灯盏细辛治疗青光眼多中心临床研究(英文)

Neuroprotective effects of erigeron breviscapus(vant) hand-mass on glaucoma-A multi-center clinical trial

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2,4,6mo2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. ·