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灯盏细辛提取物对控制眼压的青光眼视野保护作用:一项随机、双盲、临床研究。

Visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. extract on glaucoma with controlled intraocular pressure: a randomized, double-blind, clinical trial.

机构信息

Department of Ophthalmology, Ruijin Hospital Affiliated Medical School, Shanghai Jiaotong University, Shanghai, China.

出版信息

Drugs R D. 2010;10(2):75-82. doi: 10.2165/11539090-000000000-00000.

Abstract

OBJECTIVE

To evaluate the visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. (EBHM) extract on glaucoma with controlled intraocular pressure (IOP).

METHODS

Forty patients (40 eyes) with primary open-angle glaucoma, visual field defects and a postsurgical IOP of <18 mmHg were enrolled. The EBHM and placebo tablets were given orally according to the randomized and double-blind principle. Two tablets (of either EBHM or placebo) were taken three times a day for a period of 6 months. Patients were examined every 2 months after treatment commenced. At the end of the study, the results were given to the drug manufacturer.

RESULTS

All patients completed the prospective, randomized, double-blind, clinical trial. No obvious adverse effects were found in patients during the treatment period. In the placebo group, no significant difference was found in mean defect (MD) or mean sensitivity (MS) between the values at pre-treatment and after 2, 4, and 6 months of treatment. After 6 months of EBHM treatment, the MD was significantly decreased and the MS was significantly increased compared with pre-treatment (p < 0.05). In the patients with moderate and late glaucoma, the MD was significantly decreased and the MS was significantly increased after 2, 4, and 6 months of EBHM treatment compared with pre-treatment.

CONCLUSION

EBHM extract may have a partial protective effect on the visual field of glaucoma patients with controlled IOP. Further studies are needed to determine the safety and effectiveness of long-term EBHM treatment.

摘要

目的

评价灯盏细辛提取物对控制眼压的青光眼患者视野的保护作用。

方法

将 40 例(40 眼)具有原发性开角型青光眼、视野缺损和术后眼压<18mmHg 的患者纳入研究。按照随机、双盲的原则口服灯盏细辛提取物和安慰剂片。治疗期间,每天服药 3 次,每次 2 片(灯盏细辛提取物或安慰剂),连续服用 6 个月。治疗开始后每 2 个月进行 1 次检查。研究结束时,将结果交给药物制造商。

结果

所有患者均完成了前瞻性、随机、双盲、临床试验。治疗期间,患者均未出现明显不良反应。安慰剂组中,治疗 2、4 和 6 个月后的平均缺损(MD)或平均敏感度(MS)与治疗前相比均无显著差异。灯盏细辛提取物治疗 6 个月后,MD 显著降低,MS 显著升高,与治疗前相比差异有统计学意义(p<0.05)。中晚期青光眼患者中,治疗 2、4 和 6 个月后 MD 显著降低,MS 显著升高,与治疗前相比差异有统计学意义。

结论

灯盏细辛提取物可能对视神经有一定的保护作用,对控制眼压的青光眼患者的视野具有部分保护作用。需要进一步研究以确定长期服用灯盏细辛提取物的安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af81/4174498/48cdca2d75ba/40268_2012_10020075_Tab1.jpg

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