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1.甘肃中医药大学中医临床学院,兰州 730930
2.甘肃中医药大学中西医结合学院,兰州 730930
3.甘肃省人民医院感染管理科,兰州 730000
4.甘肃中医药大学基础医学院,兰州 730930
硕士研究生。研究方向:中医药对内分泌疾病的防治。E-mail:2183601469@qq.com
教授,博士。研究方向:中医藏象理论及其应用。 E-mail:875532437@qq.com
收稿日期:2024-11-04,
修回日期:2025-03-25,
录用日期:2025-03-26,
纸质出版日期:2025-04-30
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关婧楠,宗庸央措,令娟,等.抗VEGF药物治疗糖尿病性黄斑水肿的系统评价再评价 [J].中国药房,2025,36(08):996-1000.
GUAN Jingnan,Zongyongyangcuo ,LING Juan,et al.Overview of systematic evaluation of anti-VEGF drugs in the treatment of diabetic macular oedema[J].ZHONGGUO YAOFANG,2025,36(08):996-1000.
关婧楠,宗庸央措,令娟,等.抗VEGF药物治疗糖尿病性黄斑水肿的系统评价再评价 [J].中国药房,2025,36(08):996-1000. DOI: 10.6039/j.issn.1001-0408.2025.08.19.
GUAN Jingnan,Zongyongyangcuo ,LING Juan,et al.Overview of systematic evaluation of anti-VEGF drugs in the treatment of diabetic macular oedema[J].ZHONGGUO YAOFANG,2025,36(08):996-1000. DOI: 10.6039/j.issn.1001-0408.2025.08.19.
目的
2
针对抗血管内皮生长因子(VEGF)药物治疗糖尿病性黄斑水肿(DME)的系统评价/Meta分析进行再评价,以期为该药的临床应用提供循证支持。
方法
2
检索中国知网、万方数据、维普网、中国生物医学文献服务系统、PubMed、Web of Science、Embase、Cochrane Library,收集抗VEGF药物治疗DME的系统评价/Meta分析,检索时间为建库至2024年3月。通过PRISMA2020声明、AMSTAR2量表和GRADE工具分别进行报告质量、方法学质量和证据质量评价,同时对系统评价/Meta分析的定量结果进行综合质量分析。
结果
2
共纳入22篇文献。PRISMA2020声明评价结果显示,13项研究的信息相对完整(≥21分),9项研究存在一定信息缺陷(18~<21分);AMSTAR2量表评价结果显示,21项研究的方法学质量均为极低级,1项研究为低级;GRADE工具评价结果显示,89个结局指标中,28个(31.46%)为高级,34个(38.20%)为中级,24个(26.97%)为低级,3个(3.37%)为极低级。综合质量分析结果显示,与激光光凝术比较,抗VEGF药物治疗后患者的最佳矫正视力改变,治疗1、6个月及1、2年视网膜厚度改变,以及治疗1、3、6个月后的最佳矫正视力和视网膜厚度均显著改善(
P
<0.05);与安慰剂比较,抗VEGF药物治疗1年后患者的最佳矫正视力显著改善(
P
<0.05);与类固醇药物比较,抗VEGF药物治疗6个月后患者的视网膜厚度显著增加(
P
<0.05)。与类固醇药物比较,抗VEGF药物治疗后患者的眼部、白内障、眼压的不良事件发生率均显著降低(
P
<0.05);与激光光凝术比较,抗VEGF药物治疗后患者的眼部不良事件发生率显著降低,死亡不良事件发生率显著升高(
P
<0.05)。
结论
2
抗VEGF药物治疗DME可能具有一定的疗效和安全性优势,但死亡不良事件的发生风险较高;纳入系统评价/Meta分析研究的证据质量大部分较高。
OBJECTIVE
2
To re-evaluate the use of systematic evaluation/meta-analysis of anti-VEGF drugs in the treatment of diabetic macular oedema (DME), aiming to provide evidence-based support for the clinical application of this medication.
METHODS
2
A comprehensive search was conducted across a range of databases, including CNKI, Wanfang data, VIP, CBM, PubMed, Web of Science, Embase, and Cochrane Library. The objective was to identify systematic evaluation/meta-analysis of anti-VEGF drugs for DME, with search time from the inception of the databases to March 2024. The report quality, methodological quality, and evidence quality were assessed by using PRISMA2020 statement, AMSTAR2 scale and GRADE tool. A comprehensive analysis of systematic evaluation/meta-analysis results was also conducted.
RESULTS
2
A total of 22 articles were included. According to the PRISMA2020 statement evaluation, 13 studies provided relatively complete information (≥21 points), while 9 studies had information deficiencies (18-<21 points). The AMSTAR 2 scale evaluation revealed that 21 studies had very low methodological quality, and one study had low methodological quality. The GRADE tool evaluation showed that out of 89 outcome indicators, 28 (31.46%) were classified as high-quality evidence, 34 (38.20%) as moderate-quality evidence, 24 (26.97%) as low-quality evidence, and 3 (3.37%) as very low-quality evidence. The comprehensive quality analysis results demonstrated that, compared with laser photocoagulation, anti-VEGF drugs significantly enhanced the improvement in best-corrected visual acuity (BCVA), as well as significant change in retinal thickness at 1 and 6 months, and 1 and 2 years post-treatment, and also in BCVA and retinal thickness at 1, 3, and 6 months post-treatment (
P
<0.05). Compared with placebo, patients treated with anti-VEGF drugs showed significant improveme
nt in BCVA after 1 year of treatment (
P
<0.05). However, when compared with corticosteroid drugs, patients treated with anti-VEGF drugs exhibited a significant increase in retinal thickness after 6 months of treatment (
P
<0.05). Compared with corticosteroid drugs, the incidence of adverse events related to the eyes, cataract formation and intraocular pressure were significantly decreased in patients treated with anti-VEGF drugs (
P
<0.05). Compared with laser photocoagulation, the incidence of ocular adverse events was significantly decreased in patients treated with anti-VEGF drugs, while the incidence of fatal adverse events was significantly increased (
P
<0.05).
CONCLUSIONS
2
Anti-VEGF therapy for DME may possess certain advantages in terms of efficacy and safety, but it is associated with a higher risk of fatal adverse events; the evidence included in systematic reviews/meta-analyses is of moderate to high quality.
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