Health Services Research Unit, University of Aberdeen, Health Services Building, Aberdeen AB25 2ZD, UK.
BMJ. 2012 Aug 13;345:e5182. doi: 10.1136/bmj.e5182.
To indirectly compare the effectiveness of ranibizumab and bevacizumab in the treatment of diabetic macular oedema.
Systematic review and indirect comparison.
Medline (1996-September 2011), Embase (1996-September 2011), and the Cochrane Central Register of Controlled Trials (Issue 4, 2011).
Randomised trials evaluating ranibizumab or bevacizumab in diabetic macular oedema with a common comparator and sufficient methodological similarity to be included within an indirect comparison were eligible for inclusion.
The primary outcome was the proportion of patients with an improvement in best corrected visual acuity of more than two lines on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. Secondary outcomes included mean changes in best corrected visual acuity and in central macular thickness, and adverse events. Best corrected visual acuity was converted to logMAR units, a linear scale of visual acuity with positive values representing increasing visual loss. Indirect comparisons were done using Bayesian methods to estimate relative treatment effects of bevacizumab and ranibizumab.
Five randomised controlled trials with follow-up of 6-12 months and a common comparator (multiple laser treatment) were sufficiently similar to be included in the indirect comparison. Generally studies were small, resulting in wide credible intervals. The proportions of patients with an improvement in best corrected visual acuity of >2 lines were 21/77 participants (27%) for bevacizumab and 60/152 participants (39%) for ranibizumab (odds ratio 0.95 (95% credible interval 0.23 to 4.32)). The wide credible intervals cannot exclude a greater improvement, or worse outcome, for either drug. The mean change in best corrected visual acuity non-significantly favoured bevacizumab (treatment effect -0.08 logMAR units (-0.19 to 0.04)). The difference in mean change in central macular thickness was not statistically significant between ranibizumab and bevacizumab (treatment effect -6.9 μm (-88.5 to 65.4)).
Results suggest no difference in effectiveness between bevacizumab and ranibizumab, but the wide credible intervals cannot exclude the possibility that either drug might be superior. Sufficiently powered, direct head to head trials are needed.
间接比较雷珠单抗和贝伐单抗治疗糖尿病黄斑水肿的疗效。
系统评价和间接比较。
Medline（1996 年-2011 年 9 月）、Embase（1996 年-2011 年 9 月）和 Cochrane 对照试验中心注册库（2011 年第 4 期）。
纳入的随机试验必须评估雷珠单抗或贝伐单抗治疗糖尿病黄斑水肿的疗效，且有共同的对照药物，并且方法学上具有足够的相似性，以便进行间接比较。
主要结局是采用早期治疗糖尿病性视网膜病变研究（ETDRS）量表评估的最佳矫正视力提高两行以上的患者比例。次要结局包括最佳矫正视力和中央黄斑厚度的平均变化，以及不良反应。最佳矫正视力转换为对数最小分辨角对数（logMAR）单位，是一种表示视力损失的线性刻度，正值表示视力逐渐下降。采用贝叶斯方法进行间接比较，以估计贝伐单抗和雷珠单抗的相对治疗效果。
5 项随机对照试验的随访时间为 6-12 个月，采用共同的对照药物（多次激光治疗），这些研究足够相似，可以进行间接比较。通常情况下，这些研究规模较小，导致可信区间较宽。最佳矫正视力提高两行以上的患者比例分别为贝伐单抗组 21/77 例（27%）和雷珠单抗组 60/152 例（39%）（比值比 0.95，95%可信区间 0.23 至 4.32）。可信区间较宽不能排除两种药物中任何一种药物的改善效果或预后更差。最佳矫正视力的平均变化没有显著偏向贝伐单抗（治疗效果-0.08 logMAR 单位，-0.19 至 0.04）。雷珠单抗和贝伐单抗组之间中央黄斑厚度的平均变化差异无统计学意义（治疗效果-6.9μm，-88.5 至 65.4）。
结果表明，贝伐单抗和雷珠单抗的疗效无差异，但宽可信区间不能排除任何一种药物可能更优的可能性。需要进行足够大样本量的直接头对头试验。
