低浓度阿托品眼液的眼部药效和不良反应比较

The compare of ocular efficacy and side effects of low concentration atropine eyedrops

目的通过5种低浓度阿托品眼液的比较,为临床阿托品近视防治的研究提供参考依据。方法选取40名大学生志愿者,随机分为ABCDE 5组,每组8名,单眼分别点用0.1%,0.05%,0.025%,0.01%和0.005%5种低浓度的阿托品眼液,观察用药后的情况。一期试验,1次给药后观察瞳孔,调节幅度,远近视力和同视机立体视的持续变化情况。二期试验,每日给药1次,持续2个月,观察畏光,视近模糊,过敏,异物感,疼痛等眼部不适和全身不良反应,以及裂隙灯和眼压检査。结果瞳孔散大持续时间和调节幅度减少量随各组药物浓度下降而逐渐下降,单因素方差分析均P<0.01。远视力各组均有轻度下降,平均为(0.08±0.02)。近视力ABCD组有不同程度下降,E组近视力正常。5组同视机三级功能无变化。不良反应以畏光最常见,其次为视近模糊(E组无视近模糊发生);少数出现一过性结膜充血和过敏,无异物感、疼痛等不适发生。70%受试者诉说有3 m远外立体感觉异常。眼压均正常。无全身中毒症状等不良反应。结论低浓度阿托品眼液用于近视防治总体是安全的。其调节幅度减少量和瞳孔散大持续时间均与药物浓度呈相关趋势。0.005%浓度的阿托品眼液适合双眼每天使用且不会影响正常生活学习,其它浓度的阿托品眼液可按一定的时间间隔进行单眼交替或双眼使用。单眼使用导致的远立体感丢失需要引起重视。

Objective To provide clinical basis of atropine in the prophylaxis and treatment of myopia by comparing 5 low concentration atropine eyedrops.Methods All 40 college volunteers were involved and randomly divided into 5 groups(ABCDE,8 in each group).Group A,B,C,D,E were administered with 0.1%,0.05%,0.025%,0.01% and 0.005% atropine eyedrops respectively in one eye.In stage one,after the application,the changes of pupil sizes,the amplitudes of accommodation,the distant and near visual acuity and stereopsis were observed.In stage two,after the application once a day for 2 months,any side effects were recorded,including the photophobia,near vision difficulty,allergy,foreign body sensation,pain,discomfort,as well as slit lamp and IOP exams.Results The duration time of mydriasis and the decrease amplitude of accommodation declined upon concentration(P<0.01).The distant visual acuity decreased slightly(0.08±0.02).The near vision declined at different degrees in group ABCD,while group E had no effect.The stereoptic functions did not change in all groups.The most common side effects was photophobia,followed by near vision blurring(except group E),the rare side effects were congestion and allergy.Foreign body sensation,pain and other discomfort were not found.70% candidates complained a stereoscopic sensation loss at a distance more than 3 meters.The IOPs were the same.No general side effect was found.Conclusions All low concentration atropine eyedrops are safe in general.The decreases of accommodative amplitude and mydriatic duration are positively related to atropine eyedrops concentration.0.05% atropine eyedrops is suitable for daily use bilaterally without interfering the life and study,while the other atropine eyedrops are preferred to be used in eyes alternately or bilaterally at settled intervals.The loss of distant stereoscopic sensation caused by unilateral use should be paid attention.