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雷珠单抗联合光动力疗法与雷珠单抗单药疗法治疗年龄相关性黄斑变性的比较:一项随机对照试验的系统评价和荟萃分析

Combination of ranibizumab with photodynamic therapy vs ranibizumab monotherapy in the treatment of age-related macular degeneration: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Si Jun-Kang, Tang Kai, Bi Hong-Sheng, Guo Da-Dong, Guo Jun-Guo, Du Yu-Xiang, Cui Yan, Pan Xue-Mei, Wen Ying, Wang Xing-Rong

机构信息

Department of Ophthalmology, Shandong University of Traditional Chinese Medicine, Jinan 250002, Shandong Province, China.

Department of Ophthalmology, the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250002, Shandong Province, China.

出版信息

Int J Ophthalmol. 2014 Jun 18;7(3):541-9. doi: 10.3980/j.issn.2222-3959.2014.03.28. eCollection 2014.

Abstract

AIM

To compare the efficacy and safety of combination of ranibizumab with photodynamic therapy (PDT) vs ranibizumab monotherapy in the treatment of age-related macular degeneration (AMD).

METHODS

The Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, Pubmed, and Embase were searched. There were no language or data restrictions in the search for trials. Only randomized controlled trials (RCTs) were included. Methodological quality of the literatures was evaluated according to the Jadad Score. RevMan 5.2.6 software was used to do the meta-analysis.

RESULTS

Seven studies were included in our systematic review, among which four of them were included in quantitative analysis. The result shows that the ranibizumab monotherapy group had a better mean best corrected visual acuity (BCVA) change vs baseline at month 12 compared with that of the combination treatment group, and the statistical difference was significant (WMD, -2.61; 95% CI, -5.08 to -0.13; P=0.04). However, after the removal of one study, the difference between the two groups showed no significant difference (WMD, -2.29; 95% CI, -4.81 to 0.23; P=0.07). Meanwhile, no significant central retinal thickness (CRT) reduction was found in the combination treatment group and the ranibizumab monotherapy group at 12 months follow-up. Nevertheless, the combination group tended to have a greater reduction in CRT (WMD, -4.13µm; 95%CI, -25.88 to 17.63, P=0.71). The proportion of patients gaining more than 3 lines at month 12 in the ranibizumab group was higher than in the combination group and there was a significant difference (RR, 0.72; 95% CI, 0.54 to 0.95; P=0.02). Whereas there was no significant difference for the proportion of patients gaining more than 0 line at month 12 between the two groups (RR, 0.93; 95% CI, 0.76 to 1.15; P=0.52). The general tendency shows a reduction in ranibizumab retreatment number in the combination treatment group compared with the ranibizumab monotherapy group. As major adverse events, the differences in the number of eye pain, endophthalmitis, hypertension and arterial thromboembolic events were not significant between the two groups, and the incidence of serious adverse events in the two groups was very low.

CONCLUSION

For the maintenance of vision, the comparison of the combination of ranibizumab with PDT vs ranibizumab monotherapy shows no apparent difference. Compared with the combination of ranibizumab and PDT, patients treated with ranibizumab monothearpy may gain more visual acuity (VA) improvement. The combination treatment group had a tendency to reduce the number of ranibizumab retreatment. Both the two treatment strategies were well tolerated.

摘要

目的

比较雷珠单抗联合光动力疗法(PDT)与雷珠单抗单药治疗年龄相关性黄斑变性(AMD)的疗效和安全性。

方法

检索Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL)、Pubmed和Embase。检索试验时无语言或数据限制。仅纳入随机对照试验(RCT)。根据Jadad评分评估文献的方法学质量。使用RevMan 5.2.6软件进行荟萃分析。

结果

我们的系统评价纳入了7项研究,其中4项纳入定量分析。结果显示,与联合治疗组相比,雷珠单抗单药治疗组在第12个月时平均最佳矫正视力(BCVA)较基线的变化更好,且差异有统计学意义(加权均数差,-2.61;95%可信区间,-5.08至-0.13;P = 0.04)。然而,剔除一项研究后,两组间差异无统计学意义(加权均数差,-2.29;95%可信区间,-4.81至0.23;P = 0.07)。同时,在12个月随访时,联合治疗组和雷珠单抗单药治疗组的中心视网膜厚度(CRT)均未显著降低。不过,联合组CRT降低的趋势更大(加权均数差,-4.13μm;95%可信区间,-25.88至17.63,P = 0.71)。雷珠单抗组在第12个月时视力提高超过3行的患者比例高于联合组,且差异有统计学意义(相对危险度,0.72;95%可信区间,0.54至0.95;P = 0.02)。而两组在第12个月时视力提高超过0行的患者比例差异无统计学意义(相对危险度,0.93;95%可信区间,0.76至1.多中心前瞻性随机对照试验(RCT)是研究某种治疗方法有效性和安全性的最佳设计方案。多中心RCT可以在不同的医疗机构同时进行研究,纳入大量的患者,从而提高研究结果的代表性和可靠性。

15;P = 0.52)。总体趋势显示,联合治疗组与雷珠单抗单药治疗组相比,雷珠单抗再治疗次数减少。作为主要不良事件,两组间眼痛、眼内炎、高血压和动脉血栓栓塞事件的数量差异无统计学意义,且两组严重不良事件的发生率都很低。

结论

对于视力维持,雷珠单抗联合PDT与雷珠单抗单药治疗相比无明显差异。与雷珠单抗联合PDT相比,接受雷珠单抗单药治疗的患者可能视力改善更多。联合治疗组有减少雷珠单抗再治疗次数的趋势。两种治疗策略耐受性均良好。

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