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Biomedical subjects

A Lassus

Publications and source records attributed to A Lassus.

At least 19 recordsLinked to original sources

Comparison of fleroxacin and penicillin G plus probenecid in the treatment of acute uncomplicated gonococcal infections.

OBJECTIVE: To investigate the activity of fleroxacin in acute uncomplicated infections with N. gonorrhoeae in comparison with conventional penicillin G plus probenecid treatment. DESIGN: Multicentre open label randomised parallel group study. SUBJECTS: Male patients aged 18 years or over from university departments of urology, epidemiology and dermatology and a clinic for sexually transmitted diseases. INTERVENTIONS: Two hundred and sixty male patients were randomly assigned to treatment with either a single oral dose of fleroxacin 400 mg (130 patients) or a single intramuscular dose of penicillin G (2.4 or 5.0 mega units) plus a single oral dose of probenecid 1 gram (130 patients). Efficacy and safety assessments were undertaken at follow-up (3-14 days after treatment). Efficacy was assessed as bacteriological outcome of treatment. Safety was assessed by evaluation of adverse events, laboratory abnormalities and changes in vital signs. RESULTS: Two hundred and twenty four patients (114 in the fleroxacin group and 110 in the penicillin plus probenecid group) were evaluated for efficacy. Bacteriological cures were achieved in 100% of patients in the fleroxacin group and 97% of patients in the penicillin plus probenecid group. There was no statistically significant difference between the two groups in this respect (Fisher exact test, p = 0.25). Clinical cures were achieved in 100% of patients receiving fleroxacin and 95% of patients receiving penicillin plus probenecid. Safety analyses were undertaken on 255 patients (126 in the fleroxacin group and 129 in the penicillin plus probenecid group). No adverse events were reported for either treatment group, and no clinically relevant laboratory abnormalities were apparent. Thus, there appeared to be no difference in the efficacy or safety of these two treatments when used to treat acute, uncomplicated urethral gonorrhoea in males. CONCLUSIONS: In this study fleroxacin proved to be highly effective therapy for uncomplicated gonococcal urethritis in males and may provide a favourable alternative to standard treatment.

Acute Disease

The effect of Vivida cream as compared with placebo cream in the treatment of sun-damaged or age-damaged facial skin.

Vivida when used orally has been previously shown to be effective in treating degenerated skin of women. In the present study, 30 women with moderate to severe sun-damaged facial skin applied Vivida cream twice daily for 120 days on one side of the face and placebo to the other. Vivida was significantly (P < 0.001) more effective than placebo in improving wrinkles. The effects of Vivida cream on mottles and telangiectasis were also significantly (P < 0.01) greater than those of placebo. Scanner measurement showed that epidermal thickness increased from 0.13 mm to 0.29 mm and dermal thickness from 0.91 mm to 1.29 mm on the Vivida-treated side; only minimal changes were observed on the placebo-treated side. The elasticity index increased from about 50% to 69% on the Vivida-treated side and from 49% to 50% on the placebo-treated side.

Administration, Oral

A comparative study of a new food supplement, ViviScal, with fish extract for the treatment of hereditary androgenic alopecia in young males.

A controlled, randomized, double-blind, parallel-group study compared the effects of ViviScal (a new food supplement incorporating special marine extracts and a silica compound) with those of a fish extract in the treatment of young males with hereditary androgenic alopecia. The pretreatment histological diagnosis was alopecia with a mild to moderate perifollicular inflammation zone. The study consisted of 20 subjects who received two tablets of ViviScal once daily and 20 who received two tablets of fish extract once daily for 6 months. The mean patient age and mean duration and severity of baldness compared well between the two groups. Most patients had been treated with long-term topical 2% minoxidil for 1 year or more prior to the study. At baseline and after 6 months' treatment, a biopsy was taken for histological examination. A non-vellus hair count was performed at baseline and after 2, 4 and 6 months. In the fish extract treatment group three patients withdrew from the study before the fourth month due to lack of therapeutic effect. After 6 months' treatment, patients receiving ViviScal showed a mean increase in non-vellus hair of 38% compared with a 2% increase in the fish extract treatment group (P < 0.0001). In the ViviScal group, 19 (95%) subjects showed both clinical and histological cure, whereas none treated with fish extract showed any clinical or histological difference after 6 months' treatment (P < 0.0001). In both groups, a minimal decrease in the erythemal index was observed. In conclusion, ViviScal appears to be the first highly active treatment for androgenic alopecia in young males.

Administration, Oral

Comparative studies of azithromycin in skin and soft-tissue infections and sexually transmitted infections by Neisseria and Chlamydia species.

Two open, randomized, single centre studies have investigated the efficacy and safety of azithromycin (CP-62,993) in the treatment of infections by azithromycin-sensitive pathogens: (A) acute bacterial infections of skin or soft tissue (compared with erythromycin; n = 82); and (B) urethritis and/or cervicitis caused by Neisseria gonorrhoeae and/or Chlamydia trachomatis (compared with doxycycline; n = 108). In study A, azithromycin was administered to 42 patients for five days at a dosage of 250 mg bd on day 1 and 250 mg once daily on days 2-5; erythromycin was given to 40 patients for seven days at a dosage of 500 mg every 6 h. In study B, azithromycin was administered either as a single 1 g dose or as a single 500 mg dose on day 1 and 250 mg once daily on days 2 and 3; doxycycline was given at a dose of 100 mg every 12 h for seven days. In study A, 68 patients were clinically assessed: clinical cure or improvement in patients receiving azithromycin or erythromycin was achieved in 86% and 82%, respectively. The principal causative pathogen was Staphylococcus aureus; there was eradication of 15/25 pathogens (60%) with azithromycin and 13/23 (57%) with erythromycin. In study B, 94 and 93 patients were clinically assessed at weeks 1 and 2, respectively: clinical cure was achieved with all treatment regimens at week 1; at week 2 there was reappearance of symptoms in one patient with a mixed infection who had received 3-day azithromycin.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent

Topical idoxuridine for treatment of genital warts in males. A double-blind comparative study of 0.25% and 0.5% cream.

Fifty heterosexual male patients with histologically verified genital warts of short duration (less than 3 months) were randomly allocated to treatment with either 0.25% or 0.5% idoxuridine cream. The application of the cream to the warts was performed twice daily for an initial period of 14 days, whereafter patients with partial improvement or no response were retreated in the same way for another period of 14 days. Patients not completely healed after 28 days were regarded as treatment failures and withdrawn from the study. After the initial treatment period of 14 days, 19 of 25 patients (76%) treated with 0.5% idoxuridine cream, and 9 of 25 patients (36%) treated with 0.25% idoxuridine cream were completely healed. This difference is significant (p less than 0.01). The corresponding figures at the second follow-up examination (28 days after start of the study) were 19 of 25 (76%) and 13 of 25 (52%), respectively. At the last follow-up examination three months after start of treatment, four patients treated with 0.5% idoxuridine cream and five patients treated with 0.25% idoxuridine cream had a relapse. Thus, the overall rate of complete healing was 15 of 25 (60%) for the patients treated with 0.5% idoxuridine cream and 8 of 25 (32%) for those treated with 0.25% idoxuridine cream. The difference is significant (p less than 0.01). No adverse reactions were observed or reported by the patients.

Administration, Topical

Genivir (DIP-253) 1% cream versus placebo cream in the treatment of recurrent genital herpes: a double-blind study.

A total of 100 heterosexual adults of either sex with frequent episodes of recurrent genital herpes were allocated to treatment with either Genivir (DIP-253) 1% cream or placebo cream. All patients had genital herpes previously verified by a positive viral culture. The study was carried out as a double-blind parallel group trial. Fifty patients were allocated to each of the two treatment groups. The treatment was initiated within 24 hours after the first sign of a recurrence, and at the pretreatment examination all patients had developed typical lesions with blisters and/or sores. At baseline a sample for herpes virus culture and typing was obtained. The creams were applied four times daily for five days. Follow-up examinations were carried out on days 1, 2, 4 and if needed on days 7, 10 and 14. The major factor used for assessment of efficacy was the time to complete healing of all lesions. Duration of pruritus and pain were also recorded. In the group of patients treated with Genivir cream the time to complete healing was 3.3 days and in the placebo group 6.1 days. The difference was statistically significant (P less than 0.001). The mean duration of pain was 1.3 days in the Genivir group and 2.5 days in the placebo group: this difference also reached significance (P less than 0.01). The duration of pruritus was about the same in both groups. The active agent in Genivir, DIP-253, is a heterocyclic aromatic complex with confirmed anti-herpetic activity and with evidence of a local immunomodulatory effect. It was concluded that the efficacy of topical application of DIP-253 may be due to combined antiviral and immunomodulatory activities.

Administration, Topical

Clinical experience with 1000 patients treated with cefetamet pivoxil.

Clinical studies have been carried out world-wide on cefetamet pivoxil, a new orally active cephalosporin. This paper reports on the first 1000 patients treated with the antibiotic; another 505 patients received standard antibiotics, mainly cefadroxil and cefaclor, for comparison. The results show that single doses of 1500 and 1200 mg cefetamet pivoxil were fully effective in gonorrhoea. Comparative trials in uncomplicated urinary tract infection indicate a significant superiority of a single dose of 2 g cefetamet pivoxil (n = 158; 90.0% cure) versus 2 g cefadrox (n = 162; 77.0% cure). In complicated urinary tract infections, a comparable outcome was achieved with a single daily dose of 2 g cefetamet pivoxil for 10 days (n = 99; 90% cure) and 1 g cefadroxil twice daily for 10 days (n = 98; 76.5% cure). The clinical response rate in acute exacerbation of chronic bronchitis was 89.4% in the group receiving cefetamet pivoxil (136 patients) and 83% in the cefaclor-treated group (n = 122). Treatment with 1000 or 2000 mg cefetamet pivoxil achieved a (bacteriological) success rate of 96% compared to 95% with cefaclor in acute ear, nose and throat-infections (n = 91). Overall, based on 894 isolated pathogens prior to therapy, the bacteriological response rate was 90% and it would appear that in vivo the spectrum of this cephalosporin covers a wide range of Gram-negative and Gram-positive pathogens, including urinary pathogens, but excluding Enterococci and Pseudomonas. Cefetamet pivoxil proved to be well tolerated. Mild to moderate adverse events were reported in 7.1% of patients but only 2 of the 1000 patients treated with cefetamet pivoxil were withdrawn because of diarrhoea, which subsided rapidly. There were no clinically relevant deviations in laboratory parameters.

Adult

Ciprofloxacin versus amoxycillin and probenecid in the treatment of uncomplicated gonorrhoea.

In a randomized study 100 patients, 78 males and 22 females, with uncomplicated gonorrhoea were treated with either a single oral dose of 250 mg of ciprofloxacin or a single oral dose of 3 g of amoxycillin and 1 g of probenecid. Three of the gonococcal strains produced penicillinase and, in addition, nine strains had MIC-values of amoxycillin ranging between 0.6 and 1.2 mg/l and five other strains MIC-values higher than 1.2 mg/l. Twenty-two patients had a concomitant infection due to Chlamydia trachomatis. All patients treated with ciprofloxacin were cured, while two patients treated with amoxycillin had treatment failures. Neither treatment regimen had any effect on the chlamydial infections. No adverse effects were observed. It was concluded that ciprofloxacin is the drug of choice in the treatment of uncomplicated infections due to Neisseria gonorrhoeae.

Adolescent

Ciprofloxacin versus doxycycline in the treatment of uncomplicated urogenital Chlamydia trachomatis infections. A double-blind comparative study.

Two-hundred patients with confirmed Chlamydia trachomatis infection of the urogenital region were treated with either ciprofloxacin 1.5 g/day or doxycycline 100 mg/day for seven days. One-hundred and fifty-seven patients were males and 43 females. C. trachomatis was isolated prior to treatment from urethra alone in 155 patients, from cervix alone in 27 and from both urethra and cervix in 15. The first re-examination was carried out at the end of treatment and the second one week later. Six patients in the ciprofloxacin group and three in the doxycycline group never returned for the first re-examination. At the second re-examination there were seven defaulters in the ciprofloxacin group and 11 in the doxycycline group. Altogether there were 12 bacteriological failures in both groups. Clinical failure despite bacteriological cure occurred in 20 patients in the ciprofloxacin group and eight in the doxycycline group. The total number of treatment failures was 32 in the ciprofloxacin group and 20 in the doxycycline group. The results suggested that neither treatment was efficient enough in the treatment of uncomplicated urogenital infections caused by C. trachomatis.

Adult

Fleroxacin versus standard therapy in gonococcal urethritis.

Eighty male patients with gonococcal urethritis were randomly allocated to receive, in an open study, either a single oral 400 mg dose of fleroxacin, or, as standard therapy, a single intramuscular dose of 2.4 million units of penicillin G plus 1.0 g of probenecid orally. Microbiological analysis of the urethral smear and complete physical examination with blood and midstream urine samples was carried out before and after therapy (day 7 or 8). Urethral Neisseria gonorrhoeae was the only pathogen in 50 patients while 29 presented with mixed infections of both N. gonorrhoeae and Chlamydia trachomatis. In one case, the culture was not positive for either of the pathogens. N. gonorrhoeae was eradicated by both regimens in all 78 evaluable patients. However, the 29 patients with mixed infections remained clinically symptomatic and still showed C. trachomatis irrespective of the treatment regimen. Two patients failed to return for follow-up. No adverse reactions were reported.

Adult

Acitretin and etretinate in the treatment of palmoplantar pustulosis: a double-blind comparative trial.

Sixty patients with palmoplantar pustulosis were treated in a double-blind trial with either acitretin (etretin, Ro 10-1670) or with etretinate. The study consisted of 4 weeks of therapy with three 10 mg capsules/day followed by 8 weeks of therapy with a varying number of capsules given daily according to therapeutic response. At the end of the 12-week treatment period, the mean number of pustules (+/- SEM) had decreased from 57.8 (+/- 8.6) to 3.9 (+/- 1.6) in the acitretin group and from 57.1 (+/- 14.1) to 5.7 (+/- 2.7) in the etretinate group. With regard to influence on erythema, infiltration, scaling, and area involved, similar improvements were obtained in both treatment groups. Adverse reactions of the hypervitaminosis A type were observed with almost the same frequency and severity in both treatment groups. The mean number of 10 mg capsules used daily was comparable in the two groups: 2.82 (range 1.23-4.67) for acitretin and 2.77 (range 1.60-4.82) for etretinate. It can be concluded that acitretin and etretinate do not significantly differ with regard to efficacy and overall safety in the treatment of patients with palmoplantar pustulosis.

Acitretin

Comparison of ciclopirox olamine 1% cream with ciclopirox 1%-hydrocortisone acetate 1% cream in the treatment of inflamed superficial mycoses.

The hydroxypyridone antifungal agent ciclopirox olamine cream 1% has been shown to be as effective in the treatment of inflamed, superficial fungal infections as a formulation in which ciclopirox 1% and hydrocortisone acetate 1% were combined. In a randomized, double-blind, parallel group comparison study, 138 patients with culture-confirmed superficial fungal diseases applied their assigned medication twice daily for 21 days. Clinical assessments were made at the baseline visit; at visits on days 4, 7, 14, and 21 during treatment; and on day 28 (one week posttreatment). Specimens for cultures were taken at baseline and on day 28. There were no differences for the 69 patients in either treatment group at any visit with respect to improvement in the signs/symptoms evaluated; mycological cures in the two treatment groups also were not significantly different.

Administration, Topical

Treatment of severe psoriasis with etretin (RO 10-1670).

Eighty patients with severe psoriasis were treated in a double-blind fashion with either an initial dose of 10 mg, 25 mg or 50 mg of etretin daily or with placebo. Follow-up examinations were carried out monthly and the efficacy of treatment was evaluated by using the PASI score. Adverse effects of the treatment were recorded monthly; liver enzymes, cholesterol and triglycerides were measured. After 2 months of treatment the maintenance dose was reduced in some of the patients either because of complete remission or adverse effects. After 2 months treatment, groups receiving 25 mg/day and 50 mg/day showed significantly lower PASI scores than the placebo group. The 10 mg/day group showed a response intermediate between the 25 mg and 50 mg groups and the placebo group. Thus, the optimal initial dose seems to be approximately 25 mg/day and the maintenance dose somewhat lower. Six months after the start of treatment there were no significant differences between the four groups; the last follow-up examination took place during the summer and some of the patients probably experienced spontaneous improvement. Although clinical adverse effects were frequent in all groups, severe side effects, namely hair loss and paronychia, occurred frequently only among patients treated with an initial dose of 50 mg of etretin daily. The effect of treatment on liver enzymes, cholesterol and triglycerides was minimal.

Acitretin

Oral acyclovir suppression of recurrent genital herpes: a double-blind, placebo-controlled, crossover study.

A randomised, double-blind, placebo-controlled, crossover study was conducted in 31 male patients with a history of frequently recurrent genital herpes who received consecutively 200 mg acyclovir and matching placebo by mouth four times a day for 12 weeks each. During acyclovir therapy recurrences were completely prevented in 24 (77%) and were reduced in both frequency and duration in the remainder compared with those occurring during treatment with placebo. The incidence and nature of adverse events reported during each treatment period was virtually identical. No long-term effects on recurrence rates were discernible but chronic suppressive therapy can be considered to offer the means of controlling the severe forms of disease experienced by some patients.

Acyclovir