The relative clinical effectiveness of ranibizumab and bevacizumab in diabetic macular oedema: an indirect comparison in a systematic review.

The relative clinical effectiveness of ranibizumab and bevacizumab in diabetic macular oedema: an indirect comparison in a systematic review.
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DOI:
10.1136/bmj.e5182
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发表时间:
2012-08-13
期刊:
BMJ (Clinical research ed.)
影响因子:
--
通讯作者:
Waugh N
Waugh N
中科院分区:
其他
文献类型:
--
作者:
Ford JA;Elders A;Shyangdan D;Royle P;Waugh N

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目的间接比较雷珠单抗与贝伐单抗治疗糖尿病性黄斑水肿的疗效。设计系统审查和间接比较。数据来源 Medline(1996 年至 2011 年 9 月)、Embase(1996 年至 2011 年 9 月)和 Cochrane 对照试验中央注册库(2011 年第 4 期)。研究的选择标准 使用共同比较器评估雷珠单抗或贝伐单抗治疗糖尿病黄斑水肿的随机试验,并且具有足够的方法学相似性以纳入间接比较,符合纳入条件。 主要结果指标 主要结果是早期治疗糖尿病视网膜病变研究 (ETDRS) 量表中最佳矫正视力提高超过两行的患者比例。次要结局包括最佳矫正视力和黄斑中心厚度的平均变化以及不良事件。最佳矫正视力被转换为 logMAR 单位,这是视力的线性标度,正值代表视力丧失增加。使用贝叶斯方法进行间接比较,以估计贝伐珠单抗和雷珠单抗的相对治疗效果。 结果 五项随访 6-12 个月的随机对照试验和一个共同的比较器(多次激光治疗)足够相似,可以纳入间接比较。一般来说,研究规模较小,导致可信区间较宽。贝伐单抗组最佳矫正视力改善>2线的患者比例为21/77名受试者(27%),雷珠单抗组为60/152名受试者(39%)(比值比0.95(95%可信区间0.23至4.32))。广泛的可信区间不能排除这两种药物有更大的改善或更差的结果。最佳矫正视力的平均变化不显着有利于贝伐珠单抗(治疗效果-0.08 logMAR单位(-0.19至0.04))。雷珠单抗和贝伐单抗之间黄斑中心厚度平均变化的差异不具有统计学意义(治疗效果-6.9μm(-88.5至65.4))。结论 结果表明贝伐珠单抗和雷珠单抗之间的有效性没有差异,但广泛的可信区间不能排除任何一种药物可能更优越的可能性。需要有足够的动力、直接的头对头试验。
Objective To indirectly compare the effectiveness of ranibizumab and bevacizumab in the treatment of diabetic macular oedema. Design Systematic review and indirect comparison. Data sources Medline (1996–September 2011), Embase (1996–September 2011), and the Cochrane Central Register of Controlled Trials (Issue 4, 2011). Selection criteria for studies 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. Main outcome measures 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. Results 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)). Conclusions 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.
DOI: 10.1016/j.ophtha.2010.12.033
发表时间: 2011-04
期刊: Ophthalmology
影响因子: 13.7
作者:
Elman MJ;Bressler NM;Qin H;Beck RW;Ferris FL 3rd;Friedman SM;Glassman AR;Scott IU;Stockdale CR;Sun JK;Diabetic Retinopathy Clinical Research Network
通讯作者: Diabetic Retinopathy Clinical Research Network
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期刊: Retina (Philadelphia, Pa.)
影响因子: --
作者:
Diabetic Retinopathy Clinical Research Network;Googe J;Brucker AJ;Bressler NM;Qin H;Aiello LP;Antoszyk A;Beck RW;Bressler SB;Ferris FL 3rd;Glassman AR;Marcus D;Stockdale CR
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