clinical_ophtalmologyСсыл­ка на PubMed | Ссылка на DOI

Ав­то­ры с долж­но­стя­ми и зва­ни­я­ми:

Mark Borchert, Suzanne Bruce, David Wirta, Steven G Yoelin, Sungwook Lee, Cheri Mao, Amanda VanDenburgh


Вы­ход­ные дан­ные
Epub 2016 Dec 21.

Муль­ти­цен­тро­вое, ран­до­ми­зи­ро­ван­ное, двой­ное-сле­пое ис­сле­до­ва­ние в па­рал­лель­ных груп­пах бы­ло про­ве­де­но в 7 цен­трах в США и Бра­зи­лии. Бы­ли вклю­че­ны па­ци­ен­ты с ги­по­три­хо­зом рес­ниц вслед­ствие хи­мио­те­ра­пии или гнезд­ной ало­пе­ции (в воз­расте 5−17 лет) и здо­ро­вые под­рост­ки в воз­расте от 15 до 17 лет (N=71). Па­ци­ен­ты при­ме­ня­ли би­ма­то­прост 0,03% или на­пол­ни­тель на край верх­не­го ве­ка один раз в день ве­че­ром в те­че­нии 4 ме­ся­цев с по­сле­ду­ю­щим на­блю­де­ни­ем в те­че­нии 1 ме­ся­ца по­сле ле­че­ния. Рес­нич­ный бу­го­рок оце­ни­вал­ся с ис­поль­зо­ва­ни­ем ва­ли­ди­ро­ван­ной 4 уров­не­вой гло­баль­ной шка­лы для оцен­ки рес­ниц с фо­то­чис­ло­вой ин­струк­ци­ей.

Из­ме­не­ния дли­ны, тол­щи­ны и тем­но­ты из­ме­ря­лись ана­ли­за­то­ром циф­ро­вых изо­бра­же­ний. Без­опас­ность оце­ни­ва­лась по неже­ла­тель­ным яв­ле­ни­ям и во вре­мя оф­таль­мо­ло­ги­че­ско­го на­блю­де­ния.

Цель

Це­лью ис­сле­до­ва­ния бы­ла оцен­ка без­опас­но­сти и эф­фек­тив­но­сти би­ма­то­про­ста 0,03% в те­ра­пии ги­по­три­хо­за рес­ниц в де­тей.

Ре­зуль­та­ты

Рес­нич­ный бу­го­рок уве­ли­чил­ся у до­сто­вер­но боль­ше­го чис­ла па­ци­ен­тов, при­ни­мав­ших би­ма­то­прост по срав­не­нию с на­пол­ни­те­лем в те­че­нии 4 ме­ся­цев (70,8% про­тив 26,1%; p<0,001). Это пре­иму­ще­ство бы­ло под­твер­жде­но 5 крат­ным на­блю­де­ни­ем в те­че­нии ме­ся­ца по­сле окон­ча­ния те­ра­пии. По­ка­за­те­ли циф­ро­во­го фо­то­ана­ли­за до­сто­вер­но бы­ли луч­ше на би­ма­то­про­сте.

До­сто­вер­ное пре­иму­ще­ство ле­че­ния би­ма­то­про­стом про­тив на­пол­ни­те­ля бы­ло вы­ра­жен­ным сре­ди здо­ро­вых под­рост­ков, но не в под­груп­пах по­ле хи­мио­те­ра­пии или гнезд­ной ало­пе­ции. Про­филь без­опас­но­сти би­ма­то­про­ста со­гла­со­вы­вал­ся с преды­ду­щи­ми ис­сле­до­ва­ни­я­ми у взрос­лых.

Би­ма­то­прост был без­опа­сен и хо­ро­шо пе­ре­но­сил­ся детьми с ги­по­три­хо­зом рес­ниц. В этом ис­сле­до­ва­нии с огра­ни­че­ни­ем раз­ме­ра вы­бор­ки, ана­лиз под­групп по­ка­зал, что ле­че­ние бы­ло эф­фек­тив­ным у здо­ро­вых под­рост­ков без кон­ку­рент­ных со­пут­ству­ю­щих за­боле­ва­ний, но не у па­ци­ен­тов с ги­по­три­хо­зом рес­ниц вслед­ствие хи­мио­те­ра­пии или гнезд­ной те­ра­пии.

Клю­че­вые сло­ва: под­рост­ки, де­ти, ги­по­три­хоз, ла­тис­се


Table 1

Sample size of each etiology by age group

Age group, years Overall (N=71)

 Healthy adolescent (n=40)

 Postchemotherapy (n=16)

 Alopecia areata (n=15)
BIM Vehicle BIM Vehicle BIM Vehicle BIM Vehicle
5−11 6 3 0 0 3 1 3 2
12−14 6 4 0 0 3 1 3 3
15−17 36 16 26 14 7 1 3 1

Abbreviation: BIM, bimatoprost.

Figure 1

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Percentage of pediatric subjects with at least a 1-grade improvement from baseline in Global Eyelash Assessment scores.
Notes: (A) Overall population. (B) Healthy adolescents. (C) Postchemotherapy pediatric subjects. (D) Pediatric subjects with alopecia areata. Study treatment was applied once nightly for 4 months. Subjects did not use study treatment between months 4 and 5. *P=0.004 versus vehicle. **P<0.001 versus vehicle.

Figure 2

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Examples of response to bimatoprost treatment with a 1-grade improvement in GEA score from baseline to month 4.
Notes: In a healthy subject aged 17 years, GEA score at baseline was 3 (A) and improved to GEA score of 4 at month 4 (B). In a postchemotherapy subject aged 13 years, baseline GEA score of 2 (C) improved to GEA score of 3 at month 4 (D).
Abbreviation: GEA, Global Eyelash Assessment.

Figure 3

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Responses to the ESQ-3 at month 4 for (A) satisfaction with eyelash length, (B) satisfaction with eyelash fullness/thickness, and (C) overall eyelash satisfaction for the overall pediatric population aged 12−17 years.
Notes: Study treatment was applied once nightly for 4 months; subjects did not use study treatment between months 4 and 5.

Abbreviation: ESQ-3, 3-item Eyelash Satisfaction Questionnaire.

Table 3
Adverse events reported in more than one subject in the overall population treated with bimatoprost

Adverse event, n (%) Bimatoprost 0.03%a
Overall (N=48) Healthy adolescent (n=26) Postchemotherapy (n=13) Alopecia areata (n=9)
Conjunctival hyperemia 2 (4.2) 1 (3.8) 0 1 (11.1)
Conjunctivitis 2 (4.2) 0 1 (7.7) 1 (11.1)
Eczema 2 (4.2) 1 (3.8) 0 1 (11.1)
Erythema of eyelid 2 (4.2) 1 (3.8) 0 1 (11.1)
Nasopharyngitis 2 (4.2) 0 2 (15.4) 0
Sinusitis 2 (4.2) 0 2 (15.4) 0

Note:
aNo adverse events were reported in >1 subject in the vehicle group of the overall population (n=23).


An evaluation of the safety and efficacy of bimatoprost for eyelash growth in pediatric subjects

This multicenter, randomized, double-masked, parallel-group study was conducted at seven sites in the US and Brazil. Subjects with eyelash hypotrichosis caused by chemotherapy or alopecia areata (aged 5−17 years) or healthy adolescents aged 15−17 years were enrolled (N=71). Subjects applied bimatoprost 0.03% or vehicle to upper eyelid margins once nightly for 4 months and were followed for 1 month post-treatment. Eyelash prominence was assessed using the validated 4-grade Global Eyelash Assessment scale with photo numeric guide. Changes in eyelash length, thickness, and darkness were measured by digital image analysis. Safety was assessed by adverse events and ophthalmic observations.
Evaluate the safety and effectiveness of bimatoprost 0.03% for treatment of eyelash hypotrichosis in a pediatric population.
Results
Eyelash prominence improved in a significantly greater proportion of subjects treated with bimatoprost compared with vehicle at month 4 (70.8% versus 26.1%; P<0.001). This benefit was sustained at month 5 post-treatment assessment. Digital image analysis measures were significantly improved with bimatoprost. Significant treatment benefits with bimatoprost versus vehicle were evident among the healthy adolescents but not in the postchemotherapy or alopecia areata subgroups. The safety profile of bimatoprost was consistent with previous studies in adults.
Bimatoprost was safe and well tolerated in pediatric subjects with eyelash hypotrichosis. In this study with limited sample size, subgroup analyses showed that treatment was effective in healthy adolescents with no concurrent contributing medical condition, but not in those with eyelash hypotrichosis due to chemotherapy or alopecia areata.

Keywords: adolescent, child, hypotrichosis, Latisse