2007, Number 6
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Rev Mex Oftalmol 2007; 81 (6)
Estudio multicéntrico comparativo de la seguridad y la eficacia de meloxicam al 0.03% y diclofenaco sódico al 0.1% en postoperados de LASIK
Baiza DLM, González JR, Quintana HJD, Alanis VL, Ávalos UG, Domene HJL, Gómez BP, Ibáñez HMÁ, Méndez NA, Navarro SJ, Velasco GG, Velasco RR, Viggiano AD
Language: Spanish
References: 17
Page: 312-316
PDF size: 53.61 Kb.
ABSTRACT
Purpose: To compare the safety, tolerance and efficacy of both meloxicam 0.03% ophthalmic solution and sodium diclofenac 0.1% on LASIK postoperative patients.
Methods: Comparative, multicentric, prospective, cross-over, randomized, and double-blinded study. 156 LASIK
postoperative patients were included. During 14 consecutive days after surgery, 78 patients were treated with a topical
solution of meloxicam 0.03% and other 78 patients received a topical solution of sodium diclofenac 0.1%. Several efficacy and safety parameters were evaluated.
Results: The corneal surface with fluorescein stain, expressed as a severity rate and analyzed with Mann-Whitney Z test, reached values of p‹0.01 on day 4, 7, and 14, all of them in favor of meloxicam. Ciliary injection where analyzed as an efficacy parameter (severity rate), reaching values of p‹0.05 on days 7 and 14 also in favor of meloxicam. The flare, considered as an efficacy rate, showed a statistically significant difference on day two (p‹0.05) in favor of meloxicam.
Conclusions: Meloxicam 0.03% is equal or safer than sodium diclofenac 0.1% in LASIK refractive surgery. Meloxicam 0.03% exceeds the anti-inflammatory potency of sodium diclofenac 0.1%, especially on days 4 and 7. Therefore, a faster anti-inflammatory response can be assumed.
REFERENCES
Brooks JJ, Yanoff M, Fine BS: Basic principles of pathology. En: Tasman W, Jaeger EA (eds.). Duane’s Foundations of Clinical Ophthalmology. Philadelphia. Lippincontt Williams & Wilkins. 1985; Vol. 3, Chap. 1.
P. Stei, B Kruss y cols. Local tissue tolerability of meloxicam, a new NSAID: indications for parenteral, dermal and mucosal administration; Br J Rheumatol 1996; 35 (supl. 1): 44-50.
Blanco FJ y cols. Effect of Antiinflamatory Drugs on COX-1 and COX-2 Activity in Human Articular Chondrocytes. J Rheumatol 1999; 26(6):1366-1373.
Flach AJ. D. Cyclooxigenasa inhibitors in ophthalmology. Surv Ophthalmology 1992; 36:259-284.
Price FW y cols. Pain reduction after Laser in Situ Kertomileusis with ketorolac tromethamine ophthalmic solution 0.5%: A randomized, double-masked, placebo-controlled trial. J Cataract Refract Surg 2002; 18:140-144.
Van Hecken A, Schwartz J y cols. Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol 2000; 1109-1120.
Kay-Mugford P y cols. In vitro effects of nonsteroidal antiinflamatory drugs on cyclooxigenase activity in dogs. Am J Vet Res 2000; 61(7):802-810.
Vantesone DL, Luna JD y cols. Effects of topical diclofenac and prednisolone eyedrops in laser in situ keratomileusis patients. J Cataract Refract Surg 1999; 25(6): 836-841.
Alió JL y cols. Postoperative Inflammation. Microbial complications, and wound healing following Laser In Situ Keratomileusis. J Refract Surg 2000; 16(5):523-538.
Holzer MP y cols. Corneal Flap Complications in refractive Surgery. J Cataract Refract Surg 1999; 25(6):836-841.
Bevis PJ, Bird HA, Lapham G. An open study to assess the safety and tolerability of meloxicam 15 mg in subjects with rheumatic disease and mild renal impairment. Br J Rheumatol 1996; 35(supl.1):56-60.
Quaratino D, Romano A, Di Fonso M y cols. Tolerability of Meloxicam in patients with histories of adverse reactions to nonsteroidal anti-inflammatory drugs. Ann Allergy Asthma Immunol 2000; 84:613-617.
Masferrer JL, Zweifel BS, Manning PT. Selective inhibition of inducible cyclooxygenase 2 in vivo is anti-inflammatory and nonulcerogenic. Proc Natl Acad Sci 1994; 91:3228-3232.
Van Hecken A, Schwartz J y cols. Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol 2000; 1109-1120.
Yocum D, Fleischmann R, Dalgin P. Safety and efficacy of meloxicam in the treatment of osteoarthritis. Arch Intern Med 2000; 160:2947-2954.
Bosch HC, Sigmund R, Hettich M. Efficacy and tolerability of intramuscular and oral meloxicam in patients with acute lumbago: a comparison with intramuscular and oral piroxicam. Curr Med Res Opin 1997; 14:29-38.
Miyamoto T, Saika S, Okada Y y cols. Expression of cyclooxygenase- 2 in corneal cells after photorefractive keratectomy and laser in situ keratomileusis in rabbits. J Cataract Refract Surg 2004; 30:2612-2617.