Hettinger M E, Gill D J, Robin J B, Levy R H, Koester J
Kansas City Eye Clinic, Overland Park, Kansas 66204-2622, USA.
Cornea. 1997 Jul;16(4):406-13.
Patients frequently have ocular pain, photophobia, foreign-body sensation, and burning/stinging after radial keratotomy. This study was a prospective, randomized, double-masked, multicenter, fellow-eye comparison of diclofenac sodium (Voltaren Ophthalmic, 0.1% solution) and placebo for controlling these ocular symptoms after bilateral radial keratotomy.
Patients who were pain free in both eyes before surgery were randomly assigned to treatment with diclofenac sodium in one eye and placebo in the other. One drop of each masked trial medication was administered 30-60 min before surgery, 5 min and 6 h after surgery, at bedtime on the day of surgery, and four times daily for 2 additional days. Patients evaluated ocular symptoms in each eye 0.5, 1, 2, 4, 6, 24, and 48 h after surgery and provided a global evaluation 6, 24, and 48 h after surgery. For each assessment, the difference in scores between eyes was analyzed by using a paired t test.
Diclofenac sodium was significantly (p < 0.001) superior to placebo in controlling each ocular symptom at each interval after surgery and for patient global assessments 6, 24, and 48 h after surgery.
Diclofenac sodium 0.1% ophthalmic solution is clinically effective in controlling adverse ocular symptoms occurring after bilateral radial keratotomy.
行放射状角膜切开术后，患者常出现眼痛、畏光、异物感以及烧灼感/刺痛感。本研究是一项前瞻性、随机、双盲、多中心的自身对照研究，比较双氯芬酸钠（扶他林眼药水，0.1%溶液）和安慰剂对双侧放射状角膜切开术后这些眼部症状的控制效果。
术前双眼均无疼痛的患者被随机分配，一只眼用双氯芬酸钠治疗，另一只眼用安慰剂。在手术前30 - 60分钟、手术后5分钟和6小时、手术当天睡前，各滴一滴每种双盲试验药物，术后额外2天每天滴4次。患者在术后0.5、1、2、4、6、24和48小时评估每只眼的眼部症状，并在术后6、24和48小时进行整体评估。每次评估时，双眼得分的差异采用配对t检验进行分析。
在术后各时间段控制眼部症状以及术后6、24和48小时的患者整体评估中，双氯芬酸钠均显著优于安慰剂（p < 0.001）。
0.1%双氯芬酸钠眼药水在控制双侧放射状角膜切开术后出现的不良眼部症状方面临床效果显著。
