bluuebunny/crossref_metadata_2025 huggingface dataset:
Crotamiton Cream and Lotion in the Treatment of Infants and Young Children with Scabies
Authors: Konstantinov D , Stanoeva L , Yawalkar S J
Published: January 2017

Fifty hospitalized infants and small children in the age-group of 3 months to 2 years admitted with scabies were treated with 5 applications of either 10% crotamiton cream or lotion on consecutive days. In this trial, the second to be performed exclusively in infants and young children, an improvement in itching was observed in all patients within 3 days of starting the treatment and the examination on Day 7 showed absence of skin lesions in all patients. Crotamiton cream as well as lotion rendered a 100% cure rate. All patients, including those having secondary pyoderma and/or eczematization tolerated the treatment with crotamiton cream and lotion well and no adverse reactions, either due to the topical application or to the transcutaneous systemic absorption of crotamiton, were reported. Post-treatment laboratory investigations did not reveal any unwanted effect due to transcutaneous systemic absorption of crotamiton on the blood, kidneys or liver.

Crotamiton is the only scabicide available today which displays not only antipruritic but also marked antibacterial properties. It is especially indicated in the treatment of scabies in children as they are very prone to secondary bacterial infection following scratching. In view of its good efficacy and excellent tolerability the 5-application treatment schedule, with crotamiton cream applied to the whole body from the chin downward, can therefore be recommended as an optimum form of treatment for scabies in infants and young children.
A Comparison of Three Injectable Corticosteroids for the Treatment of Patients with Seasonal Hay Fever
Authors: Ohlander Bengt O , Hansson Roy E , Karlsson Karl-Erik
Published: January 2017

Three injectable corticosteroids, betamethasone dipropionate betamethasone disodium phosphate and betamethasone acetate, and methylprednisolone acetate, were compared for onset and duration of action in patients with severe seasonal allergic rhinoconjunctivitis. The sixty patients who were entered into the trial had been well-studied in our allergy clinic. They were assigned, on the basis of a random number code, to treatment with one of the corticosteroids. Following a single intramuscular injection with one of the preparations, plasma Cortisol and blood glucose concentrations also were compared at days 1, 2-3, 5-7 and 14. All three preparations improved the nasal symptoms. There were no individual differences with respect to onset or to duration of action. However, there were some differences in the effects on endogenous Cortisol production and on blood glucose levels. Two of the preparations, betamethasone dipropionate and methylprednisolone acetate, suppressed endogenous Cortisol for more than 14 days, while betamethasone phosphate/acetate did not suppress Cortisol beyond 12 days. Betamethasone dipropionate produced a moderate increase in blood glucose concentrations for the first two days after administration; betamethasone phosphate/acetate caused an increase for one day and methylprednisolone acetate had no effect.
Treatment of Localized Dermatoses with Intralesional Betamethasone Dipropionate
Authors: Lodolo Juan C
Published: January 2017

Intralesional administration of betamethasone dipropionate, 5 mg/ml, was a safe and effective method of treating resistant localized lesions of patients with steroid-responsive dermatoses. Following a single injection, three-quarters of the patients had a good to excellent response which was maintained for the eight-week follow-up period.
The Efficacy of Hydrocortisone in Different Ointment Bases
Authors: Ludvigsen Knud , Hallinger Lise
Published: January 2017

A study was designed to ascertain whether hydrocortisone 1% in a recently formulated ointment base was as efficacious as a well established hydrocortisone ointment formulation. There was no difference in the results of any observed parameter. It is concluded that Hydroderm ointment base is as good as previously used vehicles. It has the additional benefit of being hypo-allergic.
Usefulness of Caerulein in the Treatment of Post-Operative Intestinal Atony
Authors: Montero V Ferreira , Laganga A Martinez , Garcia E Aznar
Published: January 2017

We conducted a controlled clinical trial designed “to test caerulein for tolerability and effectiveness in post-operative patients recovering from abdominal surgery. The test product was administered 24 hours after surgery, by intravenous drip infusion, at the rate of 2 nanograms/kg/minute. The results were compared with parallel observations made in a matched group of patients receiving no drugs or manipulation likely to promote intestinal peristalsis with the exception of the application of a nasogastric tube for aspiration and the water and electrolyte replenishment customary in the post-operative period.

The results of this study evince a clear-cut difference between the two groups of patients in regard to the restoration of intestinal peristalsis and the passing of flatus and faeces, as confirmed by statistical analysis (Cochran's test) demonstrating the significant (p<0.01) superiority of caerulein treatment relative to the untreated control group.

Likewise, the study revealed the excellent tolerability of the test drug at the dosage employed.
A Study to Determine the Effect of Betadine Vaginal Cleansing Kit on Cervical Flora after Insertion of an Intra-Uterine Contraceptive Device
Authors: Obaidullah M
Published: January 2017

Twenty-four women with negative high vaginal swabs, who attended for insertion of an intra-uterine contraceptive device, were randomly allocated to two groups. One group used the Betadine Vaginal Cleansing Kit before and after insertion of the intra-uterine device; the other group did not use any cleansing agent. After 4 to 6 weeks, the patients were re-examined and a cervical swab was taken. The bacteriological findings were of interest and significance. In the study group there was bacterial growth in only one patient out of the twelve, whereas in the control group there was bacterial growth in ten out of the twelve.

The bacteria grown were of doubtful clinical significance, but in certain circumstances they could take a pathogenic role. The marked absence of bacterial growth in the study group is significant because, during a 4 to 6 week period, the cervical mucus remained sterile thus minimizing the risk of pelvic infection during and immediately after insertion. Whether it has any significant effect in the long-term reduction of the incidence of pelvic infection remains to be seen, and further studies are needed.
A New Citrated Formulation of Nalidixic Acid (Mictral® U.K.) for the Treatment of Acute Cystitis
Authors: Dulake C , Adam G , Allenby F , Anderson A R , Clark-Jones A , Cure S M F
Published: January 2017

A 3-day course of a new citrated formulation of nalidixic acid (Mictral) was assessed in fifty-four women presenting with acute uncomplicated cystitis.

Over 96% of women with a significant Gram-negative bacteriuria were cured of the infection following a course of treatment. Only two relapses occurred in this group during the follow-up period. Relief of symptoms occurred in nearly 90% of infected patients and generally by the second day of treatment. Although the incidence of side-effects was about 20% they were not considered serious.
Effect of Pentoxifylline on Cerebral Blood Flow in Patients with Chronic Cerebrovascular Disease
Authors: Passero Stefano , Nardini Marcello , Battistini Noé
Published: January 2017

The effect of pentoxifylline on cerebral blood flow (CBF) was studied with the intravenous 133Xe clearance technique in eleven patients with chronic cerebrovascular disease. Pentoxifylline was administered orally at a dose of 1200 mg/day over a period of 30 days (eight patients) or by intravenous infusion of 100 ml saline containing 400 mg of the drug in 1 hour (three patients). CBF was measured before and after pharmacological treatment. CBF was found to be significantly increased by both acute and chronic administration of pentoxifylline.
Comparative Non-Blind Trial of Ceftriaxone and Gentamicin in the Treatment of Complicated Urinary Tract Infections
Authors: Lentini M , Castiello G , Scorza C , Calvosa F
Published: January 2017

Forty hospitalized patients with complicated urinary tract infections were treated with gentamicin 240 mg die i.m. or ceftriaxone, a new parenteral cephalosporin, 2 g die i.v. for 7 days.

Ceftriaxone gave good clinical and bacteriological results which were better than those obtained with gentamicin, showing also an appreciable activity in cases of infection due to problematic organisms.
Efficacy and Safety of a Non-Acetylated Salicylate, Choline Magnesium Trisalicylate, in the Treatment of Rheumatoid Arthritis
Authors: Rothwell K G
Published: January 2017

The results of three double-blind, multicentre trials are reviewed to compare the efficacy of acetysalicylic acid (ASA) and a non-acetylated salicylate, choline magnesium trisalicylate (CMT), in the treatment of rheumatoid arthritis. In each trial, patients were randomly assigned to receive comparable doses of salicylate as either ASA or CMT. Mean values for clinical indicators of rheumatoid arthritis (number of painful joints, articular index, number of swollen joints, swelling index, duration of morning stiffness) showed similar or greater improvement among groups of patients receiving CMT, compared to those receiving ASA. In addition, the incidence of gastro-intestinal side-effects was lower among patients receiving CMT.
Comparison between Fenoprofen and Ibuprofen in the Treatment of Soft-Tissue Rheumatism
Authors: Williams Wyn R
Published: January 2017

Fenoprofen calcium 600 mg, four times daily, and Ibuprofen 400 mg, four times daily, were compared in a double-blind crossover study involving the treatment of soft-tissue rheumatism in fifty patients.

After 7 days there was no significant deference between the efficacy of the two drugs with respect to ‘pain at rest', pain on movement', ‘tenderness’ or ‘sleep disturbance’ but fenoprofen was significantly better when considering ‘limitation of movement’ and ‘The physician's assessment of the severity of the condition'.

Combining data from Weeks 1 and 2 of treatment, 14 days fenoprofen treatment brought about significant improvements in all of the above parameters. Ibuprofen did not significantly improve ‘pain at rest’ but did improve the other parameters.
Indoprofen and Pentazocine in Post-Traumatic Pain. A Double-Blind, Parallel-Group Comparative Trial
Authors: Soave G , Lavezzari M , Ferrati G , Sacchetti G
Published: January 2017

In a double-blind, randomized, parallel-group study involving sixty patients with severe pain due to fractures, the analgesic activity of indoprofen and pentazocine was evaluated. Each patient received one of the following treatments in random order: indoprofen 400 mg i.v., pentazocine 30 mg i.v., placebo.

The analgesic effect was measured by rating the intensity of pain before treatment and after 1/2, 1, 2, 4 and 6 hours. Patients' final opinions on efficacy were assessed on the basis of categoric and visual analogue scales. Highly significant differences were found between the active drugs and placebo for all variables analyzed. Indoprofen was significantly superior to pentazocine when assessed through variables measuring total analgesic effects. Since both drugs were well tolerated, i.v. indoprofen appears to offer an effective and safe alternative to narcotic analgesics in acute pain due to fractures.
A Study on the Treatment of Arterial Hypertension with Atenolol/Chlorthalidone Tablets: Preliminary Results of a Post-Marketing Surveillance Clinical Trial on 2449 Patients
Authors: Emanueli A , Born A , Lavezzari M
Published: January 2017

A post-marketing clinical trial was carried out in ambulatory patients to assess the efficacy and toleration of atenolol (100 mg)/chlorthalidone (25 mg) tablets in the treatment of arterial hypertension. Data are reported on a cut-off at 2449 patients. Analysis of results in the different age groups has shown that after 4 weeks of treatment there was a mean fall of 16–17% in systolic and of 16–18% in diastolic blood pressure. Adequate blood pressure reduction was obtained for all age groups. The frequency of adverse reactions/events was low, these being reported in only 5·7% of cases. As discontinuation of treatment on account of adverse reactions/events occurred in 3·8% of patients, the risk-to-benefit relationship of atenolol/chlorthalidone tablets was very favourable.
Amoxicilline Orale dans les Méningites Purulentes de l'Enfant: Relais Précoce et Réduction de la Posologie
Authors: Tazi-Lakhassi L , Benbachir M , Mdaghri N El , Zaghloul J
Published: January 2017

The pharmacokinetics of amoxycillin in the CSF following intravenous and oral administration at a 150 mg/kg per day or 250 mg/kg per day dosage in the treatment of purulent meningitis is described.

A significant correlation between meningeal inflammation and CSF levels of amoxycillin were observed, including a correlation between the initial neurological state and the outcome of the Illness.

Despite the early introduction of oral therapy and the reduction in dosage following meningeal and pneumococcal meningitis, no treatment failures could be attributed to this therapeutic regime. Such a treatment schedule, moreover, reduces the risk of superinfection in hospital as well as the cost of treatment and aids the comfort to the patient.

La pharmacocinétique de l'amoxicilline dans le liquide céphalo-rachidien suivant des administrations intra-veineuses et orales de 150 mg/kg/j ou 250 mg/kg/j lors des méningites purulentes est décrite.

Une corrélation significative entre l'inflammation méningée et les taux intra-rachidiens d'amoxicilline, de même entre l'état neurologique initial et l'issue de la maladie sont observées.

En dépit de la précociteé du relais oral, et de la réduction des posologies lors des méningites à méningocoque, et pneumocoque, aucun échec ne peut être attribué à ce protocole thérapeutique. Ce protocole efficace réduit de plus les risques de surrinfections hospitalières et le coût du traitement, et augmente le confort du malade.
A Clinical Comparison of Pivmecillinam plus Pivampicillin (Miraxid) and a Triple Tetracycline Combination (Deteclo) in Respiratory Infections Treated in General Practice
Authors: Beatson J M , Marsh B T , Talbot D J
Published: January 2017

Seven-day courses of either pivmecillinam 200 mg plus pivampicillin 250 mg (Miraxid) or a combination of tetracycline hydrochloride, Chlortetracycline hydrochloride and demeclocycline hydrochloride (Deteclo) 300 mg, both given twice daily, were compared in a multicentre general practice study in 408 patients with symptoms of upper or lower respiratory tract infection. Patients were stratified into four diagnostic groups: sinusitis, otitis media, throat infections, and acute bronchitis and randomly allocated to treatment within these groups. Assessment at 7 days showed no difference in clinical efficacy between the two treatments where 193 of the 208 infections receiving Miraxid (93%) were rated as either cured or improved compared with 181 of the 201 infections treated with Deteclo (90%). At 7 days, the percentage of patients completely free of symptoms was the same for both groups (66%). The mean time for symptoms to clear was 3·9 days in the Miraxid group and 4·0 days in the Deteclo group. Side-effects were reported by significantly fewer patients in the Miraxid group (9·3%) than the Deteclo group (17·5%) (p< 0·05) and six patients in the latter group failed to complete the course of treatment. Miraxid given twice daily for respiratory tract infections is as effective as Deteclo but causes significantly fewer side-effects.
A General Practice Study Investigating the Effect of Minocin 50 mg b.d. for 12 Weeks in the Treatment of Acne Vulgaris
Authors: Cohen P M
Published: January 2017

In a multicentre general practice open study, 338 acne sufferers were treated with Minocin 50 mg b.d. (254 for 12 weeks).

A highly significant improvement trend (p < 0·0001) was found following analysis of visual analogue scales measuring (i) severity of acne, (ii) area covered by acne, (iii) number of inflamed lesions, (iv) density of acne lesions. Over all, 79% of patients thought the therapy to be effective or very effective; 70% of patients continued on the same therapy after the study period.

Mean first improvement was noted by the patients after 4 ½ weeks of treatment.

One hundred and twenty-two patients had taken prior oxytetracycline therapy, of these, ninety-four (77%) stopped Oxytetracycline therapy because of lack of efficacy. After treatment of these Oxytetracycline failures with Minocin, a highly significant improvement trend (p < 0·0001) of acne was again seen. In this group, 75% of patients thought the Minocin therapy to be effective or very effective; 69% continued Minocin therapy after the study period. In all, 74% of patients having received prior Oxytetracycline thought that Minocin therapy was better than their previous therapy.

Ninety-three patients had received either no previous therapy or topical therapy alone. Once again Minocin treatment resulted in a highly significant improvement trend (p < 0·0001) in the severity of acne. Seventy-six (82%) of these patients thought that Minocin therapy was effective or very effective. A total of 73% of patients continued with Minocin therapy following the study period.

Adverse events were noted in 6% of patients. Of these, 3% were definitely drug-related and only six (2%) of patients left the trial because of adverse reactions. None of the adverse reactions reported were serious in nature.

Minocin therapy has been shown to be a highly effective treatment for acne resulting in a rapid onset of action and good patient tolerance. Marked efficacy was seen even in those patients who had previously failed on Oxytetracycline treatment.
Comparison of the Efficacy of Furosemide with Two Furosemide-Triamterene Combinations in the Treatment of Cardiac Insufficiency
Authors: Saarimaa Heikki , Ojasalo Tapani
Published: January 2017

Nine patients suffering from cardiac insufficiency were given furosemide and two furosemide-triamterene combination products in random order. A statistically significant diuretic response was achieved with all these preparations. The combination of furosemide and triamterene brought about a ‘softer’ diuresis, no hypokalemia and the advantage of dosage as only one tablet, thus eliminating the need for taking two separate drugs.
Food Poisoning — Fact or Fiction?
Authors: Ackerley Lisa M , Jones Alan
Published: January 2017

The Communicable Disease Report number 84/52 has given a clear indication that Campylobacter infections are now the most significant reported causes of gastrointestinal infection. The figures given indicate approximately 22,000 Campylobacter infections in 1984 as opposed to approximately 14,000 Salmonella infections, with, more importantly, the trend increasing with regard to Campylobacter, and decreasing with regard to Salmonella infections.

Campylobacter enteritis would now appear to be a major problem both in terms of human suffering and in its economic effects. It is reported, for example, that at least 80,000 working days may be lost in the United Kingdom per year.

The fundamental problem raised by Campylobacter enteritis is whether we need to have a standardized definition of food poisoning accepted in law to allow central government and local authorities to manage in particular the problems related to Campylobacter enteritis.

From information available, it appears that local authorities have differing interpretations as to the classification and subsequent management of Campylobacter enteritis. In order to control the identified trend in the increase of Campylobacter infections, the need for a clear and explicit definition is rapidly becoming essential.
A Crossover Study of Clocapramine and Haloperidol in Chronic Schizophrenia
Authors: Yamagami S
Published: January 2017

Therapeutic efficacy and target symptoms with clocapramine were compared with those with haloperidol by the crossover method, in a total of 26 chronic schizophrenic patients, by administration of one of the drugs for the first 14 weeks and the other for the next 14 weeks. The final global improvement rating showed no significant difference between the two groups, but clocapramine administered as first drug appeared to have a more pronounced effect than haloperidol. According to the improvement rate in psychotic symptoms, clocapramine tended to be superior to haloperidol for motor retardation, scanty speech and disturbance of thought. In addition the frequency of side-effects was lower with clocapramine than with haloperidol. Neither the side-effects nor abnormal laboratory test results were severe enough to terminate the trial. Clocapramine is considered to be equivalent or superior to haloperidol in terms of anti-psychotic effect in chronic schizophrenia, and is relatively safer than haloperidol.
Human Calcitonin in the Management of Osteoporosis: A Multicentre Study
Authors: Maresca V
Published: January 2017

In a multicentre open trial 530 patients suffering from primary osteoporosis, secondary osteoporosis and Sudeck's disease were enrolled to assess synthetic human calcitonin efficacy on bone pain relief.

Spontaneous pain, pain on movement, provoked pain, functional impairment and patient's assessment were recorded.

During the first 30 days of treatment, all the parameters significantly improved (p < 0·01) and the tolerability was satisfactory. Four hundred and ten patients entered a follow-up study, this number gradually decreasing over a 6-month period due to a satisfactory outcome. Efficacy on bone pain remained very high in most of the patients, many of whom continued to improve. These results suggest that synthetic human calcitonin is highly effective on pain and functional impairment in bone disease and is well tolerated.
Sucralfate Compared with Ranitidine in the Short-Term Healing of Duodenal Ulcers
Authors: Lam K T , Lai S T , Kan Y S , Chan A Y T
Published: January 2017

The efficacy of sucralfate (1 g four times daily) and ranitidine (150 mg twice daily) in the short-term healing of duodenal ulcers has been assessed in a randomized single-blind trial involving 104 patients with three drop-outs. The healing rate at 3 weeks of 83% for sucralfate and 84% for ranitidine improved to 96% and 92%, respectively, at 6 weeks. The difference between the two treatment groups was not statistically significant. Smoking and male sex had no influence on the healing rates. Constipation was a prominent symptom in sucralfate treatment which was otherwise a safe and effective therapy.
Haemodynamic Abnormalities in Hypertensive Patients: A Review of the Influence of Vasodilating Drugs
Authors: Abshagen U , von Möllendorff E
Published: January 2017

Mean arterial pressure is determined primarily by cardiac output and total peripheral resistance, in addition to blood volume and compliance of the arterial system. The regulation of these determinants occurs via reflex neurogenic mechanisms and metabolic or humoral mechanisms. The haemodynamic situation in the early stages of arterial hypertension is characterized by a slight hypercirculatory state due to a moderate increase in heart rate and cardiac output, whereas the total peripheral resistance is increased only moderately, if at all. In later stages, however, a progressive increase in total peripheral resistance prevails, accompanied by a decrease in left ventricular performance due to the development of left ventricular hypertrophy, changes in ventricle geometry and coronary heart disease. A pharmacologically-induced decrease of total peripheral resistance by means of vasodilators, therefore, represents a logical approach to therapy, at least of advanced hypertension. Vasodilators can be classified into three categories: (1) those with preferential activity on the arterial resistance vessels, eg hydralazine, diazoxide, minoxidil; (2) those with preferential activity on venous capacitance vessels, eg organic nitrates; and (3) those with activities on both branches, eg sodium nitroprusside, urapidil, prazosin and other α-blockers. Brief reference is made to new and possibly more acceptable vasodilators – in particular carvedilol and prizidilol.
Effect of Clonidine on Insulin Secretion: A Case Report
Authors: Okada Soji , Miyai Yooichiro , Sato Kimiaki , Masaki Yositugu , Higuchi Toru , Ogino Yasuhisa , Ota Zensuke
Published: January 2017

We have recently seen a case of non-insulin-dependent diabetes mellitus with hypertension in which chronic treatment with oral clonidine gave rise to elevation of blood glucose and decreased insulin secretion. When the response of insulin secretion to glucose administration during clonidine therapy was compared with that after 12 days of wash-out for clonidine in this patient (who was then receiving phentolamine mesylate), there was a marked suppression of insulin secretion to stimulation by intravenous glucose during oral clonidine therapy. This result indicates that the decreased insulin secretion associated with oral clonidine therapy is very unlikely to be due to any direct action of clonidine on β cells of the pancreatic islets and may be due to suppression of catecholamine release via central α-adrenergic receptor stimulation.
Guide to Therapy with Theophylline for the Treatment of Obstructive Lung Disease
Authors: Bernocchi D. , Castiglioni C. L.
Published: January 2017

During the last 10–15 years, therapy with theophylline for the treatment of obstructive lung disease has been rationalized because of increased investigation into drug pharmacokinetics and metabolism and the introduction of new techniques for measuring drug concentration in plasma. Orally administered sustained-release preparations of theophylline have recently been introduced as therapy following the development of new technology. Such preparations allow more effective use of theophylline through increased patient compliance and the maintenance of more stable plasma theophylline concentrations.
Bioavailability of Three Commercial Preparations of Ibuprofen 600 mg
Authors: Källström E. , Heikinheimo M. , Quiding H.
Published: January 2017

The pharmacokinetic variables of ibuprofen 600 mg were investigated after administration of Brufen and compared to administration of Burana and Ibumetin. The investigation was carried out as a randomized single-dose crossover study in 17 healthy volunteers. The mean maximum plasma concentrations of ibuprofen were 58, 45 and 54 μg/ml after administration of Brufen, Burana and Ibumetin, respectively, the time to reach this being 1.4, 2.1 and 1.6 h, respectively, after administration. The differences between Brufen and Burana were significant. The relative bioavailability was very similar between Brufen and Burana but about 8% lower for Ibumetin and this difference between Brufen and Ibumetin was significant. Thus, different brands of ibuprofen may not be pharmacokinetically interchangeable and the results show that Brufen is superior to either Burana or Ibumetin when considering both the rate and extent of absorption. These findings are clinically interesting since a high and early plasma concentration of ibuprofen seems to be related to increased analgesic efficacy.
The Pharmacokinetics of Loratadine in Normal Geriatric Volunteers
Authors: Hilbert J. , Moritzen V. , Parks A. , Radwanski E. , Perentesis G. , Symchowicz S. , Zampaglione N.
Published: January 2017

The pharmacokinetics of loratadine, a non-sedating anti-histamine, were studied in 12 normal geriatric volunteers. In an open label fashion, each volunteer received one 40 mg loratadine capsule. Blood was collected prior to and at specified times (up to 120 h) after dosing. Plasma loratadine concentrations were determined by a specific radioimmunoassay and those of an active metabolite, descarboethoxyloratadine, by high performance liquid chromatography. Concentrations of loratadine in the disposition phase were fitted to a biexponential equation and those of descarboethoxyloratadine to either a monoexponential or biexponential equation for pharmacokinetic analysis. Loratadine was rapidly absorbed, reaching a maximum plasma concentration of 50.5 ng/ml at 1.5 h after dosing. The disposition half-lives of loratadine in the distribution and elimination phases were 1.5 and 18.2 h, respectively. The area under the plasma concentration–time curve, was 146.7 h·ng/ml. Descarboethoxyloratadine had a maximum plasma concentration of 28.0 ng/ml at 2.9 h post-dose and an area under the concentration–time curve of 394.9 h·ng/ml. Its disposition half-lives in the distribution and elimination phases were 2.8 and 17.4 h, respectively. Comparison of these data with those from a previous study of loratadine in young adults showed no clear differences in the disposition half-lives between the two groups. The clearance of loratadine tends to be lower in the elderly, but inter-individual variation within each age group appears greater than any age effect.
Brighton Sleep Survey: A Study of Sleep in 20–45-Year Olds
Authors: Mniszek D. H.
Published: January 2017

A total of 2714 people, aged 20–45 years from the Brighton area who completed a questionnaire were interviewed on their sleep patterns and complaints, medication, behavioural aids, and consumption of caffeine and alcohol. Analysis showed that 24% had delayed sleep onset, 23% awakened frequently, 19% awakened early, 21% were dissatisfied with sleep, and 8% took medication to aid sleep. Of those on night shifts, 29% awakened frequently and 25% awakened early. There were 648 responses describing behavioural sleeping aids. The moderate consumption of caffeine and alcohol had no significant effect on sleep. The main differences between this survey and other published data relate to the comparison of sleep reports from men with those from women, the sleep of nightshift and dayshift workers and the effects of caffeine and alcohol. These differences may arise from sampling characteristics and the form of the questionnaire.
Decontamination of the Oral Cavity. Effect of Six Local Anti-Microbial Preparations in Comparison to Water and Parafilm as Controls
Authors: Matula C. , Hildebrandt M. , Nahler G.
Published: January 2017

Six preparations (four liquid and two solid) were tested in a double-blind crossover design for their anti-bacterial effect on aerobic and anaerobic bacteria in saliva of 12 volunteers. The four liquid preparations contained either tyrothricin, hexetidine, hydrogen peroxide or ethanol and were tested against a rinse with water as control. The two solid preparations, in the form of lozenges, contained tyrothricin in doses of 4 or 10 mg and were tested against parafilm. A single rinse with either tyrothricin or hexetidine resulted in a significant reduction of aerobic and anaerobic bacteria in saliva which lasted for the whole 1h observation period and was considerably more effective than hydrogen peroxide or ethanol. Similar results were seen with the solid preparations. The lozenge containing 10 mg tyrothricin was the most effective and was the only formulation capable of reducing oral aerobic bacterial counts by a factor of approximately 100.
A Comparative Study of Frusemide–Amiloride and Cyclopenthiazide–Potassium Chloride in the Treatment of Congestive Cardiac Failure in General Practice
Authors: Crawford R. J. , Allman S. , Gibson W. , Kitchen S. , Richards H. H.
Published: January 2017

Forty-seven patients entered this comparison of frusemide–amiloride and cyclopenthiazide–potassium chloride in the treatment of congestive cardiac failure in general practice. Frusemide–amiloride was ‘very satisfactory’ in 92% of the patients compared to only 55% who took cyclopenthiazide–potassium chloride. Significantly more patients were free of paroxysmal nocturnal dyspnoea and orthopnoea after taking frusemide–amiloride.
Efficacy and Tolerance of Naproxen Instant Suspension Formulation: A Post-Marketing Survey
Authors: Cordaro C. I. , Sartini A. , Celotti F.
Published: January 2017

A multi-centre uncontrolled clinical trial was performed in 42 Italian hospitals to evaluate the efficacy and tolerance of an instant suspension of naproxen, a well known anti-inflammatory drug. A total of 390 adults of all ages with musculoskeletal rheumatic diseases or minor traumatic injuries entered the trial. Patients received 500 mg naproxen instant suspension twice daily after meals, for 1–4 weeks. Assessment of signs and symptoms was made before starting the therapy, after 3 days and at the end of the treatment period. The drug produced a rapid and progressive relief of pain and articular symptoms in most patients and was equally effective in all the diagnostic sub-groups. The efficacy of treatment was ‘excellent’ or ‘good’ in about 85% of patients, ‘moderate’ in 10% and ‘minimal’ or ‘absent’ in about 5%. Almost 90% of patients had no side-effects; 5% were withdrawn because of unwanted effects. No correlation between incidence or intensity of side-effects and age of the patients or duration of therapy was observed. The complaints reported are common to other anti-rheumatic drugs, e.g. epigastric pain, pyrosis, nausea, vomiting and headache. In conclusion, naproxen instant suspension is highly effective and well tolerated.
Recent Developments in the Use of Nitrates for Treatment of Angina Pectoris
Authors: Ankier S. I. , Warrington S. J. , Sneddon J. M.
Published: January 2017

Organic nitrates are effective in the treatment and prophylaxis of angina pectoris. The major clinical problem of tolerance may be avoided if the daily plasma concentrations of the active metabolite, isosorbide-5-mononitrate are maintained at 100–300 ng/ml. The most promising development in achieving this is the use of sustained release preparations.
Clinical Significance of the Negative Inotropic Effect of Disopyramide
Authors: Kenedi P. P.
Published: January 2017

This study determined the extent of the negative inotropic effect of either 200 mg standard release disopyramide given three times daily or 250 mg sustained release disopyramide given twice daily in 10 patients with normal and 10 with abnormal ventricular function. Assessment, by measurement of ejection fraction using 99mTc radionuclide ventriculography, was made 3 h after the first dose and again after 7 days' treatment, both at rest and after exercise. A similar reduction in ejection fraction occurred at rest and after exercise. Patients with an abnormal left ventricular function showed a greater decrease in ejection fraction compared with patients with normal left ventricular function, both at rest and after exercise. The extent of this reduction appeared to be correlated with the extent of left ventricular dysfunction. In no cases were these decreases statistically or clinically significant. No significant changes in heart volume occurred in any patient and none showed impaired clinical status. Plasma concentrations of disopyramide were also similar for both types of disopyramide in both groups of patients on days 1 and 7.
A Comparative Tolerance Study of Terfenadine–Pseudoephedrine Combination Tablets and Pseudoephedrine Tablets in Patients with Allergic or Vasomotor Rhinitis
Authors: Stroh J. E. , Ayars G. H. , Bernstein I. L. , Kemp J. P. , Podleski W. K. , Prenner B. M. , Schoenwetter W. F. , Salzmann J. K.
Published: January 2017

In this multicentre, double-blind, randomized, parallel group study, 315 patients with allergic or vasomotor rhinitis were treated on a twice daily dosing schedule with either a 60 mg terfenadine–120 mg pseudoephedrine hydrochloride combination or 120 mg pseudoephedrine hydrochloride (extended release) for 2 weeks. No clinically significant differences between the two groups were noted in body weight, temperature, respiration rate or blood pressure following the treatment period. An increase in mean heart rate of approximately 5 beats/min from entry to the final clinic visit was noted in both treatment groups. No clinically significant changes were noted in either treatment group when pre- and post-treatment electrocardiograms were compared. There were also no clinically significant alterations in laboratory values, which included serum chemistry, haematology and urinalysis, within or between either group. The adverse events profiles for both groups were similar. The most frequent adverse event was insomnia, in 40 (25.3%) patients given the terfenadine–pseudoephedrine combination and in 42 (26.8%) of those given pseudoephedrine. No unusual or unexpected adverse events were reported.
Comparative Study of Ketorolac and Paracetamol/Codeine in Alleviating Pain following Gynaecological Surgery
Authors: Vangen O. , Doessland S. , Lindbaek E.
Published: January 2017

In a randomized, double-blind, multiple-dose, parallel study of 107 patients, the safety and analgesic efficacy of single and multiple doses of orally administered ketorolac tromethamine (10–40 mg/day) were compared with orally administered paracetamol (1000–4000 mg/day)/codeine (60–240 mg/day) for treating moderate to severe pain after gynaecological surgery. Both drugs effectively reduced pain intensity. After the first dose of medication, over 90% of the patients in each treatment group reported pain reduction of at least 50%. The mean time until additional medication was requested was over 6 h for both groups. No statistically significant differences in analgesic efficacy were observed in the two treatment groups. Ketorolac tromethamine-treated patients reported a total of 62 adverse events (17 considered drug-related) and the paracetamol/codeine-treated patients reported 65 (20 considered drug-related); the adverse event profiles of the two treatment regimens were similar. Thus, both the single and the multiple doses of ketorolac tromethamine (10 mg) alleviated moderate to severe pain after gynaecological surgery as safely and efficaciously as paracetamol (1000 mg)/codeine (60 mg).
Comparison of Nimesulide and Flurbiprofen in the Treatment of Non-Infectious Acute Inflammation of the Upper Respiratory Tract
Authors: Cadeddu L. , Piragine F. , Puxeddu P. , Scornavacche V. , Franceschini S. Sellari
Published: January 2017

Sixty patients were enrolled in a controlled randomized single-blind study to compare the efficacy and tolerability of 200 mg/day nimesulide and 300 mg/day flurbiprofen given for 7 days, in the treatment of non-infectious acute inflammation of the upper respiratory tract. Patients were diagnosed as follows: pharyngitis, 20 (33.4%) cases; laryngitis 11 (18.3%) cases; tonsillitis, eight (13.3%) cases; and mixed forms, 21 (35.0%) cases. Both drugs showed the same efficacy in reducing mucosal congestion, local redness, fever and sore throat. Nimesulide treatment gave rise to fewer and less severe side-effects than flurbiprofen treatment.
Analgesic Efficacy and Safety Comparison of Ketorolac Tromethamine and Doleron for the Alleviation of Orthopaedic Post-Operative Pain
Authors: Johansson S. , Josefsson G. , Malstam J. , Lindstrand A. , Stenstroem A.
Published: January 2017

The analgesic efficacy and safety of ketorolac tromethamine (ketorolac), a potent analgesic with anti-inflammatory and antipyretic activities, were evaluated and compared with Doleron, a combination analgesic, in 115 patients with moderate to severe orthopaedic post-operative pain. This was a randomized, double-blind (double-dummy), parallel-group comparison of a single oral dose of one capsule of 10 mg ketorolac with a single oral dose of two Doleron tablets (each tablet contained 150 mg dextropropoxyphene napsylate, 350 mg aspirin and 150 mg phenazone). During the 6 h following treatment, 80% of ketorolac treated patients and 82% of Doleron treated patients experienced adequate pain relief. There were no statistically significant differences in the overall analgesic efficacy between the treatment groups. Three patients (one on ketorolac, two on Doleron) withdrew because of adverse events (vomiting). Nausea (two patients in each treatment group), vertigo (none on ketorolac, three on Doleron) and sore throat (none on ketorolac, two on Doleron) were the only drug-related adverse events reported by more than one person in a treatment group during the trial. A total of 82% of patients given ketorolac and 76% given Doleron experienced no adverse events. A single oral dose of 10 mg ketorolac was shown to be as effective and safe as two Doleron tablets in the treatment of moderate to severe orthopaedic post-operative pain.
Double-Blind Report on the Efficacy of Lactic Acid-Producing Enterococcus SF68 in the Prevention of Antibiotic-Associated Diarrhoea and in the Treatment of Acute Diarrhoea
Authors: Wunderlich P.F. , Braun L. , Fumagalli I. , D'Apuzzo V. , Heim F. , Karly M. , Lodi R. , Politta G. , Vonbank F. , Zeltner L.
Published: January 2017

A multicentre double-blind, placebo-controlled clinical trial, involving 123 patients at 10 centres, was carried out to assess the efficacy of a preparation of lactic acid-producing Enterococcus SF 68 in the prevention of antibiotic-associated diarrhoea and in the treatment of acute diarrhoea. In the prevention study, 45 patients being treated with antibiotics were given, concurrently, one capsule twice daily of either Enterococcus SF68 or placebo. Acute diarrhoea was present in 78 patients who were given the same treatment but three times daily. All treatments were continued for 7 days. Enterococcus SF 68 was shown to be effective in reducing the incidence of antibiotic-associated diarrhoea in comparison with placebo (8.7% compared with 27.2%, respectively). Patients with acute enteritis showed a significantly faster resolution of bowel abnormalities during treatment with Enterococcus SF68 compared with placebo.
Chlorthalidone Alone or in Fixed Combination with Slow-Release Metoprolol in the Management of Arterial Hypertension: A Long-Term Study of 545 Patients
Authors: Bichisao E. , Merlini L. , Gambini O. , Alberti D. , Pollavini G.
Published: January 2017

In a double-blind trial, 545 out-patients with essential hypertension received 25 mg/day chlorthalidone alone (274 patients) or in fixed combination with 200 mg/day slow-release metoprolol (271 patients) for 8 weeks. Both treatments significantly (P<0.001) decreased systolic and diastolic blood pressure; 45.6% of patients receiving chlorthalidone and 82.5% receiving combined therapy had a diastolic blood pressure of less than 95 mmHg. Patients not controlled by chlorthalidone or chlorthalidone plus metoprolol subsequently received chlorthalidone plus metoprolol (137 patients) or chlorthalidone plus metoprolol plus a third drug (34 patients), respectively, for 8 weeks. A total of 79.5% of patients receiving chlorthalidone plus metoprolol and 61.8% receiving chlorthalidone plus metoprolol plus a third drug had a diastolic blood pressure of less than 95 mmHg. Only 5.9% of patients experienced mild to modérate side-effects. Plasma potassium leveis significantly ( P<0.01) decreased during the first 8 weeks only. It is concluded that a diuretic alone or in fixed combination with a β-blocker is effective in the long-term treatment of arterial hypertension.
Comparison of the Myotonolytic Activity of Tizanidine, Eperisone and Afloqualone in Mouse and Rabbit
Authors: Coward D.M. , White T.G.
Published: January 2017

The central muscle relaxant activity of the antispastic agent tizanidine was compared with that of two novel clinical agents, afloqualone and eperisone, in the mouse and rabbit. Oral tizanidine strongly inhibited morphine-elicited Straub tail induction in the mouse, showing a median effective dose (ED50) of 1.2 mg/kg. Intravenous tizanidine also inhibited hind limb extensor reflex activity in the rabbit with an ED50 of 0.02 mg/kg. Afloqualone and eperisone, however, were much weaker in the mouse assay with ED50 values of 8.2 and 58.1 mg/kg, respectively. At respective intravenous doses of 2.0 and 1.0 mg/kg, afloqualone and eperisone caused maximally 32% and 41% inhibition of reflex activity in the rabbit. On this basis, afloqualone might be expected to exhibit moderate myotonolytic activity in rheumatological indications, but to be of questionable value in spasticity. Similarly, clinical myotonolytic activity of eperisone would only be expected at high doses unless its functional bioavailability were to be much better in man than in either the mouse or rabbit.
Research and Development of New Medicines
Authors: Ankier S. I. , Warrington S. J.
Published: January 2017

In order that a new chemical entity may be marketed as a drug its pharmacological effects must first be evaluated using animals. Its bioavailability must also be determined and toxicological studies are performed to assess its acute and chronic toxicity, mutagenicity, effects on fertility, perinatal effects, teratogenicity and carcinogenicity. If the results of efficacy and toxicity studies in animals are favourable, the drug is then tested in a few human volunteers, followed by pilot studies and large-scale clinical trials. Regulations that control how these trials are performed are considered. The licensing of drugs in the UK, USA and Europe is compared.
Comparison of the Effects of Magnesium Hydroxide and a Bulk Laxative on Lipids, Carbohydrates, Vitamins A and E, and Minerals in Geriatric Hospital Patients in the Treatment of Constipation
Authors: Kinnunen O. , Salokannel J.
Published: January 2017

In a crossover study the effects of magnesium hydroxide on serum lipids, carbohydrates, vitamins A and E, uric acid and whole blood minerals were compared with those of a bulk laxative containing plantago rind and sorbitol in 64 constipated, elderly long-stay patients, 55 of whom were receiving diuretics. Hypomagnesaemia occurred in 11 (17%) patients after bulk laxative and in two (2%) patients after magnesium hydroxide treatment. There was a slight reduction in low values of high-density lipoprotein cholesterol and high values of triglycerides after magnesium hydroxide treatment. There were no significant differences in plasma lipids, whole blood minerals or vitamins A and E using either laxative. Negative correlations were found between the increase in serum concentrations of magnesium and glycosylated haemoglobin A1 ( P<0.02) and the serum level of uric acid ( P<0.01). These results suggest that the long-term effects of magnesium hydroxide and bulk laxative on the absorption of nutrients may not be significantly different. Magnesium hydroxide, however, may have beneficial effects on lipid disorders, impaired glucose tolerance and hyperuricaemia in magnesium deficiency due to diuretics and thus may be a favourable laxative for use in bedridden geriatric patients receiving diuretics.
General Practice Data Derived Tolerability Assessment of Antihypertensive Drugs
Authors: Marley J.E. , Curram J.B.
Published: January 2017

A large hypertensive population of patients in general practice was used to assess the tolerability of nifedipine in previously untreated patients and was compared with other antihypertensive drugs in previously treated patients. A total of 3972 patients with a sitting diastolic blood pressure between 95 and 115 mmHg were treated with 20 mg nifedipine twice daily for 1 month. In non-responders the dose was increased to 40 mg twice daily for a second month; responders continued to take 20 mg twice daily. A total of 2772 patients had been previously untreated for hypertension, whereas 857 had previously been treated with β-blockers alone or in combination and 346 had received diuretics alone or in combination. Adverse events were recorded for 28 days prior to treatment being initiated with or changed to nifedipine and for two 28-day nifedipine treatment periods. Flushing and headache, which diminished with time, occurred during nifedipine treatment. Ankle oedema did not diminish with time. Reductions were seen in occurrences of dyspnoea, impotence, lethargy and cold extremities.