小梁消融术疗效和安全性的临床观察

Preliminary investigation on the safety and efficacy of Trabectome

目的 观察小梁消融术治疗开角型青光眼的安全性和有效性.方法 前瞻性非对照病例系列.开角型青光眼患者41例,包括POAG患者34例,发育性青光眼3例,色素性青光眼4例.全面眼科检查后行小梁消融术,其中9例联合超声乳化白内障吸除手术.记录术前和术后的眼压、降眼压药物使用情况及术后并发症等.以术后3个月后随机2次随访眼压均≤21 mmHg（1 mmHg=0.133 kPa）,眼压下降≥20％（用或不用降眼压药物）且无二次手术定义为手术成功.统计分析使用R统计软件进行（R project）.眼压和降眼压眼药数与基线的比较采用Wilcoxon符号秩检验,并采用bonferroni比较法进行校正.使用Kaplan-Meier生存分析方法对结果进行分析.结果 41例患者中随访达到12个月者为21例（51.2％）.术前平均眼压（22.5±8.1）mmHg,术后12个月平均眼压（17.6±6.4） mmHg,术后眼压下降有统计学意义（P=0.02）.术前平均用局部降眼压药（2.0±0.9）种,术后12个平均用局部降眼压药（1.2±0.9）种.术后使用局部降眼压药物数量减少有统计学意义（P=0.02）.手术中消融小梁网时均出现不同程度的一过性回血,术中无其他并发症的出现.1年成功率为85％,4例需要行二次手术.结论 小梁消融术创伤小,手术时间短,手术后护理简单,术中及术后并发症少,降压效果明确,但仍需大样本、长期随访进一步验证.

Objective To evaluate the safety and efficacy of ab interno trabeculectomy （Trabectome） surgery in Chinese open angle glaucoma patients.Methods Prospective non-comparative case series study.A total of 41 cases （34 primary open angle glaucoma patients,3 developmental glaucoma patients and 4 pigmentary glaucoma patients） were included in the study.All the cases underwent Trabectome,including 9 cases combined with phacoemulsification cataract extraction.Major outcomes include intraocular pressure （IOP）,number of glaucoma medications,secondary glaucoma surgery and postoperative complications.Criteria for successful operation were defined as IOP ≤ 21 mmHg（1 mmHg =0.133 kPa）,at least 20% IOP reduction in any two consecutive visits after 3 months with or without IOP-lowering drugs and no additional glaucoma surgery.IOP and number of glaucoma medications were compared to baseline using Wilcoxon signed-rank test with Bonferroni correction.Kaplan-Meier analysis was performed to analyze the success rate of surgery.Results In the all 41 patients,21 cases （51.2%） were followed up for up to 12 months.IOP was reduced from （22.5 ± 8.1） mmHg to （17.6 ± 6.4） mmHg （P =0.02）,meanwhile number of glaucoma medications was reduced from 2.0 ± 0.9 to 1.2 ± 0.9 （P =0.02） at 12 months.The success rate at one year was 85% and 4 cases required additional glaucoma surgery.Conclusions Trabectome has many advantages,such as shorter surgery time,simple post-operative care,less intraoperative and postoperative complications and clear IOP-lowering effect.But it slong-term efficacy is still need a large sample,long-term follow-up to verify.