摘要
目的评价雷珠单抗玻璃体腔单药注射与联合激光光凝治疗糖尿病黄斑水肿（DME）有效性及安全性的差异。方法计算机检索Pubmed、Cochrane协作网、Embase、CNKI、中国科技期刊全文数据库、中国生物医学文献数据库以及万方数据库，检索时间均从建库至2014年9月，并追述纳入文献的参考文献。获得的临床对照研究，通过纳入和排除标准限定，经质量评价后，采用RevMan5．3软件进行Meta分析，获得以上两种方案治疗DME的疗效及安全性是否具有相关差异的相关证据。结果纳入6篇临床对照研究（单药注射组445只眼，联合激光光凝447只眼），质量评分均为高质量文献。Meta分析结果显示，雷珠单抗联合视网膜激光组与单药注射组患者的最佳矫正视力提高幅度间差异有统计学意义[MD=-1．21，95％CI（-1．55，-0．87），P〈0．01]；黄斑中心凹厚度降低比较差异无统计学意义[MD=4．48，95％CI（-13．21，22．17），P=0．62〉0．05]；两组不良反应中结膜充血和球结膜下出血的发生率差异无统计学意义[OR=0．81，95％CI（0．46，1．45），P=O．48〉0．05]；白内障的发生率差异有统计学意义[OR=2．32，95％CI（1．03，5．20），P=0．04〈0．05]。结论现有的临床研究显示，雷珠单抗联合激光治疗DME时，比单药注射提高视力显著；对于降低黄斑水肿厚度的疗效两者无明显差别；但联合治疗会增加白内障的发生率。受纳人研究的质量影响，会影响结果的真实性，仍需更多多中心、大样本高质量随机对照研究对其验证。
Objective To evaluate the efficacy and safety of monotherapy of intravitreal Ranibi- zumab （IVRBZ） and the combined-use of intravitreal Ranibizumab plus laser photocoagulation （IVR- BZ＋L） for diabetic macular edema （DME）. Methods Databases including Pubmed, the Cochrane Library, Medline, Embase, CNKI, VIP, CBM and Wanfang were searched from the established date to September 2014, also the references of included studies were traced. The controlled trials on IVRBZ vs. IVRBZ＋L for DME after study selection were scored highly by Jadad. Meta-analysis was conducted by RevMan 5.3 software. Results Six studies involved 445 eyes on IVRBZ and 447 eyes on IVRBZ＋L were included in our study. Metanalysis showed there was statistical difference in the best corrected visual acuity （BCVA） between the two treatments. [MD=-1.21, 95%CI（-1.55,-0.87）, P 〈0.01]; and no statistical difference in the reduction in central macular thickness [MD=4.48, 95%CI（-13.21, 22.17）, P =0.62〉0.05]. No significant differences were found between the two groups in conjunctival congestion and subconjunctival hemorrhage. [OR=0.81, 95%CI（0.46, 1.45）, P =0.48〉 0.05]; but there was statistical difference in the cataract incidence between the two groups. [OR= 2.32, 95%CI（1.03, 5.20）, P =0.04〈0.05]. Conclusions Current study shows that the IVRBZ＋L is superior to IVRBZ on improving vision for the DME, and there is no difference of reducing macular edema between the two. But it also resulted in a high incidence of cataract. For the limitation of the quality of included studies may affect the outcomes, our conclusion need more high-quality clinical studies.
出处
《中国实用眼科杂志》
2015年第3期271-275,共5页
Chinese Journal of Practical Ophthalmology
