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一项关于0.1%可溶性吲哚美辛局部用药与0.1%双氯芬酸局部用药及安慰剂对照用于准分子激光屈光性角膜切削术后疼痛控制的前瞻性随机试验。

A prospective randomized trial of topical soluble 0.1% indomethacin versus 0.1% diclofenac versus placebo for the control of pain following excimer laser photorefractive keratectomy.

作者信息

Assouline M, Renard G, Arne J L, David T, Lasmolles C, Malecaze F, Pouliquen Y J

机构信息

Department of Ophthalmology, Hôtel-Dieu de Paris, INSERM U86, University of Paris VI, Medical School, France.

出版信息

Ophthalmic Surg Lasers. 1998 May;29(5):365-74.

PMID:9599360
Abstract

BACKGROUND AND OBJECTIVE

To compare the safety and efficacy of topical nonsteroidal antiinflammatory drugs (NSAIDs) for the control of pain after excimer laser photorefractive keratectomy (PRK).

PATIENTS AND METHODS

One hundred twenty informed patients were enrolled in a double-masked, randomized, comparative study and assigned to either 0.1% indomethacin, 0.1% diclofenac, or placebo treatment. Subjective postoperative pain, symptoms, re-epithelialization rate, and systemic medications were monitored for 2 days following photoablation.

RESULTS

Compared with the placebo, 0.1% indomethacin solution significantly reduced pain on the day of surgery (D0) (P < .05), whereas 0.1% diclofenac did not reach a significant level (P = .46). At D0, analgesic intake by the oral route was significantly greater in the placebo group (P < .05). Severe photophobia was significantly less frequent in the group treated with 0.1% indomethacin (P < .05). Corneal wound healing was significantly delayed in the patients treated with 0.1% diclofenac at D2 as compared with other groups (P = .04).

CONCLUSION

Topical 0.1% indomethacin solution helps control the pain induced by excimer laser photoablation of the cornea without any detrimental effect to the corneal epithelial wound healing.

摘要

背景与目的

比较局部使用非甾体抗炎药(NSAIDs)控制准分子激光屈光性角膜切削术(PRK)后疼痛的安全性和有效性。

患者与方法

120名知情患者参与了一项双盲、随机、对照研究,被分配接受0.1%吲哚美辛、0.1%双氯芬酸或安慰剂治疗。光凝术后2天监测患者术后主观疼痛、症状、角膜上皮再形成率及全身用药情况。

结果

与安慰剂相比,0.1%吲哚美辛溶液在手术当天(D0)显著减轻疼痛(P <.05),而0.1%双氯芬酸未达到显著水平(P = 0.46)。在D0时,安慰剂组口服镇痛药的摄入量显著更高(P <.05)。0.1%吲哚美辛治疗组严重畏光的发生率显著更低(P <.05)。与其他组相比,0.1%双氯芬酸治疗的患者在D2时角膜伤口愈合显著延迟(P = 0.04)。

结论

局部使用0.1%吲哚美辛溶液有助于控制准分子激光角膜光凝术引起的疼痛,且对角膜上皮伤口愈合无任何不利影响。

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