1 中南大学湘雅医学院附属海口医院，海口市人民医院眼科，海口 570000
2 中南大学湘雅二医院眼科，长沙 410011
目的：比较地塞米松玻璃体内植入剂(intravitreal dexamethasone implant，IDI)和雷珠单抗治疗糖尿病黄斑水肿(diabetic macular edema，DME)的疗效和安全性，为临床治疗DME用药提供依据。方法：检索PubMed、Cochrane图书馆、Embase、Web of Science、万方数据知识服务平台、中国知网、及重庆维普中文科技期刊全文数据库中这两种药物治疗DME的临床对照试验文献，对纳入文献进行风险评估，提取文献中相关指标，采用RevMan 5.3软件进行数据分析，应用随机或固定效应模型分析异质性，检测发表偏倚。结果：共纳入符合条件的文献5篇，合计593例患者。IDI组和雷珠单抗组黄斑中心凹视网膜厚度(central macular thickness，CMT)治疗后1个月加权均数差(weighted mean difference，WMD)=−107.13；95%置信区间(confidence interval，CI)：−149.44~−64.81；P<0.00001；3个月WMD=−58.10；95%CI：−88.39~−27.82；P=0.0002，IDI组患者黄斑水肿(macular edema，ME)减轻程度相比雷珠单抗组更明显，差异有统计学意义。两组患者最佳矫正视力(best corrected visual acuity，BCVA)治疗后1个月[WMD=−0.08；95%CI：−0.23~0.07；P=0.28]和3个月[WMD=−0.09；95%CI：−0.09~0.01；P=0.08]比较，差异无统计学意义。IDI组有增加白内障(OR=4.23，95%CI：1.93~9.26，P=0.0003)和升高眼压(OR=8.55，95%CI：4.63~15.81，P<0.00001)的风险，但具有较少的注射次数。结论：IDI和雷珠单抗均可改善BCVA、降低CMT，二者在视力改善方面没有差异，IDI在减轻ME方面比雷珠单抗有优势，且注射次数少，但IDI增加眼压及发生白内障的风险较雷珠单抗高。关键词： 地塞米松玻璃体内植入剂；雷珠单抗；糖尿病黄斑水肿；荟萃分析；疗效；安全
Efficacy and safety of intravitreal dexamethasone implant versus ranibizumab in diabetic macular edema: A Meta-analysis
CorrespondingAuthor: PENG Li Email: email@example.com
Foundation: Scientific Research Projects of Hainan Provincial Health and Family Planning Industry, China (18A200168).
Objective: To compare the efficacy and safety of intravitreal dexamethasone implant (IDI) and ranibizumab for the treatment of diabetic macular edema (DME). Methods: PubMed, the Cochrane Library, Embase, Web of Science, Wanfang data, CNKI, and VIP Database were comprehensively searched for studies comparing dexamethasone implant versus ranibizumab in patients with DME. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and adverse events were extracted from the final eligible studies. RevMan 5.3 software was used for data analysis. Random and fixed effect models were applied to evaluate heterogeneity and publication bias. Results: A total of 5 studies involving 593 patients were included in the Meta-analysis. The IDI group had a greater CMT reduction than the ranibizumab group at 1 month after treatment [weighted mean difference (WMD) =−107.13; 95% confidence interval (CI): −149.44 to −64.81; P<0.00001]. At 3 months after treatment, there was a significantly statistical difference in macular edema (ME) between the two groups (WMD =−58.10; 95% CI: −88.39~−27.82; P=0.0002). However, no significant difference in BCVA was found between the two groups either at 1 month (WMD =−0.08; 95%CI: −0.23 to 0.07; P=0.28) or 3 months (WMD =−0.09, 95%CI: −0.09 to 0.01; P=0.08) after treatment. The IDI group faced a higher risk of cataract (OR=4.23, 95%CI: 1.93 to 9.26; P=0.0003) and intraocular pressure (IOP) elevation (OR=8.55, 95%CI: 4.63 to 15.81; P<0.00001) than the ranibizumab group with fewer injections. Conclusion: Both IDI and ranibizumab can improve BCVA and reduce CMT. Compared with ranibizumab, IDI had no difference in improving BCVA, showed better efficacy in reducing ME with fewer injections, yet more side effects.Keywords： intravitreal dexamethasone implant; ranibizumab; diabetic macular edema; Meta-analysis; efficacy; safety