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At least 289 records · Page 16Linked to original sources
PubMed1999

Randomized, double-blind study of short-course (5 day) grepafloxacin versus 10 day clarithromycin in patients with acute bacterial exacerbations of chronic bronchitis.

The efficacy and safety of grepafloxacin were compared with clarithromycin in a randomized, double-blind, multicentre clinical trial of 805 patients with acute bacterial exacerbations of chronic bronchitis (ABECB). Patients were randomized to receive grepafloxacin 400 mg od for either 5 (n = 273) or 10 days (n = 268) or clarithromycin 250 mg bd for 10 days (n = 261). Patients were assessed pre-treatment, 3-5 days during treatment, 1-3 days post-treatment and at follow-up (21-28 days post-treatment). The clinical success rates for the evaluable patients were 91% in the 5 day grepafloxacin group, 95% in the 10 day grepafloxacin group and 86% in the clarithromycin group. At follow-up, respective rates were 72%, 81% and 73%. A total of 513 pathogens were isolated from the pre-treatment sputum specimens of 400 (49%) patients. The primary pathogens were Haemophilus influenzae (36% of isolates), Haemophilus parainfluenzae (27%), Moraxella catarrhalis (12%), Streptococcus pneumoniae (11%) and Staphylococcus aureus (3%). Pathogens were eradicated or presumed eradicated at post-treatment in 85%, 91% and 58% of evaluable patients treated with grepafloxacin for 5 days, grepafloxacin 10 days and clarithromycin 10 days, respectively. The eradication rates in both grepafloxacin groups were significantly greater than the clarithromycin group (P<0.001). All treatments were well tolerated and incidence of drug-related adverse events in each group was comparable. This study demonstrates that both a 5 and a 10 day regimen of grepafloxacin 400 mg od are as clinically and bacteriologically effective as in the treatment of ABECB clarithromycin 250 mg bd. for 10 days.

Acute Disease↗
PubMed1994

A double-blind controlled study of intramuscular zuclopenthixol acetate and liquid oral haloperidol in the treatment of schizophrenic patients with acute exacerbation.

We carried out a 9-day double-blind clinical trial comparing intramuscular zuclopenthixol acetate with liquid oral haloperidol in the treatment of 40 newly admitted schizophrenic patients with acute exacerbation. A parallel-group design was used with stratification by sex. Zuclopenthixol acetate (50 to 150 mg) was given intramuscularly every 3 days, whereas liquid haloperidol (10 to 30 mg daily) was given orally three times a day, with supplementary doses of each medication given under double-blind conditions when needed for agitation. No other sedative drugs, including benzodiazepines, were administered. The mean daily dose was 18.9 mg for haloperidol as compared with a mean dose per 3 days of 117.6 mg for zuclopenthixol. The two treatments were found to be equally efficacious on the Brief Psychiatric Rating Scale and Clinical Global Impression Scale. Both drugs induced similar extrapyramidal side effects. However, more tremors were associated with zuclopenthixol as was a tendency for tardive dyskinesia to be unmasked at the end of the injection interval. Sedation was higher with zuclopenthixol acetate than with haloperidol. Serum creatinine phosphokinase levels were not significantly increased after zuclopenthixol injections. The results of this trial suggest that zuclopenthixol acetate given intramuscularly every second to third day offers an alternative to conventional liquid oral haloperidol in the management of acute schizophrenia.

Acute Disease↗
PubMed1980

Antihypertensive and renal effects of orally administered verapamil.

In 12 in-patients with moderate uncomplicated hypertension, maintained on constant sodium intake for 15 days, single-blind oral administration of verapamil 80-160 mg t.i.d. for 10 days had a significant antihypertensive effect: in the supine position systolic blood pressure decreased from 177 +/- 5 to 150 +/- 3 mmHg, and diastolic pressure from 111 +/- 3 to 96 +/- 2 mmHg; standing values were similarly lowered from 171 +/- 7 to 143 +/- 4 mmHg, systolic, and from 118 +/- 4 to 97 +/- 2 mmHg, diastolic. The heart rate did not show any significant change (from 79 +/- 3 to 77 +/- 2 beats/min, supine, and from 92 +/- 3 to 87 +/- 3 beats/min, upright). The antihypertensive effect was uniform throughout the day, being similar 2, 3, 6 and 8 h after administration of a dose. Dynamic exercise (75-100 watts on a cycle-ergometer) caused identical increases in arterial pressure and heart rate on the last day of placebo and again on the last day with verapamil, but the peak levels of systolic pressure reached during exercise were lower after verapamil than with placebo, because of the lower blood pressure before exercise. Reduction of arterial pressure by verapamil was not accompanied by increased plasma renin activity, or by renal retention of sodium and water: there was a small increase in sodium excretion, at least during the first days of verapamil administration (from 107 +/- 15 to 113 +/- 15 mEq Na+/day), and a slight significant reduction in body weight (from 74.2 +/- 3.7 to 73.5 +/- 3.7 kg). It is concluded that oral administration of verapamil significantly lowers blood pressure without simultaneously inducing cardiac stimulation, renin secretion or salt and water retention.

Adult↗
PubMed1993

A pilot study of oral physostigmine plus yohimbine in patients with Alzheimer disease.

Effective symptomatic treatment of Alzheimer's disease (AD) may require a combination of agents that augment cholinergic as well as noradrenergic neurotransmission. We conducted a pilot study of physostigmine plus oral yohimbine challenge in AD. Ten patients were enrolled in a 12-day double-blind protocol. Each patient received placebo q2h while awake for 5 days, followed by physostigmine 2 mg q2h while awake for 7 days. During each of these drug conditions, yohimbine challenges were administered at oral doses of 10 and 20 mg in a placebo-controlled manner. There was no significant improvement in Alzheimer's Disease Assessment Scale test performance for six patients for whom complete cognitive data were obtained for the 6 challenge days. Nine patients tolerated the protocol with no clinically significant changes in blood pressure, pulse, or electrocardiogram (ECG), and no cardiovascular, gastrointestinal, or autonomic toxicity. One patient complained of chest discomfort associated with tachycardia, a modest rise in blood pressure, and had t-wave inversion in a single precordial lead. These signs and symptoms resolved within a few hours. Serial ECG tracings and cardiac enzymes revealed no evidence of myocardial injury. This pilot study did not reveal major cognitive improvement with this regimen, but underscores the importance of careful cardiovascular monitoring during future combined cholinergic-noradrenergic therapies in AD.

Administration, Oral↗
PubMed1998

A double-blind comparison of terazosin and tamsulosin on their differential effects on ambulatory blood pressure and nocturnal orthostatic stress testing.

OBJECTIVES: This single-centre, double-blind, randomized parallel-group study compared ambulatory blood pressure (AMBP) and heart rate (HR) profiles and responses to orthostatic testing (OT) for recommended regimens of tamsulosin (TAM, modified release formulation) and terazosin (TER), two alpha1-adrenoceptor antagonists that differ in their selectivity for alpha1-adrenoceptor subtypes, pharmacokinetic properties and recommended posology for the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). METHODS: 50 elderly normotensive male volunteers (mean age 68 years, range 61-78; 27 had LUTS) entered a single-blind 24-hour placebo run-in followed by a 15-day double-blind treatment in which the TER group received a 1-week treatment with 1 mg, then 1 week with 2 mg and finally a last dose of 5 mg, each dose administered once daily in the evening, while TAM subjects received 0.4 mg once daily after breakfast throughout. Subjects had AMBPs and OT while hospitalized on four occasions: during the placebo run-in and subsequent to the first dose of 1, 2 and 5 mg TER or at corresponding times under TAM. Regular OT (blood pressure after 5 min supine and after 2 min standing) was carried out between 6:00 and 6:30 a.m.; 'nocturial' OT took place whenever the subject had to leave the bed at night to void. RESULTS: The baseline blood pressure values were slightly higher in the TAM group, but under treatment there was little difference between the treatments with regard to circadian changes in AMBP and HR. Under TER, there were 10 incidents of symptomatic hypotensive OT in 9 subjects (2 with syncope); furthermore, there were 24 events of asymptomatic exaggerated (> or = 20 mm Hg) decrease in systolic blood pressure in 12 subjects. With TAM in contrast, there was only 1 subject who experienced symptomatic hypotensive OT on 3 occasions (this subject had a previous history of vertigo and ought not to have been included); 7 subjects on TAM showed 16 incidents of asymptomatic hypotensive OT. The difference between TER and TAM was statistically significant for the number of subjects with positive symptomatic OT (p = 0.011). CONCLUSION: Once-daily dosing of TAM after breakfast at a fixed dose level (0.4 mg) offers a more efficient protection against undesired cardiovascular extension effects in the normotensive elderly treated for LUTS suggestive of BPO than the usually recommended treatment schedule of TER with step-up doses (1-5 mg) administered at night.

Adrenergic alpha-Antagonists↗
PubMed2005

Topical ketoprofen patch in the treatment of tendinitis: a randomized, double blind, placebo controlled study.

OBJECTIVE: To evaluate the efficacy and tolerability of ketoprofen patch in the treatment of tendinitis. METHODS: A multicenter, 14 day, randomized, double blind placebo controlled trial of a once-a-day ketoprofen 100 mg patch in symptomatic tendinitis of recent onset, not requiring orthopedic or surgical treatment. Pain on daily activities scored on a 100 mm visual analog scale was the primary efficacy criterion. Other criteria were spontaneous pain at rest, pain on full passive motion, pain relief, and pain intensity assessed twice daily by the patient (calculation of total pain relief and summed time-weighted pain intensity difference). Statistical analysis was performed on the differences between the 2 groups in the intention-to-treat population. RESULTS: One hundred seventy-two patients were included. Good compliance was obtained in 98% of patients. Twenty-six patients (15%) discontinued the study mainly because of adverse events, inefficacy, or cure. Decrease in pain after one week of treatment (primary criterion) was -38.4 +/- 25.6 mm (56%) and -25.8 +/- 24.5 mm (37%) in the ketoprofen and placebo groups, respectively (p = 0.0013). The differences of the secondary criteria during the trial between the 2 groups were significant more often than not. Tolerance was considered satisfactory in both groups, most adverse events reported being local reactions: 47 versus 44 were possibly or probably related to treatment in the ketoprofen and placebo groups, respectively. These local skin reactions resolved spontaneously and rarely led to premature termination of treatment. CONCLUSION: This trial suggested that a 3-14 day course of treatment by ketoprofen patch is useful in nonarticular rheumatisms, the duration of treatment depending on the results obtained. The safety profile revealed no unexpected adverse events.

Administration, Topical↗
PubMed1986

Three-day and seven-day treatment in acute otitis media: a double-blind antibiotic trial.

Ninety-six children with acute otitis media were randomized into a double-blind general practice trial of three-day and seven-day courses of cefaclor 125 mg tds. These regimens were equally effective in terms of resolution of symptoms and signs of otitis media, even in children presenting with bulging of the tympanic membrane. There was no difference between the groups in the recurrence of middle-ear infection during the six weeks after entry to the trial. The results provide further evidence about the effectiveness of short courses of antibiotics for children with presumed middle-ear infection.

Acute Disease↗
PubMed1975

Potentiation of hypoglycemic effect of sulfonylureas by halofenate.

We investigated the possibility of a drug interaction between the antilipemic agent halofenate and sulfonylureas. Twelve young, healthy men were given 1 g of tolbutamide by mouth before and after 12 days of double-blind treatment with 1 g per day of halofenate, or placebo. There was a significant increase in serum tolbutamide at eight, 10 and 12 hours (P less than 0.01) and a significant (P less than 0.01) decrease in serum glucose at one, four and six hours after halofenate treatment, but not after placebo. In a long-term, double-blind study of halofenate or clofibrate treatment of patients with Type IV hyperlipoproteinemia, diabetic patients receiving a sulfonylurea and halofenate either required a reduction in the dose of the sulfonylurea or demonstrated significantly improved control of hyperglycemia (P less than 0.05) or both. No appreciable decrease in serum glucose levels was noted in diabetic patients receiving sulfonylurea and clofibrate. This interaction between halofenate and sulfonylureas is clinically important, especially in view of the association of hyperlipemia and diabetes.

Adult↗
PubMed1982

Effects of supidimide in schizophrenic inpatients undergoing neuroleptic maintenance therapy with haloperidol.

Forty schizophrenic inpatients, on constant low-dosage maintenance therapy with haloperidol, entered a superimposed, double-blind, placebo-controlled clinical trial with supidimide 2 x 200 mg per day. The double-blind phase lasted 5 days and was preceded and followed by single-blind base line and washout periods, respectively, during which all patients received matching placebos. The therapeutic effects were evaluated by BPRS, NOSIE, a post-sleep questionnaire, and, in a subgroup of patients, by objective monitoring of movements during sleep. Supidimide substantially relieved sleep disturbances, as demonstrated by subjective (p less than 0.05; n = 20) and objective (p less than 0.1; n = 3) measurements. In addition, the following drug-related effects (p less than 0.05 versus base line and placebo) on daytime behaviour were observed: a decrease in "somatic concern" (BPRS), items related to agitation (BPRS), "irritability" and "manifest psychosis" (NOSIE), and a slight increase in "retardation" (NOSIE). No adverse effects attributable to supidimide were detected. It is concluded that supidimide exerts beneficial effects on day-time behaviour and sleep in agitated schizophrenic patients undergoing low-dosage maintenance neuroleptic therapy.

Adult↗
PubMed1998

Venlafaxine's effects on healthy volunteers' driving, psychomotor, and vigilance performance during 15-day fixed and incremental dosing regimens.

Effects of venlafaxine, an antidepressant acting by selective serotonin and norepinephrine reuptake inhibition with a potency ratio of 5:1, were assessed in a standardized, actual driving test, a battery of psychomotor tests (Critical Flicker/Fusion Frequency, Critical Tracking, Divided Attention), and a 45-minute vigilance test (Mackworth Clock). Thirty-seven healthy volunteers, 22 of whom completed the study, received venlafaxine in fixed (37.5 mg twice a day) and incremental (37.5-75 mg twice a day) doses as well as mianserin (10-20 mg three times a day) and placebo according to a 4-period (15 days each), double-blind, crossover design. Testing occurred on days 1 and 7 and after dose increments, on days 8 and 15. Plasma concentrations of venlafaxine and its active metabolite were measured on test days for confirming compliance. Venlafaxine had no significant effect on the primary driving parameter (standard deviation of lateral position) and failed to impair psychomotor performance. Mianserin profoundly and consistently impaired driving and psychomotor performance. However, both drugs significantly impaired vigilance performance. Maximal effects occurred on day 1 with mianserin and similarly on day 7 with venlafaxine in both series. The increment in venlafaxine's dose on day 8 did not increase this effect. The drug's selectively impairing effect on vigilance is shared by other "serotonergic" anxiolytics and antidepressants, suggesting that interference with 5-HT transmission reduces arousal in particularly monotonous tasks or environments. This study concludes that venlafaxine does not generally affect driving ability and should be safe for use by patients who drive.

Adult↗
PubMed2005

[The CNS damage due to methanol poisoning in the case of 23-year-old male patient addicted to organic solvents].

The aim of this study is the presentation of the case of acute methanol inhalation poisoning and CSN damage connected with this incidence. 23-years old male patient addicted to organic solvents for 5 years was admitted to the Toxicological Unit because of suspicion of organic solvents poisoning. In the case history the patient was exposed to organic solvents in the admission day, he denied drinking alcohol in last time. Phenol and TCA were not confirmed in the toxicological urine analysis. Because of marked metabolic acidosis which was present in the moment of admission subsequental toxicological investigations were conducted. The 0.23 g/l of methanol in blood was revealed. The vision loss was observed in the first day of hospitalization, up to total blind in the third day. Signs of toxic optic nerves neuropathy was revealed in ophthalmological examination. Brain perfusion disturbances in frontal and basal ganglia region was found in the brain perfusion scintigraphy examination. In the 6 month follow up outpatient observation, the partial vision recover was noted. The normalisation of frontal brain perfusion in the perfusion scintigraphy was found. Until now, there is no explanation the route of methanol intoxication--it could be suspect, that the solvents inhaled by patient were contaminated with methyl alcohol.

Acidosis↗
PubMed1993

[Effects of inhaled beta-adrenergic and anticholinergic drugs on respiratory function and arterial blood gases in patients with pulmonary emphysema].

We studied the effects of inhaled anticholinergic (oxitropium bromide, 0.2 mg) and beta-adrenergic (fenoterol 0.4 mg) drugs on respiratory function and arterial blood gases in fourteen male patients with pulmonary emphysema (age 63 +/- 8 years; FEV1/FVC 1.41 +/- 0.73 L) using a three day, randomized, double-blind placebo-controlled design. Each day, spirometry and arterial blood gas analyses were performed before and 45 min after inhalation. Both fenoterol and oxitropium bromide significantly improved FEV1 by 21% and 16%, respectively, although there was no significant difference between the two drugs. However, the mean value of PaO2 significantly decreased from 74.5 +/- 2.6 to 69.3 +/- 2.7 Torr with fenoterol, but not with oxitropium and placebo. Change of PaO2 with fenoterol was significantly correlated with %FRC, but not with FEV1 nor change of FEV1. We therefore conclude that an anticholinergic inhalant bronchodilator is more favorable for patients with COPD than a beta-adrenergic agent.

Adrenergic beta-Agonists↗
PubMed1996

Once-daily, 3-day azithromycin versus a three-times-daily, 10-day course of co-amoxiclav in the treatment of adults with lower respiratory tract infections: results of a randomized, double-blind comparative study.

A 3-day regimen of azithromycin (500 mg once daily) and a 10-day regimen of co-amoxiclav (625 mg three times daily) were compared in a double-blind study of 67 patients with acute infectious exacerbations of chronic bronchitis (AIECBs, n = 54), acute bronchitis (n = 7), or pneumonia (n = 6). In patients treated with azithromycin, satisfactory clinical responses (cure or improvement) were seen in 24/28 (86%) patients with AIECBs, 2/4 (50%) with acute bronchitis and 2/2 (100%) with pneumonia. Responses were satisfactory in 24/26 (92%), 4/4 (100%) and 4/4 (100%) patients, respectively, receiving co-amoxiclav. Streptococcus pneumoniae and Haemophilus influenzae were the commonest pathogens isolated at baseline. At the end of treatment, baseline pathogens were eradicated in 9/10 microbiologically-assessable patients treated with azithromycin and in 10/10 treated with co-amoxiclav. Adverse events related or possibly related to treatment occurred in five patients in each treatment group; the majority of these events affected the gastrointestinal system. One patient in each treatment group discontinued therapy because of adverse events. The study, therefore, demonstrates that 500 mg azithromycin administered once daily for 3 days is as efficacious and well tolerated as co-amoxiclav given three times daily for 10 days in the domiciliary treatment of adults with acute lower respiratory tract infections.

Adolescent↗
PubMed1993

Amlodipine once a day in stable angina: double-blind crossover comparison with placebo.

Although calcium antagonists form a mainstay of therapy in patients with angina pectoris, the currently available agents have significant limitations. Nifedipine, diltiazem, and verapamil are all high-clearance agents with significant hepatic extraction and rapid clearance, leading to limited and short-lived bioavailability necessitating frequent daily administration. In contrast, amlodipine, a dihydropyridine calcium antagonist, has a long half-life of 35-50 h (compared with 3 to 4 h elimination half-life of diltiazem, verapamil, and nifedipine). After oral doses, the relative bioavailability of amlodipine is high (64%) and absorption is smooth, with peak plasma levels being achieved 6-12 h postdose. Bioavailability is not affected by the consumption of food. In common with other dihydropyridine calcium antagonists, amlodipine is eliminated mainly by metabolism. None of the metabolites of amlodipine has significant calcium antagonist effects in humans. In contrast to verapamil or diltiazem, amlodipine has no effect on sinus or atrioventricular node and little or no effect on the resting heart rate. Amlodipine does not have any appreciable negative inotropic effect with the relevant clinical dose. Other clinical studies have shown amlodipine to be effective when used once-daily in chronic stable angina and vasospastic angina. Comparative studies indicate that the antianginal efficacy of amlodipine is comparable to the beta blocker nadolol and the benzothiazepine calcium antagonist diltiazem. Amlodipine has also been found to provide improved antianginal effects when combined to treatment with beta blockers and/or long-acting nitrates. Treatment with amlodipine either as monotherapy or combined with other antianginal therapy for up to 26 weeks shows that efficacy is maintained, with no evidence of tolerance.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1982

Rapid and substantial lowering of human serum cholesterol by mevinolin (MK-803), an inhibitor of hydroxymethylglutaryl-coenzyme A reductase.

Mevinolin (MK-803) is a potent inhibitor of HMG-CoA reductase. After a placebo run-in period, mevinolin 5,15 or 50 mg, or placebo was given twice daily for 7-11 days under double -blind conditions ot 4 groups of 6 normocholesterolemic male volunteers. After 7 days, mean serum cholesterol fell 14%, 25% and 24% on 5, 15 and 50 mg, respectively, which was significantly greater than the fall on placebo (4%) in the case of the two higher doses (P less than 0.01). Serum triglycerides did not change significantly. Mevinolin was generally well-tolerated and there were no serious adverse effects.

Adult↗
PubMed1994

NMDA receptor blockade and spinal cord ischemia due to aortic crossclamping in the rat model.

Recent brain research proposes that, during ischemia, synaptically released excitatory amino acid neurotransmitters accumulate at toxic concentrations with ensuing neuronal death. Their action is mediated by the receptor subtype N-methyl-D-aspartate (NMDA). The protective effect of NMDA receptor blockade with intrathecal MgSO4 and MK-801 was investigated during spinal cord ischemia induced by aortic occlusion of 12 minutes. Male Sprague-Dawley rats, 250-300g, underwent intrathecal administration of 20 microL of normal saline (SA n = 16), MgSO4 1M (MG n = 16), or MK-801, 25 mM solutions (MK n = 16) in a randomized order. After 2 hours, the animals underwent occlusion of the thoracic aorta and subclavian arteries for 12 min. An additional control group (CO n = 16) underwent occlusion for 12 minutes, without intrathecal injection. The animals were scored according to their functional performance (LS = lesion score) each day for four days by a blinded observer. Mean LS were calculated for each group at a given day. Treatment and control groups were not different at day 1 (P = 0.302). Group MG was improved from groups SA (P = < 0.0039) and CO (P = < 0.0048) at day 4. This study demonstrates that although intrathecal NMDA receptor blockade with MgSO4 or MK-801 does not prevent paraplegia due to spinal cord ischemia in the rat, it could however influence the rate of recovery after ischemic injury.

Animals↗
PubMed1998

Spinal anaesthesia for paediatric day-case surgery: a double-blind, randomized, parallel group, prospective comparison of isobaric and hyperbaric bupivacaine.

We have compared bupivacaine 5 mg ml-1, either isobaric in saline 0.9% or hyperbaric in 8% glucose, for spinal anaesthesia in 100 children, aged 2-115 months, in a double-blind, randomized, parallel group, prospective study. Children were premedicated with diazepam 0.5 mg kg-1 orally. Seventy-two children were sedated before, and 25 children after, lumbar puncture, with either propofol or thiopental (thiopentone). After lumbar puncture in the lateral decubitus position with a 24-27-gauge paediatric spinal needle, isobaric or hyperbaric bupivacaine 5 mg ml-1 was injected in a dose of 0.3-0.5 mg kg-1 using a blinded procedure. Maximum cephalad extent of the block was tested by transcutaneous electrical stimulation. The success rate of the block was greater with hyperbaric bupivacaine (96%) compared with isobaric bupivacaine (82%) (P = 0.025, 95% confidence intervals (CI) 0-28%). Intense motor block was associated with adequate sensory block. Spread and duration of sensory block showed a similar wide scatter in both groups. The highest median level of sensory block was T4 (range T1-12) in the isobaric group and T4 (T1-7) in the hyperbaric group. Times to two segment regression of block were similar: 80 (55-190) min in the isobaric and 80 (30-190) min in the hyperbaric group. Cardiovascular stability was good. Etilefrin was administered to one child to treat hypotension and atropine to one child to treat bradycardia. The study gave an impression of a delayed onset time of spinal block, as most of the nine children who required either fentanyl or a sedative for a mild reaction to skin incision had complete block when transferred to the recovery room after operation. Five children developed a mild, position-dependent headache.

Ambulatory Surgical Procedures↗