摘要目的:评价质量分数3.5%盐酸利多卡因眼用凝胶眼部表面麻醉的有效性和安全性。方法:采用多中心、随机双盲、安慰剂对照临床试验，于2018年8月至2019年4月在中国10个医院眼科按照统一的纳入和排除标准纳入一侧眼拟行眼科手术受试者220例220眼。采用随机数字表法将受试者随机平均分为对照组和试验组，所有受试者术眼对侧眼作为受试眼。试验组在受试眼6：00位角膜缘后约5 mm处点入2滴3.5%盐酸利多卡因眼用凝胶，对照组以同样方法点入空白凝胶。用药后在规定时间内用0.3 mm无齿显微镊夹持结膜进行疼痛测试，受试者依据自身感觉报告"疼痛"或"不疼痛"。主要有效性指标为用药5 min内获得眼表麻醉效果的眼数和百分比；次要有效性指标包括麻醉起效时间、眼表麻醉持续时间；药物安全性评价包括眼局部和全身不良反应发生率。结果:试验组受试眼用药5 min内获得眼表麻醉效果者104眼，占94.55%，对照组5 min内获得眼表麻醉效果者29眼，占26.36%，试验组麻醉有效比例明显高于对照组，差异有统计学意义( χ2＝106.948， P<0.001)；试验组受试眼中位麻醉起效时间为40.0(20.0，61.0)s，短于对照组的300.0(224.0，300.0)s，差异有统计学意义( Z＝-15.17， P<0.001)；试验组有效麻醉的104眼中麻醉维持时间平均为860.5(577.5，1 180.0)s，对照组有效麻醉的29眼中麻醉维持时间平均为676.0(280.0，1 401.0)s，差异无统计学意义( Z＝0.898， P>0.05)；2个组间不良反应发生率分别为5.45%(6/110)和4.55%(5/110)，差异无统计学意义( P＝1.000)。 结论:3.5%盐酸利多卡因眼用凝胶用于眼部表面麻醉时起效快，作用时间长，不良反应发生率低，是眼科手术中一种安全有效、使用方便的麻醉用药选择。

abstractsObjective:To evaluate the effectiveness and safety of 3.5% lidocaine hydrochloride ophthalmic gel for eye surface anesthesia.Methods:A multicenter, randomized, double-blind, placebo controlled clinical trial was conducted in 10 hospitals in China from August 2018 to April 2019 under the approval of an Ethics Committee of Beijing Hospital (No.2018BJYYEC-014-02). A total of 220 fellow eyes of 220 subjects who received ocular surgery in one eye were actually enrolled according to a same included criteria in different institutes.The 220 eyes were randomly divided into control group and trail group.Two drops of lidocaine hydrochloride gel were dropped at about 5 mm away from corneal limbus at 6 o'clock direction of experimental eye of the trail group, and the blank gel was used in the eyes of the control group in the same way.The pain sensation was assessed with a 0.3 mm toothless micro forceps on conjunctiva within a specified time, and ''pain'' or ''no pain'' was answered by the subjects.The primary effective indexes, namely the number of eyes and percentage of ''no pain'' within 5 minutes following dropping, as well as the secondary indexes including the onset time point of the drug and the duration of anesthesia were recorded and evaluated.Safety evaluation took ocular and system adverse events into account.Results:Within 5 minutes after dropping, ''no pain'' occurred in 104 eyes (94.55%) and 29 eyes (26.36%) in the trail group and control group, respectively, showing a significant difference between the two groups ( χ2=106.948, P<0.001). And there was a significant difference in anesthesia onset time between the trail group and control group (40.0 seconds vs. 300.0 seconds) ( Z=-15.17, P<0.001). The duration of anesthesia was 860.5 (577.5, 1 180.0) seconds in the trail group and 676.0 (280.0, 1 401.0) seconds in the control group, with no statistically significant difference between the two groups ( Z=0.898, P>0.05). The incidence of adverse events in the trail group and control group were 5.45% (6/110) and 4.55% (5/110), respectively, without statistical significance between them ( P=1.000). Conclusions:The 3.5% lidocaine hydrochloride is a safe, effective, easy to use and high-quality surface anesthesia drug for eye surgery.