bluuebunny/crossref_metadata_2025 huggingface dataset:
Clinical Study of Broncholytic Effect and Side-Effects of Isoetharine ('Numotac')
Authors: Kiviloog J , Svedmyr N
Published: January 2017

In thirty-nine adult asthmatics a clinical trial was carried out with 10 mg slow-release tablets of isoetharine ( 'Numotac', 3 M Riker) at two dose levels: 10 mg and 20 mg four times a day. The trial was double-blind with crossover after six weeks. Twenty-three patients reported a positive effect on their respiratory symptoms when isoetharine had replaced their previous treatment; negative effect was reported by one patient while twelve patients were undecided. Tremor was a common side-effect but except in three cases it was slight. There was no difference in side-effects between the high and the low doses if the initial dose was low. However, there were significantly more side-effects when the trial was started with the high dose.
A Double-Blind Comparative Study of Otoseptil Ear Drops and Otosporin Ear Drops in Otitis Externa
Authors: Bain D J G
Published: January 2017

A double-blind comparative study of Otoseptil Ear Drops and Otosporin Ear Drops in otitis externa in fifty-eight patients revealed them both to be equally effective in a series with very few fungal infections. In view of the normally high proportion of infections including fungi, there are obvious advantages in using Otoseptil Ear Drops.
The Effect of Forewarning on the Occurrence of Side-Effects and Discontinuance of Medication in Patients on Dothiepin
Authors: Myers E D , Calvert E J
Published: January 2017

Dothiepin was prescribed for 100 depressed out-patients alternately allocated to one of two groups. Patients in Group A were forewarned about side-effects and patients in Group B were not forewarned. None of the patients had previously received dothiepin. After two weeks the patients were questioned regarding side-effects and continuance with medication. Eighty-nine patients were included in the final analysis. The results failed to confirm the hypotheses that forewarning patients of side-effects causes a greater number of patients to complain of such effects, or that where patients experience side-effects, forewarning is associated with any less frequent discontinuance of therapy. Compared with a previous study with amitriptyline, the results of this study are much closer to statistical significance. This may be due to the lower overall incidence of side-effects with dothiepin and calls for further work with a larger sample of patients.
Neonatal Jaundice—A Comparison between Intravenous Oxytocin and Oral Prostaglandin E2
Authors: Conway D I , Read M D , Bauer C , Martin R H
Published: January 2017

The total serum bilirubin levels at two and occasionally five days after birth were studied in 162 infants whose mothers received either intravenous oxytocin or oral Prostaglandin E2 during labour, and the results were compared with those obtained in forty-two control patients.

Following labour of spontaneous onset, whether the mother received intravenous oxytocin or oral Prostaglandin E2, neonatal total serum bilirubin levels were not different from those in controls.

After induction by amniotomy and an active agent, higher mean total serum bilirubin levels were found in infants whose mothers received intravenous oxytocin than in those given oral Prostaglandin E2; a significant rise in the total serum bilirubin level appeared to occur when mothers received a total of more than 12,000 milliunits of oxytocin or more than 4,000 milliunits per kg birthweight of the infant.
Preference Studies of Triazolam with Standard Hypnotics in Out-Patients with Insomnia
Authors: Fabre Louis F , McLendon David M , Harris Robert T
Published: January 2017

One hundred and four patients suffering from insomnia took part in four different two-night double-blind crossover trials of triazolam. In three separate studies, triazolam 0·5 mg was compared to placebo, flurazepam 30 mg and chloral hydrate 500 mg. Triazolam 0·5 mg was found to be preferred and to be superior to placebo, flurazepam and chloral hydrate in the treatment of insomnia. Analysis of sleep questionnaire data showed triazolam to be superior to the other treatments on the following: How much did the medication help you sleep, onset of sleep, duration of sleep and number of awakenings. Additionally, triazolam was superior to chloral hydrate on the feeling in the morning parameter. In another comparison of triazolam 0·25 mg to flurazepam 15 mg, triazolam was not significantly better than flurazepam on any of the efficacy parameters except that the patients felt more alert the morning following triazolam than following flurazepam. On all efficacy endpoints, trends for all parameters favoured triazolam 0·25 mg over flurazepam 15 mg. Untoward side-effects in these four studies were minimal.
Butorphanol: A Double-Blind Comparison with Pentazocine in Post-Operative Patients with Moderate to Severe Pain
Authors: Gilbert M S , Forman R S , Moylan D S , Caruso F S
Published: January 2017

A double-blind, randomized trial was conducted with 124 post-operative patients to compare the analgesic activity and possible side-effects of a new synthetic analgesic—butorphanol tartrate (1, 2, and 4 mg)—and pentazocine lactate (30 and 60 mg), administered intramuscularly. Butorphanol was determined to be 16 times more potent than pentazocine, on a weight basis. Both medications provided maximum pain relief within one hour after administration, and had comparable durations of action. Drowsiness was the most common side-effect, and it appeared to be dose-related in all test groups.
Comparative Efficacy and Safety of Cephradine and Cephalexin in Children
Authors: Mouallem Raja
Published: January 2017

Cephradine was compared to cephalexin in a randomized, double-blind study for the treatment of bacterial infections in 162 children between four months and eleven years of age. In addition to evaluations of clinical and bacteriologic responses to therapy, the relative safety of the two cephalosporins was assessed for all children, including eight who were not included in the evaluation of drug efficacy. The children in the efficacy evaluation had either lobar pneumonia or skin infections and received oral suspensions of cephradine (25-110 mg/kg per day) or cephalexin (25-150 mg/kg per day) for five to fifteen days. Overall clinical and bacteriologic responses were nearly identical in the two groups, and both antibiotics proved to be equally safe and effective for use in paediatric practice.
Micro-Encapsulated Aspirin (Levius®) Compared with Aloxiprin (Palaprin Forte®) in the Treatment of Rheumatoid Arthritis
Authors: Wright M G
Published: January 2017

A randomized crossover trial of micro-encapsulated aspirin (Levius) and aloxiprin (Palaprin Forte) was carried out on thirty-three hospital out-patients with rheumatoid arthritis. Both preparations improved the clinical status of the patients. The difference in response to the two preparations was not significant, except for effect on functional status where the micro-encapsulated aspirin was found to be significantly better at the 5% level. Apart from six complaints of constipation with aloxiprin compared with only one with Levius, the side-effects were similar. The trial has shown that Levius can be conveniently given in divided doses thrice daily without loss of efficacy.
Polygraphic Sleep Recordings before and after the Administration of Flunitrazepam
Authors: Jovanović U J
Published: January 2017

By means of polygraphic sleep recordings (EEG, EOG, EMG, ECG’ EDG, Respirogram, Positogram), neurologic-psychologic investigations and questionnaires on subjective feeling, ten patients aged from 22 to 40 years (mean: 29 years), who suffered from irregular disturbances in falling asleep and in sleeping continuously, were examined over a period of ten consecutive nights. The first investigation night was reserved for adaptation of the patients and could therefore not be evaluated. On the following three evenings placebo (Placebo I) was given, then 2 mg of flunitrazepam for the ensuing three nights and placebo again (Placebo II) for the last three nights. Thus, 90 investigation nights could be evaluated.

The following results were obtained:

Latency times until the patients felt asleep and up to the first deep sleep were reduced significantly by the active preparation. Latency times up to the first REM-phase were prolonged. The frequency of nocturnal awakenings was lessened significantly. Thus, disturbances in sleeping continuously disappeared for the duration of the treatment. Duration of wakefulness after having woken during the night decreased considerably. Duration of wakefulness during the total night was reduced considerably, deeper sleep stages, such as D (stage III) and E(stage IV) were prolonged. Duration of the REM-phases was reduced slightly. This reduction was not significant according to the t-test. According to these results, the preparation showed a clear effect. A placebo-effect can be excluded, since the improvements mentioned were not found when placebo was given before administration of the medication and afterwards (Placebo I and II). When comparing our results to those of other authors, who described the effects of various preparations, we found that the substance flunitrazepam showed different effects.
A Comparative Study of Epicillin and Chloramphenicol in the Treatment of Enteric Fever
Authors: Hassau A , Sippel J , Farid Z , Tadros S S , Brian M
Published: January 2017

One hundred patients with acute enteric fever were randomly assigned to treatment with either chloramphenicol 50 mg/kg body-weight or epicillin 1 g six hourly. Eighty-one patients had a positive blood culture for typhoid or paratyphoid bacilli and nineteen had a positive stool culture with a significant Widal titre.

All fifty patients in the group treated with chloramphenicol responded, however there was one relapse with bacteraemia. In the group treated with epicillin, six from the total of fifty patients were considered treatment failures. Treatment was considered as a failure if the patient was febrile after ten days treatment or if there was a deterioration despite antibiotic therapy.
Once-Daily Treatment for Mixed Anxiety/Depressive States: A Comparison of Slow Release Amitriptyline and Fluphenazine with Nortriptyline
Authors: Magnus R V , Schiff A A
Published: January 2017

Patients suffering from mixed anxiety/depressive states referred to a psychiatric out-patient clinic completed a four week course of either a once-daily tablet of 30 mg nortriptyline with 1· 5 mg fluphenazine, or a sustained release capsule of 50 mg amitriptyline once daily, on a double-blind basis. Depression improved satisfactorily on either treatment, but there was a greater reduction of anxiety on fluphenazine/nortriptyline. Drowsiness, however, occurred more frequently among the patients on amitriptyline, suggesting the sedative properties of this drug did not substitute adequately for a specific anxiolytic effect. Dry mouth was also noticeably more frequent with amitriptyline.

As might be expected on pharmacokinetic and physiological grounds, the results suggest that the sustained release characteristics of the amitriptyline preparation lead to a maximization of side-effects during the day without conferring any therapeutic advantage.
Dermatologic Investigation of Betamethasone 17,21-Dipropionate Ointment with Chinoform
Authors: Tølløfsrud Arne
Published: January 2017

In an open investigation on 50 patients with various dermatological lesions 17 (81%) out of 21 psoriatics and 28 out of 29 other patients improved considerably or were clinically cured after three weeks' treatment with an ointment containing 0·05% betamethasone dipropionate and 3·0% chinoform. Among the patients chosen for the study 34 had previously tried topical corticosteroids without success. Of these 31 improved markedly during the steroid trial.
Comparison of Fenoterol and Orciprenaline with regard to Broncho-Dilating Action and β2 – Selectivity
Authors: Sasaki Takao , Takishima Tamotsu , Sugiura Ryoichi
Published: January 2017

A double-blind crossover trial was performed comparing orciprenaline (10 mg) and fenoterol (5 mg) by oral administration in forty-four patients with bronchial asthma. Measurement of VC, FEV1, respiratory impedance (ZR), blood pressure and pulse rate, and observation of subjective symptoms, rales and side-effects, were made over the 4 hours following oral administration of the drugs. FEV1 increased through the 4 hours reaching a peak at 3 hours with both drugs. The per cent increase of FEV1 was statistically significant at each measuring time for both drugs (p < 001), and was significantly larger in fenoterol than in orciprenaline at 2 and 3 hours (p < 0.05). ZR with fenoterol decreased from 2 hours to 4 hours with a significant difference from ZR with orciprenaline (p < 0.05). Side-effects such as palpitation, finger tremor or headache were seen in 36.4% cases with fenoterol and 30.5% with orciprenaline, but the degree of the side-effects was minimal. Finger tremor was observed in one case with orciprenaline and ten cases with fenoterol. Palpitation was observed in five cases with each of the drugs. Because finger tremor seems to be due to β2-stimulation and palpitation seems to be due to β1-stimulation, fenoterol was supposed to be more β2-selective than orciprenaline. In conclusion fenoterol had a high β2 selectivity and a powerful and long-lasting broncho-dilating effect compared with orciprenaline.
Clinical Trial of Two Inhalation Techniques for Pressurized Aerosols
Authors: Stauder J , Hidinger K G
Published: January 2017

The clinical effects of a bronchodilator, terbutaline sulphate, were compared after administration in the beginning of the inhalation by means of a standard inhaler and administration by actuating 2 seconds before starting the inhalation by means of an inhaler furnished with a 32 × 100 mm tube. No differences could be seen in the parameters measured-forced vital capacity (FVC), 1-second forced expiratory volume (FEV1), forced mid-expiratory flow (FMF), and oscillatory resistance (R05). The results indicate that when attaching a tube to the standard inhaler co-ordination of inhalation and actuation of the aerosol is not of vital importance.
Once-Daily Penbutolol or Atenolol Can Replace Combination Therapy in Essential Hypertension
Authors: Houtzagers J J R , Chadha Dev R
Published: January 2017

Antihypertensive therapy was stopped in twenty-one patients with moderate hypertension. Almost all of them had been on combination therapy, usually propranolol or metoprolol with chlorthalidone, for more than a year. After a placebo ‘wash-out’ period of 4 weeks patients were randomly allocated in a controlled trial to a fixed daily dose of either 100 mg atenolol or 40 mg penbutolol for 6 weeks. Single-agent therapy at these doses successfully controlled the blood pressure in nineteen of the twenty-one patients, including six previously inadequately controlled on a combination. Although no conclusions can be drawn about the long-term benefits, in the patient population under study either penbutolol or atenolol given at a standard dose should provide good initial blood pressure control in most patients with mild to moderate hypertension.
Comparative Antihypertensive Effects of Guanabenz and Clonidine
Authors: Walker Barry R , Hare Larry E , Deitch Marc W
Published: January 2017

The safety and efficacy of guanabenz and clonidine were compared in 188 hypertensive patients during a 6-month double-blind trial. Mean supine diastolic blood pressure (SDBP) decreased from 103 to 88 mm Hg (p < 0.01) among guanabenz patients and from 101 to 88 mm Hg (p < 0.01) among clonidine patients who completed 6 months of b.i.d. therapy. Clinically significant individual SDBP decreases occurred in 85% of the guanabenz patients and in 83% of the clonidine patients after 6 months. Adverse effects, consisting primarily of drowsiness, dry mouth, dizziness, and weakness, were similar in the two therapy groups. The responses obtained with guanabenz (b.i.d.) were maintained, along with a decrease in adverse effects, by an equivalent single daily dose of guanabenz during a second 6 months of therapy. Seventy-six per cent (13/17) of the patients whose blood pressure was not adequately controlled by guanabenz alone after 8 weeks of therapy subsequently responded to a combination of guanabenz and hydrochlorothiazide. Similarly, 85% (17/20) of the patients who failed to respond to clonidine alone subsequently responded to guanabenz either alone or in combination with hydrochlorothiazide. These results suggest that guanabenz or the combination of guanabenz and hydrochlorothiazide is effective therapy for the majority of hypertensive patients.
2% Miconazole Nitrate Powder in Aerosol Spray Form: Its Efficacy in Treating Tinea Pedis
Authors: Shellow William V R
Published: January 2017

Forty-six patients with acute tinea pedis were treated with either 1% tolnaftate aerosol spray powder or 2% miconazole nitrate aerosol spray powder, not previously available. Products were coded, and the study was conducted in a double-blind manner. At the end of 28 days of therapy, 68% of the miconazole-treated group achieved therapeutic cure, versus 50% in the tolnaftate-treated group. Symptomatic relief and mycological clearing based on potassium hydroxide examination took place in less time for the patients treated with miconazole nitrate. The aerosol spray powder form is an effective alternative vehicle to both cream and solution.
Intramuscular Administration of 15-Methyl Prostaglandin F2α in Mid-Trimester Termination of Pregnancy
Authors: Bhalla K , Jenkins C R M
Published: January 2017

15-methyl prostaglandin F2α was administered by intramuscular injection to thirty patients to terminate pregnancy in the mid-trimester. Termination was considered successful if this occurred within 24 hours and this was so in twenty-seven cases (90%). There were no serious complications. Prochlorperazine mesylate and diphenoxylate hydrochloride reduced the incidence and severity of vomiting and diarrhoea.
The Clinical Efficacy and Safety of Bacampicillin Twice Daily in Comparative Studies
Authors: Blomqvist M. , Hedström S. Å.
Published: January 2017

In 16 controlled, randomized, comparative studies a total of 953 patients were treated for urinary tract infection, sinusitis, otitis media or chronic bronchitis. The aim was to evaluate the efficacy and safety of bacampicillin in a twice daily dosage, compared with three times daily dosages of bacampicillin, ampicillin, amoxycillin and a twice daily dosage of co-trimoxazole. Bacampicillin was given in amounts of either 400 or 800 mg to 422 of the patients in these studies. The twice daily dosage of bacampicillin eradicated 89% of the causative bacteria of urinary tract infections compared to 86% with the other regimens. In acute sinusitis 92% and 96% of the patients were either cured or improved when treated with 400 and 800 mg bacampicillin twice daily respectively. Similar percentages occurred in the groups given the three times daily dosages. In exacerbation of chronic bronchitis, 800 mg bacampicillin twice daily was the minimum effective dosage and 84% of the patients were either cured or improved with this regimen. Adverse drug reactions due to bacampicillin at all dose levels were less frequent than those of other anti-microbials. The lowest frequency of diarrhoea, 2.4%, was seen in the group given 400 mg bacampicillin twice daily. Dosages of 400 or 800 mg bacampicillin twice daily had a reliable efficacy combined with a low frequency of adverse reactions in respiratory and urinary tract infections.
Preliminary Data on the Action of Nesosteine, a Mucomodifying Drug, on Mucociliary Transport
Authors: Braga P. C. , Bossi R. , Castiglioni C. L. , Romandini S. , Allegra L.
Published: January 2017

Nesosteine, which is active on airway secretions, has been studied by assessment of the mucociliary clearance of the frog palate. Sputum was collected from patients admitted to hospital with acute exacerbations of chronic bronchitis with mucous expectoration. The relative speed of transport was measured for each patient before and after oral administration of 600mg/day nesosteine. A significant increase in the mucus transport rate was found at the end of treatment
Effect of Ibuprofen on Blood Pressure Control by Propranolol and Bendrofluazide
Authors: Davies J. G. , Rawlins D. C. , Busson M.
Published: January 2017

The effect of 1600 mg/day ibuprofen in two groups of patients with hypertension controlled by either propranolol or bendrofluazide was studied in a double-blind, double-placebo, randomized crossover trial. No significant difference in blood pressure was found at the end of the crossover period in either group, suggesting that the routine co-administration of ibuprofen does not attenuate the antihypertensive effect of thiazide diuretics or propranolol. Significant weight gain, attributable to fluid retention, had occurred in the bendrofluazide-treatment group by the end of the drug-free washout period. No significant change in mean weight occurred in the crossover stages in either group, although substantial weight gain was noted during ibuprofen treatment in two patients given bendrofluazide and one given propranolol. Biochemical variables were unaffected by ibuprofen throughout the crossover period. This study suggests that ibuprofen may be administered routinely to patients receiving thiazides or propranolol without loss of control of the anti-hypertensive action of these drugs but it is recommended that individuals are monitored for possible weight gain or an increase in diastolic blood pressure.
Night Pain and Morning Stiffness in Osteoarthritis: A Crossover Study of Flurbiprofen and Diclofenac Sodium
Authors: Siegmeth W. , Noyelle R. M.
Published: January 2017

Forty patients took part in an observer-blind multiple dose crossover study to compare the efficacy and tolerability of 300 mg flurbiprofen (100 mg twice a day orally and 100 mg suppository at night) with 75 mg diclofenac sodium (25 mg twice daily orally and 25 mg suppository at night) in the relief of night pain and morning stiffness in patients with osteoarthritis. Equal numbers of patients were randomized to receive one of the treatments for the first 7-day treatment period and then the other treatment for the second 7-day treatment period. There were significant differences in favour of flurbiprofen for the reduction in night pain, improvement in quality of sleep and patients' assessment of overall improvement on treatment. Two patients withdrew from the study due to side-effects experienced whilst taking diclofenac sodium during the first treatment period. Eight patients in all reported a total of 18 side-effects during this study. Six patients reported 12 side-effects whilst taking diclofenac sodium compared with three patients who reported six side-effects whilst taking flurbiprofen. This study confirms the good efficacy and tolerability of flurbiprofen in the symptomatic relief of osteoarthritis.
Clinical Efficacy of Codergocrine Mesylate in Children with Learning Difficulties
Authors: Tareen K. I. , Bashir A. , Saeed K. , Hussain T.
Published: January 2017

A double-blind placebo-controlled study in children showed codergocrine mesylate to be effective in improving cognitive functions and behavioural symptoms associated with learning disorders. Forty randomly grouped children of either sex were given an increasing dosage of codergocrine mesylate and followed up for 12 weeks. A significant improvement was noted in speech (acquisition of new words, comprehensibility/meaningfulness of speech), sociability, attention/concentration, comprehension and memory. Improvement in behaviour (emotional lability and cooperativeness) was also noted. Problems of assessing cognitive progress in very young children with culturally appropriate methods were encountered.
Dipyrone versus Paracetamol: A Double-Blind Study in Typhoid Fever
Authors: Ajgaonkar V. S. , Marathe S. N. , Virani A. R. , Pereira L. M. Pinto
Published: January 2017

In a double-blind study in patients with typhoid fever 25 patients received 500 mg dipyrone and 28 received 500 mg paracetamol. Rectal temperature and pulse records were monitored every 30 min. The onset of anti-pyresis in patients given dipyrone (30 min) was significantly different from those given paracetamol (1 h). The area under the time–temperature curves was significantly greater for patients given dipyrone. The sum of the reduction in temperature at all times significantly favoured patients who had been given dipyrone. Both treatments were well tolerated.
Clinical Study of Recombinant Hepatitis B Vaccine
Authors: Ichida F. , Yoshikawa A. , Mizokami M. , Yamamoto M. , Inaba N. , Takamizawa H. , Ohmura T. , Ohmizu A. , Ohata J. , Uemura Y. , Nishida M.
Published: January 2017

The efficacy and safety of a recombinant yeast-derived hepatitis B vaccine were evaluated in 209 subjects after three administrations at 0, 4 and 20 weeks. Subjects were divided into four groups given 5 μg vaccine subcutaneously, 10 μg subcutaneously, 10 μg intramuscularly and 20 μg subcutaneously to define the effective dose and to compare the effect of administration. Seroconversion of the antibody to hepatitis B surface antigen after the third vaccination reached 96.6 % in the group given 5 μg vaccine subcutaneously and 100% in the other groups. The final geometric mean antibody titres were 700 IU/1 in subjects given 5 μg subcutaneously, 2004 IU/1 in those given 10 μg subcutaneously, 4674 IU/1 in those given 10 μg intramuscularly and 3342 IU/1 in those given 20 μg subcutaneously. In the groups given 10 μg, the early seroconversion rate of the antibody to hepatitis B surface antigen and the geometric mean antibody titres after the third vaccination were significantly higher in subjects administered intramuscularly than subcutaneously ( P<0.05). No major adverse effects were observed and minor reactions were the same as, or less than, those reported for the plasma-derived vaccine. Before and after administration, no significant fluctuation in the yeast antibody titre was observed. These results demonstrate the efficacy and safety of the yeast-derived vaccine, and show that 10 μg was the effective dose.
Preliminary Report on Activity and Tolerability of Epomediol, Administered by Intravenous Infusion, in Patients with Chronic Hepatopathies
Authors: Mazzeo F. , Bernocchi D. , Cavalli C. , Manini G.
Published: January 2017

The therapeutic activity and tolerability of epomediol were studied in 28 patients with chronic hepatopathies. Treatment was continued, parenterally, for 10 days (400–600 mg once daily by intravenous infusion). Clinical parameters (headache, right hypochondrial pain, bitter taste in the mouth, asthenia and nausea) and hepatic function (transaminase, alkaline phosphatase and γ-glutamyl transpeptidase) showed significant improvements. Clinical and systemic tolerabilities of epomediol were satisfactory.
Comparison of Flavoxate Hydrochloride in Daily Dosages of 600 versus 1200 mg for the Treatment of Urgency and Urge Incontinence
Authors: Milani R. , Scalambrino S. , Carrera S. , Pezzoli P. , Ruffmann R.
Published: January 2017

Flavoxate hydrochloride at a daily dosage of 600 mg was compared to a daily dosage of 1200 mg for the treatment of unstable bladder. Twenty-seven patients were treated for 4 weeks in a double-blind, randomized, parallel-group trial. Clinically, both schedules were equally successful. In urodynamic terms, however, particularly with respect to uninhibited detrusor contractions, 1200 mg/day was significantly superior to 600 mg/day. Tolerability was excellent for both regimens. The side-effect free treatment of urgency and urge incontinence is of paramount importance for a patient's quality of life.
Infections in the Compromised Host
Authors: Mandell L.A.
Published: January 2017

The skin and/or mechanical factors, such as coughing, ciliary action or urine flow, along with phagocytes and humoral and cell-mediated immunity, help to protect the body from infection. In compromised patients, these mechanisms are impaired or bypassed, rendering patients susceptible to infection by opportunistic organisms (bacteria, mycobacteria, fungi, viruses, parasites). Mechanical barriers may be breached in patients with burns or indwelling catheters, in diabetics or cancer patients, and in parenteral drug abusers. Humoral or cell-mediated immunity may be suppressed in non-neoplastic patients following splenectomy, in diabetics, in alcoholics and in those with certain rheumatic disorders, as well as in patients undergoing haemodialysis or receiving steroids or immunosuppressive drugs. In cancer patients infection is often a cause of death, frequently occurring as a result of granulocytopenia, obstruction of natural passages, or suppression or dysfunction of humoral or cell-mediated immunity. Diagnosis of the infection may be difficult and expert advice should be sought. Treatment should be started before a conclusive diagnosis has been made, particularly in neutropenic patients since infections may be life-threatening.
A Multicentre Study to Evaluate the Effect of Sulbactam/Ampicillin Combination on Anaerobic Micro-Organisms
Authors: Leone F. , Morandotti M.G. , Mazzella P. , Sanna A. , Ravizzola G. , Colombrita D. , Pinzi G. , Turano R. , Menozzi M.G. , Lecchini R. , Viani I. , Avanzini P. , Chezzi C.
Published: January 2017

Ampicillin combined with the β-lactamase inhibitor sulbactam was compared with ampicillin alone, cefoxitin and metronidazole against 569 clinical strains of anaerobic organisms. The strains included 289 species of Bacteroides, 160 strains of Clostridium and 120 strains of various species of Streptococcus/Peptostreptococus, Fusobacterium, Veillonella, Eubacterium, Bifidobacterium, Actinomyces and Propionibacterium. Sulbactam/ampicillin was as effective as cefoxitin and metronidazole against all anaerobic species tested, inhibiting more than 90% of strains at the breakpoints (16, 32 and 32 mg/l, respectively). Sulbactam/ampicillin was also significantly more active than ampicillin against strains of Bacteroides, the minimal inhibitory concentration being at least four-fold lower. In contrast, the activity of the combination did not differ from that of ampicillin alone against Fusobacterium species and Gram-positive rods and cocci.
Double-Blind Study of 5-Hydroxytryptophan versus Placebo in the Treatment of Primary Fibromyalgia Syndrome
Authors: Caruso I. , Puttini P. Sarzi , Cazzola M. , Azzolini V.
Published: January 2017

A double-blind, placebo-controlled study of the efficacy and tolerability of 5-hydroxytryptophan (5-HTP) was conducted in 50 patients with primary fibromyalgia syndrome. All the clinical parameters studied were significantly improved by treatment with 5-HTP and only mild and transient side-effects were reported. Further controlled studies are required to define properly the value of 5-HTP in patients with primary fibromyalgia syndrome.
Astemizole and Cetirizine in the Treatment of Seasonal Allergic Rhinitis: A Comparative Double-Blind, Multicentre Study
Authors: Rijntjes E. , Ghys L. , Rihoux J.-P.
Published: January 2017

In a double-blind, multicentre trial, 105 patients with seasonal allergic rhinitis were treated with 10 mg astemizole or 10 mg cetirizine once daily for 4 days. Patients were thereafter allowed to change their treatment if not satisfied with the clinical efficacy. In the cetirizine-treated group, there were significantly fewer ( P = 0.02) patients who asked to change their treatment compared to patients receiving astemizole for 4 days. At day 4, there was a significant improvement in the clinical scores for the patients who did not want to change treatment but scores were hardly altered in those patients that wished to change. After treatment for a further 10 days, there was a decrease in all the scored symptoms but this was less marked in the two groups of patients who wanted to change treatment.
Comparative Study of Cefuroxime Axetil Suspension and Amoxycillin Syrup in the Treatment of Acute Otitis Media in General Practice
Authors: Brodie D.P. , Griggs J.V. , Cunningham K.
Published: January 2017

In a multicentre general practice study, 660 children aged between 3 months and 12 years with otitis media were randomized to receive a 10-day course of cefuroxime axetil suspension or amoxycillin syrup. Children under 2 years of age were given 125 mg cefuroxime axetil twice daily after food or 125 mg amoxycillin three times daily; older children received 250 mg cefuroxime axetil twice daily or 250 mg amoxycillin three times daily. The overall cure or improvement rate was 94.3% for those treated with cefuroxime axetil and 94.5% for those receiving amoxycillin. Both treatments were well tolerated, with no differences in the number of patients who experienced at least one adverse event or who were withdrawn from treatment. Haemophilus influenzae was isolated in 29% of specimens obtained, Streptococcus pneumoniae in 22% and Moraxella catarrhalis in 6%. Some Strep. pneumonia and M. catarrhalis infections were resistant to amoxycillin. It is concluded that cefuroxime axetil suspension given twice daily has comparable efficacy to amoxycillin syrup given three times daily in the treatment of children with otitis media.
A Review of Long-Term Safety Data with Buflomedil
Authors: Bachand R. T. , Dubourg A.Y.
Published: January 2017

Tolerance of long-term buflomedil was assessed by compiling safety data (adverse effects, vital signs and clinical laboratory results) from three multicentre clinical trials in patients with intermittent claudication or Alzheimer's disease-type senile dementia. The three studies were similar in design: open placebo lead-in; double-blind, placebo-controlled treatment; and open long-term treatment. Patients were randomly assigned to receive 600 mg/day buflomedil given orally for 3 or 6 months ( n = 297) or placebo ( n = 298). Buflomedil was continued for a further 6 – 12 months in 193 patients and for 12 months or more in 99 patients. Side-effects occurred in 20.5% and 18.1% of buflomedil- and placebo-treated patients, respectively, with discontinuation in 14.5% and 13.1%, respectively. In the open phase, 10.9% experienced side-effects, with 1.5% of patients discontinuing treatment. Mean changes in vital signs and laboratory tests were occasionally statistically, but not clinically, significant. Overall long-term tolerance was excellent.
Fibrinolytic Activity of Oral Cyclandelate in Patients with Generalized Atherosclerotic Vasculopathy: A Double-Blind Study
Authors: Forconi S. , Cappelli R. , Guerrini M. , Frigerio C. , Messa G.L. , Furesi L.
Published: January 2017

In a double-blind study, a single dose of 1600 mg cyclandelate or placebo was administered to 10 patients with cerebrovascular and/or peripheral vascular disease, and fibrinolytic activity was evaluated before and 1, 2, 4 and 6 h after treatment. Cyclandelate induced a reduction in euglobulin lysis time, an increase in tissue plasminogen activator concentration and a reduction in plasminogen activator inhibitor, α2-antiplasmin and immunological fibrinogen concentrations, but no changes in antithrombin III and plasminogen concentrations were observed. After placebo administration no significant changes were observed. After treating two patients with 800 mg cyclandelate twice daily for 14 days, 1600 mg cyclandelate stimulated fibrinolysis for 8 h. It is concluded that the fibrinolytic activity of cyclandelate has implications for the treatment of cardiovascular complications of atherosclerosis.
Ketorolac, a New Non-Opioid Analgesic: A Double-Blind Trial versus Pentazocine in Cancer Pain
Authors: Estapé J. , Viñolas N. , González B. , Inglés F. , Bofill T. , Guzmán M.C. , Tarragó E.
Published: January 2017

A randomized double-blind trial was performed to evaluate the efficacy of a new non-steroidal anti-inflammatory analgesic drug, ketorolac, in the treatment of cancer pain compared with the opioid pentazocine. A total of 40 patients with moderate to severe cancer pain were studied, 20 patients being treated with 10 mg ketorolac given orally every 6 h and 20 receiving 50 mg pentazocine given orally every 6 h for up to 7 days. A reduction in the severity of the pain was recorded in both treatment groups with no significant difference in efficacy being found between the two therapies, although withdrawals due to adverse reactions were significantly less in the ketorolac-treated group ( P < 0.005). It is concluded that ketorolac may be a useful and more acceptable alternative to opioids in the treatment of cancer pain.
Placebo-Controlled Comparison of Single Intramuscular Doses of Ketorolac Tromethamine and Pethidine for Post-Operative Analgesia
Authors: Folsland B. , Skulberg A. , Halvorsen P. , Helgesen K.G.
Published: January 2017

The analgesic efficacy and safety of single doses of 10 mg and 30 mg ketorolac tromethamine and 100 mg pethidine were evaluated in a double-blind, parallel-group study. The drugs were administered intramuscularly to patients experiencing moderate, severe or very severe pain immediately following major abdominal surgery. A total of 129 patients were randomly assigned to receive either active drug ( n = 32 for each treatment group) or placebo ( n = 33), and the patients assessed pain intensity and pain relief on a visual analogue scale at regular intervals over the following 8 h. During the first 2 h, pethidine had a more rapid onset of action than ketorolac or placebo, and thereafter 100 mg pethidine and 30 mg ketorolac were equally effective. Ketorolac, at a dose of 10 or 30 mg, and 100 mg pethidine were clinically and statistically more effective than placebo, with 30 mg ketorolac having a similar efficacy to 100 mg pethidine over the 8-h study period and 10 mg ketorolac being slightly less effective than 30 mg ketorolac. No serious adverse events were reported.
Pharmacokinetics and Therapeutic Study with Nimesulide Suppositories in Children with Post-Operative Pain and Inflammation
Authors: Schärli A.F. , Brülhart K. , Monti T.
Published: January 2017

The pharmacokinetic pattern of 100 mg nimesulide administered rectally at different times prior to undergoing minor surgery was studied in 45 children. Absorption of nimesulide was relatively fast, a peak plasma concentration of 75 mg/1 being reached 3 h after administration, and the elimination half-life was 3.15 h. The efficacy and tolerability of the nimesulide suppositories were assessed in a randomized, double-blind, dipyrone-controlled study of 50 children suffering from moderate to severe post-operative pain, the drugs being administered one to three times daily as required; 26 patients received nimesulide and 24 dipyrone. A consistent reduction in pain was recorded during nimesulide therapy given for a mean period of 2.5 days, with a mean consumption of 3.5 suppositories. Similar results were obtained in dipyrone-treated patients. The efficacy of both drugs was judged by the physicians to be good or very good in 70% of cases and there were no statistically significant differences between the two treatment groups in the dosage required or the pain relief. Tolerability of both drugs was excellent, with only one patient in each treatment group complaining of nausea.
Modifications in the Serum Concentrations of Prolyl Hydroxylase in Patients with Chronic Hepatitis B during and after Interferon Therapy
Authors: Testa R. , Picciotto A. , Bardellini E. , Bindi P. , Dagnino F. , Mela G.S. , Valle F. , Celle G.
Published: January 2017

A total of eight patients with chronic active HBsAg-positive hepatitis was treated with recombinant interferon-α2b for 12 months and serum aspartate aminotransferase, alanine aminotransferase, γ-globulin and prolyl hydroxylase concentrations were determined every 3 months. Liver biopsies after 12 months' treatment revealed a significant ( P < 0.05) reduction in the histological activity score. After 6 months, alanine aminotransferase ( P < 0.01) and aspartate aminotransferase ( P < 0.05) concentrations fell significantly compared with baseline concentrations. Serum prolyl hydroxylase concentrations declined significantly ( P < 0.05) after 15 months and remained depressed. It is concluded that interferon-α2b therapy reduced fibrogenetic activity in chronic active hepatitis B.
Treatment of Respiratory Tract Infections in Children: A Study of a Combination of Amoxycillin and Clavulanic Acid
Authors: Fiocchi A. , Zuccotti G. , Bellù R. , Marangione P. , Riva E. , Giovannini M.
Published: January 2017

In an open study, 70 in-patients and 23 out-patients aged between 1 and 14 years with sinusitis ( n = 1), perforated otitis media ( n =4), pharyngotonsillitis ( n =25), tracheobronchitis ( n = 30) or bronchopneumonia ( n = 33) were treated daily with a combination of 40 mg/kg amoxycillin and 10 mg/kg clavulanic acid in three equal doses for between 6 and 15 days. Purulent specimens were cultured when obtainable and pathogenic organisms identified were Staphylococcus aureus, β-haemolytic streptococcal group A, Pseudomonas aeruginosa, Pseudococcus species and Klebsiella pneumoniae infections, of which 45.7% were β-lactamase-producing and 54.3% were ampicillin-susceptible. After treatment, only one β-lactamase-producing Streptococcus and one Staphylococcus infection persisted. Side-effects (vomiting, nausea, diarrhoea, maculopapular exanthema, rash) occurred in 16 patients and treatment was withdrawn in eight. It is concluded that the amoxycillin – clavulanic acid combination is a suitable first choice for the treatment of respiratory tract infections in children in whom the pathogenic organism may not have been established.
Pharmacological Modulation by Cetirizine and Loratadine of Antigen and Histamine-Induced Skin Weals and Flares, and Late Accumulation of Eosinophils
Authors: Fadel R. , Herpin-Richard N. , Dufresne F. , Rihoux J.-P.
Published: January 2017

In a double-blind, randomized, crossover study performed in atopic subjects, the inhibitory effects of single doses of 10 mg cetirizine and 10 mg loratadine on histamine- and grass pollen-induced skin reactions were evaluated 4 h after drug intake. Cetirizine significantly inhibited histamine- and antigen-induced skin reactions, as well as the accumulation of eosinophils measured 24 h after antigen challenge. Loratadine, however, did not significantly inhibit the skin reactions induced by histamine and grass pollen, nor eosinophil accumulation.
A Comparison of Butoconazole Nitrate Cream with Econazole Nitrate Cream for the Treatment of Vulvovaginal Candidiasis
Authors: Ruf H. , Vitse M.
Published: January 2017

In a randomized, single-blind, parallel study the safety and efficacy of 2% butoconazole nitrate cream used for 3 days were compared with those of 1% econazole nitrate cream used for 7 days at night in patients with vulvovaginal candidiasis. Patients in both treatment groups had positive potassium hydroxide smears and fungal cultures, and were similar in age, disease duration and history, obstetric history and contraceptive use. Of the 75 patients enrolled, 63 with a Candida albicans infection were included in the efficacy analyses. Evaluations were made at the start of the study (visit 1), after 10 – 23 days (visit 2) and after 24 − 45 days (visit 3). Both drugs significantly reduced all signs and symptoms, and at visits 2 and 3 the percentages of patients considered microbiologically, clinically and therapeutically cured were consistently higher for butoconazole-than for econazole-treated patients, although differences were not statistically different. Although both drugs were safe and well tolerated, it is concluded that butoconazole because of its much shorter regimen and superior clinical and microbiological performance was the drug of choice.

Lors d'une étude parallèle randomisée en simple aveugle, l'innocuité et l'efficacité du nitrate de butoconazole crème à 2% appliqué pendant 3 jours ont été comparées à celles du nitrate d'éconazole crème à 1% administré la nuit pendant 7 jours à des patientes présentant une candidose vulvo-vaginale. Les deux groupes présentaient des cultures et des frottis à l'hydroxyde de potassium positifs et étaient comparables au point de vue âge, durée et évolution de l'infection, antécedents obstétricaux et utilisation de contraceptifs. Sur les 75 patientes traitées, 63 présentant une infection à Candida albicans ont été incluses dans l'analysis d'efficacité. Des évaluations ont été effectuées au début de l'étude (visite 1), après 10 à 23 jours (visite 2), et après 24 à 45 jours (visite 3). Les deux médicaments ont nettement réduit tous les signes cliniques et les symptômes, et lors des visites 2 et 3 les pourcentages de patientes considérées comme microbiologiquement, cliniquement et thérapeutiquement guéries étaient régulièrement plus élevés chez celles traitées avec le butoconazole que chez celles traitées avec l'éconazole, bien que les différences n'aient pas été statistiquement significatives. Comme les deux produits se sont révélés sans danger et ont été bien tolérés, nous conclusons que le butoconazole, à cause de son effet beaucoup plus rapide et de ses performances cliniques et microbiologiques supérieures, constitue le traitement de choix.
Bioavailability of Single and Multiple Doses of Enteric-Coated Mesalamine and Sulphasalazine
Authors: Corey A.E. , Rose G.M. , Conklin J.D.
Published: January 2017

The bioavailibility of mesalamine from enteric-coated mesalamine and sulphasalazine was determined following a single dose and at steady state in healthy subjects in crossover studies. Plasma concentrations and urinary excretion of mesalamine and its major metabolite, N-acetyl-5-aminosalicylic acid, were measured. After a single dose of enteric-coated mesalamine, about 10 h elapsed before the onset of measurable plasma drug concentrations, probably representing gastro-intestinal transit prior to drug release near the ileocaecal junction. The elimination kinetics were similar for a single oral dose and steady state using enteric-coated mesalamine, but after both single and multiple administration of enteric-coated mesalamine only about 20% of the mesalamine given was absorbed, with about 80% estimated to remain for colon therapeutic activity. It is concluded that, despite different mechanisms of mesalamine release, enteric-coated mesalamine and sulphasalazine produced similar mesalamine absorption.
Evaluation of the Efficacy and Safety of Sobrerol Granules in Patients Suffering from Chronic Rhinosinusitis
Authors: Bellussi L. , Manini G. , Buccella M.G. , Cacchi R.
Published: January 2017

In a double-blind, randomized, placebo-controlled clinical trial, the safety and efficacy of 900 mg/day sobrerol granules given for up to 10 days was assessed in 40 patients with chronic catarrhal rhinosinusitis. At the beginning of treatment a total of six patients had a fever, whereas body temperature was normal in all patients at the end of the treatment. Treatment with sobrerol significantly ( P < 0.01) reduced frontal headache and rhinorrhoea, efficacy being confirmed by rhinomanometry. Patients treated with placebo experienced an improvement in frontal headache, rhinorrhoea and overall rhinomanometry scores. Treatment with sobrerol was well tolerated but two patients treated with placebo reported adverse reactions (stomach pain and cutaneous rash). These preliminary data suggest that sobrerol could be useful if administered with an anti-inflammatory drug for the treatment of chronic catarrhal rhinosinusitis.