Effectiveness And Safety Of Intravitreal Ra- Nibizumab Alone Or Combined With Laser Ve- Rsus Laser Monotherapy For Diabetic Macul- Ar Edema:a Meta-Analysis

Objective:To evaluate the efficacy and safety of intravitreal ranibizumab alone(IVR) or combined with laser (IVR+Laser) versus laser monotherapy for the tr-eatment of diabetic macular edema (DME).Methods:A comprehensive literature search using PUBMED, ClinicalTrials.gov,EMbase,Cochrane Library,CBM,VIP,CNKI and Wanfang Data from the date of their establishment to February 2015, and the references of all included studies werealso traced,so as to identify the randomized controlled trials (RCTs) comparing IVR or IVR+Laser to laser monotherapy in patients with DME. We tried to obtain in the evdence of efficacy and safety of the three methods according to Jadad quality assessment rating scale by using Cochrane systematic review methods and RevMan 5.2 statistical software to do Meta-analysis. Efficacy estimates were determined by comparing weighted mean differences (WMD) in the change of best corrected visual acuity (BCVA) and central macular thickness (CMT) frombaseline, and the odds ratios (OR) for the proportions of patients with at least 15 letters change from baseline. Safety analysis estimated the OR of cardiac disorders and eye disorders in ranibizumab therapy vs. laser monotherapy. Result Eight RCTs were selected for this meta-analysis, including 1749 patients(394 patients in the IVR group,642 patients in the IVR+Laser group, and 713 patients in the Laser group). IVR and IVR+Laser were superior to laser monotherapy in the mean change of BCVA and CMT from baseline (WMD=5.65,95%CI(4.44～6.87), P<0.01; WMD=4.94,95%CI(3.81-6.06),Z=8.30,P<0.00001andWMD=-50.70,95 %CI (-69.17～-32.23),P<0.01;WND=-50.76,95%CI (-92.02～-9.50) P=0.02,respectively). The pooled OR comparing the proportions of patients with at least 15 letters improvement was in favor of IVR and IVR+ Laser(OR=3.45,95%CI (2.01～5.93),P<0.01; 0R=2.39,95%CI(1.65 ～3.47),P<0.01).While the pooled OR comparing the proportions of patients with at least 15 letters improvement was no differences between the RBZ arms and the laser monotherapy (OR=0.2,95%CI (0.06-0.69),P=0.01;OR=0.50,95%CI (0.27-0.94) P=0.03,respectively).There were no significant differences between IVR and IVR+Laser for any of the parameters There were no difference in the safety profile between the RBZ arms and laser.Conclusion:IVR and IVR+Laser had better visual and anatomic outcomes than laser monotherapy in the treatment of DME. IVR+Laser seemed to be equivalent to IVR.