct thrombin inhibitor, ximelagatran, with warfarin in order to evaluate the safety and efficacy of the medication for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. METHODS: Following surgery, patients were randomly assigned to fixed-dose oral ximelagatran (36 mg twice daily) or warfarin (target international normalized ratio, 2.5), both administered for seven to twelve days in a double-blind, double-dummy design. Warfarin was initiated on the evening of the day of surgery, and ximelagatran, on the morning after surgery. The primary efficacy end point was the incidence of asymptomatic deep-vein thrombosis determined by bilateral venography, objectively confirmed symptomatic deep-vein thrombosis or pulmonary embolism, and death from all causes during treatment. RESULTS: Adequate venograms or confirmed symptomatic events (efficacy population) were obtained for 1949 patients. Venous thromboembolism and death from all causes occurred in 22.5% (221) of 982 ximelagatran-treated patients and in 31.9% (308) of 967 warfarin-treated patients (p < 0.001). Proximal deep-vein thrombosis and pulmonary embolism were observed in 3.1% (thirty) and 0.2%, respectively, of the patients in the ximelagatran group and in 3.4% (thirty-three) and 0.4%, respectively, of the patients in the warfarin group. The six deaths from all causes included 0.3% (four) of the ximelagatran-treated patients and 0.2% (two) of the warfarin-treated patients. Major bleeding was noted in 1% (twelve) of the ximelagatran-treated patients and in 0.4% (five) of the warfarin-treated patients (p = 0.09). CONCLUSIONS: Oral ximelagatran (36 mg twice daily), administered without coagulation monitoring or dose adjustment and started the day after total knee arthroplasty, demonstrates superior efficacy compared with warfarin prophylaxis, with no wound complications and no significant difference with respect to bleeding events, although the rate of major bleeding events was greater with ximelagatran than with warfarin. LEVEL OF EVIDENCE: Therapeutic Level I.

Aged↗
PubMed1997

Skin tolerance of adapalene 0.1% gel in combination with other topical antiacne treatments.

BACKGROUND: Adapalene (Differin gel) is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. OBJECTIVE: We assessed, in healthy volunteers, the skin irritancy potential of three combinations, each including adapalene 0.1% gel and one topical marketed antiacne product. METHODS: Twenty-five healthy volunteers were enrolled in a 21-day cumulative irritancy study performed in a double-blind, randomized, controlled, intraindividual design. Five days a week, the three materials (benzoyl peroxide, clindamycin phosphate, and erythromycin) were applied in a nonocclusive manner either alone or in combination with adapalene gel on seven cutaneous sites on the upper back. Adapalene was applied in the evening whereas the three other materials were applied in the morning. Irritation was evaluated and scored daily except on weekends. RESULTS: All materials were well-tolerated when tested alone. The combinations of adapalene 0.1% gel and either benzoyl peroxide, clindamycin phosphate, or erythromycin were also well-tolerated. The mean cumulative irritancy indices indicated that all three combinations were nonirritating. CONCLUSION: Under the conditions of the study, all tested treatments alone or in combination appeared nonirritating.

Adapalene↗
PubMed1990

Comparison of the efficacy and systemic effects of 4 mg and 8 mg formulations of salbutamol controlled release in patients with asthma.

The purpose of the present study was to compare the efficacy and systemic effects of 4 mg and 8 mg doses of salbutamol controlled release (SCR) after single dosing and at steady state in patients with asthma. Fifteen asthmatic patients (Age 36 y, FEV1 85% predicted) were given SCR 4 mg and 8 mg twice daily for 7 days in a randomised double-blind cross-over design, with at least 7 days washout between treatments. There were no differences between the bronchodilator effects of 4 mg and 8 mg doses. There was no evidence of tolerance to the bronchodilator effects after chronic dosing. Morning and evening PEFR measurements also showed improvements during treatment with SCR 4 mg and SCR 8 mg, although there were no differences between the two formulations. Both doses of SCR caused significant objective tremor responses which were maintained after chronic dosing. The 8 mg dose produced a larger tremor response after single dosing, but not at steady-state. Subjective tremor occurred in 7 patients with SCR 8 mg, and in 2 patients with SCR 4 mg. There were no cardiac arrhythmias on Holter ECG monitoring. These results suggest that the 8 mg dose of SCR was no more effective than the 4 mg formulation, and was associated with more systemic adverse effects.

Adult↗
PubMed1996

Tacrolimus (FK506)-induced cerebral blindness following bone marrow transplantation.

Three patients who developed acute onset of cerebral blindness within 5-47 days of BMT using tacrolimus (FK506) as primary GVHD prophylaxis are described. This syndrome has been described with the use of cyclosporin A (CsA) and FK506 in solid organ transplant recipients. CsA-induced cerebral blindness has also been noted in BMT recipients but to date there have been no reports of this complication in BMT patients receiving FK506. We have noted a striking similarity in the clinical and radiographic presentations between these patients and those with CsA-associated cerebral blindness. Reversibility within 1-2 weeks of onset and the potential for substitution of CsA for FK506 in these patients is described.

Adult↗
PubMed1991

Failure of nimodipine to improve neurologic outcome after eighteen minutes of cardiac arrest in the cat.

The calcium entry blocker nimodipine was administered to cats following resuscitation from 18 min of cardiac arrest to evaluate its effect on neurologic and neuropathologic outcome in a clinically relevant model of complete cerebral ischemia. Cardiac arrest (ventricular fibrillation) was maintained for 18 min and resuscitation was performed by a standardized protocol in 40 cats. Beginning at 5 min post-resuscitation, nimodipine, 10 micrograms/kg over 2 min followed by 1 microgram/kg per min for 10 h, or the same volume of placebo was administered in a randomized, blinded fashion. Neurologic deficits were scored at 2, 4, and 7 days post-resuscitation by observers blinded to the treatment group. Thirty cats were evaluated neurologically at 7 days post-resuscitation and were entered into data analysis (n = 15 per group). Neither neurologic deficit scores nor neuropathologic scores were significantly different between groups. The authors conclude that nimodipine administration in the manner and doses stated does not improve neurologic outcome in cats following resuscitation from cardiac arrest.

Animals↗
PubMedDate not supplied

Bactericidal antimicrobial cover in primary suture of perianal or pilonidal abscess. A prospective, randomized, double-blind clinical trial.

The effect of 1-day treatment vs. 4-day treatment with metronidazole and ampicillin in association with primary closure of perianal and pilonidal abscesses was evaluated in a double-blind clinical trial. The patients were randomly allocated to 1-day (group I) or 4-day (group II) antibiotic regimen. No clinical signs of sepsis appeared in any patient. Primary healing, without fistula formation was achieved in all 17 perianal abscesses in the 1-day therapy group and in 14 of 15 in the 4-day group (non-significant difference). Excision with primary suture of pilonidal abscess resulted in primary healing in 20 of 26 cases in group I and 20 of 30 in group II (non-significant difference). Healing with formation of a new sinus or secondary healing occurred in four and two cases, respectively, in the 1-day therapy group, and in two and nine of the 4-day group. One-day administration of metronidazole/ampicillin is as effective as 4-day treatment in primary closure of perianal and pilonidal abscess. The procedure appears to be safe in both groups, but more efficacious in perianal abscess.

Abscess↗
PubMed1995

Low-dose droperidol reduces postoperative vomiting in paediatric day surgery.

In a prospective, randomized, blind study, we assessed the effectiveness of droperidol 20 micrograms kg-1 i.v., given at induction of anaesthesia, in preventing postoperative vomiting in paediatric day-case patients. We studied 270 children, aged 1-15 yr, undergoing body surface surgery. There was a significant reduction in the incidence of vomiting in the recovery room (1.4% vs 9.2%, P < 0.005) and in the day ward (9.4% vs 18.3%, P < 0.05) in patients receiving droperidol. There was no significant difference on the journey home (9.5% vs 17.83%, ns) or at home (16.7% vs 10.3%, ns). There was also a reduction in the severity of vomiting in the droperidol group. There were no adverse side effects.

Adolescent↗
PubMed1995

Influence of piroxicam coadministration on pharmacodynamic parameters and the plasma concentration/effect relationship of recombinant hirudin (CGP 39393).

Recombinant hirudins are currently under investigation for use in myocardial infarction and unstable angina. In this study the influence of piroxicam on the pharmacodynamics and pharmacokinetics of a recombinant hirudin preparation (CGP 39393) administered intravenously was determined. Twelve healthy, male volunteers received piroxicam 10 mg and matching placebo once daily for 12 days according to a double-blind, randomised cross-over design. On the 12th day, the dose of piroxicam was followed by a 6-hour infusion of hirudin 0.1 mg.kg-1.h-1. Plasma concentrations and urinary excretion of hirudin and repeated measurements of the activated partial thromboplastin time (APTT), bleeding time and platelet adhesion index were assessed up to 24 h after the start of the infusion. The maximum APTT was 83 s (placebo) and 84 s (piroxicam), 3 to 4 h after the start of the infusion, and was comparable on both study days. The AUD0-24 (APTT) came to 913 s.h.kg-1 under placebo and it was slightly increased to 1,017 s.h.kg-1 after piroxicam; the 95%- confidence interval according to MOSES ranged from 0.97 to 1.24, and the point estimator was 1.10. Bleeding time was significantly prolonged from 290 s under placebo to 345 s under piroxicam before the start of the infusion of hirudin. No further prolongation was found during or after the infusion. No change was observed in the platelet adhesion index. Responsiveness parameters according to a sigmoidal Emax-model were obtained from the hirudin-plasma concentration/effect (i.e. APTT-prolongation)-curves after placebo and piroxicam.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1999

A comparison of subcutaneous morphine and fentanyl in hospice cancer patients.

This study compares subcutaneous (s.c.) morphine and fentanyl with respect to pain control and side effects using a 6-day randomized, double-blind, cross-over design. Results were obtained from 23 patients (12 males and 11 females: mean age of 70.5 years) who could tolerate morphine. Thirteen patients were randomized to receive morphine for the first 3 days followed by fentanyl; 10 received fentanyl first followed by morphine. There were no significant differences in the scores for pain between the two drugs, suggesting that fentanyl is equally efficacious and the conversion ratio of morphine 10 mg: fentanyl 150 micrograms is appropriate. Patients had more frequent bowel movements during days 4-6 while on the fentanyl arm [t-test, df (22), P = 0.015]. Other measures for nausea, delirium, and cognitive function showed no differences between the two drugs. This study highlights the need to further assess the role of various opioids in hospice patients, and emphasizes the requirement for sensitive and simple cognitive tests in this population.

Aged↗