OFF-LABEL PRIMENA LEKOVA U DERMATOLOGIJI – IZAZOVI NOVIH PUTEVA PRIMENE NEKIH STARIH LEKOVA
Sažetak
"Off-label” upotreba lekova, tj. upotreba lekova van/bez dozvole podrazumeva propisivanje lekova u smislu doze, indikacija, farmaceutskog oblika i puta primene ili ciljne grupe pacijenata za koje ne postoji zvanično odobrenje. U poslednje vreme ističu se nove indikacije za neke lekove koji se često koriste u lokalnom tretmanu dermatoloških oboljenja. "Off-label” upotreba lekova češća je u dermatologiji u odnosu na druge specijalnosti, i uglavnom su dostupni u obliku magistralno izrađenih preparata za lokalnu upotrebu na koži; u tom slučaju obično se ne poklanja dovoljno pažnje izboru nosača i bezbednosti lokalno primenjenog leka koji je inače indikovan za sistemsku primenu. Štaviše, podloge (baze) koje se tradicionalno koriste kao nosači za magistralno izrađene lekove obično su stabilizovane surfaktantima koji mogu da iritiraju kožu što svakako nije povoljno imajući u vidu da se stanje inflamatornih dermatoza može pogoršati kada se iste izlažu iritansima.
U ovom radu dat je prikaz nekoliko sistemskih lekova koji se u poslednje vreme upotrebljavaju u lokalnom tretmanu čestih dermatoloških oboljenja, i to van zvanično odobrene indikacije. Izbor lekova napravljen je na osnovu informacija o najčešćim magistralnim preparatima ovog tipa izrađenih prema receptu lekara u apotekama. Cilj rada bio je i prikaz dostupnih naučnih informacijama koje se tiču dva, po našem mišljenju, najveća nedostatka “off-label” lokalne upotrebe lekova u dermatologiji – bezbednosti primene finalnih formulacija na kožu i izboru nosača za određene lekove u smislu njihove stabilnosti i bezbednosti primene.
Reference
REFERENCES
França K, Litewka S. Controversies in off-label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies. Int J Dermatol. 2019; 58(7):788-94. https://onlinelibrary.wiley.com/doi/10.1111/ijd.14222
Savić M. Lekovi za dermatološku primenu - klasifikacija i mehanizmi dejstva. Arhiv za farmaciju, 2013; 63(2): 116-28.
Kelidari HR, Saeedi M, Akbari J et al. Formulation optimization and in vitro skin penetration of spironolactone loaded solid lipid nanoparticles. Colloids Surf. B: 2015; 128: 473-79. https://www.ncbi.nlm.nih.gov/pubmed/25797482
Sugarman J, Fleischer A, Feldman S. Off-label prescribing in the treatment of dermatologic disease. J Am Acad Dermatol. 2002; 47: 217-23.
https://www.sciencedirect.com/science/article/pii/S0190962202000506?via%3Dihub
Hsien-Yi C, Tsen-Fang T. Topical use of systemic drugs in dermatology: A comprehensive review. J Am Acad Dermatol. 2011; 65(5): 1048.e1-1048.e22.
https://www.jaad.org/article/S0190-9622(10)01052-2/abstract
Kohler C, Tschumi K, Bodmer C, et al. Effect of finasteride 5 mg (Proscar) on acne and alopecia in female patients with normal serum levels of free testosterone. Gynecol Endocrinol 2007; 23: 142-45. https://www.tandfonline.com/doi/abs/10.1080/09513590701214463?journalCode=igye20
Research and development in the pharmaceutical industry. The Congress of the United States. Congressional Budget Office; October 2006.
https://www.cbo.gov/sites/default/files/109th-congress-2005-2006/reports/10-02-drugr-d.pdf
Kapoor R, Phiske M, Jerajani HR. Evaluation of safety and efficacy of topical prostaglandin E2 in treatment of vitiligo. Br J Dermatol 2009; 160: 861-3.
https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2133.2008.08923.x
Piana, M., Silva, M., Trevisan, G., et al. 2013. Antiinflammatory effects of Viola tricolor gel in a model of sunburn in rats and the gel stability study.J. Ethnopharmacol. 150, 458–465.
https://www.sciencedirect.com/science/article/pii/S0378874113005941?via%3Dihub
Jaksic I, Lukic M, Malenovic A, et al. Compounding of a topical drug with prospective natural surfactant-stabilized pharmaceutical bases: Physicochemical and in vitro/in vivo characterization – A ketoprofen case study. Eur J Pharm Biopharm. 2012; 80: 164-75.
https://www.sciencedirect.com/science/article/pii/S0939641111002463?via%3Dihub
Barany E, Lindberg M, Loden M. Unexpected skin barrier influence from nonionic emulsifiers. Int J Pharm 2000; 195: 189–95.
https://www.sciencedirect.com/science/article/pii/S0378517399003889?via%3Dihub
Bárány E, 243–250. In: M.LODÉN, H.I.MAIBACH (Eds.), Dry Skin and Moisturizers. CRC Press LLC, Boca Raton (2000).
Sato K, Matsumoto D, Iizuka F, et al. Anti-androgenic Therapy Using Oral Spironolactone for Acne Vulgaris in Asians. Aesthet. Surg. J. 2006; 30: 689–94.
https://link.springer.com/article/10.1007%2Fs00266-006-0081-0
Yamamoto A, Ito M. Topical spironolactone reduces sebum secretion rates in young adults. J Dermatol 1996;23:243-6.
https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1346-8138.1996.tb04006.x
Corazza M, Strumia R, Lombardi AR, Virgili A. Allergic contact dermatitis from spironolactone. Contact Dermatitis 1996;35: 365-6.
https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1600-0536.1996.tb02421.x
Ilić D, Cvetković M, Blažević-Kamenov N, Tasić-Kostov M. Topical spironolactone in a natural non-ionic emulsifier based vehicle – a safety assessment, Skin and Formulation, 5th Symposium & 17th Skin Forum, Book of abstracts, 2019.pp.57
Price A, Rai S, Mcleod RWJ, Birchall JC, Elhassan HA. Topical propranolol for infantile haemangiomas: a systematic review. J Eur Acad Dermatol Venereol. 2018; 32(12):2083-89.
https://onlinelibrary.wiley.com/doi/abs/10.1111/jdv.14963
Ji, Y., Chen, S., Xu, C. et al. The use of propranolol in the treatment of infantile haemangiomas: An update on potential mechanisms of action. Br J Dermatol 2015; 172: 24–32.
https://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.13388
Hoeger, P. H. et al. Treatment of infantile haemangiomas: recommendations of a European expert group. Eur. J. Pediatr. 2015; 174: 855–65.
https://link.springer.com/article/10.1007%2Fs00431-015-2570-0
Marqueling, A. L., Oza, V., Frieden IJ. Propranolol and infantile hemangiomas four years later: A systematic review. Pediatr. Dermatol. 2013; 30: 182–191.
https://onlinelibrary.wiley.com/doi/abs/10.1111/pde.12089
Tan, CES., Itinteang, T., Leadbitter, P., et al. Low-dose propranolol regimen for infantile haemangioma. J. Paediatr. Child Health 2015; 51: 419–424.
https://onlinelibrary.wiley.com/doi/abs/10.1111/jpc.12720
Kunzi-Rapp, K. Topical Propranolol Therapy for Infantile Hemangiomas. Pediatr. Dermatol 2012;29:154–9.
https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1525-1470.2011.01615.x
Bonifazi E, Milano A, Colonna V. Evaluation of safety and efficacy of a galenic preparation of 1% propranolol in 89 cases of cutaneous infantile hemangioma. Eur J Pediat Dermatol 2013;23:93-104. https://www.ejpd.com/journal/index.php/EJPD/article/view/922
Baselga, E. Risk factors for degree and type of sequelae after involution of untreated hemangiomas of infancy. JAMA Dermatology 2016;152: 1239–1243.
https://doi.org/10.1001/jamadermatol.2016.2905
Xu G, Lu R., Zhao Z, Huo R. Topical propranolol for treatment of superficial infantile hemangiomas. J. Am Acad Dermatol 2012; 67: 1210–13.
https://www.sciencedirect.com/science/article/pii/S0190962212003507?via%3Dihub
Wang, Y., Zhang, X., Zhang, J., et al.. Efficacy and Safety of 2% Topical Propranolol Cream for the Treatment of Proliferating Infantile Strawberry Hemangiomas. Indian J. Pediatr. 2017; 17:1–5.
https://link.springer.com/article/10.1007/s12098-017-2303-7
Mashiah, J. Assessment of the effectiveness of topical propranolol 4% gel for infantile hemangiomas. Int. J. Dermatol. 2017; 56: 148–53.
https://onlinelibrary.wiley.com/doi/abs/10.1111/ijd.13517
Tanghetti E; Dover J, Goldberg DJ et al. Topical oxymetazoline hydrochloride 1.0% effectively reduces persistent facial erythema of rosacea on day 1. J Am Acad Dermatol. 2018;79 (3), Supplement 1: AB299. https://www.jaad.org/issue/S0190-9622(18)X0002-4
Callender V, Alexis A; Stein Gold L et al. Long-term topical oxymetazoline hydrochloride 1.0% demonstrates sustained and increasing effect in persistent facial erythema of rosacea. J Am Acad Dermatol.2018;79 (3), Supplement 1: AB182.
https://www.jaad.org/issue/S0190-9622(18)X0002-4
Stein-Gold L, Kircik LH, Draelos ZD, et al. Efficacy and safety oftopical oxymetazoline cream 1.0% for treatment of persistentfacial erythema associated with rosacea: findings from the twophase 3, 29-day, randomized, controlled REVEAL trials.J Am Acad Dermatol. In press.
Draelos ZD, Gold MH, Weiss RA et al. Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label REVEAL trial. J Am Acad Dermatol.2018; 78 (6): 1156-63.
https://www.sciencedirect.com/science/article/pii/S0190962218301464
Jaksic I, Lukic M, Malenovic A et al. Compounding of a topical drug with prospective natural surfactant-stabilized pharmaceutical bases: Physicochemical and in vitro/in vivo characterization – A ketoprofen case study. Eur J Pharm Biopharm. 2012; 80: 164-75.
https://www.sciencedirect.com/science/article/pii/S0939641111002463?via%3Dihub