目的：探讨曲伏前列腺素联合甲磺酸倍他司汀协同治疗早期原发性开角型青光眼的疗效。

方法：本研究为前瞻性、随机、对照、开放标签的单中心临床试验，纳入2020年1月至2023年1月大庆龙南医院东湖院区眼科中心就诊的早期原发性开角型青光眼患者82例82眼(符合纳入标准的患病眼入组，若双眼均符合则选择右眼入组)，按1：1的比例根据随机数字表法随机分为单药治疗组41眼仅使用曲伏前列腺素滴眼液治疗和联合治疗组41眼使用曲伏前列腺素滴眼液与口服甲磺酸倍他司汀治疗。随访12 mo，比较两组患者的治疗前后眼压(IOP)、视网膜神经纤维层厚度(RNFL)、眼部血流动力学\〖收缩期峰值流速(PSV)、舒张末期流速(EDV)、阻力指数(RI)、搏动指数(PI)\〗、肝肾功能以及生活质量和临床症状评分。

结果：共4例患者因各种原因未能完成全部随访，其中单药治疗组2例，联合治疗组2例，失访率为5%。联合治疗组治疗后各时间点眼压值明显低于单药治疗组(均P<0.05)，RNFL减少速度低于单药治疗组(均P<0.05)。血流动力学参数显示，联合治疗组患者PSV和EDV治疗12 mo时高于单药治疗组，而RI和PI低于单药治疗组(均P<0.05)。联合治疗组患者生活质量评分和VAS评分均优于单药治疗组(均P<0.05)。治疗6、12 mo，两组患者的肝功能指标(ALT、AST、TBIL)和肾功能指标(Scr、BUN、UA)均处于正常参考值范围内，均未发现严重肝肾功能损害或其他系统性不良反应。联合治疗组头痛的发生率低于单药治疗组(P=0.042)，其余不良反应发生率比较均无差异(均P>0.05)，

结论：曲伏前列腺素与甲磺酸倍他司汀联合治疗早期原发性开角型青光眼患者的协同作用显著，具有更好的眼压控制、视神经保护和氧化应激抑制效果，可为青光眼的综合治疗提供新的临床参考。

METHODS:This study is a prospective, randomized, controlled, open label single center clinical trial that enrolled 82 patients(82 eyes)with early primary open-angle glaucoma from January 2020 to January 2023(eligible eyes were included, and the right eye was selected if both eyes met the inclusion criteria). The patients were randomly divided into a monotherapy group(41 eyes)treated with only travoprost eye drops and a combination therapy group(41 eyes)treated with travoprost eye drops and oral betahistine mesylate according to a 1:1 ratio using a random number table method. Followed-up for 12 mo, the intraocular pressure(IOP), retinal nerve fiber layer(RNFL)thickness, ocular hemodynamics \〖peak systolic velocity(PSV), end diastolic velocity(EDV), resistance index(RI), pulsatility index(PI)\〗, liver and kidney function, quality of life, and clinical symptom scores before and after treatment were compared between the two groups of patients.

RESULTS:Totally 4 patients were unable to complete all follow-up visits due to various factors, including 2 cases in the monotherapy group and 2 cases in the combination therapy group, with a lost rate of follow-up of 5%. The IOP in the combination therapy group was significantly lower than that in the monotherapy group at all time points(all P<0.05). Additionally, the rate of reduction in RNFL thickness was significantly slower in the combination therapy group compared to the monotherapy group(all P<0.05). Hemodynamic parameters revealed that PSV and EDV were significantly higher in the combination therapy group at 12 mo, while RI and PI were significantly lower than those in the monotherapy group(all P<0.05). The quality of life scores and visual analog scale(VAS)scores were also significantly better in the combination therapy group compared to the monotherapy group(all P<0.05). There were no statistically significant differences in liver functions, including alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(TBIL), and kidney functions, including serum creatinine(Scr), blood urea nitrogen(BUN), and uric acid(UA)between the two groups at 6 and 12 mo after treatment, with no serious damage to liver and kidney or other systemic adverse reactions observed in either groups. Furthermore, the incidence of headache in the combination group was lower than that of the monotherapy group(P=0.042), and there were no statistical significance in the incidence of other adverse reactions(all P>0.05).

CONCLUSION:The combination therapy of travoprost and betahistine mesylate exhibits significant synergistic effects in patients with early primary open angle glaucoma, offering better IOP control, neuroprotection of the optic nerve, and oxidative stress inhibition. This combination may provide a new clinical reference for comprehensive glaucoma treatment.