Liu Wei-Shai, Li Yan-Jie
Department of Ophthalmology, the First Hospital of Shanxi Medical University, Taiyuan 030000, Shanxi Province, China.
Int J Ophthalmol. 2019 Sep 18;12(9):1479-1486. doi: 10.18240/ijo.2019.09.17. eCollection 2019.
To evaluate the efficacy of intravitreal injection of conbercept (IVC) and ranibizumab (IVR) in patients with diabetic macular edema.
Reviewers have searched 12 databases, including PubMed, Medline, EMBASE, Web of Science, Springer, ScienceDirect, OVID, Cochrane Library, ClinicalTrials.gov, cqVIP, WanFangdata and China National Knowledge Infrastructure (CNKI), up to December 28, 2018. RevMan 5.3 (Cochrane Library Software, Oxford, UK) was employed for statistical analysis. Fixed and random effects models were applied to assess heterogeneity. Odds ratio (OR) was applied for dichotomous variables; weighted mean difference (WMD) was applied for continuous variables. The confidence interval (CI) was set at 95%. Central macular thickness (CMT) and best-corrected visual acuity (BCVA) were employed to analyze the improvement of DME patients. Inclusion criteria for picking out studies were retrospective studies and randomized controlled trials (RCTs) that compared IVC and IVR for the treatment of diabetic macular edema.
Four retrospective studies and five RCTs were included with a total of 609 patients. No statistically significant difference was observed in mean CMT and mean BCVA in the baseline parameters [BCVA (WMD: -0.48; 95%CI: -1.06 to 0.10; =0.1), CMT (WMD: -0.83; 95%CI: -15.15 to 13.49; =0.91). No significant difference was found in the improvement of BCVA and adverse event (AE) in IVC group, compared with IVR group after treatment of loading dosage [the 1 month BCVA (WMD: 0.01; 95%CI: -0.26 to 0.27; =0.96), the 3 month BCVA (WMD: -0.04; 95%CI: -0.14 to 0.06; =0.46); the 6 month BCVA (WMD: -0.24; 95%CI: -1.62 to 1.14; =0.73)], AE (OR: 0.84; 95%CI: 0.38 to 1.84; =0.66)]. A slight difference was found in the effectiveness rate (OR: 1.70; 95%CI: 0.97 to 2.96; =0.06), There were statistically significant differences between IVC and IVR treatment in terms of CMT [1 month CMT (WMD: -19.88; 95%CI: -27.94 to -11.82; <0.001), 3 month CMT (WMD: -23.31; 95%CI: -43.30 to -3.33; =0.02), 6 month CMT (WMD: -74.74; 95%CI: -106.22 to -43.26; <0.001)].
Pooled evidence suggests that both IVC and IVR are effective in the therapy of diabetic macular edema and affirms that IVC presents superiority over IVR therapy in regard of CMT in patients with diabetic macular edema, but no statistically significant difference with regard to visual improvement. Relevant RCTs with longer-term follow-up are necessary to back up our conclusion.
评估玻璃体内注射康柏西普（IVC）和雷珠单抗（IVR）治疗糖尿病性黄斑水肿患者的疗效。
检索者检索了12个数据库，包括PubMed、Medline、EMBASE、Web of Science、Springer、ScienceDirect、OVID、Cochrane图书馆、ClinicalTrials.gov、维普资讯、万方数据和中国知网，检索截止至2018年12月28日。采用RevMan 5.3（英国牛津Cochrane图书馆软件）进行统计分析。应用固定效应模型和随机效应模型评估异质性。二分类变量采用比值比（OR）；连续变量采用加权均数差（WMD）。设定置信区间（CI）为95%。采用中心黄斑厚度（CMT）和最佳矫正视力（BCVA）分析糖尿病性黄斑水肿患者的改善情况。挑选研究的纳入标准为比较IVC和IVR治疗糖尿病性黄斑水肿的回顾性研究和随机对照试验（RCT）。
纳入4项回顾性研究和5项RCT，共609例患者。基线参数的平均CMT和平均BCVA未观察到统计学显著差异[BCVA（WMD：-0.48；95%CI：-1.06至0.10；P = 0.1），CMT（WMD：-0.83；95%CI：-15.15至13.49；P = 0.91）]。在负荷剂量治疗后，IVC组与IVR组相比，BCVA改善和不良事件（AE）方面未发现显著差异[1个月时的BCVA（WMD：0.01；95%CI：-0.26至0.27；P = 0.96），3个月时的BCVA（WMD：-0.04；95%CI：-0.14至0.06；P = 0.46）；6个月时的BCVA（WMD：-0.24；95%CI：-1.62至1.14；P = 0.73）]，AE（OR：0.84；95%CI：0.38至1.84；P = 0.66）]。有效率存在轻微差异（OR：1.70；95%CI：0.97至2.96；P = 0.06），IVC和IVR治疗在CMT方面存在统计学显著差异[1个月时的CMT（WMD：-19.88；95%CI：-27.94至-11.82；P < 0.001），3个月时的CMT（WMD：-23.31；95%CI：-43.30至-3.33；P = 0.02），6个月时的CMT（WMD：-74.74；95%CI：-106.22至-43.26；P < 0.001）]。
汇总证据表明，IVC和IVR在糖尿病性黄斑水肿治疗中均有效，并证实IVC在糖尿病性黄斑水肿患者的CMT方面优于IVR治疗，但在视力改善方面无统计学显著差异。需要进行长期随访的相关RCT来支持我们的结论。
