Wang Wen-Jie, Chen Jian, Zhang Xiao-Ling, Yao Min, Liu Xiao-Yong, Zhou Qing, Qu Yi-Xin
Department of Ophthalmology, the First Affiliated Hospital of Jinan University, Guangzhou 510632, Guangdong Province, China.
Int J Ophthalmol. 2015 Feb 18;8(1):138-47. doi: 10.3980/j.issn.2222-3959.2015.01.26. eCollection 2015.
To systematically compare the efficacy and safety of off-label bevacizumab versus licensed ranibizumab intravitreal injections as well as monthly regimen versus pro re nata [PRN (as needed)] regimen in the treatment of neovascular age-related macular degeneration (nAMD).
Relevant publications were identified through automatically retrieve of database and manually retrieving. The methodological quality of studies included was assessed using the Jadad score and the risk-of-bias assessment. The efficacy estimates were measured by the weight mean difference (WMD) for the improvement of best-corrected visual acuity (BCVA) and central retinal thickness (CRT) reduction. The safety estimates were measured by odds ratios (OR) for adverse events rates. Statistical analysis was conducted by Revman 5.2.7.
Seven studies were included in the Meta-analysis. There were no statistically significant differences between bevacizumab and ranibizumab in BCVA at 1 and 2y (P=0.37, P=0.18, respectively), However, both drugs has better BCVA given monthly than given as needed at 1 and 2y (P<0.05). The results demonstrated the mean decrease in CRT was less in bevacizumab group than ranibizumab group at 1y (P<0.05), while the difference was not significant at 2y (P=0.24). Treatment monthly gained much more decrease in CRT at 1 and 2y (P<0.005). There were no differences between drugs in the rates of death, arterial thrombotic events and venous thrombotic events (P=0.41, P=0.55, P=0.10, respectively), while the rates of medical dictionary for regulatory activities (MedDAR) system organ class events and ≥1 systemic serious adverse events were higher in bevacizumab group than ranibizumab group (P<0.05). But the incidences of death, arterial thrombotic events, venous thrombotic events, MedDAR system organ class events as well as ≥1 systemic serious adverse events were not statistically different between both treatment regimens of monthly and as needed (P=0.14, P=0.76, P=0.73, P=0.12, P=0.11, respectively).
Bevacizumab was equivalent to ranibizumab for BCVA, however bevacizumab tended to gain less decrease in CRT and had higher rates of serious adverse events. Compared with treatment as needed, treatment monthly showed superior efficacy in BCVA improvement and CRT reduction, while the rates of adverse events were similar in the two dosing regimens.
系统比较玻璃体内注射未获批准的贝伐单抗与已获许可的雷珠单抗,以及每月给药方案与按需给药方案在治疗新生血管性年龄相关性黄斑变性(nAMD)中的疗效和安全性。
通过数据库自动检索和手动检索来识别相关出版物。使用Jadad评分和偏倚风险评估对纳入研究的方法学质量进行评估。疗效评估通过改善最佳矫正视力(BCVA)的加权平均差(WMD)和视网膜中央厚度(CRT)降低来衡量。安全性评估通过不良事件发生率的比值比(OR)来衡量。采用Revman 5.2.7进行统计分析。
Meta分析纳入了7项研究。贝伐单抗和雷珠单抗在1年和2年时的BCVA方面无统计学显著差异(分别为P = 0.37,P = 0.18),然而,在1年和2年时,两种药物每月给药时的BCVA均优于按需给药(P < 0.05)。结果显示,在1年时,贝伐单抗组CRT的平均降低幅度小于雷珠单抗组(P < 0.05),而在2年时差异不显著(P = 0.24)。每月治疗在1年和2年时CRT的降低幅度更大(P < 0.005)。在死亡、动脉血栓事件和静脉血栓事件发生率方面,两种药物无差异(分别为P = 0.41,P = 0.55,P = 0.10),而贝伐单抗组的监管活动医学词典(MedDAR)系统器官分类事件和≥1次全身性严重不良事件发生率高于雷珠单抗组(P < 0.05)。但在每月给药和按需给药两种治疗方案之间,死亡、动脉血栓事件、静脉血栓事件、MedDAR系统器官分类事件以及≥1次全身性严重不良事件的发生率无统计学差异(分别为P = 0.14,P = 0.76,P = 0.73,P = 0.12,P = 0.11)。
贝伐单抗在BCVA方面与雷珠单抗相当,然而贝伐单抗在CRT降低方面的幅度往往较小,且严重不良事件发生率较高。与按需治疗相比,每月治疗在改善BCVA和降低CRT方面显示出更好的疗效,而两种给药方案的不良事件发生率相似。