PDF(Pubmed)
Abstract：
OBJECTIVE: To evaluate the efficacy of intravitreal injection of conbercept (IVC) and ranibizumab (IVR) in patients with diabetic macular edema.
METHODS: 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.
RESULTS: 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; P=0.1), CMT (WMD: -0.83; 95%CI: -15.15 to 13.49; P=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 1st month BCVA (WMD: 0.01; 95%CI: -0.26 to 0.27; P=0.96), the 3rd month BCVA (WMD: -0.04; 95%CI: -0.14 to 0.06; P=0.46); the 6th month BCVA (WMD: -0.24; 95%CI: -1.62 to 1.14; P=0.73)], AE (OR: 0.84; 95%CI: 0.38 to 1.84; P=0.66)]. A slight difference was found in the effectiveness rate (OR: 1.70; 95%CI: 0.97 to 2.96; P=0.06), There were statistically significant differences between IVC and IVR treatment in terms of CMT [1st month CMT (WMD: -19.88; 95%CI: -27.94 to -11.82; P<0.001), 3rd month CMT (WMD: -23.31; 95%CI: -43.30 to -3.33; P=0.02), 6th month CMT (WMD: -74.74; 95%CI: -106.22 to -43.26; P<0.001)].
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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; P=0.1), CMT (WMD: -0.83; 95%CI: -15.15 to 13.49; P=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 1st month BCVA (WMD: 0.01; 95%CI: -0.26 to 0.27; P=0.96), the 3rd month BCVA (WMD: -0.04; 95%CI: -0.14 to 0.06; P=0.46); the 6th month BCVA (WMD: -0.24; 95%CI: -1.62 to 1.14; P=0.73)], AE (OR: 0.84; 95%CI: 0.38 to 1.84; P=0.66)]. A slight difference was found in the effectiveness rate (OR: 1.70; 95%CI: 0.97 to 2.96; P=0.06), There were statistically significant differences between IVC and IVR treatment in terms of CMT [1st month CMT (WMD: -19.88; 95%CI: -27.94 to -11.82; P<0.001), 3rd month CMT (WMD: -23.31; 95%CI: -43.30 to -3.33; P=0.02), 6th month CMT (WMD: -74.74; 95%CI: -106.22 to -43.26; P<0.001)].
CONCLUSIONS: 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.
摘要：
目的：观察玻璃体腔注射康柏西普（IVC）和雷珠单抗（IVR）治疗糖尿病性黄斑水肿的疗效。
方法：审稿人搜索了12个数据库，包括PubMed,Medline,EMBASE,WebofScience,Springer,ScienceDirect,OVID,科克伦图书馆,ClinicalTrials.gov,cqVIP,万方数据与中国国家知识基础设施(CNKI)，截至2018年12月28日。RevMan5.3(Cochrane图书馆软件，牛津,英国）用于统计分析。应用固定效应和随机效应模型评估异质性。赔率比（OR）适用于二分变量；加权平均差（WMD）适用于连续变量。置信区间(CI)设定为95%。采用中央黄斑厚度（CMT）和最佳矫正视力（BCVA）分析DME患者的改善情况。筛选研究的纳入标准是回顾性研究和随机对照试验（RCT），比较IVC和IVR治疗糖尿病性黄斑水肿。
结果：纳入了4项回顾性研究和5项随机对照研究，共609例患者。在基线参数[BCVA（WMD：-0.48;95CI：-1.06至0.10;P=0.1）中，平均CMT和平均BCVA无统计学差异，CMT（WMD：-0.83；95CI：-15.15至13.49；P=0.91）。IVC组BCVA和不良事件(AE)的改善无显著差异。与IVR组治疗后负荷剂量[第1个月BCVA（WMD：0.01;95CI：-0.26至0.27;P=0.96）相比，第3个月BCVA（WMD：-0.04；95CI：-0.14至0.06；P=0.46）；第6个月BCVA（WMD：-0.24；95CI：-1.62至1.14；P=0.73）]，AE（OR：0.84；95CI：0.38至1.84；P=0.66）]。有效率略有差异（OR：1.70；95CI：0.97至2.96；P=0.06），IVC和IVR治疗在CMT方面有统计学差异[CMT第1个月(WMD:-19.88;95CI:-27.94至-11.82;P<0.001)，CMT第3个月（大规模杀伤性武器：-23.31；95CI：-43.30至-3.33；P=0.02），第6个月CMT（WMD：-74.74；95CI：-106.22至-43.26；P<0.001）]。
结论：汇集的证据表明，IVC和IVR在糖尿病性黄斑水肿的治疗中都是有效的，并确认IVC在糖尿病性黄斑水肿患者的CMT方面优于IVR治疗。但在视觉改善方面无统计学差异。有必要进行长期随访的相关随机对照试验来支持我们的结论。
方法：审稿人搜索了12个数据库，包括PubMed,Medline,EMBASE,WebofScience,Springer,ScienceDirect,OVID,科克伦图书馆,ClinicalTrials.gov,cqVIP,万方数据与中国国家知识基础设施(CNKI)，截至2018年12月28日。RevMan5.3(Cochrane图书馆软件，牛津,英国）用于统计分析。应用固定效应和随机效应模型评估异质性。赔率比（OR）适用于二分变量；加权平均差（WMD）适用于连续变量。置信区间(CI)设定为95%。采用中央黄斑厚度（CMT）和最佳矫正视力（BCVA）分析DME患者的改善情况。筛选研究的纳入标准是回顾性研究和随机对照试验（RCT），比较IVC和IVR治疗糖尿病性黄斑水肿。
结果：纳入了4项回顾性研究和5项随机对照研究，共609例患者。在基线参数[BCVA（WMD：-0.48;95CI：-1.06至0.10;P=0.1）中，平均CMT和平均BCVA无统计学差异，CMT（WMD：-0.83；95CI：-15.15至13.49；P=0.91）。IVC组BCVA和不良事件(AE)的改善无显著差异。与IVR组治疗后负荷剂量[第1个月BCVA（WMD：0.01;95CI：-0.26至0.27;P=0.96）相比，第3个月BCVA（WMD：-0.04；95CI：-0.14至0.06；P=0.46）；第6个月BCVA（WMD：-0.24；95CI：-1.62至1.14；P=0.73）]，AE（OR：0.84；95CI：0.38至1.84；P=0.66）]。有效率略有差异（OR：1.70；95CI：0.97至2.96；P=0.06），IVC和IVR治疗在CMT方面有统计学差异[CMT第1个月(WMD:-19.88;95CI:-27.94至-11.82;P<0.001)，CMT第3个月（大规模杀伤性武器：-23.31；95CI：-43.30至-3.33；P=0.02），第6个月CMT（WMD：-74.74；95CI：-106.22至-43.26；P<0.001）]。
结论：汇集的证据表明，IVC和IVR在糖尿病性黄斑水肿的治疗中都是有效的，并确认IVC在糖尿病性黄斑水肿患者的CMT方面优于IVR治疗。但在视觉改善方面无统计学差异。有必要进行长期随访的相关随机对照试验来支持我们的结论。
