Fenticonazole is an imidazole derivative which possesses a broad spectrum antimycotic activity, including activity against Candida albicans. Its therapeutic activity and tolerability have been evaluated, in a double-blind clinical trial versus clotrimazole, in 54 patients affected by mycologically confirmed symptomatic vaginal candidiasis. Both drugs were administered intravaginally as a cream once a day for 7 days. Assessment was by laboratory mycological investigations and symptomatic evaluation. Patients 'cured' at the end of the trial were re-evaluated after 4-6 weeks for possible relapses. Both treatments resulted in a progressive, statistically significant reduction in vaginal symptoms (itching and discharge) and in elimination of Candida in more than 95% of patients. When 'cured' patients were reassessed 4-6 weeks after therapy, relapses occurred in four patients after fenticonazole treatment, but in none following clotrimazole treatment. This apparent difference between treatments is far from being statistically significant and, therefore, may have been a chance occurrence. It should also be noted that patients from the fenticonazole group had a previous history of significantly more frequent episodes of candidiasis suggesting that they may have been at greater risk of re-infection than patients from the control group. The tolerance of both treatments was excellent since no local or systemic signs or symptoms of toxicity were reported. An equally high efficacy and safety for both drugs in the elimination of symptoms and objective evidence of vaginal candidiasis is indicated.
Summary: 21 patients suffering from dermatomycoses were randomly assigned either to 2% fenticonazole cream or 1% clotrimazole cream. The study was performed under double‐blind conditions and on patients, with symmetrical or clinically comparable lesions. Patients were evaluated, clinically, microscopically and by culture before entering the study and then at weekly intervals for four weeks. The cream was applied twice daily. Eighteen lesions from the 21 treated with fenticonazole 2% cream and 13 lesions out of 21 treated with clotrimazole 1% cream were definitely cured. The differences between the two treatments were statistically significant in favour of fenticonazole in the third week of treatment (p < 0.05 ‐ chi square test). Zusammenfassung: 21 Patienten mit Dermatomykosen, die symmetrisch lokalisiert und klinisch vergleichbar waren, wurden in einer Doppelblindstudie seitenvergleichend mit 2% Fenticonazol‐Creme und 1% Clotrimazol‐Creme behandelt. Klinische, mikroskopische und kulturelle Untersuchungen wurden vor Beginn der Behandlung und dann in wöchentlichen Intervallen über 4 Wochen durchgeführt. Die Creme wurde zweimal täglich aufgetragen. Bei 18 von 21 mit Fenticonazol 2%‐Creme behandelten Fälle und bei 13 von 21 mit Clotrimazol 1%‐Creme behandelten wurde vollständige Abheilung erreicht. In der dritten Behandlungswoche envies sich das günstigere Behandlungsergebnis mit Fenticonazol als statistisch signifikant (p < 0,05 — chi Quadrattest).
Summary: Fifty‐two patients suffering from dermatomycoses were randomly assigned either to a treatment of fenticonazole 2% cream or to econazole 1% cream in an double blind trial. Patients were evaluated clinically, microscopically and by culture before entering the study and then at weekly intervals for 4 weeks. The creams were applied twice daily. 24 patients out of the 28 included in the fenticonazole group and only 13 from the included in the econazole group were definitively cured or presented marked improvement (difference statistically significant, p < 0,02). The onset of fenticonazole action was more rapid then that of econazole. Complete recovery based on the disappearance of direct microscopic evidence and on clinical healing was noted in 15 patients out of the 28 treated with fenticonazole and in 10 patients out of the 24 treated with econazole. No side effects were observed in either group. Zusammenfassung: 52 Patienten mit Dermatomykosen wurden in einer Doppelblindstudie mit entweder 2% Fenticonazol‐Creme oder 1% Econazol‐Creme behandelt. Die Patienten wurden klinisch und mykologisch vor der Studie und in wöchentlichen Abständen über vier Wochen untersucht. Die Creme wurde 2mal täglich angewendet. 24 von 28 mit Fenticonazol behandelten und 13 von 24 mit Econazol behandelten Patienten wurden vollständig geheilt oder zeigten deutliche Besserung (statistische Signifikanz p < 0,02). Die Wirkung trat bei Fenticonazol früher als bei Econazol ein. Nebenwirkungen wurden in keiner der beiden Gruppen beobachtet.
The aim of this study was to evaluate clinical efficacy and safety of highly concentrated inhaled solution of tobramycin (Bramitob ® , Chiesi Farmaceutici S.p.A., Italy) in patients with cystic fibrosis (CF). This was 24 wk multicenter international double blind placebo controlled ran domized trial in parallel groups. In this study, 247 patients aged 6-45 yrs with Pseudomonas aeruginosa yielded in sputum and FEV1 40 % to 80 % pred. were randomized in 2 groups: those inhaling aerosol tobramycin (161 patients, mean age, 14.8 ± 5.7 yrs) or placebo (84 patients, mean age, 14.7 ± 6.6 yrs). Tobramycin 300 mg b.i.d. was given at the time of basic and antipseudomonal therapy. Efficacy criteria were as follows: lung venti lation parameters, sputum culture and yielding P. aeruginosa, rate of exacerbations of pulmonary disease, rate of hospitalisations, number of work off or school off days, number of courses of parenteral tobramycin and other antipseudomonal antibiotics, nutritional status (weight, BMI). Safety profile included serum creatinine level, audiometric test, vital signs (heart rate, blood pressure) and adverse events. To the end of the study, FEV1 improved by 7 % in the tobramycin group and by 1 % in the placebo group (p < 0.001), FVC improved by 5.7 and 1.3 %, respectively (p = 0.002), and FEF25-75 improved by 8.8 % and 0.7 %, respectively (p = 0.001). Frequency of P. aeruginosa eradication differed significantly between the groups to the end of 4th and 20th weeks of the study (30.8 % vs. 14.3 %; p = 0.011, and 33.3 % vs. 16.5 %; p = 0.024, respectively). Exacerbations of pul monary disease occurred in 39.8 % of tobramycin patients and in 51.2 % of placebo patients (р = 0.09). Hospital admission was required in 18.6 % and 36.9 % of patients, respectively (p = 0.002). Parenteral tobramycin was administered to 6.2 % and 16.7 % of patients, respectively (p = 0.009), other antipseudomonals were given in 55.9 % and 70.2 % of the patients, respectively (p = 0.029). Number of patients with missing work/school days due to exacerbation of pulmonary disease was 32.3 % in tobramycin group and 57.1 % in placebo group (p < 0.001). Serious adverse events related to treatment with tobramycin were not noted. In conclusion, long term intermittent treatment with inhaled solution of tobramycin additionally to basic and antipseudomonal therapy in CF patients significantly improved lung ventilation and eradication of P. aeruginosa, decreased the rate of exacerbations of pulmonary disease, rate of hospitalisations, and numbers of antipseudomonal courses and missing work days. The treatment was well tolerated and could be recommended for CF patients with P. aeruginosa in culture.
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