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BMJ:贝伐珠单抗治疗AMD优于标准方案

来源:生物谷 2010-06-25 15:17

英国一项研究显示,1.25 mg贝伐珠单抗玻璃体内注射对年龄相关黄斑变性(AMD)的疗效优于标准方案,且其所致眼部严重不良反应发生率低。研究发表于《英国医学杂志》。

英国3个眼科中心的131例AMD患者被随机分为标准治疗组和贝伐珠单抗组,其中,前组患者在试验开始时分别接受维替泊芬光动力治疗、哌加他尼钠玻璃体内注射或安慰性治疗,而后组患者则接受贝伐珠单抗治疗。

结果显示,5例患者由于药物不良反应、失访或死亡而未完成研究。贝伐珠单抗组患者视力较基线获得15个或以上字母改善者有21例(32%),而标准治疗组仅有2例(3%)(P<0.001);估计的校正后比值比(OR)为18.1。与标准治疗组相比,贝伐珠单抗组中视力较基线降低少于15个字母的患者所占比例显着较高(91%对67%,P<0.001)。贝伐珠单抗组患者平均视力提高7个字母,且该组患者从治疗18周开始的视力改善持续维持至第54周,而标准治疗组患者平均视力下降了9.4个字母(P<0.001)。在使用贝伐珠单抗治疗的65例患者中,无治疗相关的眼内炎或严重葡萄膜炎发生。(生物谷Bioon.net)

生物谷推荐原文出处:

BMJ doi:10.1136/bmj.c2459

Bevacizumab for neovascular age related macular degeneration (ABC Trial): multicentre randomised double masked study
Adnan Tufail, consultant ophthalmologist, medical retina department1, Praveen J Patel, locum consultant ophthalmologist1, Catherine Egan, consultant ophthalmologist1, Philip Hykin, consultant ophthalmologist1, Lyndon da Cruz, consultant ophthalmologist1, Zdenek Gregor, consultant ophthalmologist1, Jonathan Dowler, consultant ophthalmologist1, Mohammed A Majid, consultant ophthalmologist2, Clare Bailey, consultant ophthalmologist2, Quresh Mohamed, consultant ophthalmologist3, Robert Johnston, consultant ophthalmologist3, Catey Bunce, senior statistician, research and development department1, Wen Xing, statistician, research and development department1, ABC Trial Investigators

Objectives To evaluate the efficacy and safety of intravitreous bevacizumab injections for the treatment of neovascular age related macular degeneration.
Design Prospective, double masked, multicentre, randomised controlled trial.

Setting Three ophthalmology centres in the United Kingdom.

Participants 131 patients (mean age 81) with wet age related macular degeneration randomised 1:1 to intervention or control.

Interventions Intravitreous bevacizumab (1.25 mg, three loading injections at six week intervals followed by further treatment if required at six week intervals) or standard treatment available at the start of the trial (photodynamic treatment with verteporfin for predominantly classic type neovascular age related macular degeneration, or intravitreal pegaptanib or sham treatment for occult or minimally classic type neovascular age related macular degeneration).

Main outcome measures Primary outcome: proportion of patients gaining 15 letters of visual acuity at one year (54 weeks). Secondary outcomes: proportion of patients with stable vision and mean change in visual acuity.

Results Of the 131 patients enrolled in the trial, five patients did not complete the study because of adverse events, loss to follow-up, or death. In the bevacizumab group, 21 (32%) patients gained 15 or more letters from baseline visual acuity compared with two (3%) in the standard care group (P<0.001); the estimated adjusted odds ratio was 18.1 (95% confidence interval 3.6 to 91.2) and the number needed to treat was 4 (3 to 6). In addition, the proportion of patients who lost fewer than 15 letters of visual acuity from baseline was significantly greater among those receiving bevacizumab treatment (91% (59) v 67% (44) in standard care group; P<0.001). Mean visual acuity increased by 7.0 letters in the bevacizumab group with a median of seven injections compared with a decrease of 9.4 letters in the standard care group (P<0.001), and the initial improvement at week 18 (plus 6.6 letters) was sustained to week 54. Among 65 patients treated with bevacizumab, there were no cases of endophthalmitis or serious uveitis related to the intervention. All end points with respect to visual acuity in the study eye at 54 weeks favoured bevacizumab treatment over standard care.

Conclusions Bevacizumab 1.25 mg intavitreous injections given as part of a six weekly variable retreatment regimen is superior to standard care (pegaptanib sodium, verteporfin, sham), with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 54 weeks.

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