盐酸环喷托酯滴眼液散瞳和麻痹睫状肌效果和安全性的临床研究

Clinical Research on Efficacy and Safety of Cyclopentolate Hydrochloride Eye Drops in Mydriasis and Paralysis of Ciliary Muscle

目的评价盐酸环喷托酯滴眼液的疗效及安全性。方法采用多中心随机双盲阳性药平行对照试验。结果试验药麻痹睫状肌的效应强于对照药托吡卡胺滴眼液,持续时间长。而试验药散瞳效应慢于对照药,但持续时间较长,给药后75 min试验药与对照药的散瞳效应相当。试验组和对照组的不良反应主要表现为结膜轻度充血和分泌物轻度增多。试验组和对照组发生率均为1.7%(刺激积分2分及以上均为2例),两组比较差异无统计学意义。试验组和对照组均无明显升高正常人群眼压的作用。结论盐酸环喷托酯滴眼液在眼科检查中的散瞳和麻痹睫状肌的效果肯定,耐受性好,安全性高,值得临床推广应用,特别是其麻痹睫状肌的作用较强,持续时间不超过48 h,特别适合需麻痹睫状肌功能的眼科检查。

Objective To evaluate the efficacy and safety of Cyclopentolate Hydrochloride Eye Drops with commercial Tropicamide Eye Drops as control. Methods A multicenter, randomized, double-blind positive-controlled trial was adopted. Results Compared with tropicamide, cyclopentolate hydrochloride showed a longer and stronger effect on paralysis of ciliary muscle, and a longer mydriatic effect with slower onset. At 75 min after administration, the equivalent mydriatic effects were observed. The adverse reactions for cyclopentolate or tropicamide mainly included mild conjunctival hyperemia and slight increase of secretions. The incidences both were 1.7%（ 2 case with stimulating points ≥2） without statistically significant difference. Besides, remarkably increased intraocular pressure was not observed for cyclopentolate or tropicamide. Conclusion In mydriasis and paralysis of ciliary muscle, Cyclopentolate Hydrochloride Eye Drops has good efficacy and tolerance, high safety for clinical application, especially stronger paralytic effect on ciliary muscle inside 48 h is more suitable for eye examination with paralysis of ciliary muscle.