Title灯盏细辛治疗青光眼多中心临床研究
Other TitlesNeuroprotective effects of erigeron breviscapus (vant) hand-mass on glaucoma-A multi-center clinical trial
Authors王宁利
孙兴怀
李静贞
王诤华
陈晓明
林丁
吕建华
钟一声
张纯
郭文毅
Affiliation100730,中国北京同仁医院眼科中心
200031,中国上海复旦大学医学院眼耳鼻喉科医院眼科
100730,中国北京协和医院
266003,中国青岛大学医学院附属医院眼科
610041,中国成都四川大学华西医院眼科
054001,中国河北邢台眼科医院
200025,中国上海第二医科大学瑞金医院
100083,中国北京大学眼科中心
Keywords灯盏细辛
青光眼
视神经保护
erigeron breviscapus (vant) hand-mass
glaucoma
neuroprotection
Issue Date2004
Publisher国际眼科杂志
Citation国际眼科杂志.2004,4,(4),587-592.
Abstract目的:观察美尔瑞片(中草药灯盏细辛)对眼压控制后的青光眼是否具有视神经保护作用.方法:对99例(113眼)眼压已控制的原发性开角型青光眼及闭角型青光眼进行多中心、前瞻性、随机、双盲对照临床研究,观察口服美尔瑞片6mo后对视野的疗效,本研究采用VFDS视野缺损计分法,从0(无缺损)至20(所有检测点均不可测出).结果:美尔瑞治疗组55例(66眼),安慰剂对照组44例(47眼),治疗前及治疗后2,4,6mo 2组的眼压均<15mmHg,2组间同一时期眼压无显著性差异(P>0.05).服美尔瑞2,4,6mo后VFDS净减值分别为0.44±1.60,1.27±2.16及1.42±2.37,呈现随治疗时间延长,视野缺损逐渐好转趋势.对照组2,4,6mo后VFDS净减计分值分别为-0.02±1.5,0.68±1.73和0.40±1.57.VFDS净减值两组间同一时期比较有显著性差异(P<0.05),治疗6mo后有高度显著性差异(P<0.01).结论:灯盏细辛可用于治疗青光眼性视神经病变,有助于扩大/保持视野.
AIM: To evaluate the neuroprotective effects of a Chinese herbal drug, erigeron breviscapus (vant) hand-mass (EBHM), on glaucoma patients with controlled intraocular pressure (IOP) after surgical and/or medical therapies.METHODS: A total of 99 primary glaucoma patients (113 eyes) with medically or surgically controlled IOP were given orally either EBHM or placebo for 6 mo and then evaluated in a multi-center, prospective, randomized and double masked clinical trial by quantifying the visual field changes using visual field defect scoring (VFDS).RESULTS: After 2, 4, 6 mo of treatment, the VFDS in EBHM Group (66 eyes/55 patients) decreased by 0.44±1.60, 1.27±2.16 and 1.42±2.37 respectively, indicating a time-dependent improvement of visual field upon EBHM treatment, whereas the VFDS in Placebo Control Group (47 eyes/47 patients) decreased by -0.02±1.5, 0.68±1.73 and 0.40±1.57 respectively. Statistically, the differences in VFDS between the two groups were significant (P<0.05) at 2 and 4mo, and highly significant at 6mo of treatment (P =0.007). The average IOP in both groups was 15mmHg (range 8-18mmHg) during the period of the study (P>0.05). No serious side effects were reported in glaucoma patients on EBHM.CONCLUSION: EBHM appeared to be safe and effective in neuroprotection for patients with glaucoma. More studies are needed to determine the safety and effectiveness of longer-term EBHM treatment.
URIhttp://hdl.handle.net/20.500.11897/287966
ISSN1672-5123
DOI10.3969/j.issn.1672-5123.2004.04.001
Appears in Collections:第三医院

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