背景:Xen是一种用于微创青光眼手术的装置,用于治疗POAG,假性剥脱性或色素性青光眼,以及难治性青光眼。XEN治疗青光眼的疗效尚待证实和澄清。因此,我们进行了系统评价和荟萃分析,以检查XEN植入术的疗效和相关并发症.
方法:我们在PubMed进行了文献检索,EMBASE,Cochrane系统评价图书馆,WebofScience,中国国家知识基础设施,万方和SinoMed数据库来识别研究,在2021年5月15日之前发布,评估了XEN在青光眼中的应用,测量参数包括眼内压(IOP),抗青光眼药物(NOAM)的数量,和水泡针刺率。我们比较了phaco-XEN和小梁切除术之间仅XEN手术的测量值,我们还根据时间点进行了子分析,青光眼类型,种族,等。进行了敏感性分析和发表偏倚以评估偏倚。本研究遵循了系统评价和荟萃分析的首选报告项目(PRISMA2020)报告指南。
结果:我们确定了78项符合条件的研究,分析显示XEN支架植入后IOP明显下降(SMD:1.69,95%CI1.52~1.86,p值<0.001),NOAM降低(SMD:2.11,95%CI1.84~2.38,p值<0.001)。子分析显示关于时间点没有显著差异,种族,和经济地位。在对POAG和PEXG眼的XEN治疗效果之间以及假性有晶状体眼和有晶状体眼之间没有发现显着差异。在术后眼压方面,XEN和phaco-XEN手术之间也没有发现显着差异(SMD:-0.01,95%CI-0.09至0.08,p值0.894)。然而,与仅XEN组相比,phaco-XEN组的NOAM(发表偏倚校正后)和气泡针刺率(RR:1.45,95%CI1.06至1.99,p值0.019)较低。与小梁切除术相比,XEN植入术后IOP相似,然而,气泡针刺率(RR:2.42,95%CI1.33~4.43,p值0.004)更高。
结论:我们的结果证实,XEN在术后48个月内可有效降低IOP和NOAM。值得注意的是,XEN植入导致更高的针刺率,与phaco-XEN或小梁切除术相比。进一步研究,研究非欧洲种族的XEN并发症,尤其是亚洲人,在XEN广泛应用之前是迫切需要的。
BACKGROUND: Xen is a device for minimally invasive glaucoma surgery, and is used to treat POAG, pseudoexfoliative or pigmentary glaucoma, as well as refractory glaucoma. The efficacy of XEN in treating glaucoma remains to be confirmed and clarified. Hence, we conducted a systematic review and meta-analysis to examine the efficacy and associated complication of XEN implantations.
METHODS: We conducted a literature search in PubMed, EMBASE, the Cochrane Library of Systematic Reviews, Web of Science,
China National Knowledge Infrastructure, WanFang and SinoMed databases to identify studies, published before May 15, 2021, which evaluated XEN in glaucoma, and parameters for measurements included intra-ocular pressure (IOP), number of anti-glaucoma medications (NOAM), and bleb needling rate. We compared the measurements of XEN-only procedure between phaco-XEN and trabeculectomy, and we also did sub-analysis based on time points, glaucoma types, ethnics, etc. Sensitivity analyses and publication bias were conducted for evaluating bias.This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA 2020) reporting guideline.
RESULTS: We identified 78 eligible studies, analysis revealed obvious IOP reduction after XEN stent implantation (SMD: 1.69, 95% CI 1.52 to 1.86, p value < 0.001) and NOAM reduction (SMD: 2.11, 95% CI 1.84 to 2.38, p value < 0.001). Sub-analysis showed no significant difference with respect to time points, ethnicities, and economic status. No significant difference was found between XEN treatment effect on POAG and PEXG eyes and between pseudo-phakic and phakic eyes. Also no significant difference was found between XEN and phaco-XEN surgery in terms of IOP after surgery (SMD: -0.01, 95% CI -0.09 to 0.08, p value 0.894). However, NOAM (after publication bias correction) and bleb needling rate (RR: 1.45, 95% CI 1.06to 1.99, p value 0.019) were lower in phaco-XEN group compared to XEN only group. Compared to trabeculectomy, XEN implantation had similar after-surgery IOP, however bleb needling rate (RR: 2.42, 95% CI 1.33 to 4.43, p value 0.004) was higher.
CONCLUSIONS: Our results confirmed that XEN is effective in lowering both IOP and NOAM till 48 months after surgery. It is noteworthy that XEN implantation leads to higher needling rate, compared to phaco-XEN or trabeculectomy. Further research, studying complications of XEN on non-European ethnicities, especially on Asian, are in urgent need before XEN is widely applied.