Pharmatherapeutica最新文献

In an open clinical multi-centre trial carried out in five Danish psychiatric departments, patients suffering from acute psychosis including mania or exacerbation of chronic psychosis were given injections of 5% zuclopenthixol acetate in 'Viscoleo'. The object of the trial was to evaluate the treatment by means of a global assessment of the severity of the psychosis, the therapeutic effect and the side-effects. The results showed that the treatment was rapidly effective in reducing the severity of psychotic symptoms combined with an advantageous unspecific sedation. The side-effect profile was similar to that after other neuroleptics. Special attention should be paid, however, to a possible occurrence of acute dystonia which was observed particularly in young men with acute psychosis.

A prospective study was carried out in 43 hospitalized patients with respiratory or other serious bacterial infections requiring intravenous antibiotic therapy to assess the efficacy and tolerance of amoxycillin/clavulanic acid ('Augmentin'). After bacteriological and laboratory investigations patients were started on 1 g amoxycillin plus 200 mg clavulanic acid intravenously every 8 hours for the first 3 days and then were treated orally at the same dosage. Duration of treatment varied according to the type and severity of the infection, with a minimum of 10 days. Efficacy of treatment was evaluated by the clinical response, judged by the resolution of signs and symptoms of infection. The results showed that there was a clinical cure rate of 88.4%. Local tolerance was excellent and there were few side-effects reported. Six patients experienced vomiting which led to the withdrawal of treatment in 1 patient.

Seventy-two depressed patients attending general practices were randomly allocated to treatment with either flupenthixol dihydrochloride (1 to 2 mg/day) or fluvoxamine maleate (100 to 200 mg/day) to assess efficacy and side-effects over a 4-week period. Clinical assessments were carried out before medication (Day 1) and on Days 8, 15 and 29 of treatment using the Hamilton Rating Scale for Depression, Clinical Global Impressions (CGI) and a patient self-assessment visual analogue scale for depression. Unwanted symptoms were also recorded. Reduction in mean total scores on the Hamilton scale at each assessment and therapeutic effect improvement on the CGI were greater for patients treated with flupenthixol (p less than 0.05). Reduction in unwanted symptoms was progressive in both groups, but more pronounced in patients receiving flupenthixol. Twice as many new symptoms arose in the fluvoxamine group compared to the flupenthixol group. Four patients were withdrawn in the fluvoxamine group due to untoward drug effects compared with none in the flupenthixol group.

A single-blind, placebo-controlled study was carried out in 30 patients with chronic obstructive bronchopneumopathy to assess the effectiveness and tolerability of the theophylline derivative, bamyphylline. On entry, patients were allocated to receive twice daily oral doses of either 600 mg bamyphylline or placebo for a period of 60 days. Spirometric measurements, blood pressure and respiratory rate recordings and blood gas analyses were made at baseline and after 10, 30 and 60 days of treatment, as were assessments of clinical and objective signs, such as sibili, rales and vesicular murmurs. Plasma concentrations of bamyphylline 1 hour after the first dose of the day were monitored at the same intervals. The results showed that there was a highly significant progressive improvement in pulmonary function which was already apparent after 10 days and this was accompanied by a marked improvement in cardiac dynamics and clinical signs. Plasma concentrations of bamyphylline remained stable throughout the study period and there were no reports of side-effects or significant variations in blood chemistry.

A prospective, randomized comparative trial was carried out in 31 children suffering from lower respiratory tract infections, mainly bronchopneumonia or pneumonia. Twenty-one children received oral cefetamet pivoxil in a dose of 20 mg/kg/day (10 children) or 40 mg/kg/day (11 children), and 10 children 30 mg cefaclor/kg/day for 7 days. Clinical signs and symptoms, i.e. fever, dyspnoea, altered breath sounds and cough, subsided during treatment with both cefetamet pivoxil treatment doses in all patients. All X-ray findings and blood leucocytosis normalized, while 1 out of the 10 children to whom 30 mg cefaclor/kg/day was administered deteriorated from bronchopneumonia to pneumonitis during treatment. Treatment was stopped due to vomiting in 1 patient receiving the 40 mg cefetamet pivoxil/kg/day dose.

A study was carried out in 8 patients with chronic stable bronchial asthma to compare the bronchodilator response with terbutaline, administered by a recently developed powder inhalation system ('Turbuhaler') and equipotent doses of salbutamol administered by a widely used powder inhaler ('Rotahaler'). Dose-effect relationships with usually applied clinical doses of the bronchodilators were estimated by maximal expiratory flow-volume analysis and airway resistance estimates from body plethysmography. There was no significant difference in clinical response using either inhaler. The equal and opposite changes in forced vital capacity and residual volume with increasing dose indicate an improvement in peripheral airway resistance and, therefore, adequate peripheral powder deposition of the bronchodilators. Only at the highest dose was a mild increase noted in pulse frequency and tremor score with both systems. It is suggested that, because of the multi-dose character, absence of additives, easy handling (no capsule loading) and low inspiratory flow needed for actuation, the 'Turbuhaler' system may be considered preferable for the application of a bronchodilator in children and severely obstructed adults.

A prospective, randomized controlled study was carried out in 104 patients to compare clavulanate-potentiated amoxycillin ('Augmentin') with a combination of cephalosporins (cefazoline and cefadroxil) supplemented with metronidazole in the treatment of abdominal septic states, suspected or proven after surgical intervention. Patients on 'Augmentin' received 1.2 g (1 g amoxycillin plus 200 mg clavulanic acid) intravenously 3-times daily for a mean of 6.6 days, then 375 mg (250 amoxycillin plus 125 mg clavulanic acid) orally for a further 6.4 days. Patients on the standard therapy received 1 g cefazoline intravenously 4-times daily plus 500 mg metronidazole intravenously 3-times daily for 7 days, then 500 mg cefadroxil orally 4-times daily for a mean of 6.6 days. Evaluation of the patients' condition was undertaken after 24 hours, 3 days and 7 days. The results showed a significantly better response to treatment in the 'Augmentin' group, as judged by the amelioration of clinical symptoms, bacteriological findings, and tolerance. All the patients treated with 'Augmentin' showed an excellent or satisfactory overall response at Day 7 compared with 76% of those receiving the standard therapy.

A retrospective analysis was carried out of the results of 115 intensively-treated cancer inpatients receiving 91 treatment courses of amphotericin B given in an empirical fashion. Amphotericin B was administered over 1.5 to 2 hours at a dose of 0.6 to 0.7 mg/kg/day. Median duration of neutropenic fever before amphotericin B administration was 5 days (range 1 to 32 days) and median total amphotericin B dose was 480 mg (range 10 to 2450 mg). In 56 (61%) of 91 amphotericin B courses, neutropenic fevers resolved; this occurred a median of 3 days (range 1 to 15 days) after amphotericin B was begun and at a median dose of 120 mg (range 10 to 850 mg). Response to amphotericin was independent of positive cultures for fungus or sites of positive culture. Adverse reactions to amphotericin B included rigors (89% of courses), fever (23%), bronchospasm (9%), and transient hypotension (9%). Median increase above baseline serum creatinine in patients given amphotericin B was 0.5 mg/dl (range 0 to 2.6 mg/dl) compared to a median of 0.1 mg/dl (range 0 to 2.9 mg/dl) in a similar group of intensively-treated cancer patients who did not receive amphotericin B. Amphotericin B was well tolerated when given by rapid infusion and was associated with prompt resolution of neutropenic fever in the majority of patients.

A clinical trial was carried out to compare the efficacy and tolerance of two modes of induction of labour: vaginally administered prostaglandin E2 gel vs intravenous perfusion of synthetic oxytocin. Fifty women with pregnancy at or near term in whom prompt vaginal delivery was clinically indicated were divided at random into sub-groups of 25 each. Initial dose of PGE2 gel was 1 mg followed by another application of 1 mg or 2 mg 6 hours later in case active labour stage has not been reached. Progressive oxytocin perfusion began with 1 mU/min., being increased gradually every 20 minutes until efficacious uterine dynamics were attained. Data were recorded on entry of age, parity, gestation age, cervical dilatation, Bishop score, indication for induction. Continuous materno-foetal monitoring was carried out during the induction period. Results were evaluated from induction/delivery time, type of delivery, maternal and foetal condition, and any side-effects which developed. Apart from a higher number of instrumental deliveries in the PGE2 gel series, which was not related to the induction method, there was no significant difference between any of the variables evaluated, both methods producing active labour in approximately 70% of the patients within 12 hours. The authors stress, however, the convenience, both for patients and hospital staff, of the administration of an intravaginal induction agent over a systemic therapeutic method of induction.

Ninety-eight patients suffering from skin and soft tissue infections in the Côte d'Ivoire were treated topically with a new antibiotic, mupirocine, or with placebo in a double-blind study. Patients were allocated at random to receive one or other treatment, applying the ointment, supplied in identical tubes and of similar colour base, to the lesions 3 times a day for 5 days. Overall evaluation of clinical response to treatment showed that the results with mupirocine were significantly superior to those with placebo. No unwanted effects of treatment were observed in either treatment group.