单独雷珠单抗玻璃体内注射与联合激光疗法治疗DME疗效和安全性meta分析

Efficacy and safety of intravitreal ranibizumab alone and combined laser therapy for the treatment of DME:a meta-analysis

目的评估玻璃体内注射雷珠单抗联合激光光凝(IVR+Laser)与单用玻璃体内注射雷珠单抗(IVR)治疗糖尿病性黄斑水肿(DME)的疗效和安全性。方法采用meta分析方法,检索有关IVR+Laser疗法与单用IVR治疗DME的随机对照试验(RCT)文献进行二次分析,检索文献范围包括Cochrane Library、PubMed、EMbase、Web of Science、中国生物医学文献数据库、中国知网、维普网、万方数据,检索时间均从建库起至2022年4月。由2位研究员按照纳入和排除标准独立进行文献筛选、资料提取、质量评价并交叉核对后,采用RevMan5.4.1软件进行meta分析,比较不同方法治疗后最佳矫正视力(BCVA)、黄斑中心凹厚度(CMT)、平均注射次数和不良事件的差异。结果共纳入12篇RCT,共1695眼。meta分析结果显示,随访结束时,IVR+Laser组患者BCVA和CMT改善情况优于IVR组,2个组BCVA变化和CMT变化差异均有统计学意义(WMD=-0.66,95%CI:-1.11~-0.21,P<0.01;WMD=-5.05,95%CI:-9.21~-0.89,P=0.02)。随访结束时,IVR+Laser组平均注射次数明显少于IVR组,差异有统计学意义(WMD=-1.16,95%CI:-2.07~-0.25,P=0.01)。2个组不良事件发生率比较,差异均无统计学意义(均P>0.05)。结论IVR+Laser联合治疗DME疗效优于单独IVR治疗,安全性与单独IVR治疗相当,且平均注射次数较少。

Objective To evaluate the efficacy and safety of intravitreal ranibizumab combined with laser(IVR+Laser)and the intravitreal ranibizumab(IVR)monotherapy for the treatment of diabetic macular edema(DME).Methods A meta-analysis was conducted on randomized controlled trial(RCT)literature related to IVR+Laser therapy and IVR alone for DME.Databases including Cochrane Library,PubMed,EMbase,Web of Science,SinoMed,CNKI,VIP and WanFang Data were searched from their inception to April 2022.Literature screening,data extraction,quality evaluation and cross-checking were conducted independently by two researchers according to inclusion and exclusion criteria.Then a meta-analysis was conducted using RevMan 5.4.1 software.The two therapies were compared in terms of best corrected visual acuity(BCVA),central macular thickness(CMT),mean number of injections and adverse events.Results Twelve RCTs involving 1695 eyes were included in the study.Meta-analysis showed that at the end of follow-up,IVR+Laser demonstrated better improvement in BCVA and CMT than IVR alone,and there were significant differences in the changes in BCVA and CMT between the two groups(weighted mean difference[WMD]=-0.66,95%confidence interval[CI]:-1.11--0.21,P<0.01;WMD=-5.05,95%CI:-9.21--0.89,P=0.02).IVR+Laser required significantly fewer injections than IVR alone(WMD=-1.16,95%CI:-2.07--0.25,P=0.01).There were no significant differences in the adverse events incidence between the two therapies(all at P>0.05).Conclusions The safety of IVR+Laser is comparable to IVR alone,and it requires fewer injections for the treatment of DME.