Katelaris Constance H, Ciprandi Giorgio, Missotten Luc, Turner F Darell, Bertin Donata, Berdeaux Gilles
Department of Clinical Immunology and Allergy, Westmead Hospital, Sydney, Australia.
Clin Ther. 2002 Oct;24(10):1561-75. doi: 10.1016/s0149-2918(02)80060-1.
Treatments for allergic conjunctivitis have various mechanisms of action. Cromolyn sodium stabilizes conjunctival mast cells by preventing calcium influx across the cell membrane, whereas olopatadine hydrochloride is both an antihistamine and a mast cell stabilizer.
This study compared the efficacy and tolerability of olopatadine and cromolyn in controlling the ocular signs and symptoms of seasonal allergic conjunctivitis.
This was a multicenter, randomized, double-masked, parallel-group trial. One group instilled olopatadine 0.1% ophthalmic solution and placebo BID, and the other instilled cromolyn 2% ophthalmic solution QID, both for 6 weeks. The formulation of cromolyn used in this study is currently available only in Europe and Australia.
The intent-to-treat efficacy and safety analyses included 185 patients, 91 in the olopatadine group and 94 in the cromolyn group. At 30 minutes after the first instillation, respective decreases of approximately 30% and approximately 20% were reported in self-rated ocular itching and redness with both treatments; by 4 hours, itching had decreased by approximately 38% in both groups. Differences between treatments were not statistically significant. At 4 hours, redness had decreased by approximately 38% and approximately 26% in the respective treatment groups. By day 42, both treatments had produced significant reductions from baseline in ocular signs and symptoms; however, the reductions in itching and redness were significantly greater with olopatadine compared with cromolyn (both variables, P < 0.05). The difference in physicians' impression of overall improvement on days 30 and 42 significantly favored olopatadine over cromolyn (both days, P < 0.05). Most patients (62.2%) had reacted positively to grass pollen at baseline. The regression slopes correlating itching and redness with pollen count were 5 times lower for olopatadine compared with cromolyn (P = 0.002 and P = 0.016, respectively), indicating that olopatadine's efficacy increased as the pollen count increased.
Six weeks' instillation of olopatadine 0.19% ophthalmic solution BID had a significantly greater effect on the ocular signs and symptoms of allergic conjunctivitis compared with 6 weeks' instillation of cromolyn 2% ophthalmic solution QID. Both treatments were well tolerated by patients in all age groups; however, olopatadine appeared to have better local tolerability in children aged <11 years.
过敏性结膜炎的治疗有多种作用机制。色甘酸钠通过阻止钙离子跨细胞膜内流来稳定结膜肥大细胞，而盐酸奥洛他定既是一种抗组胺药，也是一种肥大细胞稳定剂。
本研究比较了奥洛他定和色甘酸钠在控制季节性过敏性结膜炎眼部体征和症状方面的疗效和耐受性。
这是一项多中心、随机、双盲、平行组试验。一组每天两次滴入0.1%奥洛他定滴眼液和安慰剂，另一组每天四次滴入2%色甘酸钠滴眼液，均持续6周。本研究中使用的色甘酸钠制剂目前仅在欧洲和澳大利亚有售。
意向性治疗疗效和安全性分析纳入了185例患者，奥洛他定组91例，色甘酸钠组94例。首次滴入后30分钟，两种治疗方法的自评眼部瘙痒和发红分别下降了约30%和约20%；到4小时时，两组的瘙痒均下降了约38%。治疗组之间的差异无统计学意义。4小时时，各治疗组的发红分别下降了约38%和约26%。到第42天时，两种治疗方法均使眼部体征和症状较基线有显著改善；然而，与色甘酸钠相比，奥洛他定在瘙痒和发红方面的改善更为显著（两个变量均P<0.05）。在第30天和第42天，医生对总体改善情况的印象差异显著有利于奥洛他定而非色甘酸钠（两天均P<0.05）。大多数患者（62.2%）在基线时对草花粉有阳性反应。与色甘酸钠相比，奥洛他定使瘙痒和发红与花粉计数相关的回归斜率降低了5倍（分别为P=0.002和P=0.016），表明奥洛他定的疗效随花粉计数增加而提高。
与每天四次滴入2%色甘酸钠滴眼液6周相比，每天两次滴入0.1%奥洛他定滴眼液6周对过敏性结膜炎的眼部体征和症状有显著更大的疗效。所有年龄组的患者对两种治疗的耐受性均良好；然而，奥洛他定在11岁以下儿童中似乎具有更好的局部耐受性。
