Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome
Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome
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DOI：
10.1136/bjo.83.10.1121
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发表时间：
1999-10-01
影响因子：
4.1
通讯作者：
McDonald, C
中科院分区：
文献类型：
--
作者：
Condon, PI;McEwen, CG;McDonald, C
背景/目的-透明质酸(透明质酸钠)已被证明对干眼综合征患者有客观和主观的改善作用。这项研究比较了0.1%透明质酸溶液和0.9%生理盐水滴眼局部治疗严重干眼综合征症状的有效性和安全性。方法-随机、双盲、交叉临床试验，受试者随机接受透明质酸或生理盐水滴眼，每天三到四次或根据需要滴眼。结果：70名受试者进入疗效分析，透明质酸治疗期间席尔默评分(p=0.0006)和孟加拉玫瑰染色评分(p=0.0001)均有显著改善。在对两种治疗方法的效果进行主观评估时，大多数受试者认为透明质酸在缓解灼热和沙粒症状方面比生理盐水更有效(p
Background/aims-Hyaluronan (sodium hyaluronate) has been shown to confer objective and subjective improvement in patients with dry eye syndrome. This study compared the efficacy and safety of a 0.1% solution of hyaluronan with 0.9% saline, when administered topically to the eye, in the treatment of symptoms of severe dry eye syndrome.Methods-A randomised, double blind, crossover clinical trial in which subjects were randomised to receive either hyaluronan or saline, applied as one or two drops to the eye, three or four times a day or as required. After 28 days' treatment, subjects crossed over to the other study medication for a further 28 days' treatment.Results-70 subjects were included in the analyses of efficacy and significant improvements in Schirmer's score (p=0.0006) and rose bengal staining score (p=0.0001) were observed during treatment with hyaluronan. In a subjective assessment of the effectiveness of two treatments, a majority of subjects felt that hyaluronan was more effective than saline in alleviating the symptoms of burning and grittiness (p