选择性激光小梁成形术替代药物治疗原发性开角型青光眼的前瞻性随机对照研究

A prospective randomized study of selective laser trabeculoplasty （SLT） as a replacement for medical therapy in primary open-angle glaucoma

目的 探讨选择性激光小梁成形术（SLT）替代药物治疗POAG的疗效和安全性.方法 前瞻性、随机、对照研究.采用SOLO（R） SLT掺钕钇铝石榴石激光治疗仪对正在接受抗青光眼药物治疗,眼压控制≤21 mmHg（1 mmHg =0.133 kPa）的进展期POAG患者45例（67只眼）进行SLT治疗.采用简单随机化的方法生成随机数字表,将患者随机分为两组,一组为标准能量治疗组：34只眼接受标准能量270°前房角小梁网SLT治疗;另一组为阈下能量治疗组：33只眼接受阈下能量360°前房角小梁网SLT治疗.观察患者治疗前后的眼压,日眼压曲线,抗青光眼药物数量及并发症等指标.随访时间6～9个月,平均6.4个月.符合正态分布的连续变量,如基本资料、日眼压波动、激光能量使用双侧t检验或配对t检验.不符合正态分布的变量,用药种类使用非参数检验的Mann-Whitney U 检验或Wilcoxon rank检验.计数资料成功率和并发症采用卡方或确切概率法检验.结果 治疗前标准能量治疗组和阈下能量治疗组抗青光眼药物种类分别为（2.3±0.5）种和（2.1±0.4）种,治疗后最后一次随访用药种类分别为（1.3±0.5）种和（1.1±0.3）种,治疗前后用药种类差异具有统计学意义（Z=-5.477,-5.396;P ＜0.05）.标准能量治疗组和阈下能量治疗组治疗成功率分别为91.1％ 和87.9％ （P-0.70）.标准能量治疗组和阈下能量治疗组日眼压波动在治疗前分别为（3.6±1.0） mmHg和（3.9±1.4）mmHg,治疗后分别为（2.3±1.0）mmHg和（2.4±0.9）mmHg,治疗前后差异具有统计学意义（t=4.911,4.679;P＜0.05）.标准能量治疗组激光治疗总能量为（47.8±6.0） mJ高于阈下能量治疗组（43.2±5.1） mJ（t =12.006,3.233;P ＜0.05）,两组间在日眼压波动,治疗成功率、减少药物种类、治疗前后眼压及并发症等方面无明显差异.结论 SLT作为POAG患者抗青光眼药物替代治疗的方法,可以安全有效地减少患者用药的种类.阈下能量360°前房角小梁网SLT和标准能量270°前房角小梁网SLT治疗效果没有明显差异.

Objective To evaluate the efficacy and safety of selective laser trabeculoplasty （SLT）as a replacement for medical therapy in primary open-angle glaucoma （POAG）.Methods A prospective,randomized,controlled study.SLT treatment with SOLO （R） SLT Nd∶ YAG laser was provided to 45 participants with advanced POAG （67 eyes,IOP ≤ 21 mmHg,1 mmHg =0.133 kPa） under antiglaucomatous medications control）.A table of random numbers was created by simple randomization method.Participants were randomly divided into two groups：the standard-energy group （34 eyes）,which received a 270° standard-energy SLT treatment and the sub-threshold energy group （33 eyes）,which received a 360° sub-threshold energy treatment.Thc intraocular pressure （IOP） before and after SLT,daytime IOP curve,dosage of anti-glaucoma drugs and treatment complications were observed,which were be followed up for 6-9 months （average 6.4 months）.Two-tailed t-test or paired t test was used when the continuous variables were normal distribution,such as the basic data,daily fluctuations of IOP,laser energy.Non-parametric Mann-Whitney U test or Wilcoxon rank test was used when data was not distributed normally,such as drug category.Chi-square or Fisher＇s exact test was used when count variables such as success rate and complications were analyzed.Results The number of anti-glaucomatous drugs used in the standard-energy group and the sub-threshold energy group before SLT was （2.3 ± 0.5） and （2.1 ± 0.4）,respectively; whereas,after the last treatment,it reduced to （1.3 ±0.5） and （1.1 ±0.3）,respectively （Z =-5.477,-5.396 ; P 〈 0.05）.The success rate of the standard-energy group and the sub-threshold energy group was 91.1%,and 87.9%,respectively,which was not significant different （P =0.70）.Laser treatment was found to reduce the IOP fluctuation during the daytime.IOP fluctuation decreased from （3.6 ± 1.0） mmHg to（2.3 ± 1.0） mmHg in the standard-energy group,and decreased from（3.9 ± 1.4） mmHg to （2.4 ±0.9） mmHg in the sub-threshold energy group,which was significant different （t=4.911,4.679;P 〈 0.05）.The total laser energy of the standard-energy group （47.8 ± 6.0） mJ was higher than the subthreshold energy group （43.2 ± 5.1） mJ （t =12.006,3.233 ;P 〈 0.05）.However,there was no significant difference in the daily IOP fluctuations,success rate,reduction of medication categories,preoperative and postoperative IOP,and adverse reactions between the two groups.Conclusions SLT is a safe and effective replacement for medical therapy in primary open-angle glaucoma treatment.SLT could reduce the applications of anti-glaucoma drugs.There was no significant difference between therapeutic effects of which eyes received 360° sub-threshold energy and 270° standard-energy.