Donnenfeld Eric, Perry Henry D, Chruscicki Daniel A, Bitterman Adam, Cohn Stephanie, Solomon Renée
Ophthalmic Consultants of Long Island, Rockville Center, NY, USA.
Curr Med Res Opin. 2004 Nov;20(11):1753-8. doi: 10.1185/030079904X5959.
To compare the ocular tolerability of the commercially available ophthalmic solutions of the fourth-generation fluoroquinolones, gatifloxacin 0.3% (Zymar, Allergan, Inc., Irvine, CA) with benzalkonium chloride (BAK) and moxifloxacin 0.5% (Vigamox) without BAK.
A baseline evaluation was conducted on 30 healthy volunteers for conjunctival hyperemia, conjunctival vascularity, pupil size, and anterior chamber (AC) cell and flare. Pupils were measured under scotopic conditions with a Colvard pupillometer. Conjunctival hyperemia and vascularity, and AC reaction were measured on a Likert-like scale of 0-3. Subjects then received drops in both eyes from masked bottles of gatifloxacin ophthalmic solution 0.3% with BAK (in one eye determined randomly) and moxifloxacin ophthalmic solution 0.5% without BAK (in the contralateral eye) in a double-masked fashion. Subjects graded pain and ocular irritation in each eye on a scale of 1-10 after 5 min with their eyes closed. The examination was then repeated.
The average age of this study population was 34.4 years. The groups of eyes receiving moxifloxacin 0.5% demonstrated an increase in mean conjunctival hyperemia (0.21 [range: 0-1] at baseline to 1.52 [range: 0-3] at 5 min.) that was significantly greater (p = 0.0005) compared with that of the group receiving gatifloxacin 0.3% (0.22 [range: 0-1] at baseline to 0.45 [range: 0-2] at 5 min). The group receiving moxifloxacin 0.5% showed an increase in conjunctival vascularity (0.55 [range: 0-1] at baseline to 1.61 [range: 0.5-3] at 5 min.) that was significantly greater (p = 0.0005) compared with that of the group receiving gatifloxacin 0.3% (0.52 [range: 0-1] at baseline to 0.68 [range: 0-2] at 5 min.). Significantly less pain (1.2 vs. 3.2, p = 0.001) and irritation (0.64 vs. 3.42, p = 0.001) occurred with gatifloxacin 0.3% than with moxifloxacin 0.5%. Pupil size was significantly reduced (5.65 mm-5.05 mm) in eyes receiving moxifloxacin 0.5% (p = 0.004) and no significant change occurred in pupil size (5.60 mm-5.65 mm) in eyes that received gatifloxacin 0.3% (p = 0.878). No AC reaction was noted with either medication.
The group of eyes receiving gatifloxacin 0.3% with BAK demonstrated greater ocular tolerability in comparison to the group receiving moxifloxacin 0.5% without BAK. Moxifloxacin-induced pupillary miosis may be due to prostaglandin release in the anterior chamber. A limitation of this study is the relatively young age of the study population.
比较市售的第四代氟喹诺酮类眼药水的眼耐受性,即含苯扎氯铵(BAK)的0.3%加替沙星眼药水(Zymar,Allergan公司,加利福尼亚州欧文市)和不含BAK的0.5%莫西沙星眼药水(Vigamox)。
对30名健康志愿者进行基线评估,检查结膜充血、结膜血管状况、瞳孔大小以及前房(AC)细胞和闪光。在暗视条件下用科尔瓦德瞳孔计测量瞳孔。结膜充血和血管状况以及AC反应按0至3的类似李克特量表进行测量。然后受试者以双盲方式从装有0.3%加替沙星眼药水(含BAK,随机确定滴入一只眼)和0.5%莫西沙星眼药水(不含BAK,滴入对侧眼)的遮蔽瓶中接受双眼滴眼。受试者闭眼5分钟后,对每只眼的疼痛和眼部刺激进行1至10分的评分。然后重复该检查。
该研究人群的平均年龄为34.4岁。接受0.5%莫西沙星的眼组结膜充血均值增加(基线时为0.21[范围:0 - 1],5分钟时为1.52[范围:0 - 3]),与接受0.3%加替沙星的眼组相比显著更大(p = 0.0005)(基线时为0.22[范围:0 - 1],5分钟时为0.45[范围:0 - 2])。接受0.5%莫西沙星的眼组结膜血管状况增加(基线时为0.55[范围:0 - 1],5分钟时为1.61[范围:0.5 - 3]),与接受0.3%加替沙星的眼组相比显著更大(p = 0.0005)(基线时为0.52[范围:0 - 1],5分钟时为0.68[范围:0 - 2])。0.3%加替沙星引起的疼痛(1.2对3.2,p = 0.001)和刺激(0.64对3.42,p = 0.001)明显少于0.5%莫西沙星。接受0.5%莫西沙星的眼的瞳孔大小显著减小(5.65毫米 - 5.05毫米)(p = 0.004),而接受0.3%加替沙星的眼的瞳孔大小无显著变化(5.60毫米 - 5.65毫米)(p = 0.878)。两种药物均未观察到AC反应。
与接受不含BAK的0.5%莫西沙星的眼组相比,接受含BAK的0.3%加替沙星的眼组显示出更高的眼耐受性。莫西沙星引起的瞳孔缩小可能是由于前房前列腺素释放。本研究的一个局限性是研究人群年龄相对较小。