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第四代氟喹诺酮类药物加替沙星0.3%与莫西沙星0.5%的眼耐受性比较。

A comparison of the fourth-generation fluoroquinolones gatifloxacin 0.3% and moxifloxacin 0.5% in terms of ocular tolerability.

作者信息

Donnenfeld Eric, Perry Henry D, Chruscicki Daniel A, Bitterman Adam, Cohn Stephanie, Solomon Renée

机构信息

Ophthalmic Consultants of Long Island, Rockville Center, NY, USA.

出版信息

Curr Med Res Opin. 2004 Nov;20(11):1753-8. doi: 10.1185/030079904X5959.

Abstract

PURPOSE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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)。

方法

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。

结果

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。

结论

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。

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