中国实用眼科杂志
中國實用眼科雜誌
중국실용안과잡지
CHINESE JOURNAL OF PRACTICAL OPHTHALMOLOGY
2015年
3期
271-275
,共5页
董晓萱%韩笑%姬菁文%阎启昌
董曉萱%韓笑%姬菁文%閻啟昌
동효훤%한소%희정문%염계창
糖尿病黄斑水肿%Meta分析%雷珠单抗%激光光凝
糖尿病黃斑水腫%Meta分析%雷珠單抗%激光光凝
당뇨병황반수종%Meta분석%뢰주단항%격광광응
Diabetic macular edema%Meta-analysis%Ranibizumab%Laser photocoagulation
目的 评价雷珠单抗玻璃体腔单药注射与联合激光光凝治疗糖尿病黄斑水肿(DME)有效性及安全性的差异.方法 计算机检索Pubmed、Cochrane协作网、Embase、CNKI、中国科技期刊全文数据库、中国生物医学文献数据库以及万方数据库,检索时间均从建库至2014年9月,并追述纳入文献的参考文献.获得的临床对照研究,通过纳入和排除标准限定,经质量评价后,采用RevMan 5.3软件进行Meta分析,获得以上两种方案治疗DME的疗效及安全性是否具有相关差异的相关证据.结果 纳入6篇临床对照研究(单药注射组445只眼,联合激光光凝447只眼),质量评分均为高质量文献.Meta分析结果显示,雷珠单抗联合视网膜激光组与单药注射组患者的最佳矫正视力提高幅度间差异有统计学意义[MD=-1.21,95％CI (-1.55,-0.87),P＜0.01];黄斑中心凹厚度降低比较差异无统计学意义[MD=4.48,95％CI(-13.21,22.17),P=0.62＞0.05];两组不良反应中结膜充血和球结膜下出血的发生率差异无统计学意义[OR=0.81, 95％CI (0.46,1.45),P=0.48＞0.05];白内障的发生率差异有统计学意义[0R=2.32,95％CI (1.03,5.20),P=0.04 ＜0.05].结论 现有的临床研究显示,雷珠单抗联合激光治疗DME时,比单药注射提高视力显著;对于降低黄斑水肿厚度的疗效两者无明显差别;但联合治疗会增加白内障的发生率.受纳入研究的质量影响,会影响结果的真实性,仍需更多多中心、大样本高质量随机对照研究对其验证.
目的 評價雷珠單抗玻璃體腔單藥註射與聯閤激光光凝治療糖尿病黃斑水腫(DME)有效性及安全性的差異.方法 計算機檢索Pubmed、Cochrane協作網、Embase、CNKI、中國科技期刊全文數據庫、中國生物醫學文獻數據庫以及萬方數據庫,檢索時間均從建庫至2014年9月,併追述納入文獻的參攷文獻.穫得的臨床對照研究,通過納入和排除標準限定,經質量評價後,採用RevMan 5.3軟件進行Meta分析,穫得以上兩種方案治療DME的療效及安全性是否具有相關差異的相關證據.結果 納入6篇臨床對照研究(單藥註射組445隻眼,聯閤激光光凝447隻眼),質量評分均為高質量文獻.Meta分析結果顯示,雷珠單抗聯閤視網膜激光組與單藥註射組患者的最佳矯正視力提高幅度間差異有統計學意義[MD=-1.21,95％CI (-1.55,-0.87),P＜0.01];黃斑中心凹厚度降低比較差異無統計學意義[MD=4.48,95％CI(-13.21,22.17),P=0.62＞0.05];兩組不良反應中結膜充血和毬結膜下齣血的髮生率差異無統計學意義[OR=0.81, 95％CI (0.46,1.45),P=0.48＞0.05];白內障的髮生率差異有統計學意義[0R=2.32,95％CI (1.03,5.20),P=0.04 ＜0.05].結論 現有的臨床研究顯示,雷珠單抗聯閤激光治療DME時,比單藥註射提高視力顯著;對于降低黃斑水腫厚度的療效兩者無明顯差彆;但聯閤治療會增加白內障的髮生率.受納入研究的質量影響,會影響結果的真實性,仍需更多多中心、大樣本高質量隨機對照研究對其驗證.
목적 평개뢰주단항파리체강단약주사여연합격광광응치료당뇨병황반수종(DME)유효성급안전성적차이.방법 계산궤검색Pubmed、Cochrane협작망、Embase、CNKI、중국과기기간전문수거고、중국생물의학문헌수거고이급만방수거고,검색시간균종건고지2014년9월,병추술납입문헌적삼고문헌.획득적림상대조연구,통과납입화배제표준한정,경질량평개후,채용RevMan 5.3연건진행Meta분석,획득이상량충방안치료DME적료효급안전성시부구유상관차이적상관증거.결과 납입6편림상대조연구(단약주사조445지안,연합격광광응447지안),질량평분균위고질량문헌.Meta분석결과현시,뢰주단항연합시망막격광조여단약주사조환자적최가교정시력제고폭도간차이유통계학의의[MD=-1.21,95％CI (-1.55,-0.87),P＜0.01];황반중심요후도강저비교차이무통계학의의[MD=4.48,95％CI(-13.21,22.17),P=0.62＞0.05];량조불량반응중결막충혈화구결막하출혈적발생솔차이무통계학의의[OR=0.81, 95％CI (0.46,1.45),P=0.48＞0.05];백내장적발생솔차이유통계학의의[0R=2.32,95％CI (1.03,5.20),P=0.04 ＜0.05].결론 현유적림상연구현시,뢰주단항연합격광치료DME시,비단약주사제고시력현저;대우강저황반수종후도적료효량자무명현차별;단연합치료회증가백내장적발생솔.수납입연구적질량영향,회영향결과적진실성,잉수경다다중심、대양본고질량수궤대조연구대기험증.
Objective To evaluate the efficacy and safety of monotherapy of intravitreal Ranibizumab (IVRBZ) and the combined-use of intravitreal Ranibizumab plus laser photocoagulation (IVRBZ+L) for diabetic macular edema (DME).Methods Databases including Pubmed,the Cochrane Library,Medline,Embase,CNKI,VIP,CBM and Wanfang were searched from the established date to September 2014,also the references of included studies were traced.The controlled trials on IVRBZ vs.IVRBZ+L for DME after study selection were scored highly by Jadad.Meta-analysis was conducted by RevMan 5.3 software.Results Six studies involved 445 eyes on IVRBZ and 447 eyes on IVRBZ+L were included in our study.Meta-analysis showed there was statistical difference in the best corrected visual acuity (BCVA) between the two treatments.[MD=-1.21,95％CI(-1.55,-0.87),P ＜0.01];and no statistical difference in the reduction in central macular thickness [MD=4.48,95％ CI(-13.21,22.17),P =0.62＞0.05].No significant differences were found between the two groups in conjunctival congestion and subconjunctival hemorrhage.[OR=0.81,95％CI(0.46,1.45),P =0.48＞ 0.05];but there was statistical difference in the cataract incidence between the two groups.[OR=2.32,95％CI(1.03,5.20),P =0.04＜0.05].Conclusions Current study shows that the IVRBZ+L is superior to IVRBZ on improving vision for the DME,and there is no difference of reducing macular edema between the two.But it also resulted in a high incidence of cataract.For the limitation of the quality of included studies may affect the outcomes,our conclusion need more high-quality clinical studies.
