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。方法多中心随机对照研究。将2011年8至12月在北京大学第一医院、首都医科大学附属北京同仁医院北京同仁眼科中心北京市眼科研究所、第三军医大学西南医院、北京大学第三医院、中山大学中山眼科中心符合纳入标准的睑缘炎患者148例随机分为两组。试验组81例：给予妥布霉素地塞米松眼膏涂布睑缘，每晚1次；对照组67例：给予妥布霉素眼膏涂布睑缘，每晚1次。两组均同时给予热敷、清洁眼睑、羟糖苷滴眼液辅助治疗。在治疗开始7、14、28 d4个时间点观察各组患者睑缘炎的症状、体征的变化以及在治疗过程中出现的副作用。试验结果交由同一单位进行统计，双眼病例取病情严重眼统计。对于计量资料采用￡检验比较两组之间的差异，对于分级变量采用秩和检验比较两组之间的差异。结果观察结束时试验组的总有效率为95．0％，对照组为25．8％；治疗前两组烧灼感、流泪、畏光和眼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），治疗7、14及28d两组患者烧灼感（t=5．13，6．55，6．90）、流泪（t=4．43，6．13，5．99）、畏光（t=1．99，5．02，4．47）和眼痒（t=3．64，5．56，6．14）症状评分下降，试验组下降明显，两组比较差异均有统计学意义（P〈0．05）；治疗前两组体征评分比较，除角膜新生血管差异有统计学意义（t=2．32，P=0．02）外，其余各体征评分两组无明显差异，治疗后7、14和28d在睑缘外观、睑板腺开口异常、睑板腺分泌物、球结膜充血、泪膜破裂时间、角膜荧光染色和角膜缘新生血管等体征评分均下降，试验组下降更明显；不良反应：试验组和对照组分别发生眼压升高者3例和1例，发生率为3．7％和1．5％。结论妥布霉素地塞米松眼膏可以有效地改善睑缘炎患者的症状和体征。少部分患者有眼压升高的风险，随诊时应监测眼压。
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, photophbia and itch of two groups has nostatistically 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 intraoeular 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.
出处
《中华眼科杂志》
CAS
CSCD
北大核心
2013年第1期16-21,共6页
Chinese Journal of Ophthalmology
