Abelson Mark B, Turner Darell
Department of Ophthalmology, Harvard Medical School, Boston, USA.
Clin Ther. 2003 Mar;25(3):931-47. doi: 10.1016/s0149-2918(03)80115-7.
The most common form of allergic ocular disease is seasonal allergic conjunctivitis, coinciding with the pollen season and generally associated with rhinitis. Symptoms of allergic conjunctivitis include ocular itching, hyperemia, tearing, mucus production, foreign body sensation, chemosis, and lid edema. Similarly, the primary symptoms of allergic rhinoconjunctivitis are nasal itching, irritation, sneezing, watery rhinorrhea, and congestion combined with ocular itching, tearing, and swelling.
This study compared olopatadine 0.1% ophthalmic solution with placebo eyedrops (over-the-counter artificial tear product), instilled in the eye, with regard to the prevention and relief of the ocular and nasal symptoms of seasonal allergic conjunctivitis and rhinoconjunctivitis.
This was a randomized, double-blind, parallel-group study, conducted at 7 US centers, to instill either olopatadine 0.1% ophthalmic solution or placebo eyedrops (artificial tears) in both eyes twice daily for 10 weeks. Patients were evaluated for efficacy (intent-to-treat) and safety. Only patients with proven grass pollen allergy (dermal and conjunctival allergen challenge tests) were selected; all patients were studied during the same period, historically shown to be grass season; and grass pollen counts were obtained.
A total of 131 patients (64 olopatadine; 67 placebo) were assessed for efficacy (intent-to-treat); 132 patients were assessed for safety. The mean (SD) age of participants was 38.53 (11.61) years (range, 18 to 87 years), and 58.0% were women (76/131), with no significant differences between groups for age or sex. In the olopatadine group, 1.6% of patients were black (1/64), compared with 14.9% of the placebo group (10/67) (P = 0.005). Mean scores of ocular itching and hyperemia were lower at all assessment times with olopatadine than placebo. The difference was statistically significant (P < 0.05) for itching on days 7, 14, 35, 63, and 70, and for hyperemia on days 14, 28, 42, and 63, after correction for multiplicity. Linear regression slopes predicting ocular itching and hyperemia from the pollen count were significantly lower (P < 0.003 and P < 0.035, respectively) with olopatadine than with placebo. Similar results were obtained for rhinorrhea, sneezing, and nasal itching (P < 0.006, P < 0.012, and P < 0.034, respectively). With placebo, the proportion of patients with frequent ocular itching and hyperemia increased as a function of pollen level; however, with olopatadine, the proportions remained low and virtually constant.
In the population studied, olopatadine 0.1% ophthalmic solution controlled ocular and nasal symptoms of allergic conjunctivitis and rhinocojunctivitis and was well tolerated when administered twice daily for 10 weeks.
过敏性眼病最常见的形式是季节性过敏性结膜炎，与花粉季节一致，通常伴有鼻炎。过敏性结膜炎的症状包括眼部瘙痒、充血、流泪、黏液分泌、异物感、结膜水肿和眼睑水肿。同样，过敏性鼻结膜炎的主要症状是鼻痒、刺激感、打喷嚏、水样鼻分泌物和鼻塞，以及眼部瘙痒、流泪和肿胀。
本研究比较了0.1%奥洛他定滴眼液与安慰剂滴眼液（非处方人工泪液产品）滴眼对季节性过敏性结膜炎和鼻结膜炎的眼部及鼻部症状的预防和缓解作用。
这是一项在美国7个中心进行的随机、双盲、平行组研究，每天两次给双眼滴入0.1%奥洛他定滴眼液或安慰剂滴眼液（人工泪液），持续10周。对患者进行疗效（意向性治疗）和安全性评估。仅选择经证实对草花粉过敏的患者（皮肤和结膜过敏原激发试验）；所有患者在同一时期进行研究，历史上该时期为草花粉季节，并获取草花粉计数。
共131例患者（64例使用奥洛他定；67例使用安慰剂）进行了疗效（意向性治疗）评估；132例患者进行了安全性评估。参与者的平均（标准差）年龄为38.53（11.61）岁（范围18至87岁），58.0%为女性（76/131），两组在年龄或性别上无显著差异。奥洛他定组中1.6%的患者为黑人（1/64），而安慰剂组为14.9%（10/67）（P = 0.005）。在所有评估时间，奥洛他定组的眼部瘙痒和充血平均评分均低于安慰剂组。经多重性校正后，第7、14、35、63和70天的瘙痒以及第14、28、42和63天的充血差异具有统计学意义（P < 0.05）。根据花粉计数预测眼部瘙痒和充血的线性回归斜率，奥洛他定组显著低于安慰剂组（分别为P < 0.003和P < 0.035）。鼻分泌物、打喷嚏和鼻痒也得到了类似结果（分别为P < 0.006、P < 0.012和P < 0.034）。使用安慰剂时，频繁出现眼部瘙痒和充血的患者比例随花粉水平增加；然而，使用奥洛他定的患者比例较低且基本保持不变。
在所研究的人群中，0.1%奥洛他定滴眼液可控制过敏性结膜炎和鼻结膜炎的眼部及鼻部症状，每日滴眼两次，持续10周时耐受性良好。
