Resumen
Ensayo Clínico observacional y descriptivo, longitudinal y prospectivo de 22 meses de duración, en 40 pacientes de Facultad Odontología. UDELAR. Objetivo: Valorar efcacia, duración y efectos adversos del implante de Ácido Hialurónico (A.H) realizado en surcos nasolabiales. (SNL) Metodología: Ensayo clínico con implantación de A.H en la dermis media de SNL marcados, grado 2 al 5 en la escala diagnóstica WSRS. Se obtuvieron y clasifcaron registros clínicofotográfcos de cada caso, pre y post-aplicación por 12 meses utilizando las escalas WSRS, GAIS y PSSS. Resultados: expresados en tiempos, porcentajes y gráficos Efcacia: muy buena =100 % casos Duración media clínica efectiva: 10,5 meses Efectos adversos al producto: cero % Califcación de los pacientes: Bueno a muy Bueno. Conclusión: el AH inyectable a nivel dérmico (TEOSYAL Deep Lines®), es eficaz para corregir SNL. Duración promedio 10,5 meses con efecto “caída lento”. Reacciones adversas: cero.
Referencias
2. Carruthers J, Narurkar VA. Tratamiento de los labios y ángulos de la boca. In: Carruters J. Aumento de Tejidos blandos. Madrid: Elsevier, 2006. pp 109.
3. Rodriguez E et al: Materiales de relleno en el área orofacial. Dentum.2009;9(1):36-41.
4. Lemperle G, Morhenn Vand Charier U. Human histology and persistence off varios injectable fller subtances for soft tissue augmentation. Aesthetice
plast Surg. 2003;27:354
5. Jacovella PJ. Correcciones Faciales Estéticas con Rellenos Inyectables. Buenos Aires: AKADIA, 2008.
6. Bowman PH, Narins RS. Hilanos y aumento de tejidos blandos. In: Carruthers J, Carruthers A, Dover JA, Murad A. Aumento de tejidos blandos. Madrid: Elsevier, 2006. p33.
7. Rzany V, Dil Müller D, Grablowitz D, Heckmann M, Caird D. Repeated Boulinun toxin A injection for the threatments of lines in the upper face: a retrospective study of 4.103 treatments in 945 patients. Dermatol Surg 2007; 33(Sp 1): S18-25
8. Personell J. Anatomía, Fisiología e bioquímica da pele normal e do envelhecimiento cutane. Cosmetria a Ciencia da beleza. Revinter 2004. p3-26
9. Carruthers J, Klein AW, Carruthers A, Glogau RG, Canfeld D. Safety and efcacy of nonamimal stabiliced hyaluronic acid for improvement of the 10. Bezzola A, Micheeles P, Esthelis AC. Hialurónico de diseño Suizo. J Med.Esth Chr Dern. 2005;32:11
11. FriedmanPM et al.Safety data of inyectable noanimal stabilized hyaluronic acid gel for soft tissue aumentation. Derm. Surg. 2002;28:491-4
12. Sanchez C, Candelas D, Ruiz RR. Materiales de relleno: tipo indicaciones y complicaciones. Actas dermosifliogr. 2010;101(5):381-393
13. Necas J, Bartosikova L, Brauner P, Kolar J.. Hyaluronic acid (hyaluronan): a review. 2008. Veterinarni Medicina 53:397-411.
14. Fraser JRE, Laurent TC, Laurent UBG.. Hyaluronan: its nature, distribution, functions and turnover. J Int Med 1997; 242:27-33.
15. Balazs EA et al. Hyaluronan Biomaterials.: Medical applications. In: Wise DL et al. Handbook of Biomaterials and Applications. New York: Marcel Dekker. 1995. p2719-2741.
16. Ogden A, Grifths T.W. A review of minimally invasive cosmetic procedures. Br J Dermatol. 2008; 159:1036-50.
17. Erazo JP, De Carvalho AC et al. Relleno facial con ácido hialurónico: técnica de pilares y malla de sustentación. Principios básicos para obtener una remodelación facial. Cirugía Plástica IberoLatinoam 2009; 35(3).
18. Day D, et al. Te Wrinkle Severity Rating Scale: a validation study. Am.J Clin Dermatol. 2004; 5(1): 49-52
19. Larson L, Rovers J, Mackeigan L. Patient satisfaction with pharmaceutical care: update of a validated instrument. J Am Pharm Assoc 2002;42(1):44-50.
20. Narins R, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomised, double-blind, multicenter comparison of the efcacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Derm. Surg. 2003;29:588-95
21. Baumann LS, Shamban AT, Lupo MP, Monheit GD, Tomas JA, Murphy DK, Walker PS. Comparison of smooth-gel hyaluronic acid dermal fllers with cross-linked bovine: a multicenter, doublé-masket, randomized, within-subject study. Dermatol Surg. 2007;33(Suppl 2):S128-35.
22. Nast A, Reytan N, Harmann V, Pathirana D, Backmann F, Erdmann R, Rzany B. Efcacy and Durability of Two Hyaluronic Acid–Based Fillers in the Correction of Nasolabial Folds: Results of a Prospective, Randomized, Double‐Blind, Actively Controlled Clinical Pilot Study. Dermatology Surg 2011; 37(6): 768-775
23. Grimes PE, Tomas JA, Murphy D.K. Safety and effectiveness of hyaluronic acid fllers in skin of color. J Cosmet Dermatol 2009;8:162-8.
24. Williams S, Tamburic S, Weber M. Changes in skin phisiology and clinical appearance after microdoplet placement of hialuronic acid in aging hands. J Cosmetic Dermatol 2009; 8(3): 216-225.
25. Klein AW. Techniques for soft tissue augmentation: an “A” to “Z”. Am J ClinDermatol 2006;7:107-20.
26. Anido J, Félix S, Jarne C, Milotich A, Moreu C, Ruíz-De-Cueto S, Serna M, Ulecia M, VaqueroPérez MM. Reunión de consenso para recomendaciones sobre la gama de productos Restylane Skinboosters®. Rev. Plastic Iberolatinoam 2016; 42 (2): 187-195. doi: 10.4321/S0376-78922016000200013
27. Kerscher M, Bayrhammer J, Reuther T. Rejuvenating influence of a stabilized hyaluronic acidbased gel of nonanimal origin on facial skin aging. Dermatol Surg. 2008; 34 (5): 720-726.
28. Reuther T, Bayrhammer J, Kerscher M. Effects of a threesession skin rejuvenation treatment using stabilized hyaluronic acid-based gel of non-animal origin on skin elasticity: a pilot study. Arch Dermatol Res 2010; 302 (1): 37-45.
29. Gubanova EI, Dyachenko YY, Rodina MY, Koliyeva MK. New hydrobalance technology based on stabilized hyaluronic acid for long-term skin hydration.
Esteticheskaya Meditsina (Aesthetic Medicine) 2010; 1:94-1098.
30. Distante F, Pagani V, Bonfgli A. Stabilized hyaluronic acid of non-animal origin for rejuvenating the skin of the upper arm. Dermatol Surg. 2009; 35(Suppl 1): 389-393.
31. Ribé A, Ribé N. Neck skin rejuvenation: histological and clinical changes after combined therapy with a fractional nonablative laser and stabilized hyaluronic acid-based gel of non-animal origin. J Cosmet Laser Ter. 2011; 3(4): 154-161.
32. Dierickx C. Injections of stabilized hyaluronic acid gel containing lidocaine for the treatment of depressed facial acné sacrs: 5-month results. Poster presented at 17th IMCAS, Paris, January 2015.
33. Halachmi S, Ben Amitai D, Lapidoth M. Treatment of acne scars with hyaluronic acid: an improved approach. J Drugs Dermatol. 2013; 12 (7): e121-123.
34. Streker M, Reuther T, Krueger N, Kerscher M. Stabilized hyaluronic acid-based gel of non-animal origin for skin rejuvenation: face, hand, and décolletage. J Drugs Dermatol. 2013; 1 2(9): 990- 994.
35. Lee BM, Han DG, Choi WS. Rejuvenating Effects of Facial Hydroflling using Restylane Vital. Arch Plast Surg. 2015; 42 (3): 282-287. 36. Bertucci V, Lynde CB. Current Concepts in the Use of Small- Particle Hyaluronic Acid. Plast Reconstr Surg. 2015 ;136 (5 Suppl): 132S-138S.
37. Gubanova EI, Starovatova PA, Rodina MY. 12-month effects of stabilized hyaluronic acid gel compared with saline for rejuvenation of aging hands. J Drugs Dermatol. 2015 ;14 (3): 288-298.
38. Fagien S. Facial soft tissue augmentation with hyaluronic acid fllers: Juvederm and Restylane: practical considerations for their use. In: Cohen SR, Born TM., editors. Facial rejuvenation with fllers. Spain: Saunders Elsevier; 2009. p11-21.
39. Hirsch RJ, Narurkar V, Carruthers J. Management of injected hyaluronic acid induced Tyndall effects. Lasers Surg Med. 2006; 38:202-4.
40. Buck DW, Alam M, Kim J.Y.S. Injectable fllers for facial rejuvenation: a review. J Plast Reconstr Aesthet Surg. 2009; 62:11-8.
41. Carruthers JDA, Glogau RG, Blitzer A, Anderson RL, Cohen JL, Cox SE, et al, The Facial Aesthetics Consensus Group Faculty. Advances in facial rejuvenation: toxin botulinum type a, hyaluronic acid dermal fllers, and combination therapies consensus recommendations. Plast Reconstr Surg. 2008; 121(Suppl):5-30.
42. Beasley KL, Weiss MA, Weiss R.A. Hyaluronic acid fllers: a comprehensive review. Facial Plastic Surg. 2009; 25:86-94.
43. Arlette JP, Trotter M.J. Anatomic location of hyaluronic acid filler material injected into nasolabial fold: a histologic study. Dermatol Surg. 2008; 34(Suppl 1):
56-63.
44. Hilinski JM, Cohen S.R. Volumetric use of injectable fllers in the face. In: Cohen S.R., Born T.M., editors. Facial rejuvenation with fllers. Spain: Saunders Elsevier; 2009. p77-92.
45. Kablik J, Monheit GD, Yu L, Chang G, Gershkovich J. Comparative physical properties of hyaluronic acid dermal fllers. Dermatol Surg. 2009; 35:302-12.
46. Klein AW, Fagien S. Hyaluronic acid fllers and individual and combined use for injectable facial rejuvenation. Plast Reconstr Surg. 2007; 120(Suppl):81-8.
47. Rubin MG. Treatment of nasolabial folds with fllers. Aesthet Surg J. 2004; 24:489-93.
48. Lambros VS. Hyaluronic acid injections for correction of tear trough deformity. Plast Reconstr Surg. 2007; 120(Suppl):74-80.
49. Wu WTL. Periorbital rejuvenation with injectable fllers. In: Cohen S.R., Born T.M., editors. Facial rejuvenation with fllers. Spain: Saunders Elsevier; 2009. 93-105.
50. Clark CP. Animal-based hyaluronic acid fllers: scientifc and technical considerations. Plastic Reconstr Surg. 2007; 120(Suppl):27S-32S.
51. Wang F, Garza LA, Kang S, Varani J, Orringer JS, Fisher GJ, et al. In vivo stimulation of the novo collagen production cause by cross-linked hyaluronic acid dermal fller injection in photodamaged human skin. Arch Dermal. 2007; 143:155-63.
52. Alam M, Levy R, Pavjani U, Ramierez JA, Guitart J, Veen H, et al. Safety of radiofrequency treatment over human skin previously injected with medium-term injectable soft-tissue augmentation materials: a control pilot trial. Lasers Surg Med. 2006; 38:205-10.
53. Narins RS, Beer K. Liquid injectable silicone: a review of its history, immunology, technical considerations, complications, and potential. Plast Reconstr Surg. 2006; 118(3Suppl):S77-84.
54. Jones DH, Carruthers A, Orentreich D, Brody HJ, Lai MY, Azen S, et al. Highly purifed 1000-cSt silicone oil for treatment of human immunodefciency virus associated facial lipoatrophy: an open pilot trial. Dermatol Surg. 2004; 30:1279-86.
55. Sadove R. Injectable poly-L-lactic acid: a novel sculpting agent for the treatment of dermal fat atrophy after severe acne. Aesthetic Plast Surg. 2009; 33:113-6.
56. Vleggaar D. Soft tissue augmentation and the role of Poly-L-lactic acid. Plast.Reconstr. Surg.2006;118(Suppl):46S-54.
57. Butterwick K, Lowe NJ. Injectable poly-L-lactic acid for cosmetic enhancement: learning from the European experience. J Am Acad Dermatol. 2009; 61:281-93.
58. Bauer U. Improvement of facial aesthetics at 40 months with injectable poly-L-lactic acid (PLLA). Houston: International Society of Aesthetic Plastic Surgery; 2004.
59. Moyle GJ, Brown S, Lysakova L, Barton SE. Long term safety and efcacy of poly-L-lactic acid in theEstudio clínico de efcacia, duración y efectos adversos del implante de Ácido Hialurónico en el área Buco-Maxilo-Facial 89 treatment of HIV-related facial lipoatrophy. HIV Med. 2006; 7:181-5.
60. Salles AG, Lotierzo PH, Giménez R, Camargo CP, Ferreira M.C. Evaluation of the Poly-L-Lactic acid implant for the treatment of the nasolabial fold: 3
year follow-up evaluation. Aesthetic Plastic Surg. 2008; 108:496-504.
61. Gogolewski S, Jovanovic M, Perren SM, Dillon JG, Hughes M.K. Tissue response and in vivo degradation of selected polyhydroxyacids: polilactides (PLA), poly (3-hydroxibutyrate) (PHB), and poly (3-hydroxybutyrate-co-3-hydroxyvalerate) (PHB/VA). J Biomed Mater Res. 1993; 27:1135-48.
62. Glasgold M, Lam SM, Glasgold R. Autologous fat grafting for cosmetic enhancement of the perioral region. Facial Plastic Surg Clin North Am. 2007; 15:461-70.
63. Bucky LP, Kanchwala A.K. Te role of autologous fat and alternative fllers in the aging face. Plast Reconstr Surg. 2007; 120(Suppl):89-96
64. Bauer UUI, Born T.M. Shaping the future: new outcomes in Europe. En: Cohen S.R., Born T.M., editors. Facial rejuvenation with fllers. Spain: Saunders Elsevier; 2009. 121-34.
65. Bauman L. Cosmoderm/Cosmoplast (human bioengineered collagen) for the aging face. Facial Plast Surg. 2004; 20:125-8
66. Matarasso SL. Injectable collagens: lost but not forgotten--a review of products, indications, and injection techniques. Plast Reconstr Surg. 2007; 120(Suppl):17-26.
67. Smith KC. Repair of acne scars with Dermicol-P35. (collagen) Aesthet Surg J. 2009; 29(3Suppl):S16-8.
68. Monstrey SJ, Pitaru S, Hamdi M, Van Landuyt K, Blondeel P, Shiri J, et al. A two-stage phase I trial of Evolence 30 collagen for soft tissue contour correction. Plast Reconstr Surg. 2007; 120:303-11.
69. Carruthers J, Carruthers A. Two-center Canadian report on the safety and effectiveness of Evolence Breeze collagen. J Drugs Dermatol 2009; 8:830-4.
70. Inglefeld C. Nonsurgical hand rejuvenation with Dermicol-P35 30G. Aesthet Surg J 2009; 29(Suppl):S19-21.
71. Marmur ES, Phelps R, Goldberg D.J. Clinical, histologic and electron microscopic fndings after injections of a calcium hydroxiapatite fller. J Cosmet Laser Ter. 2004; 6:223-6.
72. Busso M, Karlsberg P.L. Cheek augmentation and rejuvenation using injectable calcium hydroxylapatite (Radiesse). Cosmetic Dermatol 2006; 19:583-8.
73. Berlin A, Cohen JL, Goldberg D.J. Calcium hydroxilapatite for facial rejuvenation. Sem Cutan Med Surg 2006; 25:132-7.
74. Jansen DA, Graivier M.H. Evaluation of a calcium hydroxyapatite-based implant (Radiesse) for facial soft tissue augmentation. Plast Reconstr Surg. 2006; 118(3 Suppl):S22-30.
75. Marmur ES, Al Quran H, De Sa Earp AP, Yoo J.Y. A fve-patient satisfaction pilot study of calcium hydroxylapatite injection for treatment of aging hands. Dermatol Surg. 2009; 35:1978-84.
76. Piacquadio D, Smith S, Anderson R. A comparison of commercially available polymethylmethacrylate-based soft tissue fllers. Dermatol Surg. 2008; 34(Suppl 1):S48-52.
77. Saez Carriera, Camona M, Jiménez-Quintana Z, Alfaro X. Cambios bucales en el adulto mayor. Rev. Cubana Estomatología [internet] 2007; 44(4). Cited: 30 set 2017. Available from: http://scieloprueba.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75072007000400011&lng=es&nrm=iso
78. Schindler JS, Kelly JH. Swallowing disorders in the elderly. Rev Laryngoscope. 2002; 112(4):589-602.
79. Friedman PM, Mafong EA, Kaubar AN, Geronemus RG. Safety data ofnyectable noanimal stabilized hyaluronic acid gel for soft tsuue aumentation. Derm surg. 2002;28:491-4
80. Matarasso SL, Carruthers JD, Jewell ML. Consensus Recomendations for Sof-Tissue Aumentation with Nonanimal Stabilized Hialuronic Acid (Restylane). Plastic Surg 2006; 117(Suppl 3):3S-34S.
81. Organización Mundial de la Salud. Vigilancia de la seguridad de los Medicamentos: Sistema de notifcación para el público en general. Ginebra: OMS, 2012. Cited 30 set 2017. Available from: http://apps.who.int/medicinedocs/documents/s21836es/s21836es.pdf
82. Organización Panamericana de la Salud. Red Panamericana de Armonización de la Reglamentación Farmacéutica. Grupo de trabajo en farmacovigilancia. Buenas prácticas de farmacovigilancia Américas.[internet].Washinton: OPS, 2010. Cited: 30 set 2017. Available from: http://apps. who.int/medicinedocs/documents/s18625es/s18625es.pdf
83. Laporte JR. Términos utilizados en investigación Clínica. En: Principios básicos de investigación clínica. 2da. ed. Barcelona: Satra Zéneca, 2001.90 Silvio Scardovi, Andrea Goglian, Paula Gendra, Cecilia Gendra 84. CiFuentes T, Signes F. Estudio de efectos adversos tras tratmiento con implantes de ácido hialurónico. [Tesis]. [Barcelona]: Universidad de Barcelona, 2009. 63p. Available from: http://semcc.com/master/files/Hialuronico%20y%20efectos%20 adversos%20-%20Dras.%20Cifuentes%20y%20Signes.pdf
85. Narins RS. Minimizing adverse events associated with poly-L-lactic acid injection. Dermatol Surg. 2008; 34(Suppl 1):S100-4.
86. Cohen JL. Understanding, avoiding, and managing dermal fller complications. Dermatol Surg. 2008; 34(Suppl 1):S92-9.
87. Alijotas-Reig J, García-Giménez V. Delayed immune-mediated adverse effects related to hyaluronic acid and acryl hydrogel dermal fllers: clinical fndings, long-term follow-up and review of the literature. J Eur Acad Dermatol. 2008; 22:150-61.
88. Alam M, Dover JS. Management of complications and sequelae with temporary injectable fllers. Plast Reconstr Surg. 2007; 120(Suppl 120):98S-105.
89. Reisberger EM, Landthaler M, Wiest L, Schröder J, Stolz W. Foreign body granulomas caused by polymethylmethacrylate microspheres: successful
treatment with allopurinol. Arch Dermatol. 2003; 139:17-20.
90. Alcalay J, Alcalay R, Gat A, Yorav S. Late-onset granulomas reaction to Artecoll. Dermatol Surg. 2003; 29:859-62.
91. Lemperle G, Romano JJ, Busso M. Soft tissue augmentation with Artecoll: 10 year history, indications, techniques and complications. Dermatol Surg. 2003; 29:573-87.
92. Angus JE, Afeck AG, Leach IH, Millard L.G. Two cases of delayed granulomatous reactions to the cosmetic fller Dermalive, a hyaluronic acid and acrylic hydrogel. Br J Dermatol. 2006; 155:1077-8.
93. Rossner M, Rossner F, Bachmann F, Wiest L, Rzany B. Risk of severe adverse reactions to an injectable fller based on a fxed combination of hydroxyethylmethacrylate and ethylmethacrylate with hyalurnic acid. Derm Surg. 2009; 35:367-74.
94. Lemperle G, Gauthier-Hazan N, Wolters M, Eisemann-Klein M, Zimmermann U, Duffy DM. Foreign body granulomas alter all injectable termal fllers: part I. Possible causes. Plast Reconstr Surg. 2009; 123:1842-63.
95. Lemperle G, Gauthier-Hazan N. Foreign body granulomas after all injectable dermal fllers: part II. Treatment options. Plast Reconstr Surg. 2009; 123:1864-73.
96. Dadzie OE, Mahalingam M, Parada M, El Helou T, Philips T, Bhawan J. Adverse cutaneous reactions to soft tissue fllers- a review of the histological features. J Cut Pathol. 2008; 35:536-48.
97. Morhen VB, Lemperle G, Gallo RL. Phagocytosis of different particulate dermal fller substances by human macrophages and skin cells. Dermatol Surg. 2002; 28:484-90.
98. Conejo-Mir JS, Guirado SS, Muñoz MA. Adverse granulomatous reaction to Artecoll treated by intralesional 5-fluorouracil and triamcinolone injections. Dermatol Surg. 2006; 32:1079.
99. Sánchez García V, Sanz Trelles A. Superfcial granulomatous hypoderma: successful treatment with minocycline. J Eur Acad Dermatol Venereol. 2006; 20:1134-5.
100. Gladstone HB, Cohen JL. Adverse effects when injecting facial fllers. Sem Cutan Med Surg. 2007; 26:34-9.