Abstract：
BACKGROUND: Intravitreal injection anti-vascular endothelial growth factor (IVI anti-VEGF) therapy serves as the primary treatment for centre involving diabetic macular oedema (DMO). Conventional laser therapy (CLT) adjunct has proven beneficial; however, it is not widely used due to significant risks of retinal scarring. Subthreshold micropulse laser (SML) therapy has, however, emerged as a comparable alternative to combination therapy, offering a distinct advantage by mitigating the risk of retinal scarring.
METHODS: A search of six databases was conducted. A meta-analysis of mean differences was performed including subgroup analyses where appropriate. Primary outcome was the number of injections at 12-14 months; secondary outcomes were changes in central macular thickness (CMT) and best corrected visual acuity (BCVA) at 6-8 months and 12-14 months.
RESULTS: A total of ten papers including six randomised clinical trials and four retrospective clinical studies were included in our study, capturing 563 eyes of 478 patients. Overall, the risk of bias was moderate for these studies. Significantly fewer anti-VEGF therapy injections were administered in the combination therapy versus anti-VEGF monotherapy patients at 12-14 months who had poor visual acuity (6/18 Snellen or worse) at baseline, mean difference - 2.25 (95% CI; - 3.35, - 1.15; p < 0.05). Combination therapy was not associated with significantly fewer intravitreal injections in patients with a higher visual acuity (6/15 Snellen or better) at baseline. Our analysis also showed significant improvements to both BCVA and CMT were reached at 6 - 8 month post-baseline at the 95% confidence intervals: - 1.13 (- 2.09, - 0.16) and - 4.04 (- 7.59, - 0.50). These improvements remained statistically significant at 12-14 months: - 0.94 (- 1.67, - 0.20) and - 1.92 (- 3.52, - 0.32) respectively with combination therapy.
CONCLUSIONS: Our findings demonstrate that combination therapy (SML + IVI anti-VEGF) is associated with fewer intravitreal injections. We report a better BCVA and a reduction in CMT at 6 and 12 months from baseline with combination treatment compared to the IVI anti-VEGF monotherapy comparator. SML is a proven non-scarring cost-effective therapy for DMO that should be readily available in the medical retinal therapy as it may reduce the burden of care.
METHODS: A search of six databases was conducted. A meta-analysis of mean differences was performed including subgroup analyses where appropriate. Primary outcome was the number of injections at 12-14 months; secondary outcomes were changes in central macular thickness (CMT) and best corrected visual acuity (BCVA) at 6-8 months and 12-14 months.
RESULTS: A total of ten papers including six randomised clinical trials and four retrospective clinical studies were included in our study, capturing 563 eyes of 478 patients. Overall, the risk of bias was moderate for these studies. Significantly fewer anti-VEGF therapy injections were administered in the combination therapy versus anti-VEGF monotherapy patients at 12-14 months who had poor visual acuity (6/18 Snellen or worse) at baseline, mean difference - 2.25 (95% CI; - 3.35, - 1.15; p < 0.05). Combination therapy was not associated with significantly fewer intravitreal injections in patients with a higher visual acuity (6/15 Snellen or better) at baseline. Our analysis also showed significant improvements to both BCVA and CMT were reached at 6 - 8 month post-baseline at the 95% confidence intervals: - 1.13 (- 2.09, - 0.16) and - 4.04 (- 7.59, - 0.50). These improvements remained statistically significant at 12-14 months: - 0.94 (- 1.67, - 0.20) and - 1.92 (- 3.52, - 0.32) respectively with combination therapy.
CONCLUSIONS: Our findings demonstrate that combination therapy (SML + IVI anti-VEGF) is associated with fewer intravitreal injections. We report a better BCVA and a reduction in CMT at 6 and 12 months from baseline with combination treatment compared to the IVI anti-VEGF monotherapy comparator. SML is a proven non-scarring cost-effective therapy for DMO that should be readily available in the medical retinal therapy as it may reduce the burden of care.
摘要：
背景：玻璃体腔注射抗血管内皮生长因子（IVI抗VEGF）治疗是糖尿病性黄斑水肿（DMO）中心的主要治疗方法。传统的激光治疗（CLT）辅助已被证明是有益的；然而，由于视网膜瘢痕形成的重大风险，它没有被广泛使用。亚阈值微脉冲激光（SML）治疗，然而,作为联合疗法的可比替代品，通过降低视网膜疤痕的风险提供了一个明显的优势。
方法：检索6个数据库。进行了平均差异的荟萃分析，包括适当的亚组分析。主要结果是12-14个月的注射次数；次要结果是6-8个月和12-14个月的中央黄斑厚度（CMT）和最佳矫正视力（BCVA）的变化。
结果：本研究共纳入10篇论文，包括6项随机临床试验和4项回顾性临床研究。捕获478名患者的563只眼睛。总的来说,这些研究的偏倚风险适中.在12-14个月时，联合治疗与抗VEGF单一治疗患者相比，在基线时视力差（6/18Snellen或更差）的抗VEGF治疗注射明显减少，平均差异-2.25（95%CI；-3.35，-1.15；p<0.05）。在基线时具有较高视敏度(6/15Snellen或更好)的患者中,联合治疗与显著较少的玻璃体内注射无关。我们的分析还显示BCVA和CMT在基线后6-8个月在95%置信区间达到显著改善:-1.13(-2.09,-0.16)和-4.04(-7.59,-0.50)。这些改善在12-14个月时仍具有统计学意义：联合治疗分别为-0.94（-1.67，-0.20）和-1.92（-3.52，-0.32）。
结论：我们的发现表明联合治疗（SML+IVI抗VEGF）与较少的玻璃体内注射相关。我们报告了与IVI抗VEGF单一疗法比较物相比，联合治疗在6个月和12个月时BCVA更好，CMT减少。SML是经证实的DMO的非瘢痕形成成本有效的疗法,其应该在医学视网膜疗法中容易获得,因为其可以减轻护理负担。
方法：检索6个数据库。进行了平均差异的荟萃分析，包括适当的亚组分析。主要结果是12-14个月的注射次数；次要结果是6-8个月和12-14个月的中央黄斑厚度（CMT）和最佳矫正视力（BCVA）的变化。
结果：本研究共纳入10篇论文，包括6项随机临床试验和4项回顾性临床研究。捕获478名患者的563只眼睛。总的来说,这些研究的偏倚风险适中.在12-14个月时，联合治疗与抗VEGF单一治疗患者相比，在基线时视力差（6/18Snellen或更差）的抗VEGF治疗注射明显减少，平均差异-2.25（95%CI；-3.35，-1.15；p<0.05）。在基线时具有较高视敏度(6/15Snellen或更好)的患者中,联合治疗与显著较少的玻璃体内注射无关。我们的分析还显示BCVA和CMT在基线后6-8个月在95%置信区间达到显著改善:-1.13(-2.09,-0.16)和-4.04(-7.59,-0.50)。这些改善在12-14个月时仍具有统计学意义：联合治疗分别为-0.94（-1.67，-0.20）和-1.92（-3.52，-0.32）。
结论：我们的发现表明联合治疗（SML+IVI抗VEGF）与较少的玻璃体内注射相关。我们报告了与IVI抗VEGF单一疗法比较物相比，联合治疗在6个月和12个月时BCVA更好，CMT减少。SML是经证实的DMO的非瘢痕形成成本有效的疗法,其应该在医学视网膜疗法中容易获得,因为其可以减轻护理负担。
