Baiza-Duran L M, Quintana-Hau J, Tornero-Montaño R, Ortiz M I, Castañeda-Hernández G, Alanis-Villarreal L, Avalos-Urzua G, Bustos-Zermeño R, Domene-Hinojosa J L, Gómez-Bastar P, Ibañez-Hernandez M A, Morales-Gómez M E, Velasco-Gallegos G, Villar-Kuri J
Clinical Research Department, Laboratorios Sophia S.A. de C.V. Guadalajara, Jalisco, Mexico.
Int J Clin Pharmacol Ther. 2009 Feb;47(2):89-95. doi: 10.5414/cpp47089.
A novel topical ophthalmic formulation of the preferential COX-2 inhibitor meloxicam has recently been developed. The purpose of the present study was to evaluate the efficacy and safety of this novel 0.03% meloxicam solution with regard to a reference 0.1% diclofenac formulation in a prospective, parallel, randomized, multicenter, double-blind study. Two groups of patients submitted to phacoemulsification with intraocular lens implantation were formed. Patients in one group were treated with meloxicam and those in the other group with diclofenac. Dosing was 1 drop t.i.d. for 30 days, beginning the first day after surgery, for both treatments. Inflammation was assessed by the presence of cells in the anterior chamber, anterior chamber flare, ciliary flush, photophobia and pain. Both treatments significantly reduced these indicators. Topical meloxicam and diclofenac produced a similar degree of burning sensation and conjunctival hyperemia. There was no significant difference between treatments in any of the measured parameters. It is concluded that the novel meloxicam solution is effective and safe. Meloxicam, however, did not offer any significant benefit over the diclofenac formulation in patients submitted to cataract surgery.
一种新型的优先COX - 2抑制剂美洛昔康的局部眼科制剂最近已被研发出来。本研究的目的是在一项前瞻性、平行、随机、多中心、双盲研究中，相对于参考的0.1%双氯芬酸制剂，评估这种新型0.03%美洛昔康溶液的疗效和安全性。形成了两组接受白内障超声乳化联合人工晶状体植入术的患者。一组患者用美洛昔康治疗，另一组用双氯芬酸治疗。两种治疗均在术后第一天开始，每天滴眼3次，持续30天。通过前房内细胞的存在、前房闪光、睫状充血、畏光和疼痛来评估炎症。两种治疗均显著降低了这些指标。局部应用美洛昔康和双氯芬酸产生的烧灼感和结膜充血程度相似。在任何测量参数中，两种治疗之间均无显著差异。结论是新型美洛昔康溶液是有效且安全的。然而，在接受白内障手术的患者中，美洛昔康相对于双氯芬酸制剂并没有提供任何显著优势。
