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妥布霉素地塞米松眼膏治疗睑缘炎的效果:多中心临床试验

[Effects of tobramycin dexamethasone eye ointment for blepharitis: multi-center clinical trial].

作者信息

Yan Xiao-ming, Sun Xu-guang, Xie Han-ping, Hong Jing, Wang Zhi-cong

机构信息

Department of Ophthalmology, Peking University of First Hospital, Key Laboratory of Vision Loss and Restoration, Ministry of Education, Beijing 100034, China.

出版信息

Zhonghua Yan Ke Za Zhi. 2013 Jan;49(1):16-21.

PMID:23601460
Abstract

OBJECTIVE

To realize the effectiveness and security of Tobramycin and Dexamethasone Eye Ointment for blepharitis treatment. Design Case control studies. Participants 148 patients be diagnosed as blepharitis including 81 cases as research group and 67 cases as control group.

METHODS

Multi-center randomized controlled clinical trial. The patients met the inclusion criteria from First Hospital Peking University, Beijing Tongren Hospital, Southwest Hospital, Ophthalmology Center Zhongshan University and Third Hospital Peking University were divided into two groups in Aug. to Dec. 2011. Tobramycin dexamethasone eye ointment was applied to eye lid in research group while patients in control group used tobramycin eye ointment. All patients were informed to apply warm compress to the lids, mechanically washing to the eyelids and artificial tears. At the beginning, the 7(th) day, the 14(th) day and the 28(th) day of treatment, observation of symptom, sign and side effect were recorded.

RESULTS

Before treatment the difference of the symptom scores of burning sensation, tears, photophobia and itch of two groups has no statistically significant (t = 1.87, 0.43, -0.64, 0.93, P > 0.05), but the symptom scores have a statistically significant decrease (t = 1.99 - 6.90, P < 0.05) at the 7(th) day, 14(th) day, 28(th) day. Before treatment the difference of signs scores have no statistically significant except the term of new blood vessels (t = 2.32, P = 0.02) while all the signs scores have a statistically significant decrease at the 7(th) day, 14(th) day, 28(th) day. Side effect: the number of patients with elevated intraocular pressure of research and control group is 3 and 1 respectively and the ratio is 3.7% and 1.5%.

CONCLUSIONS

The tobramycin dexamethasone eye ointment can improve signs and symptoms of blepharitis patients. Some patients have to face with the risk of elevated intraocular pressure and it's necessary to monitor the intraocular pressure.

摘要

目的

了解妥布霉素地塞米松眼膏治疗睑缘炎的有效性和安全性。设计病例对照研究。参与者148例被诊断为睑缘炎的患者,其中81例为研究组,67例为对照组。

方法

多中心随机对照临床试验。2011年8月至12月,将符合入选标准的来自北京大学第一医院、北京同仁医院、西南医院、中山大学眼科中心和北京大学第三医院的患者分为两组。研究组患者眼睑涂抹妥布霉素地塞米松眼膏,而对照组患者使用妥布霉素眼膏。告知所有患者对眼睑进行热敷、机械清洗眼睑并使用人工泪液。在治疗开始时、第7天、第14天和第28天,记录症状、体征和副作用。

结果

治疗前,两组烧灼感、流泪、畏光和瘙痒症状评分差异无统计学意义(t = 1.87、0.43、-0.64、0.93,P > 0.05),但在第7天、第14天、第28天症状评分有统计学意义下降(t = 1.99 - 6.90,P < 0.05)。治疗前,除新生血管项外,体征评分差异无统计学意义(t = 2.32,P = 0.02),而在第7天、第14天、第28天所有体征评分均有统计学意义下降。副作用:研究组和对照组眼压升高患者人数分别为3例和1例,比例分别为3.7%和1.5%。

结论

妥布霉素地塞米松眼膏可改善睑缘炎患者的体征和症状。部分患者需面临眼压升高的风险,监测眼压很有必要。

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