Xing Yi, Jiang Fa-Gang, Li Teng
Department of Ophthalmology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
Int J Ophthalmol. 2014 Oct 18;7(5):879-90. doi: 10.3980/j.issn.2222-3959.2014.05.26. eCollection 2014.
To assess the effects of the fixed combination of 0.005% latanoprost and 0.5% timolol (FCLT) vs their individual components for primary open angle glaucoma (POAG) and ocular hypertension (OHT).
After searched PubMed, EMBASE, the Cochrane Library and SCI, all randomized controlled clinical trials (RCTs) and cross-over studies were included. The control groups were the mono therapy or the concomitant therapy of latanoprost and timolol. The outcomes were visual field defect, optic atrophy, mean intraocular pressure (IOP) and IOP fluctuation. The analysis was carried out in RevMan version 5.1 software.
The post-intervention mean IOP of FCLT was significantly lower compared to timolol [mean difference (MD) -2.92, 95%CI -3.28 to -2.55, P<0.00001] and latanoprost (MD -1.11, 95%CI -1.51 to -0.72, P<0.00001). The post-intervention IOP fluctuation was also significantly lower compared to timolol (MD -0.88, 95%CI -1.23 to -0.53, P<0.00001) and latanoprost (MD -0.63, 95%CI -1.04 to -0.22, P=0.002). The mean IOP was higher in FCLT morning dose group than the one in unfixed combination of 0.005% latanoprost and 0.5% timolol (UFCLT) (MD 1.10, 95%CI 0.81 to 1.39, P<0.00001). Otherwise, there was no difference between FCLT evening dose group and UFCLT (MD 0.34, 95% CI -0.01 to 0.69, P=0.06). There was no statistical difference for the incidence of visual field defect and optic atrophy between FCLT and the monotherapy of components.
A better IOP lowering effect has been demonstrated for FCLT compared to the mono therapy of components. The IOP lowering effect was worse for FCLT morning dose and almost same for FCLT evening dose compared to the UFCLT. We need more long-term high quality RCTs to demonstrate the outcomes of visual field defect and optic atrophy.
评估0.005%拉坦前列素与0.5%噻吗洛尔固定复方制剂(FCLT)及其单一组分对原发性开角型青光眼(POAG)和高眼压症(OHT)的疗效。
检索PubMed、EMBASE、Cochrane图书馆和SCI后,纳入所有随机对照临床试验(RCT)和交叉研究。对照组为拉坦前列素单药治疗或拉坦前列素与噻吗洛尔联合治疗。观察指标为视野缺损、视神经萎缩、平均眼压(IOP)和眼压波动。采用RevMan 5.1软件进行分析。
与噻吗洛尔相比,FCLT干预后的平均眼压显著降低[平均差值(MD)-2.92,95%置信区间(CI)-3.28至-2.55,P<0.00001],与拉坦前列素相比也显著降低(MD -1.11,95%CI -1.51至-0.72, P<0.00001)。与噻吗洛尔相比,FCLT干预后的眼压波动也显著降低(MD -0.88,95%CI -1.23至-0.53,P<0.00001),与拉坦前列素相比也显著降低(MD -0.63,95%CI -1.04至-0.22,P=0.002)。FCLT早晨剂量组的平均眼压高于0.005%拉坦前列素与0.5%噻吗洛尔非固定复方制剂(UFCLT)组(MD 1.10,95%CI 0.81至1.39,P<0.00001)。否则,FCLT晚上剂量组与UFCLT组之间无差异(MD 0.34,95%CI -0.01至0.69,P=0.06)。FCLT与单一组分治疗组之间视野缺损和视神经萎缩的发生率无统计学差异。
与单一组分治疗相比,FCLT具有更好的降眼压效果。与UFCLT相比,FCLT早晨剂量的降眼压效果较差,晚上剂量的降眼压效果几乎相同。我们需要更多长期高质量的RCT来证明视野缺损和视神经萎缩的结果。