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[贝伐单抗用于治疗渗出性年龄相关性黄斑变性的安全性和有效性]

[Safety and efficacy of using bevacizumab in the treatment of exudative age-related macular degeneration].

作者信息

Muzyka-Woźniak Maria, Oficjalska-Młyńczak Jolanta, Gołebiowska Bozena

机构信息

Z Osrodka Okulistyki Klinicznej NZOZ Spektrum.

出版信息

Klin Oczna. 2008;110(7-9):280-6.

PMID:19112862
Abstract

PURPOSE

To evaluate the efficacy and safety of intravitreal bevacizumab administered on "as required" basis in patients with exudative age-related macular degeneration (AMD).

MATERIAL AND METHODS

A prospective uncontrolled cohort study of patients with exudative AMD treated with intravitreal bevacizumab administered "as required" based on PRONTO reinjection criteria. Main outcome measures include standardized best-corrected visual acuity (BCVA) and central macular thickness (CMT) measured with optical coherence tomography (Stratus OCT).

RESULTS

153 eyes of 153 consecutive patients with AMD were treated with intravitreal bevacizumab injection, followed monthly and reinjected "as required". Mean follow-up time was 14.2 weeks (4-52 weeks). Distance BCVA improved from 0.79 log MAR at baseline to 0.69 at 4 weeks, 0.7 at 8 weeks, 0.64 at 12 weeks, 0.71 at 16 weeks and 0.63 at 20 weeks (p<.05). Near BCVA improved from 0.13 at baseline to 0.22 at 4 and 8 weeks, 0.25 at 12 weeks, 0.22 at 16 weeks and 0.28 at 20 weeks (p<.05). Mean CMT decreased from 395 microm at baseline to 265 at 4 weeks, 260 at 8 weeks, 268 at 12 weeks, 255 at 16 weeks and 257 at 20 weeks (p<.05). Mean time between first and second injection was 91.9 days, and between second and third injection 99.7 days. No adverse events were observed.

CONCLUSIONS

Short-term results suggest that intravitreal bevaciuzmab administered "as required" is safe and effective in patients with exudative AMD. "As required" schedule may decrease the risk of adverse events and lower the cost of treatment.

摘要

目的

评估玻璃体内注射贝伐单抗按需给药治疗渗出性年龄相关性黄斑变性(AMD)患者的疗效和安全性。

材料与方法

一项前瞻性非对照队列研究,对渗出性AMD患者根据PRONTO再注射标准按需给予玻璃体内注射贝伐单抗治疗。主要观察指标包括用光学相干断层扫描(Stratus OCT)测量的标准化最佳矫正视力(BCVA)和中心黄斑厚度(CMT)。

结果

153例连续的AMD患者的153只眼接受了玻璃体内注射贝伐单抗治疗,随后每月随访并按需再次注射。平均随访时间为14.2周(4 - 52周)。远距离BCVA从基线时的0.79 log MAR改善至4周时的0.69、8周时的0.7、12周时的0.64、16周时的0.71和20周时的0.63(p<0.05)。近距离BCVA从基线时的0.13改善至4周和8周时的0.22、12周时的0.25、16周时的0.22和20周时的0.28(p<0.05)。平均CMT从基线时的395微米降至4周时的265、8周时的260、12周时的268、16周时的255和20周时的257(p<0.05)。首次和第二次注射之间的平均时间为91.9天,第二次和第三次注射之间为99.7天。未观察到不良事件。

结论

短期结果表明,按需给予玻璃体内注射贝伐单抗治疗渗出性AMD患者是安全有效的。按需给药方案可能会降低不良事件风险并降低治疗成本。

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