첨가제 구성이 다른 라타노프로스트 장기 사용이 안압, 충혈, 눈 불편감에 미치는 영향 비교
Long-term Effects of Latanoprost with Different Excipient Compositions on Intraocular Pressure, Hyperemia and Discomfort
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목적: 첨가제 구성이 다른 두 종류의 무보존제 0.005% 라타노프로스트 점안액을 장기적으로 사용할 경우 안압, 결막충혈도, 주관적점안감, 안구건조감에 미치는 영향을 비교하고자 하였다. 대상과 방법: 본원에서 원발개방각녹내장 또는 정상안압녹내장으로 진단받고 Xalost S®나 Monoprost®로 치료를 시작한 환자들의 의무기록을 후향적으로 분석하였다. 골드만안압계로 안압을 측정하였고, 결막충혈도는 Keratograph® 5M의 자동화 시스템으로 측정되었다. 점안감･건조감은 visual analog scale로 기록되었다. 치료 시작 후 1주, 1, 3, 6개월, 1년째에 경과 관찰하였다. 일반화 추정방정식으로 지표들의 반복 측정에 대해 시간에 따른 차이의 유의성을 분석하였다. 결과: Xalost S® 를 사용한 환자는 31명(60안), Monoprost®를 사용한 환자는 27명(50안)이었다. 기저 특성은 두 군 간 유의한 차이가없었다. Xalost S®군에서는 치료 전 안압과 비교하였을 때 치료 후 안압이 모든 시점에서 유의한 감소를 보였지만(p<0.001), Monoprost® 군에서는 1개월 이후부터 유의한 안압 감소를 보였다(1주 p=0.054; 1개월 p=0.005; 이후 p<0.001). 충혈도, 점안감･건조감은 두 군 모두 모든 시점에서 초기값과 유의한 차이가 없었다. 결론: 두 약제 간의 부작용 빈도는 차이가 없었다. 약제 간 안압하강 효과는 시간이 경과할수록 비슷하였으나, 초기 안압하강 정도는Xalost S®군에서 더욱 컸다. 이는 약제 간 서로 다른 첨가제 구성에 기인한 것으로 추측된다.
Abstract
Purpose: To compare the long-term effects of two preservative-free 0.005% latanoprost ophthalmic solutions with different excipient compositions on intraocular pressure (IOP), conjunctival hyperemia, and subjective ocular discomfort. Methods: The medical records of patients newly diagnosed with normal tension glaucoma or primary open angle glaucoma who started treatment using Xalost S® or Monoprost® were reviewed. IOP was measured with Goldmann applanation tonometry. Conjunctival hyperemia was measured with a Keratograph® 5M and subjective ocular discomfort was surveyed using a visual analog scale. Routine examinations were scheduled 1 week and 1, 3, 6, and 12 months after treatment. A generalized estimating equation was used to evaluate the changes of these parameters with time. Results: Xalost S® was used in 31 patients (60 eyes) and Monoprost® in 27 patients (50 eyes). The baseline characteristics were generally similar in the two groups with no significant differences. In the Xalost S® group, the IOP difference from baseline was significant at all time points (p < 0.001). However, in the Monoprost® group, after 1 month of treatment, the IOP difference decreased significantly (p = 0.054 at 1 week; p = 0.005 at 1 month; p < 0.001 after 1 month). Conjunctival hyperemia and subjective ocular discomfort did not differ significantly from baseline in either group. Conclusions: There was no significant difference in the frequency of side effects between the two drugs. The effect on the IOP drop was similar over time, but the initial IOP drop was greater in the Xalost S® group. This difference is presumed to be due to the different excipient compositions of the two drugs.
참고문헌 (28)
- Casson RJ, "Definition of glaucoma : clinical and experimental concepts", Clin Exp Ophthalmol, 40, pp.341~349 (2012)
- Sit AJ, "Intraocular pressure variations : causes and clinical significance", Can J Ophthalmol, 49, pp.484~488 (2014)
- "European Glaucoma Society Terminology and guidelines for glaucoma, 4th edition - chapter 3: treatment principles and options supported by the EGS foundation: part 1: foreword; introduction; glossary;chapter 3 treatment principles and options", Br J Ophthalmol, 101, pp.130~195 (2017)
- Alm A, "Latanoprost in the treatment of glaucoma", Clin Ophthalmol, 8, pp.1967~1985 (2014)
- Perry CM, "Latanoprost : an update of its use in glaucoma and ocular hypertension", Drugs Aging, 20, pp.597~630 (2003)
- Honrubia F, "Conjunctival hyperaemia with the use of latanoprost versus other prostaglandin analogues in patients with ocular hypertension or glaucoma : a metaanalysis of randomised clinical trials", Br J Ophthalmol, 93, pp.316~321 (2009)
- Rouland JF, "Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma", Br J Ophthalmol, 97, pp.196~200 (2013)
- "Ophthalmic composition for lowering intraocular pressure" (2021)[URL]
- "MONOPOST latanoprost 50 mcg/ml eye drops, solution in single-dose container" (2022)[URL]
- Hodapp E, "Clinical Decisions in Glaucoma", pp.52~61 (1993), Mosby-Year Book
- Sjöquist B, "Ocular and systemic pharmacokinetics of latanoprost in humans", Surv Ophthalmol, 47(Suppl 1), pp.S6~S12 (2002)
- Ichhpujani P, "Comparison of human ocular distribution of bimatoprost and latanoprost", J Ocul Pharmacol Ther, 28, pp.134~145 (2012)
- Schachtschabel U, "The mechanism of action of prostaglandins on uveoscleral outflow", Curr Opin Ophthalmol, 11, pp.112~115 (2000)
- Poyer JF, "Prostaglandin F2 alpha effects on isolated rhesus monkey ciliary muscle", Invest Ophthalmol Vis Sci, 36, pp.2461~2465 (1995)
- Wan Z, "Bimatoprost, prostamide activity, and conventional drainage", Invest Ophthalmol Vis Sci, 48, pp.4107~4115 (2007)
- Bahler CK, "Prostaglandins increase trabecular meshwork outflow facility in cultured human anterior segments", Am J Ophthalmol, 145, pp.114~119 (2008)
- Winkler NS, "Effects of prostaglandin analogues on aqueous humor outflow pathways", J Ocul Pharmacol Ther, 30, pp.102~109 (2014)
- Baudouin C, "Preservatives in eyedrops : the good, the bad and the ugly", Prog Retin Eye Res, 29, pp.312~334 (2010)
- Malhotra M, "Permeation through cornea", Indian J Exp Biol, 39, pp.11~24 (2001)
- Kim JM, "Comparison of the safety and efficacy between preserved and preservative-free latanoprost and preservative-free tafluprost", Pharmaceuticals(Basel), 14, pp.501~ (2021)
- Cha SH, "Corneal epithelial cellular dysfunction from benzalkonium chloride(BAC)in vitro", Clin Exp Ophthalmol, 32, pp.180~184 (2004)
- Furrer P, "Ocular tolerance of preservatives on the murine cornea", Eur J Pharm Biopharm, 47, pp.105~112 (1999)
- Jaenen N, "Ocular symptoms and signs with preserved and preservative-free glaucoma medications", Eur J Ophthalmol, 17, pp.341~349 (2007)
- Broadway DC, "Adverse effects of topical antiglaucoma medication. II. The outcome of filtration surgery", Arch Ophthalmol, 112, pp.1446~1454 (1994)
- Baudouin C, "In vitro studies of antiglaucomatous prostaglandin analogues : travoprost with and without benzalkonium chloride and preserved latanoprost", Invest Ophthalmol Vis Sci, 48, pp.4123~4128 (2007)
- Smedowski A, "Excipients of preservative-free latanoprost induced inflammatory response and cytotoxicity in immortalized human HCE-2 corneal epithelial cells", J Biochem Pharmacol Res, 2, pp.175~184 (2014)
- Cucherat M, "Relative efficacy and safety of preservative-free latanoprost(T2345)for the treatment of open-angle glaucoma and ocular hypertension : an adjusted Indirect comparison meta-analysis of randomized clinical trials", J Glaucoma, 23, pp.e69~75 (2014)
- Zeger SL, "Models for longitudinal data : a generalized estimating equation approach", Biometrics, 44, pp.1049~1060 (1988)