地塞米松玻璃体内植入剂治疗继发黄斑水肿安全性与有效性的Meta分析  

Safety and Efficacy of Dexamethasone Intravitreal Implant in Secondary Macular Edema Patients:A Metaanalysis

作　　者：赵紫楠[1] 吕俊玲[1] 田超 李超[1] 李婷[1] 李可欣[1] 薛薇[1] 谭玲[1] ZHAO Zi-nan;Lü Jun-ling;TIAN Chao;LI Chao;LI Ting;LI Ke-xin;XUE Wei;TAN Ling(Department of Pharmacy,National Center of Gerontology,Clinical Trial Center,Beijing Hospital,Beijing 100730,China;Department of Pharmacy,Beijing Children's Hospital Affiliated to The Capital Medical University,National Center for Children's Health,Beijing 100045,China)

机构地区：[1]北京医院药学部,国家老年医学中心,药物临床风险与个体化应用评价北京市重点实验室,临床试验研究中心,北京100730 [2]首都医科大学附属北京儿童医院药学部,国家儿童医学中心,北京100045

出　　处：《中国药学杂志》2020年第8期643-649,共7页Chinese Pharmaceutical Journal

摘　　要：目的系统评价地塞米松玻璃体内植入剂(dexamethasone intravitreal implant,DEX)治疗继发黄斑水肿(macular edema,ME)的安全性和有效性。方法检索有关数据库,纳入评价地塞米松玻璃体内植入剂治疗继发ME的随机对照试验(randomized controlled trial,RCT)。检索时间截至2019年4月。按纳入与排除标准筛选文献、提取资料并评价纳入研究的方法学质量后,采用Rev Man5.3软件进行Meta分析。结果共9项RCTs纳入分析,包括1530例患者,试验组737例,对照组793例。试验组患者使用药物为DEX,对照组患者使用药物为抗血管内皮生长因子(vascular endothelial growth factor,VEGF)和/或假注射。有效性结局显示,在视网膜静脉阻塞(retinal vein occlusion,RVO)继发ME人群,DEX在最佳矫正视力(best corrected visual acuity,BCVA)改善率上显著优于抗-VEGF治疗[MD=-10.59,95%CI:-13.96^-7.23,P=0.01]。DEX在糖尿病黄斑水肿(diabetic macular edema,DME)人群中降低中央子域厚度(central subfield thickness,CST)/视网膜中央厚度(central retinal thickness,CRT)显著优于抗-VEGF[MD=-63.60,95%CI:-114.83^-12.37,P=0.01],但在RVO继发ME人群DEX降低CST/CRT效果显著劣于anti-VEGF[MD=114.89,95%CI:48.68~181.09,P=0.00]。安全性结局显示,在RVO继发ME人群,DEX治疗的严重不良事件(serious adverse event,SAE)发生率显著高于抗-VEGF治疗[9.36%(28/299)比5.23%(19/363),RR=1.94,95%CI:1.05~3.59,P=0.04]。在RVO继发ME人群,DEX导致白内障或白内障加重发生率显著高于抗-VEGF治疗[4.87%(22/452)比0.97%(5/513),RR=5.06,95%CI:1.96~13.06,P=0.00]。结论在DME人群,DEX较抗-VEGF有更好的疗效,安全性相当。在RVO继发ME人群中,DEX疗效与抗-VEGF相当,安全性劣于抗-VEGF。OBJECTIVE To systematically review the safety and efficacy of dexamethasone intravitreal implant(DEX)in secondary macular edema(ME)patients.METHODS Multiple databases were searched electronically for randomized controlled trials(RCTs)of DEX in secondary ME patients up to April 2019.Two reviewers independently screened literatures according to the inclusion and exclusion criteria,extracted data,and assessed the methodological quality of the included studies.Then Meta-analysis was performed using Rev Man 5.3 software.RESULTS A total of nine randomized controlled trials involving 1530 patients were included.There were 737 patients in the experimental group and 793 patients in the control group.DEX was retrieved.Anti-vascular endothelial growth factor(anti-VEGF)or sham injection were used to treat the patients in the control group.The efficacy analysis results showed that the improvement rate of best corrected visual acuity(BCVA)in DEX group was significant higher than the control group in retinal vein occlusion(RVO)patients[MD=-10.59,95%CI:-13.96--7.23,P=0.01].The CST/CRT decrease in DEX was significant lower than control group in diabetic macular edema(DME)patients[MD=-63.60,95%CI:-114.83--12.37,P=0.01],but higher than the control group in RVO[MD=-114.89,95%CI:-48.68--181.09,P=0.00].The safty analysis results showed that the incidence of serious adverse events(SAEs)in DEX was significant higher than control group[9.36%(28/299):5.23%(19/363),RR=1.94,95%CI:1.05-3.59,P=0.04]in RVO.The cataractin DEX was significant higher in RVO[4.87%(22/452):0.97%(5/513),RR=5.06,95%CI:1.96-13.06,P=0.00]than the control group.CONCLUSION DEX has better efficacy than anti-VEGF in DME patients.DEX is similar in efficacy but inferior in safety to anti-VEGF in patients with ME secondary to RVO.

关 键 词：地塞米松玻璃体内植入剂 黄斑水肿 系统评价 META分析 随机对照试验 

分 类 号：R969.3[医药卫生—药理学]