Ελληνική Επιθεώρηση Δερματολογίας - Τεύχος 3/2010

82 Pages·2015·5.62 MB·Greek

1.qxd 18/11/2011 4:08 (cid:31)(cid:31) Page 143
Áíáóêüðçóç
KíÞöç ôôçò êêýçóçò
Âáóéëåßïõ Í.
ÐåñïãéÜííç Ê. Á´ ÊëéíéêÞ Äåñìáôéêþí êáé Áöñïäéóßùí Íüóùí ÉáôñéêÞò Ó÷ïëÞò ÅÊÐÁ, Íïóïêïìåßï “Á. Óõããñüò”
Óôáõñüðïõëïò Ð.Ã.
Ðåñßëçøç
Ç êíÞöç ôçò êýçóçò ðåñéëáìâÜíåé ôçí êíÞöç êýçóçò ôïõ Besnier, ôçí ðñþé-
ìçò Ýíáñîçò êíÞöç ôïõ Nurse êáé ôçí âëáôéäþäç äåñìáôïðÜèåéá ôçò êýçóçò ôïõ Spangler. Ç åðßðôùóç
õðïëïãßæåôáé ðåñßðïõ óå ìßá áíÜ 300 êõÞóåéò. ÐáñïõóéÜæåôáé ùò êíçóìþäåéò âëáôßäåò êõñßùò óôéò åêôá-
ôéêÝò åðéöÜíåéåò ôùí Üêñùí. Ç áéôéïëïãßá åßíáé Üãíùóôç, ìðïñåß üìùò íá ó÷åôßæåôáé ìå ôï áðïôÝëåóìá
ôùí áìõ÷þí óôï äÝñìá áôïðéêþí ãõíáéêþí. Ç èåñáðåßá åßíáé óõìðôùìáôéêÞ ìå ôïðéêÜ êïñôéêïóôåñïåéäÞ,
áíôéúóôáìéíéêÜ áðü ôï óôüìá êáé UVB óôåíïý öÜóìáôïò. Ç ðñüãíùóç ãéá ôç ìçôÝñá êáé ôï Ýìâñõï åßíáé
öõóéïëïãéêÞ.
PPrruurriiggoo ooff PPrreeggnnaannccyy
Vasiliou N., Perogianni K., Stavropoulos P.G.
Summary
Prurigo of pregnancy encompasses Besnier's prurigo gestationis, Nurse's early-
onset form of prurigo, and Spangler's papular dermatosis of pregnancy. The incidence is approximately
one in 300 pregnancies. Ét presents as pruritic papules primarily on the extensor aspects of the extremiti-
es. The cause is unknown, but may be related to the effect of scratching on the skin of atopic women.
Treatment is symptomatic with topical corticosteroids, oral antihistamines, or narrowband UVB. There is
normal maternal and fetal prognosis.Key words: Prurigo of Pregnancy, clinical signs, treatment.
ËÅÅÎÎÅÅÉÉÓÓ ÅÅÕÕÑÑÅÅÔÔÇÇÑÑÉÉÏÏÕÕ• ÊíÞöç êýçóçò, êëéíéêÞ åéêüíá, èåñáðåßá.
KEEYY WWOORRDDSS• Prurigo of Pregnancy, clinical signs, treatment.
ÏÏÑÑÉÉÓÓÌÌÏÏÓÓ –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– ëÜâåé üëåò ôéò áóèåíåßò ìå åîÜíèçìá óôçí åãêõìïóýíç,
åêôüò áðü ôïí Ýñðçôá ôçò êýçóçò.1Áñãüôåñá ï Nurse,16
Ç êíÞöç ôçò êýçóçò åßíáé ìéá ó÷åôéêÜ êïéíÞ, êá- ôï 1968 äéáßñåóå ôçí êíÞöç ôçò êýçóçò óå äýï êýñéåò
ëïÞèçò äåñìáôïðÜèåéá ÷áñáêôçñéæüìåíç áðü êíç- ïìÜäåò: ôçí "ðñþéìçò Ýíáñîçò" êáé ôçí "üøéìçò Ýíáñ-
óìþäåéò âëáôßäåò êõñßùò óôéò åêôáôéêÝò åðéöÜíåéåò îçò" êíÞöç ôçò êýçóçò, ìå ôçí äåýôåñç ðñïöáíþò íá
ôùí Üêñùí. Ç ðñüãíùóç ãéá ôçí ìçôÝñá êáé ôï Ýì- ðåñéëáìâÜíåé ðåñéðôþóåéò êíçóìùäþí, êíéäùôéêþí
âñõï åßíáé Üñéóôç. âëáôßäùí êáé ðëáêþí ôçò êýçóçò (ÊÊÂÐÊ).1
Óôéò ìÝñåò ìáò, ç êíÞöç ôçò êýçóçò åßíáé Ýíáò
üñïò ðïõ ðåñéëáìâÜíåé ôçí êíÞöç êýçóçò ôïõ Besni-
ÅÅÉÉÓÓÁÁÃÃÙÙÃÃÇÇ–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– er, ôçí ðñþéìçò Ýíáñîçò êíÞöç ôïõ Nurse êáé ôçí
âëáôéäþäç äåñìáôïðÜèåéá ôçò êýçóçò ôïõ Span-
Ï üñïò "prurigo gestationis" êíÞöç ôçò êýçóçò, åé- gler.19Ç êíÞöç ôçò êýçóçò äýíáôáé íá åßíáé ìéá äéá-
óÞ÷èç áðü ôïí Besnier êáé óõí.4 ôï 1904 ãéá íá ðåñé- êñéôÞ ïíôüôçôá êáé ìðïñåß íá áíôéðñïóùðåýåé ìéá
Eëë. Åðéè. Äåñì. Áöñ. 2211::33 114433-114466,, 2010
1.qxd 18/11/2011 4:08 (cid:31)(cid:31) Page 144
144
Í. ÂÂáóéëåßïõ, ÊÊ. ÐÐåñïãéÜííç, ÐÐ.Ã.Óôáõñüðïõëïò
áóõíÞèéóôç ðáñáëëáãÞ ôùí ÊÊÂÐÊ,8 åîáéôßáò ìéáò ñáôçñïýíôáé óå ïæþäç êíÞöç ìç åãêõìïíïýíôùí ãõ-
åõñåßáò êëéíéêÞò áëëçëåðéêÜëõøçò, çìéôåëïýò áîéï- íáéêþí.19,21
ëüãçóçò êáé ôïõ ãåãïíüôïò üôé ç ðáèïãÝíåéá äåí Ý÷åé Ôá ïæßäéá üìùò óôçí êíÞöç ôçò êýçóçò åßíáé ìé-
ðëÞñùò áðïóáöçíéóôåß.14,19 êñüôåñá áðü áõôÜ ôçò ïæþäïõò êíÞöçò êáé äåí åßíáé
¸÷åé õðÜñîåé äéáöùíßá ùò ðñïò ôï áí ç ãñáììéêÞ ôüóï óêïýñá, áêüìç êáé óå áóèåíåßò ìå óêïõñü÷ñù-
ÉgÌ äåñìáôïðÜèåéá ôçò êýçóçò -üðùò ðåñéãñÜöåôáé ìï äÝñìá. Ç äåñìáôïðÜèåéá ðáñïõóéÜæåé ðáñáôåôá-
áðü ôïí Alcalay êáé óõí.2 - èá Ýðñåðå íá ïñéóôåß ùò ìÝíç äéÜñêåéá êáôÜ ôçí åãêõìïóýíç, êáé åíþ õðï÷ù-
äéáöïñåôéêÞ ïíôüôçôá Þ ùò ìéá äéáöïñïðïßçóç ôçò ñåß óõíÞèùò ìåôÜ ôïí ôïêåôü, ìðïñåß íá åðéìåßíåé
ÊÊÂÐÊ Þ ôçò êíÞöçò ôçò êýçóçò.18,19,23 Ôï 2006 ïé Ýùò êáé 3 ìÞíåò áêüìç.13-15Ç åðáíåìöÜíéóç êáôÜ ôç
Ambros-Rudolph êáé óõí.3 ðñüôåéíáí ôïí åðáíá- äéÜñêåéá ìåôáãåíÝóôåñùí êõÞóåùí ðïéêßëåé.12,14,16,19
ðñïóäéïñéóìü ôçò êíÞöçò ôçò êýçóçò ùò ìÝñïò åíüò
íåï- ïñéæüìåíïõ óõìðëÝãìáôïò áóèåíåéþí, áðïêá-
ëïýìåíï "áôïðéêü åîÜíèçìá ôçò åãêõìïóýíçò". ÅÅÑÑÃÃÁÁÓÓÔÔÇÇÑÑÉÉÁÁÊÊÁÁ ÁÁÐÐÏÏÔÔÅÅËËÅÅÓÓÌÌÁÁÔÔÁÁ––––––––––––––––––––––––
ÅñãáóôçñéáêÝò ìåëÝôåò äåí Ý÷ïõí áðïêáëýøåé
ÅÅÐÐÉÉÐÐÔÔÙÙÓÓÇÇ –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– áíùìáëßåò.5 Ôá áðïôåëÝóìáôá ïñïëïãéêþí åîåôÜóåùí
åßíáé öõóéïëïãéêÜ.13 Ïé ïñìïíéêÝò äéáôáñá÷Ýò (áõ-
Ç êíÞöç ôçò êýçóçò åßíáé ìéá ó÷åôéêÜ óõ÷íÞ äé- îçìÝíç â-÷ïñéáêÞ ãïíáäïôñïðßíç êáé ìåéùìÝíç êïñ-
áôáñá÷Þ ôïõ äÝñìáôïò êáôÜ ôç äéÜñêåéá ôçò åãêõìï- ôéæüëç êáé åðßðåäá ïéóôñïãüíùí) êáé ïé åðéðôþóåéò
óýíçò.11 Ç óõ÷íüôçôÜ ôçò êõìáßíåôáé ìåôáîý ìßáò óôï Ýìâñõï, ðïõ áíáöÝñèçêáí áðü ôïí Spangler êáé
áíÜ 300 êáé ìßáò áíÜ 450 åãêõìïóýíåò,16,17 êáé óõí.,20 äåí Ý÷ïõí åðéâåâáéùèåß áðü ïðïéåóäÞðïôå
ìðïñåß íá áíÝëèåé óôï 6% ôùí äåñìáôïðáèåéþí ðïõ Üëëåò ìåëÝôåò.15
óõó÷åôßæïíôáé ìå ôçí êýçóç.22 Åßíáé ßóùò ðéï êïéíÞ
óå ãõíáßêåò ìå áôïðéêÞ äåñìáôßôéäá, üðïõ ïé óïâá-
ñÝò ðåñéðôþóåéò êíçóìïý Ý÷ïõí ùò áðïôÝëåóìá ôçí ÉÉÓÓÔÔÏÏÐÐÁÁÈÈÏÏËËÏÏÃÃÉÉÁÁ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
áíÜðôõîç êíéäùôéêþí âëáâþí.1
Ç äéÜãíùóç ôçò êíÞöçò ôçò êýçóçò åßíáé êõñßùò
êëéíéêÞ. Ùò åê ôïýôïõ, äåí åêôåëåßôáé ðÜíôïôå âéïøßá
ÊÊËËÉÉÍÍÉÉÊÊÇÇ ÅÅÉÉÊÊÏÏÍÍÁÁ–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– äÝñìáôïò.1 ¼ôáí åêôåëåßôáé éóôïëïãéêÞ åîÝôáóç äÝñ-
ìáôïò, ìðïñåß íá äåßîåé áêÜíèùóç ìå õðåñêåßìåíç
Ç êíÞöç ôçò êýçóçò Ý÷åé áíáöåñèåß óå üëá ôá ðáñáêåñÜôùóç, åíäåßîåéò åêäïñþí êáé äñõöÜäùí
ôñßìçíá ôçò åãêõìïóýíçò, áëëÜ ðáñïõóéÜæåôáé óõ- (åöåëêéäïðïßçóç êáé éíþäåéò åíáðïèÝóåéò), êáèþò
íÞèùò êáôÜ ôï äåýôåñï Þ ôï ôñßôï ôñßìçíï, óõíçèÝ- êáé ÷ñüíéá ðåñéáããåéáêÞ öëåãìïíþäç êõôôáñéêÞ äéÞ-
óôåñá ìåôáîý 25çò êáé 30çò åâäïìÜäáò ôçò êýç- èçóç ìå ëåìöïêýôôáñá, éóôéïêýôôáñá, ïõäåôåñüöéëá
óçò.8,14,19×áñáêôçñßæåôáé áðü ìéêñÝò ïìÜäåò äéáêñé- êáé çùóéíüöéëá óôï áíþôåñï ÷üñéï.13,14 Ôá åõñÞìáôá
ôþí, åñõèçìáôùäþí Þ óôï ÷ñþìá ôïõ äÝñìáôïò âëá- áðü ôïí Üìåóï êáé Ýììåóï áíïóïöèïñéóìü åßíáé
ôßäùí êáé ïæéäßùí, ôá ïðïßá åßíáé åîáéñåôéêÜ êíçóìþ- êëáóóéêÜ áñíçôéêÜ.19
äç, ìå áðïôÝëåóìá äåõôåñïðáèåßò âëÜâåò ìå åêäï-
ñÝò êáé äñõöÜäåò. Áíáðôýóóïíôáé áñ÷éêÜ óôéò åêôá-
ôéêÝò åðéöÜíåéåò Üíù êáé êÜôù Üêñùí êáé óôéò ñá- ÐÐÁÁÈÈÏÏÖÖÕÕÓÓÉÉÏÏËËÏÏÃÃÉÉÁÁ ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
÷éáßåò åðéöÜíåéåò Üêñùí ÷åéñþí êáé ðïäþí êáé ðåñé-
óôáóéáêÜ óôçí êïéëéáêÞ ÷þñá.1,6,8,11,14 Óå ïñéóìÝíåò Ôá áßôéá ôçò êíÞöçò ôçò êýçóçò äåí åßíáé ðëÞñùò
ðåñéðôþóåéò ïé âëÜâåò ìðïñåß íá åîáðëùèïýí óôï êáôáíïçôÜ11,19 êáé åìðëÝêïíôáé ðïëõÜñéèìïé üðùò
óôÞèïò êáé ôç ñÜ÷ç.5 êáé åôåñïãåíåßò ðáèïãåíåôéêïß ìç÷áíéóìïß.19 Ï öáý-
Ïé âëÜâåò åßíáé óõíÞèùò ìéêñÝò, 0,5 Ýùò 1 cm óå ëïò êýêëïò ¨êíçóìüò-åîÜíèçìᨠóõíôçñåßôáé ÷ùñßò
ìÝãåèïò, ìå Þ ÷ùñßò êåíôñéêÝò åöåëêßäåò êáé ôï äÝñ- óõãêåêñéìÝíï áßôéï.10
ìá ãýñù áðü áõôÝò ðáñáìÝíåé êáíïíéêü.1,19 Ïé áë- Ç êíÞöç ôçò êýçóçò ìðïñåß íá ó÷åôßæåôáé ìå ïéêï-
ëïéþóåéò ìðïñåß íá åìöáíßæïíôáé ðåñéóôáóéáêÜ ãåíåéáêü éóôïñéêü åíäïçðáôéêÞò ÷ïëüóôáóçò ôçò êýç-
åöåëêéäïðïéçìÝíåò Þ åêæåìáôïðïéçìÝíåò.14,15 Óå óçò (Å×Ê), êáé ç äéáöïñïäéÜãíùóÞ ôçò áðü Å×Ê ìðï-
áíôßèåóç ìå ôéò öëýêôáéíåò, êýóôåéò äåí åìöáíßæï- ñåß íá áðïôåëÝóåé ðñüêëçóç.15,17 ÐåñéóôáóéáêÜ, ôï
íôáé.14 Ïé âëÜâåò åßíáé ðáñüìïéåò ìå áõôÝò ðïõ ðá- ìüíï ÷áñáêôçñéóôéêü ðïõ äéáöïñïðïéåß ôéò äýï êëéíé-
ÅÅËËËËÇÇÍÍÉÉÊÊÇÇ ÅÅÐÐÉÉÈÈÅÅÙÙÑÑÇÇÓÓÇÇ ÄÄÅÅÑÑÌÌÁÁÔÔÏÏËËÏÏÃÃÉÉÁÁÓÓ ÁÁÖÖÑÑÏÏÄÄÉÉÓÓÉÉÏÏËËÏÏÃÃÉÉÁÁÓÓ
1.qxd 18/11/2011 4:08 (cid:31)(cid:31) Page 145
145
ÊÍÍÇÇÖÖÇÇ ÔÔÇÇÓÓ ÊÕÕÇÇÓÓÇÇÓÓ
êÝò ïíôüôçôåò åßíáé ç áðïõóßá ðñùôïãåíþí âëáâþí ñá÷Þ, ÷ùñßò óõó÷åôéæüìåíç åðßäñáóç óôçí åãêõìï-
óôçí Å×Ê.15 Ìåñéêïß óõããñáöåßò Ý÷ïõí ðñïôåßíåé üôé óýíç Þ óôï íåïãÝííçôï âñÝöïò.1 Ôï âÜñïò ãÝííçóçò
ç êíÞöç ôçò êýçóçò êáé ç Å×Ê ìðïñåß íá åêöñÜæïõí åßíáé öõóéïëïãéêü,22 êáé ç ðÜèçóç óõíÞèùò õößåôáé
äéáöïñåôéêÜ åðßðåäá óïâáñüôçôáò ôçò ßäéáò íüóïõ.7 ìåôÜ ôïí ôïêåôü.14 ÅðåéäÞ äåí õðÜñ÷åé óõó÷Ýôéóç ìå
Ç êíÞöç ôçò êýçóçò åßíáé äõíáôüí íá ìïéÜæåé ìå åìâñõéêÞ íïóçñüôçôá Þ èíçóéìüôçôá, äåí õðÜñ÷åé
áôïðéêÞ äåñìáôßôéäá,11 êáé ï Black5,13 ðñüôåéíå üôé ôá Ýíäåéîç ãéá êáíåíüò åßäïõò åðÝìâáóç.8,19
êëéíéêÜ åõñÞìáôá ðéèáíüí íá åßíáé ôï áðïôÝëåóìá
ôçò Å×Ê óå ãõíáßêåò ìå áôïðéêÞ ðñïäéÜèåóç. Áõôü
åíéó÷ýåôáé áðü ôï ãåãïíüò üôé ðïëëïß áóèåíåßò ìå ÂÂÉÉÂÂËËÉÉÏÏÃÃÑÑÁÁÖÖÉÉÁÁ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
êíÞöç ôçò êýçóçò Ý÷ïõí èåôéêü éóôïñéêü áôïðßáò
(Ýêæåìá, Üóèìá êáé áëëåñãéêÞ ñéíßôéäá), êáèþò êáé
1. Al-Fares SI, Jones SV, Black MM. The specific dermatoses
áðü ôá áõîçìÝíá åðßðåäá ôçò IgE óôïí ïñü, ç ïðïßá of pregnancy: a re-appraisal. J Eur Acad Dermatol Vene-
áðïôåëåß äåßêôç áôïðßáò, ðïõ áíé÷íåýèçêå óå áóèå- reol 2001; 15:197-206.
íåßò ìå êíÞöç ôçò êýçóçò.18,22 Ç óõó÷Ýôéóç ìå áôï- 2. Alcalay J, Ingber A, Hazaz B et al. Linear IgM dermatosis
ðßá äåí åðéâåâáéþèçêå áðü Üëëåò ìåëÝôåò.17 of pregnancy. J Am Acad Dermatol 1988; 18:412-5.
3. Ambros-Rudolph CM, Mullegger RR, Vaughan-Jones SA
et al. The specific dermatoses of pregnancy revisited and
reclassified: results of a retrospective two-center study
ÄÄÉÉÁÁÃÃÍÍÙÙÓÓÇÇ ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
on 505 pregnant patients. J Am Acad Dermatol 2006;
54:395-404.
Ôï êýñéï äéáöïñïäéáãíùóôéêü ðñüâëçìá ðñïêý- 4. Besnier E, Brocq L, Jacquet L. La pratique dermatolo-
ðôåé ìåôáîý ìéáò óõãêåêñéìÝíçò äåñìáôïðÜèåéáò ôçò gique. Masson et Cie, Paris (1904).
åãêõìïóýíçò êáé ôçò åõñåßáò ðïéêéëßáò ôùí êíçóìù- 5. Black MM. Prurigo of pregnancy, papular dermatitis of
äþí íïóïëïãéêþí ïíôïôÞôùí ðïõ äåí ó÷åôßæïíôáé ìå pregnancy, and pruritic folliculitis of pregnancy. Semin
Dermatol 1989; 8:23-5.
ôçí êýçóç.19 ÐáñáóéôéêÞ êíÞöç, äÞãìáôá áñèñïðü-
6. Black MM. Progress and new directions in the investiga-
äùí, êáé êõñßùò ç øþñá èá ðñÝðåé íá áðïêëåßï-
tion of the specific dermatoses of pregnancy. Keio J Med
íôáé.14,19 ¼ëåò ïé áóèåíåßò åðéâÜëëåôáé íá õðïâÜëëï-
1997; 46:40-1.
íôáé óå åñãáóôçñéáêÝò åîåôÜóåéò çðáôéêÞò ëåéôïõñãß-
7. Bos JD. Reappraisal of dermatoses of pregnancy. Lancet
áò êáé ðñïóäéïñéóìïý ôéìþí ÷ïëéêþí ïîÝùí,19 åíþ 1999; 354:1140.
êáé áóèÝíåéåò ðñïêáëïýìåíåò áðü ÷ñÞóç ôïîéêþí 8. Cohen LM. Dermatoses of pregnancy. West J Med 1998;
ïõóéþí èá ðñÝðåé íá áðïêëåßïíôáé.19 169:223-4.
9. Dahdah MJ, Kibbi AG. Less well-defined dermatoses of
pregnancy. Clin Dermatol 2006; 24:118-21.
10. Errickson CV, Matus NR. Skin disorders of pregnancy.
ÈÈÅÅÑÑÁÁÐÐÅÅÉÉÁÁ ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Am Fam Physician 1994; 49:605-10.
11. Fuhrman L. Common dermatoses of pregnancy. J Perinat
Ç êíÞöç ôçò êýçóçò åßíáé ìßá äåñìáôïðÜèåéá åíï- Neonatal Nurs 2000; 14:1-16.
÷ëçôéêÞ, áëëÜ êáëïÞèçò, êáé ç èåñáðåßá åßíáé óõ- 12. Hayashi RH. Bullous dermatoses and prurigo of pregnan-
ìðôùìáôéêÞ.8,19 Ïé âëÜâåò áíôáðïêñßíïíôáé éêáíïðïé- cy. Clin Obstet Gynecol 1990; 33:746-53.
çôéêÜ óå ìÝôñéá Ýùò ðïëý éó÷õñÜ ôïðéêÜ êïñôéêïóôå- 13. Holmes RC, Black MM. The specific dermatoses of pre-
ñïåéäÞ.1,5,9¢ëëïé áíôéêíçóìþäåéò ðáñÜãïíôåò, óõìðå- gnancy. J Am Acad Dermatol 1983; 8:405-12.
14. Kroumpouzos G, Cohen LM. Dermatoses of pregnancy. J
ñéëáìâáíïìÝíùí áíôéúóôáìéíéêþí áðü ôïõ óôüìáôïò,
Am Acad Dermatol 2001; 45:1-19; quiz 19-22
üðùò ÷ëùñöáéíéñáìßíç ðéèáíüí íá åßíáé åðùöå-
15. Kroumpouzos G, Cohen LM. Specific dermatoses of pre-
ëåßò.1,11 Ç ÷ñÞóç ôçò äéÜöáíçò áõôïêüëëçôçò ôáéíßáò
gnancy: an evidence-based systematic review. Am J Ob-
åìðïôéóìÝíçò ìå öëïõñáíäñåíïëüíç (ôáéíßá Cordran) stet Gynecol 2003; 188:1083-92.
ìðïñåß íá óõíôåëÝóåé óôç èåñáðåõôéêÞ áíôéìåôþðéóç 16. Nurse DS. Prurigo of pregnancy. Australas J Dermatol
åíüò ìéêñïý áñéèìïý ôïðéêþí äéáêñéôþí âëáâþí.1Ìßá 1968; 9:258-67.
Üëëç åíáëëáêôéêÞ èåñáðåõôéêÞ ðñüôáóç áðïôåëåß ç 17. Roger D, Vaillant L, Fignon A et al. Specific pruritic dise-
ases of pregnancy. A prospective study of 3192 pregnant
óôåíïý ìÞêïõò êýìáôïò õðåñéþäçò áêôéíïâïëßá Â.
women. Arch Dermatol 1994; 130:734-9.
18. Sasseville D, Wilkinson RD, Schnader JY. Dermatoses of
ÐÐÑÑÏÏÃÃÍÍÙÙÓÓÇÇ ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
pregnancy. Int J Dermatol 1981; 20:223-41.
19. Shornick JK. Dermatoses of pregnancy. Semin Cutan Med
Ç êíÞöç ôçò êýçóçò åßíáé ìßá êáëïÞèçò äéáôá- Surg 1998; 17:172-81.
Ôüìïò 2211, Ôåý÷ïò 33, ÉÉïïýýëëééïïòò - ÓÓååððôôÝÝììââññïïòò 22001100
1.qxd 18/11/2011 4:08 (cid:31)(cid:31) Page 146
146
Í. ÂÂáóéëåßïõ, ÊÊ. ÐÐåñïãéÜííç, ÐÐ.Ã.Óôáõñüðïõëïò
20. Spangler AS, Reddy W, Bardawil WA et al. Papular der- gnancy correlating clinical findings with hormonal and
matitis of pregnancy. A new clinical entity? JAMA 1962; immunopathological profiles. Br J Dermatol 1999;
181:577-81. 141:71-81.
21. Vaughan Jones SA, Black MM. Pregnancy dermatoses. J 23. Velthuis PJ, de Jong MC, Kruis MH. Is there a linear IgM
Am Acad Dermatol 1999; 40:233-41. dermatosis? Significance of linear IgM junctional staining
22. Vaughan Jones SA, Hern S, Nelson-Piercy C et al. A pro- in cutaneous immunopathology. Acta Derm Venereol
spective study of 200 women with dermatoses of pre- 1988; 68:8-14.
Áëëçëïãñáößá: Ð.Ã.Óôáõñüðïõëïò
Íïóïêïìåßï “Á. Óõããñüò”,
Áíïóïäåñìáôïëïãéêü ÅñãáóôÞñéï
Äñáãïýìç 5 , ÊáéóáñéáíÞ
Ôçë.: 210 7293395
Fax: [phone]
ÅÅËËËËÇÇÍÍÉÉÊÊÇÇ ÅÅÐÐÉÉÈÈÅÅÙÙÑÑÇÇÓÓÇÇ ÄÄÅÅÑÑÌÌÁÁÔÔÏÏËËÏÏÃÃÉÉÁÁÓÓ ÁÁÖÖÑÑÏÏÄÄÉÉÓÓÉÉÏÏËËÏÏÃÃÉÉÁÁÓÓ
1.qxd 18/11/2011 4:08 (cid:31)(cid:31) Page 147
1.qxd 18/11/2011 4:09 (cid:31)(cid:31) Page 148
2.qxd 18/11/2011 4:09 (cid:31)(cid:31) Page 149
Áíáóêüðçóç
ToðéêÞ èèåñáðåßá ôôçò ááêôéíéêÞò õõðåñêåñÜôùóçò
ìå ããÝëç 00,3% ííáôñéïý÷ïõ ääéêëïöåíÜêçò
óå 22,5% õõáëïõñïíéêü
Ðáíáãéùôüðïõëïò Á. ô ÄåñìáôïëïãéêÞ ÊëéíéêÞ, Íïóïêïìåßï Äåñìáôéêþí êáé Áöñïäéóßùí Íüóùí, “Á. Óõããñüò”
Äåóéíéþôç Ê. Ðáí/êÞ ÄåñìáôïëïãéêÞ ÊëéíéêÞ, Íïóïêïìåßï Äåñìáôéêþí êáé Áöñïäéóßùí Íüóùí “Á. Óõããñüò”
Óôáõñüðïõëïò Ð.Ã. Ðáí/êÞ ÄåñìáôïëïãéêÞ ÊëéíéêÞ, Íïóïêïìåßï Äåñìáôéêþí êáé Áöñïäéóßùí Íüóùí “Á. Óõããñüò”
ÂÝññá Ð. Ðáí/êÞ ÄåñìáôïëïãéêÞ ÊëéíéêÞ, Íïóïêïìåßï Äåñìáôéêþí êáé Áöñïäéóßùí Íüóùí “Á. Óõããñüò”
ÐáðáãéáííÜêç Ê. Ðáí/êÞ ÄåñìáôïëïãéêÞ ÊëéíéêÞ, Íïóïêïìåßï Äåñìáôéêþí êáé Áöñïäéóßùí Íüóùí “Á. Óõããñüò”
ÊáôóÜìðáò Á. Ðáí/êÞ ÄåñìáôïëïãéêÞ ÊëéíéêÞ, Íïóïêïìåßï Äåñìáôéêþí êáé Áöñïäéóßùí Íüóùí “Á. Óõããñüò”
Ðåñßëçøç
Õðüâáèñï: H áêôéíéêÞ õðåñêåñÜôùóç (ÁÊ) áðïôåëåß äåñìáôéêü êáñêßíùìá in
situ ìå ðéèáíüôçôá åîÝëéîçò óå áêáíèïêõôôáñéêü êáñêßíùìá (AKK) êáé áðáéôåß áðïôåëåóìáôéêÞ èåñáðåßá.
Óêïðüò: Ç ðáñïýóá ìåëÝôç áöïñÜ ôç èåñáðåßá ôçò ÁÊ ìå ãÝëç 3.0% íáôñéïý÷ïõ äéêëïöåíÜêçò óå 2.5%
õáëïõñïíéêü (ãÝëç DHA) óôç èåñáðåßá ôçò ÁÊ óå äåßãìá ôïõ åëëçíéêïý ðëçèõóìïý.
ÌÝèïäïé: Ðñüêåéôáé ãéá ôõ÷áéïðïéçìÝíç, äéðëÜ-ôõöëÞ, åëåã÷üìåíç ìå åéêïíéêü öÜñìáêï (placebo) êëéíéêÞ
ìåëÝôç ðáñÜëëçëùí ïìÜäùí, óå åîùôåñéêïýò áóèåíåßò ìå äéÜãíùóç ôïõëÜ÷éóôïí 2 âëáâþí ÁÊ. Ç äéÜñ-
êåéá ôçò ìåëÝôçò Þôáí 4 ìÞíåò êáé áöïñïýóå ôçí åöáñìïãÞ åßôå äñáóôéêÞò èåñáðåßáò (ãÝëç DHA) Þ åê-
äü÷ïõ (ãÝëç õáëïõñïíéêïý), äéò çìåñçóßùò ãéá 3 ìÞíåò êáé ôåëéêÞ åîÝôáóç áîéïëüãçóçò (follow-up) ìå-
ôÜ áðü Ýíá ìÞíá. Ïé áîéïëïãÞóåéò óôçñß÷èçêáí óôéò âáèìïëïãßåò ôùí êëéìÜêùí TLNS (Áñéèìüò Âëáâþí
Óôü÷ùí), CLNS (Áèñïéóôéêüò Áñéèìüò Âëáâþí), IGII (Äåßêôçò ÓõíïëéêÞò Âåëôßùóçò áðü ôïí ÅñåõíçôÞ) êáé
PGII (Äåßêôçò ÓõíïëéêÞò Âåëôßùóçò áðü ôïí ÁóèåíÞ).
ÁðïôåëÝóìáôá: Ôá áðïôåëÝóìáôá ôïõ êýñéïõ ðëçèõóìïý áîéïëüãçóçò ôçò áðïôåëåóìáôéêüôçôáò (Per Pro-
tocol Set of Patients, n=71), äçëáäÞ üóùí áóèåíþí ïëïêëÞñùóáí ôïõò 4 ìÞíåò ôçò ìåëÝôçò, äåß÷íïõí
óôáôéóôéêþò óçìáíôéêÜ ìåãáëýôåñï ðïóïóôü áóèåíþí õðü èåñáðåßá ìå ãÝëç DHA íá åðéôõã÷Üíïõí ðëÞñç
(100%) åêêáèÜñéóç ôùí AK óå ó÷Ýóç ìå ôïõò áóèåíåßò ôçò ïìÜäáò placebo (42.4% vs 7.9%, p<0.05). Åðßóçò,
ðïóïóôü 51.5% ôùí áóèåíþí ìå äñáóôéêÞ èåñáðåßá óçìåßùóáí ≥75% åêêáèÜñéóç AK óå ó÷Ýóç ìå 21.1% ôùí
áóèåíþí ìå placebo (p<0.05). Äåí ðáñáôçñÞèçêáí óôáôéóôéêÜ óçìáíôéêÝò äéáöïñÝò óôçí åìöÜíéóç áíåðé-
èýìçôùí åíåñãåéþí áíÜìåóá óôéò äõï ïìÜäåò èåñáðåßáò êáé ç èåñáðåßá ìå ãÝëç DHA Þôáí êáëÜ áíåêôÞ.
ÓõìðÝñáóìá: H ôïðéêÞ èåñáðåßá ôçò áêôéíéêÞò õðåñêåñÜôùóçò ìå ãÝëç DHA (3.0% íáôñéïý÷ïò äéêëïöåíÜêç
óå 2.5% õáëïõñïíéêü), Þôáí áðïôåëåóìáôéêÞ êáé êáëÜ áíåêôÞ êáé áðïôåëåß ìéá óçìáíôéêÞ èåñáðåõôéêÞ åðé-
ëïãÞ óôçí áíôéìåôþðéóç ôùí ÁÊ.
ÔÔooppiiccaall 33..00%% DDiiccllooffeennaacc iinn 22..55%% HHyyaalluurroonniicc AAcciidd GGeell
ffoorr tthhee TTrreeaattmmeenntt ooff AAccttiinniicc KKeerraattoosseess
Panagiotopoulos A., Dessinioti C., Stavropoulos P.G., Verra P., Papagiannaki K., Katsambas A.
Summary
Âackground: Actinic keratosis (AK) represents an in situ skin carcinoma that
may progress to squamous cell carcinoma, thus necessitating effective treatment.
Objectives: To investigate topical 3.0% diclofenac in 2.5% hyaluronic acid gel for the treatment of AK in a
population from Greece.
MEthods: This is a randomized, double-blind, placebo controlled, parallel group study in patients with the
diagnosis of at least 2 AK. The study duration was 4 months and included a treatment period of twice dai-
ly application of either study drug (DHA gel) or placebo (vehicle, hyaluronic acid gel) for 3 months, and a
follow-up evaluation visit after 1 month. The evaluations were based on the scores of TLNS (Target Lesion
Number Score), CLNS (Cumulative Lesion Number Score), IGII (Investigator Global Improvement Index),
and PGII (Patient Global Improvement Index).
Eëë. Åðéè. Äåñì. Áöñ. 2211::33 114499-115577,, 2010
2.qxd 18/11/2011 4:09 (cid:31)(cid:31) Page 150
150
A. ÐÐáíáãéùôüðïõëïò êêáé óóõí.
Summary
Results: Regarding the per protocol set of patients (those that concluded 4
months, n=71), a statistically higher percentage of patients treated with DHA gel achieved 100% clearance
of AK compared with patients in the placebo group (42.4% vs. 7.9%, p<0.05). Also, 51.5% of patients trea-
ted with active treatment had ≥75% clearance of AK compared with 21.1% in the placebo group (p<0.05).
No statistically significant differences in the occurrence of adverse events were noted between treatment
groups and DHA gel was well tolerated.
Conclusions: Topical 3.0% diclofenac in 2.5% hyaluronic acid (DHA) gel was effective and well tolerated in
the treatment of actinic keratoses and is a valuable treatment option for AK management.
ËÅÅÎÎÅÅÉÉÓÓ ÅÅÕÕÑÑÅÅÔÔÇÇÑÑÉÉÏÏÕÕ• AêôéíéêÝò õðåñêåñáôþóåéò, èåñáðåßá, ãÝëç 3% äéêëïöáéíÜêçò óå 2,5% õáëïõñïíéêü ïîý.
KEEYY WWOORRDDSS• Actinic keratoses, treatment, 3% diclofenac in 2.5% hyaluronic acid gel
ÅÅÉÉÓÓÁÁÃÃÙÙÃÃHH–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Ïé äéáèÝóéìåò åðåìâáôéêÝò èåñáðåßåò ãéá ôéò ÁÊ
ðåñéëáìâÜíïõí ôç êñõï÷åéñïõñãéêÞ, ôç ÷åéñïõñãéêÞ
Ç áêôéíéêÞ õðåñêåñÜôùóç (ÁÊ) åßíáé íåïðëáóìá- åêôïìÞ, ôç ÷ñÞóç laser êáé ôçí çëåêôñï-áðïîÞñáí-
ôéêÞ åîåñãáóßá ðïõ ðñïÝñ÷åôáé áðü ôá êåñáôéíïêýô- óç. Ïé ôïðéêÝò ìç-åðåìâáôéêÝò èåñáðåßåò ìðïñåß íá
ôáñá êáé áíáðôýóóåôáé óôéò çëéïåêôåèåéìÝíåò ðåñéï- åßíáé ðñïôéìüôåñåò áöïý ìðïñïýí íá ìåéþóïõí ôçí
÷Ýò ôïõ äÝñìáôïò. Ç ÁÊ åßíáé ìßá óõ÷íÞ íüóïò ìå ðéèáíüôçôá ðüíïõ, ëïßìùîçò êáé ïõëþí åíþ ìðïñïýí
åðéðïëáóìü ðïõ óå ðáãêüóìéï åðßðåäï áõîÜíåé íá áíôéìåôùðßóïõí âëÜâåò óå êïóìçôéêÜ åõáßóèçôåò
äéáñêþò.1,2 Ç åðßðôùóç ôçò ÁÊ óå ÷þñåò ôïõ âïñåß- êáé äýóêïëåò óôç èåñáðåßá ðåñéï÷Ýò.13,14 Åðéðñü-
ïõ çìéóöáßñéïõ üðùò ç Áããëßá åßíáé 34% ãéá ôïõò óèåôá, ç ÷ñÞóç ôùí ôïðéêþí èåñáðåéþí åîõðçñåôåß
Üíäñåò êáé 18% ãéá ôéò ãõíáßêåò, åíþ óôï íüôéï çìé- êáé ôçí ðáñÜëëçëç èåñáðåßá ôùí õðïêëéíéêþí âëá-
óöáßñéï, üðùò óôçí Áõóôñáëßá áããßæåé ôï 77%.36,37 âþí ÁÊ, ôïõ "ðåäßïõ êáñêéíïãÝíåóçò".1 Ç ýðáñîç
Ç ÁÊ åìöáíßæåôáé ùò åñõèçìáôþäçò ëåðéäþäçò ìéáò ôïðéêÞò, ìç åðåìâáôéêÞò, áðïôåëåóìáôéêÞò êáé
Þ õðåñêåñáôùóéêÞ âëáôßäá Þ ðëÜêá, ç ïðïßá åíôïðß- êáëÜ áíåêôÞò èåñáðåßáò, èá óõìâÜëëåé óôçí Ýãêáé-
æåôáé óå çëéïåêôåèåéìÝíç ðåñéï÷Þ ôïõ äÝñìáôïò. Ç ñç áíôéìåôþðéóç ôùí ÁÊ êáé ðáñÜëëçëá èá ìåéþóåé
Ýêèåóç óôçí õðåñéþäç áêôéíïâïëßá ðéóôåýåôáé üôé åß- óçìáíôéêÜ ôïí êßíäõíï ìç óõììüñöùóçò óôçí áãùãÞ
íáé ôï êõñßáñ÷ï åñÝèéóìá ãéá ôçí áíÜðôõîç ôçò ÁÊ. ëüãù áíåðéèýìçôùí åíåñãåéþí. Óôéò õðÜñ÷ïõóåò ôï-
¢ëëïé ðáñÜãïíôåò êéíäýíïõ ãéá ôçí åìöÜíéóç ÁÊ, ðéêÝò èåñáðåßåò óõìðåñéëáìâÜíïíôáé ç ÷ñÞóç 5-
åßíáé ôï Üññåí öýëï, ç çëéêßá (>50 åôþí), ôï áíïé- öëïõïñï-ïõñáêßëçò óå äéÜöïñåò óõãêåíôñþóåéò, ç
êôü÷ñùìï äÝñìá, ç åõáéóèçóßá óôïí Þëéï ìå ÷áìçëÞ ÷ñÞóç ãÝëçò 3% íáôñéïý÷ïõ äéêëïöåíÜêçò êáé ç
éêáíüôçôá ìáõñßóìáôïò êáé ôÜóç ãéá åãêáýìáôá (öù- ÷ñÞóç êñÝìáò 5% éìéêïõúìüäçò.15,16 Ôüóï ç ÷ñÞóç
ôüôõðïò É, ÉÉ), ç áíïóïêáôáóôïëÞ, ïé ëïéìþîåéò áðü 5-öëïõïñï-ïõñáêßëçò, üóï êáé ç ÷ñÞóç êñÝìáò 5%
èçëùìáôïúïýò (HPV) êáé ãåíåôéêÝò íüóïé üðùò ç ìå- éìéêïõúìüäçò, ðáñüôé áðïôåëåóìáôéêÝò, Ý÷ïõí óõíäå-
ëáã÷ñùìáôéêÞ îçñïäåñìßá.5-8 èåß ìå Ýíôïíåò ôïðéêÝò äåñìáôéêÝò áíôéäñÜóåéò üðùò
¸÷åé áíáöåñèåß ðùò ç ÁÊ ðáñéóôÜ áêáíèïêõôôá- ðüíï, öëåãìïíÞ, äçìéïõñãßá åëêþí êáé åó÷áñïðïßç-
ñéêü êáñêßíùìá in situ. ÅðéðëÝïí, óõíÞèùò óõíõ- óç/äéÜâñùóç ôïõ äÝñìáôïò,1,4 ÷áñáêôçñéóôéêÜ ôá
ðÜñ÷åé åêôåôáìÝíç âëÜâç ðåäßïõ, ãíùóôÞ êáé ùò ïðïßá ìðïñåß íá ìåéþíïõí óçìáíôéêÜ ôçí áðïäï÷Þ
"ðåäßï êáñêéíïãÝíåóçò", üðïõ óõíõðÜñ÷ïõí ïñáôÝò ôçò èåñáðåßáò áðü ôïõò áóèåíåßò êáé ðáñÜëëçëá èÝ-
áëëÜ êáé õðïêëéíéêÝò âëÜâåò ÁÊ.1,3,9 ôïõí óå êßíäõíï ôç óõììüñöùóç óôçí áãùãÞ.
Ïé ÁÊ ìðïñïýí íá åîåëé÷èïýí óå áêáíèïêõôôáñé- Ðñïçãïýìåíåò (áíïéêôÝò Þ äéðëÜ-ôõöëÝò) êëéíé-
êü êáñêßíùìá (ÁÊÊ). Ç åêôßìçóç ãéá ôïí êßíäõíï êÝò ìåëÝôåò ìå ÷ñÞóç ãÝëçò DHA (3.0% äéêëïöåíÜ-
êáêïÞèïõò åîáëëáãÞò ôçò áêôéíéêÞò õðåñêåñÜôùóçò êç óå 2.5% õáëïõñïíéêü), Ýäåéîáí üôé ç óõãêåêñéìÝ-
óå ÁÊÊ áíÜ Ýôïò ðïéêßëëåé áðü 0.025-16%, áí êáé íç áãùãÞ åßíáé áðïôåëåóìáôéêÞ êáé êáëþò áíåêôÞ
óå äéÜñêåéá ÷ñüíïõ 10 åôþí Ýíá Üôïìï ìå êáôÜ ìÝóï óôç èåñáðåßá ôçò ÁÊ.6,17-22 Ôá ðëÝïí ðñüóöáôá äç-
üñï 8 âëÜâåò áêôéíéêÞò õðåñêåñÜôùóçò Ý÷åé 6-10% ìïóéåõìÝíá äåäïìÝíá áíáöÝñïõí üôé ç áðïôåëåóìá-
ðéèáíüôçôá áíÜðôõîçò ÁÊÊ.10-12 ôéêüôçôá ôçò áãùãÞò áõôÞò äéáôçñåßôáé ãéá ôïõëÜ÷é-
ÅÅËËËËÇÇÍÍÉÉÊÊÇÇ ÅÅÐÐÉÉÈÈÅÅÙÙÑÑÇÇÓÓÇÇ ÄÄÅÅÑÑÌÌÁÁÔÔÏÏËËÏÏÃÃÉÉÁÁÓÓ ÁÁÖÖÑÑÏÏÄÄÉÉÓÓÉÉÏÏËËÏÏÃÃÉÉÁÁÓÓ
2.qxd 18/11/2011 4:09 (cid:31)(cid:31) Page 151
151
ÔÏÏÐÐÉÉÊÊÇÇ ÈÅÅÑÑÁÁÐÐÅÅÉÉÁÁ ÔÔÇÇÓÓ ÁÊÊÔÔÉÉÍÍÉÉÊÊÇÇÓÓ ÕÐÐÅÅÑÑÊÊÅÅÑÑÁÁÔÔÙÙÓÓÇÇÓÓ ÌÌÅÅ ÃÅÅËËÇÇ 3% ÍÍÁÁÔÔÑÑÉÉÏÏÕÕXXÏÏÕÕ ÄÉÉÊÊËËÏÏÖÖÅÅÍÍÁÁÊÊÇÇÓÓ ÓÓÅÅ 2,5% ÕÕÁÁËËÏÏÕÕÑÑÏÏÍÍÉÉÊÊÏÏ
óôïí 1 ÷ñüíï ìåôÜ ôï ðÝñáò ôçò åöáñìïãÞò ôçò.23 íïåéäÞ, ôïðéêÜ óôåñïåéäÞ, êõêëïóðïñßíç) êáé áóèå-
ÊáìéÜ áðü ôéò ðñïáíáöåñèåßóåò ìåëÝôåò äåí Ý÷åé íåßò ìå ãíùóôÞ õðåñåõáéóèçóßá óôç äéêëïöåíÜêç
ðñáãìáôïðïéçèåß óôçí ÅëëÜäá, ÷þñá ç ïðïßá ÷áñá- êáé óôá Ýêäï÷á ôïõ ðñïúüíôïò.
êôçñßæåôáé áðü éäéáßôåñá õøçëÜ ðïóïóôÜ çëéïöÜíåé-
áò êáé çëéïÝêèåóçò ôïõ ðëçèõóìïý ôçò. Êýñéïò óôü- ÈÈååññááððååõõôôééêêüü ÓÓ÷÷ÞÞììáá
÷ïò ôçò ðáñïýóáò ìåëÝôçò Þôáí ç áîéïëüãçóç ôçò
áðïôåëåóìáôéêüôçôáò êáé ôçò áóöÜëåéáò ôçò ãÝëçò ÌåôÜ ôçí åðßóêåøç åðéëïãÞò, ïé áóèåíåßò êáôáíå-
DHA óå óýãêñéóç ìå placebo óôç èåñáðåßá áóèåíþí ìÞèçêáí ôõ÷áéïðïéçìÝíá þóôå íá ëáìâÜíïõí åßôå ôç
ìå ÁÊ óôïí Åëëçíéêü ðëçèõóìü. äñáóôéêÞ èåñáðåßá (ãÝëç DHA) Þ placebo, ôï ïðïßï
áðïôåëåßôï ìüíïí áðü ôï Ýêäï÷ï (ãÝëç õáëïõñïíé-
êïý 2.5%). Ç äïóïëïãßá Þôáí 0.5g, äõï öïñÝò çìå-
ÁÁÓÓÈÈÅÅÍÍÅÅÉÉÓÓ ÊÊÁÁÉÉ ÌÌÅÅÈÈÏÏÄÄÏÏÉÉ–––––––––––––––––––––––––––––––––––––––––––––––––– ñçóßùò, óå êÜèå åðéöÜíåéá-óôü÷ï ôùí 5 cm2. Óõíïëé-
êÜ Ýãéíå èåñáðåßá óå ôïõëÜ÷éóôïí äýï ÁÊ, êáôáíå-
ÓÓ÷÷ååääééááóóììüüòò ôôççòò ÌÌååëëÝÝôôççòò ìçìÝíåò óå ìßá Ýùò ôñåéò ðåñéï÷Ýò-óôü÷ïõò, Ýêôáóçò
5 cm2, åíôïðéóìÝíåò óôï ìÝôùðï, óôï êåíôñéêü ìÝñïò
Ðñüêåéôáé ãéá ìßá ôõ÷áéïðïéçìÝíç, äéðëÜ-ôõöëÞ, ôïõ ðñïóþðïõ, óôï äÝñìá ôïõ êñáíßïõ êáé óôç ñá-
åëåã÷üìåíç ìå åéêïíéêü öÜñìáêï (placebo) êëéíéêÞ ÷éáßá åðéöÜíåéá ôçò Üêñáò ÷åéñüò. Óå üëïõò ôïõò
ìåëÝôç ðáñáëëÞëùí ïìÜäùí áóèåíþí, ç ïðïßá áóèåíåßò äüèçêáí ïäçãßåò çëéïðñïóôáóßáò.
ðñáãìáôïðïéÞèçêå ìåôáîý 2008 êáé 2010 óôï ÔìÞ-
ìá Êñõïèåñáðåßáò ôçò ô ÊëéíéêÞò ôïõ Íïóïêïìåßïõ ÖÖÜÜññììááêêáá ôôççòò ììååëëÝÝôôççòò
Äåñìáôéêþí & Áöñïäéóßùí Íüóùí "ÁíäñÝáò Óõã-
ãñüò". Ç ìåëÝôç áðïôåëåßôï áðü ôñßá ìÝñç: åðéëïãÞ Ç ãÝëç DHA Ý÷åé ùò äñáóôéêÞ ïõóßá íáôñéïý÷ï
áóèåíþí (åðßóêåøç 0, 14 çìÝñåò ðñéí ôç èåñáðåßá, äéêëïöåíÜêç 3.0%, åíþ ôï õáëïõñïíéêü ïîý 2.5%
èåñáðåßá 3 ìçíþí ìå êëéíéêÞ áîéüëïãçóç ôùí áóèå- áðïôåëåß Ýíá áðü ôá Ýêäï÷á ôïõ éäéïóêåõÜóìáôïò.
íþí áíÜ 1 ìÞíá (åðéóêÝøåéò 1-4) êáé ôåëéêÞ åðßóêå- Ôï placebo äéáöÝñåé óå óýóôáóç áðü ôç ãÝëç DHA
øç áîéïëüãçóçò (follow-up, åðßóêåøç 5), 30 çìÝñåò ùò ðñïò ôç Ýëëåéøç ôçò äñáóôéêÞò ïõóßáò.
ìåôÜ ôçí ïëïêëÞñùóç ôçò èåñáðåßáò. Ç ìåëÝôç äéå- Ôá áíùôÝñù óêåõÜóìáôá ðáñáóêåõÜóôçêáí êáé
îÞ÷èç óýìöùíá ìå ôéò Ïäçãßåò ôçò ÏñèÞò ÊëéíéêÞò ðáñá÷ùñÞèçêáí, óôá ðëáßóéá äéåîáãùãÞò ôçò êëéíé-
ÐñáêôéêÞò (ICH GCP) êáé ôç ÄéáêÞñõîç ôïõ Helsin- êÞò ìåëÝôçò, áðü ôç HELP ÁÂÅÅ.
ki, åíþ ç äéåîáãùãÞ ôçò åãêñßèçêå áðü ôçí Åðéóôçìï-
íéêÞ ÅðéôñïðÞ ôïõ íïóïêïìåßïõ "ÁíäñÝáò Óõããñüò", ÁÁîîééïïëëïïããÞÞóóååééòò ÁÁððïïôôååëëååóóììááôôééêêüüôôççôôááòò
ôïí Åèíéêü Ïñãáíéóìü ÖáñìÜêùí (ÅÏÖ) êáé ôçí
ÅèíéêÞ ÅðéôñïðÞ Äåïíôïëïãßáò (ÅÅÄ). ¼ëïé ïé Ìå óêïðü ôçí áîéïëüãçóç ôçò áðïôåëåóìáôéêüôç-
áóèåíåßò õðÝãñáøáí Ýíôõðï óõãêáôÜèåóçò ìåôÜ áðü ôáò åêôéìÞèçêáí ôÝóóåñéò ìåôáâëçôÝò óå êÜèå åðß-
åíçìÝñùóç ðñéí ôçí åéóáãùãÞ ôïõò óôçí ìåëÝôç. óêåøç, áðü ôçí åðßóêåøç 2 Ýùò ôçí ôåëéêÞ åðßóêåøç
áîéïëüãçóçò (åðßóêåøç 5). Ïé ðïóïôéêÝò ìåôáâëçôÝò
ÁÁóóèèååííååßßòò Þôáí ç âáèìïëïãßá ôçò êëßìáêáò TLNS (Target Le-
sion Number Score, Áñéèìüò Âëáâþí-Óôü÷ùí) êáé
ÓõìðåñéåëÞöèçóáí áóèåíåßò ìå ôïõëÜ÷éóôïí äýï ôçò êëßìáêáò CLNS (Cumulative Lesion Number
ÁÊ, êáôáíåìçìÝíåò óå 1 Ýùò 3 ðåñéï÷Ýò-óôü÷ïõò, Score, Áèñïéóôéêüò Áñéèìüò Âëáâþí). Ç êëßìáêá
Ýêôáóçò 5 cm2. ÊáôáãñÜöçêå ï öùôüôõðïò êáôÜ Fi- TLNS áíáöÝñåôáé óôï óõíïëéêü áñéèìü ôùí âëáâþí
tzpatrick. Ïé ãõíáßêåò Ýðñåðå íá ÷ñçóéìïðïéïýí ïé ïðïßåò âñßóêïíôáé óôéò ðñïêáèïñéóìÝíåò ðåñéï-
áðïäåêôÝò ìåèüäïõò áíôéóýëëçøçò. Áðïêëåßóôçêáí ÷Ýò-óôü÷ïõò ôçò èåñáðåßáò, êáôÜ ôçí áñ÷éêÞ (âáóé-
áóèåíåßò ìå ãíùóôÞ áëëåñãßá óôçí áóðéñßíç Þ Üëëá êÞ) åðßóêåøç. Áíôßóôïé÷á, ç êëßìáêá CLNS (Áèñïé-
ÌÓÁÖ, ìå êáêïÞèåéá Þ Üëëç äåñìáôïëïãéêÞ âëÜâç óôéêüò Áñéèìüò Âëáâþí), áíáöÝñåôáé óôï óõíïëéêü
óôçí ðåñéï÷Þ ôçò èåñáðåßáò êáé óôç ãåéôïíéêÞ ðåñéï- áñéèìü ôùí âëáâþí ïé ïðïßåò âñßóêïíôáé óôéò ðåñéï-
÷Þ (ìÝ÷ñé 3 åêáôïóôÜ áðüóôáóç), áóèåíåßò ïé ïðïßïé ÷Ýò-óôü÷ïõò, äçë. üóåò áðü ôéò áñ÷éêÝò âëÜâåò ðá-
÷ñçóéìïðïéïýóáí ìç åðéôñåðüìåíç ðñüóöáôç (<1 ñáìÝíïõí áëëÜ êáé ïé íÝåò âëÜâåò ðïõ åìöáíßæïíôáé
ìÞíá ðñéí ôçí Ýíôáîç ôïõò óôç ìåëÝôç) Þ ôáõôü÷ñïíç êáôÜ ôç äéÜñêåéá ôçò èåñáðåßáò. Ïé ðïéïôéêÝò ìåôñÞ-
öáñìáêåõôéêÞ áãùãÞ ãéá ôçí áíôéìåôþðéóç ôçò ÁÊ óåéò Ýãéíáí áíåîÜñôçôá, áðü ôïõò éáôñïýò-åñåõíçôÝò
(éìéêïõúìüäç, 5-öëïõïñï-ïõñáêßëç, åôñåôéíÜôç, ñåôé- (IGII -Äåßêôçò ÓõíïëéêÞò Âåëôßùóçò áðü ôïí Åñåõíç-
Ôüìïò 2211, Ôåý÷ïò 33, ÉÉïïýýëëééïïòò - ÓÓååððôôÝÝììââññïïòò 22001100
2.qxd 18/11/2011 4:09 (cid:31)(cid:31) Page 152
152
A. ÐÐáíáãéùôüðïõëïò êêáé óóõí.
ôÞ) êáé áðü ôïõò áóèåíåßò (PGII -Äåßêôçò ÓõíïëéêÞò ëïãßá CLNC/TLNS ßóç ìå 0 ìåôáîý ôùí äõï ïìÜäùí
Âåëôßùóçò áðü ôïí ÁóèåíÞ) êáé áíáöÝñïíôáí óôçí èåñáðåßáò (áðü 20% Ýùò 50%)13 ìå éó÷ý 80% êáé
áíôßëçøç ôçò ìåôáâïëÞò ôçò óïâáñüôçôáò ôùí âëá- åðßðåäï óçìáíôéêüôçôáò á=0.05. Ìå âÜóç ôéò áíùôÝ-
âþí ôùí ðñïêáèïñéóìÝíùí ðåñéï÷þí - óôü÷ùí óå ñù õðïèÝóåéò, ï õðïëïãéóìüò ôïõ ìåãÝèïõò ôïõ äåßã-
ó÷Ýóç ìå ôçí ðñïçãïýìåíç åðßóêåøç. Ïé ìåôñÞóåéò ìáôïò Þôáí 77 áóèåíåßò, ìå ðåñßðïõ 38 áóèåíåßò óå
áìöïôÝñùí ôùí ðïéïôéêþí ìåôáâëçôþí ðñáãìáôïðïé- êÜèå èåñáðåõôéêü óêÝëïò.
Þèçêáí ÷ñçóéìïðïéþíôáò ôçí áêüëïõèç, åðôáâÜèìéá Ãéá ôçí áíÜëõóç ôùí äåäïìÝíùí ôçò ìåëÝôçò ÷ñç-
êëßìáêá: -2: óïâáñÞ åðéäåßíùóç, -1: Þðéá åðéäåßíù- óéìïðïéÞèçêáí ïé áêüëïõèåò ïìÜäåò äåäïìÝíùí:
óç, 0: êáìßá ìåôáâïëÞ, 1: Þðéá âåëôßùóç, 2: ìÝôñéá • ÏìÜäá ¼ëùí ôùí Áóèåíþí óå ÁãùãÞ (All-Pati-
âåëôßùóç, 3: óïâáñÞ âåëôßùóç, 4: ðëÞñçò âåëôßùóç. ents-Treated Set -APTS): üëïé ïé áóèåíåßò ðïõ
Ôá êýñéá ôåëéêÜ óçìåßá Þôáí ôï ðïóïóôü ôùí áóèå- Ýëáâáí ôçí áãùãÞ ôçò ìåëÝôçò åðß äåêáðåíèÞìå-
íþí óôçí ôåëéêÞ åðßóêåøç áîéïëüãçóçò (åðßóêåøç 5) ñï ôïõëÜ÷éóôïí, ìå ðïóïóôü óõììüñöùóçò óôç
ìå ðëÞñç åîÜëåéøç ôùí âëáâþí ôçò áêôéíéêÞò õðåñ- èåñáðåßá >85%.
êåñÜôùóçò (TLNS = 0 & CLNS = 0) êáé ðëÞñç âåë- • ÏìÜäá ÐëÞñïõò ÁíÜëõóçò (Full Analysis Set-
ôßùóç ôçò åéêüíáò ôùí âëáâþí (IGII & PGII = 4). Ðá- FAS): üëïé ïé áóèåíåßò ôçò ïìÜäáò APTS ðïõ
ñÜëëçëá, êáôáìåôñÞèçêå êáé ôï ðïóïóôü ôùí áóèå- Ý÷ïõí ôïõëÜ÷éóôïí ìßá Ýãêõñç áîéïëüãçóç ôçò
íþí óôï ïðïßï åðåôåý÷èç óôçí åðßóêåøç 5, åêêáèÜ- êýñéáò ìåôáâëçôÞò áðïôåëåóìáôéêüôçôáò, ìåôÜ ôçí
ñéóç ôùí âëáâþí ≥75% óå ó÷Ýóç ìå ôç âáóéêÞ åðß- Ýíáñîç ôçò äïêéìÞò.
óêåøç êáèþò èåñáðåõôéêüò óôü÷ïò ìå êëéíéêÞ óçìá- • OìÜäá Áóèåíþí ÊáôÜ ôï Ðñùôüêïëëï (Per-Proto-
óßá åßíáé ç åêêáèÜñéóç ðïóïóôïý ≥75% ôùí âëáâþí col Set-PPS): üëïé ïé áóèåíåßò ôçò ïìÜäáò FAS,
ðïõ êáôáìåôñÞèçêáí óôçí åðßóêåøç áíáöïñÜò.24 Ïé ðïõ ðëçñïýóáí ôá áêüëïõèá êñéôÞñéá:
ìåôñÞóåéò ôùí ìåôáâëçôþí áðïôåëåóìáôéêüôçôáò êá- – äåí ðáñáâßáóáí ïðïéáäÞðïôå êñéôÞñéá Ýíôáîçò
ôÜ ôçí ôåëéêÞ åðßóêåøç áîéïëüãçóçò (30 çìÝñåò ìå- Þ áðïêëåéóìïý.
ôÜ ôçí ïëïêëÞñùóç ôçò èåñáðåßáò - åðßóêåøç 5), – Ýëáâáí èåñáðåßá ôïõëÜ÷éóôïí åðß 90 çìÝñåò
åðéëÝ÷èçêáí äåäïìÝíïõ üôé ðñïçãïýìåíåò ìåëÝôåò – åß÷áí ôïõëÜ÷éóôïí ìßá áîéïëüãçóç ôçò êýñéáò
åß÷áí äåßîåé üôé ç âÝëôéóôç áíôáðüêñéóç óôç èåñá- ìåôáâëçôÞò, ìåôÜ áðü 90 çìÝñåò áãùãÞò.
ðåßá ðáñáôçñåßôáé ìåôÜ ðáñÝëåõóç êÜðïéïõ äéáóôÞ-
ìáôïò áðü ôçí ïëïêëÞñùóç ôçò èåñáðåßáò.20
ÁÁÐÐÏÏÔÔÅÅËËEEÓÓÌÌÁÁÔÔÁÁ ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
ÁÁîîééïïëëïïããÞÞóóååééòò ÁÁóóööááëëååßßááòò
ÁÁóóèèååííååßßòò
Ç áóöÜëåéá êáé ç áíåêôéêüôçôá ôïõ öáñìÜêïõ
áîéïëïãÞèçêáí ìå âÜóç ôéò áõèïñìÞôùò áíáöåñüìå- ÓõíïëéêÜ, 100 áóèåíåßò ôõ÷áéïðïéÞèçêáí óôá èå-
íåò áíåðéèýìçôåò åíÝñãåéåò (ÁÅ), ôéò ðåñéðôþóåéò ñáðåõôéêÜ óêÝëç ôçò ìåëÝôçò. Áðü áõôïýò, 71 áóèå-
ðñüùñçò äéáêïðÞò ëüãù áíåðéèýìçôùí åíåñãåéþí íåßò ïëïêëÞñùóáí ôç èåñáðåßá ôçò ìåëÝôçò (Ýëáâáí
êáé ôïí Ýëåã÷ï ôùí æùôéêþí óçìåßùí óôéò åíäåäåéãìÝ- áãùãÞ ôïõëÜ÷éóôïí Ýùò ôçí çìÝñá 90 - ïìÜäá áíÜ-
íåò åðéóêÝøåéò. Ï åñãáóôçñéáêüò Ýëåã÷ïò ðåñéÝëáâå ëõóçò ÑÑS). ¼ëïé ïé áóèåíåßò Þóáí ìåóÞëéêåò, áíÞ-
åîåôÜóåéò áßìáôïò (ãåíéêÞ áßìáôïò êáé âéï÷çìéêÝò êáí óôçí ÊáõêÜóéá öõëÞ êáé óå ðïóïóôü 64.8%
ðáñÜììåôñïé) êáé ïýñùí. Ïé åñãáóôçñéáêÝò åîåôÜ- Þóáí Üíäñåò (Ðßíáêáò 1). Äåí õðÞñîáí óçìáíôéêÝò
óåéò ðñáãìáôïðïéÞèçêáí êáôÜ ôç âáóéêÞ åðßóêåøç äéáöïñÝò ìåôáîý ôùí èåñáðåõôéêþí ïìÜäùí óôçí ìÝ-
êáé ôçí åðßóêåøç 4 (ôÝëïò èåñáðåßáò). Ç áîéïëüãçóç óç çëéêßá ôùí áóèåíþí (67.8±5.3 óôçí ïìÜäá DHA
ôçò óõììüñöùóçò óôç èåñáðåßá Ýãéíå ìå ôç âïÞèåéá Ýíáíôé 68.8 ±4.9 óôçí ïìÜäá placebo, p>0.05). Ç
ìßáò åéäéêÜ ó÷åäéáóìÝíçò êëßìáêáò óõììüñöùóçò 4 êáôáíïìÞ ôùí öùôïôýðùí ôïõ äÝñìáôïò êáôÜ Fitzpa-
óçìåßùí êáé ôáõôü÷ñïíç êáôáìÝôñçóç ôùí åðéóôñå- trick, óôéò èåñáðåõôéêÝò ïìÜäåò, Þôáí ðáñüìïéá. Ï
öüìåíùí ðïóïôÞôùí öáñìÜêïõ, óå êÜèå åðßóêåøç, ìÝóïò áñéèìüò ôùí âëáâþí áêôéíéêÞò õðåñêåñÜôù-
ìåôÜ ôçí åðßóêåøç 1. óçò Þôáí ðáñüìïéïò ìåôáîý ôùí ïìÜäùí (5.1 ± 1.9
óôçí ïìÜäá ãÝëçò DHA Ýíáíôé 4.9 ± 2.2 óôçí ïìÜäá
ÓÓôôááôôééóóôôééêêÞÞ ÁÁííÜÜëëõõóóçç placebo, p>0.05), åíþ óå áìöüôåñåò ôéò èåñáðåõôé-
êÝò ïìÜäåò ïé âëÜâåò åíôïðßæïíôáí óõ÷íüôåñá óôï
Ç ìåëÝôç ó÷åäéÜóôçêå þóôå íá êáôáäåßîåé ìßá ìÝôùðï Þ ôï êåíôñéêü ôìÞìá ôïõ ðñïóþðïõ. Ç óõì-
äéáöïñÜ 20% óôï ðïóïóôü ôùí áóèåíþí ìå âáèìï- ìüñöùóç óôçí áãùãÞ Þôáí õøçëÞ êáé óôéò äýï ïìÜ-
ÅÅËËËËÇÇÍÍÉÉÊÊÇÇ ÅÅÐÐÉÉÈÈÅÅÙÙÑÑÇÇÓÓÇÇ ÄÄÅÅÑÑÌÌÁÁÔÔÏÏËËÏÏÃÃÉÉÁÁÓÓ ÁÁÖÖÑÑÏÏÄÄÉÉÓÓÉÉÏÏËËÏÏÃÃÉÉÁÁÓÓ