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学科主题: 临床医学
题名:
A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore
作者: Gong, Lan1; Sun, Xinghuai1; Ma, Zhizhong2; Wang, Qinmei3; Xu, Xun4; Chen, Xiaoming5; Shao, Yan6; Yao, Ke7; Tang, Luosheng8; Gu, Yangshun9; Yuan, Huiping10; Chua, Wei Han11; Chuan, Jacob Cheng Yen12; Tong, Louis13
刊名: BRITISH JOURNAL OF OPHTHALMOLOGY
发表日期: 2015-07-01
DOI: 10.1136/bjophthalmol-2014-306084
卷: 99, 期:7, 页:903-908
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Ophthalmology
研究领域[WOS]: Ophthalmology
关键词[WOS]: EPITHELIAL-CELLS ; MUCIN SECRETION ; ROSE-BENGAL ; TETRASODIUM ; CONJUNCTIVA ; HYALURONAN ; INCREASES ; EFFICACY ; SAFETY ; RABBIT
英文摘要:

Aims To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore.

Methods A total of 497 patients with dry eye (Schirmer′s test, 5 mm; fluorescein and RB score, 3 points) from China and Singapore were randomised to receive either diquafosol ophthalmic solution (diquafosol) or sodium hyaluronate ophthalmic solution (HA) at 1:1 ratio. The fluorescein staining scores and rose bengal (RB) subjective symptom scores and tear film breakup time were evaluated before treatment and 2 and 4 weeks after start of treatment.

Results In the diquafosol group, changes in fluorescein and RB scores compared with baseline at week 4 or at the time of discontinuation were -2.1 +/- 1.5 and -2.5 +/- 2.0, respectively. Compared with the HA group, changes in fluorescein score were non-inferior and changes in RB score were superior (p=0.019). In addition, diquafosol and HA improved tear film breakup time by 1.046 +/- 1.797 and 0.832 +/- 1.775 s, respectively (no significant intergroup difference). Adverse event onset rates were 16.3% (40 of 246 subjects) and 10.0% (25 of 251 subjects) in the diquafosol group and HA group, respectively, with borderline significant intergroup differences (p=0.046), while adverse drug reaction incidence rates were 12.2% (30 of 246 subjects) and 6.0% (15 of 251 subjects), respectively (p=0.019). Only mild adverse drug reactions (>2%) in the form of eye discharge, itching or irritation were observed.

Conclusions Diquafosol improved fluorescein staining score in a manner similar to HA, and significantly improved RB score compared with HA.

语种: 英语
项目资助者: Santen Pharmaceutical Co, Ltd.
WOS记录号: WOS:000356603000006
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/52538
Appears in Collections:北京大学第三临床医学院_眼科_期刊论文

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作者单位: 1.Fudan Univ, Dept Ophthalmol, Eye & ENT Hosp, Shanghai 200031, Peoples R China
2.Peking Univ, Hosp 3, Dept Ophthalmol, Beijing 100871, Peoples R China
3.Wenzhou Med Coll, Sch Ophthalmol & Optometry, Wenzhou, Zhejiang, Peoples R China
4.Shanghai First Peoples Hosp, Dept Ophthalmol, Shanghai, Peoples R China
5.Sichuan Univ, West China Med Sch, West China Hosp, Dept Ophthalmol, Chengdu 610064, Peoples R China
6.Dalian Med Univ, Affiliated Hosp 2, Dept Ophthalmol, Dalian, Peoples R China
7.Zhejiang Univ, Coll Med, Affiliated Hosp 2, Dept Ophthalmol, Hangzhou 310003, Zhejiang, Peoples R China
8.Cent S Univ, Dept Ophthalmol, Xiangya Hosp 2, Changsha, Hunan, Peoples R China
9.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Dept Ophthalmol, Hangzhou 310003, Zhejiang, Peoples R China
10.Harbin Med Univ, Affiliated Hosp 2, Dept Ophthalmol, Harbin, Peoples R China
11.Mt Elizabeth Hosp, Pkwy Eye Ctr, Singapore, Singapore
12.Mt Alvernia Hosp, Eagle Eye Ctr, Singapore, Singapore
13.Duke NUS Grad Med Sch, Singapore Natl Eye Ctr, Singapore Eye Res Inst, Singapore, Singapore

Recommended Citation:
Gong, Lan,Sun, Xinghuai,Ma, Zhizhong,et al. A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore[J]. BRITISH JOURNAL OF OPHTHALMOLOGY,2015,99(7):903-908.
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