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Gazzetta Medica Italiana Archivio per le Scienze Mediche 1999 October;158(5):141-9

Copyright © 1999 EDIZIONI MINERVA MEDICA

language: Italian

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


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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.

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