Gupta V P, Dhaliwal U, Prasad N
Department of Ophthalmology, University College of Medical Sciences, Shahdara, Delhi, India.
Ophthalmic Surg Lasers. 1997 Sep;28(9):731-8.
Mydriatics and antiprostaglandins are routinely applied preoperatively to facilitate the aspiration of cortical material during extracapsular cataract surgery and to prevent intraoperative miosis. Unfortunately, the ideal antiprostaglandin has yet to be introduced. This study represents the first prospective, case-controlled, randomized, masked, clinical trial comparing the efficacy of oral ketorolac tromethamine (KT) with the efficacy of topical flurbiprofen sodium (FS) and a placebo (normal saline) in maintaining intraoperative mydriasis without adrenaline in the irrigation solution.
Sixty-three patients, undergoing extracapsular cataract extraction with posterior chamber intraocular lens implantation, were randomly divided into three equal groups. Group 1 received 20 mg of oral KT 2 hours prior to surgery, group 2 received 0.03% FS topical solution at the recommended dosage, and group 3 received topical normal saline in a regimen identical to that of group 2. Identical mydriatics were used in both groups. The patients' pupils were measured at five stages of surgery.
The mean pupillary diameters at each surgical stage were greater in group 1 than in group 2; however, the difference was not statistically significant. The pupils in group 3 were significantly smaller than those of group 1 or group 2 (P < .05). No systemic toxicity to KT was observed. Moreover, the need for additional postoperative analgesics was significantly greater in groups 2 and 3.
Oral KT is safe, convenient, and as effective as topical FS, and has the added advantage of reducing postoperative pain.
在白内障囊外摘除术中,散瞳剂和抗前列腺素药物常用于术前以利于皮质物质的吸出,并防止术中瞳孔缩小。遗憾的是,理想的抗前列腺素药物尚未问世。本研究是第一项前瞻性、病例对照、随机、双盲的临床试验,比较口服酮咯酸氨丁三醇(KT)与局部应用氟比洛芬钠(FS)及安慰剂(生理盐水)在冲洗液中无肾上腺素的情况下维持术中散瞳效果的疗效。
63例行白内障囊外摘除联合后房型人工晶状体植入术的患者被随机分为三组,每组人数相等。第1组在手术前2小时口服20毫克KT,第2组按推荐剂量使用0.03% FS局部溶液,第3组使用与第2组相同方案的局部生理盐水。两组均使用相同的散瞳剂。在手术的五个阶段测量患者的瞳孔。
第1组在每个手术阶段的平均瞳孔直径均大于第2组,但差异无统计学意义。第3组的瞳孔明显小于第1组或第2组(P < 0.05)。未观察到KT的全身毒性。此外,第2组和第3组术后需要额外镇痛药物的需求明显更大。
口服KT安全、方便,与局部应用FS效果相同,且具有减轻术后疼痛的额外优势。