Total amount: € 0,00
HOW TO ORDER
GAZZETTA MEDICA ITALIANA ARCHIVIO PER LE SCIENZE MEDICHE
A Journal on Internal Medicine and Pharmacology
Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Gazzetta Medica Italiana Archivio per le Scienze Mediche 1999 October;158(5):141-9
Controlled clinical trial on the effects of an original antimycotic drug in the out-patient treatment of candidiasis
Scupilliti E. 2, Bastanzio C. 1, De Lorenzi G. 1
1 Benedetti SpA, Direzione Medica - Pistoia;
2 CMS, Centro Medico Specialistico - Milano
Background. The Candida albicans is a clinical reality, more or less evident also in healthy persons; when and if the immunological protections, due to various reasons, are becoming weaker, the Candida may come up in a more pathological way in different body localizations: in the mouth, as well as in dermal areas, or in the vulvo-vaginal region. Diagnosis of this illness can receive a real help by using in clinical practice specific lab analysis systems, more and more sensitive and easy-to-use today, as a consequence of the development of new biotechnological approaches and of very simple “quick tests” useful in the day-by-day clinical experience. By using such an approach, a clinical study was performed following an open/controlled design, on a sample of women affected by some vulvo-vaginal troubles of a mycotic type, showing a symptomatic pattern like that of Candida albicans infection.
Methods. A total number of 135 female patients was selected among those coming to a day-by-day clinical practice, by checking their subjective symptoms and by using as a “confirmation” tool a “quick test”, very easy to use, of enzymatic type. The patients have been treated by an original antimycotic drug (treatment P) or, alternatively on the basis of a randomization list, by a commonly used antimycotic item of the market (treatment M): both treatments were in form of a vaginal douche “ready-to-use”. The treatment time was planned for an 8-day period, and in any case until symptoms disappeared. The subjective symptoms, in addition to measuring the local (internal) temperature, were collected by using “semi-quantitative” scales, both in basal and at final (post-treatment) condition; at the same time the “confirmation” test was complied, by collecting the positive or negative outcomes both as a diagnostic information and as a (final) evaluation about treatment effectiveness. At the end of the investigation, the final judgement of both the investigator and the woman was also registered for adding an “overall” information about the efficacy and tolerability of the pharmacological treatment. Last but not least, information on the side effects (if any) and other follow-up data were registered.
Results. The statistical analysis of data collected shows the following results: a) The two treatment subsamples P and M were homogenous in basal condition, so comparable for the main statistical parameters; b) The two antimycotic drugs showed an efficacy on the various symptoms during the therapeutic period (including the local temperature evolution); they were both effective, also having a similarly good tolerability, but the treatment P showed a slightly better performance on some selected parameters; c) The “confirmation” test was appreciated as being effective and of an easy use both by the doctors and by the patients.
Conclusions. In conclusion, the trial, performed under a controlled multicenter (not formal) design, suggested the effectiveness of such a therapeutic approach by the new antimycotic agent (P), also in the light of the application of a “rapid test” for diagnostic help in that pathological area.