Bevacizumab与Ranibizumab治疗新生血管性眼病的疗效及安全性的Meta分析
Bevacizumab여Ranibizumab치료신생혈관성안병적료효급안전성적Meta분석
Efficacy and safety in treatment of ocular neovascularization by Bevacizumab versus Ranibizumab: meta-analysis
  • 万方数据
    中华眼科杂志 중화안과잡지
    Chinese Journal of Ophthalmology
    2010年 3期 263-267 ,共5页

    麻南%贺翔鸽

    마남%하상합

    抗体,单克隆%新生血管化,病理性%眼疾病%Meta分析 抗體,單剋隆%新生血管化,病理性%眼疾病%Meta分析
    항체,단극륭%신생혈관화,병이성%안질병%Meta분석
    Antibodies,monoclonal%Neovascularization,pathologic%Eye diseases%Meta-analysis
    目的 评价Bevacizumab与Ranibizumab玻璃体腔内注射治疗新生血管性眼病的有效性及安全性.方法 荟萃分析.采用Cochrane系统评价方法,检索Medline(1966至2009年)、Embase(1966至2009年)、Cochrane图书馆(2009年)及中国生物医学文献数据库CBM(1979至2009年)有关Bevacizumab与Ranibizumab治疗新生血管性眼病的临床研究文献资料,按照纳入和排除标准限定研究对象,通过Jadad评分量表进行文献质量评估后,使用Cochrane协作网提供的RevMan 4.2统计软件进行数据分析.Bevacizumab与Ranibizumab治疗新生血管性眼病的疗效和安全性比较采用合并效应检验,结果以Z值表示.结果 共纳入Bevacizumab与Ranibizumab治疗新生血管性眼病的临床对照研究7项(1620只眼).各项研究中的疗效存在异质性,采用随机效应模型,将纳入的研究结果进行Meta分析.结果 显示,Bevacizumab治疗组患者的logMAR视力从治疗前的一0.9031±0.0323提高至-0.7635±0.0214,平均提高了0.1396±0.0225;Ranibizumab治疗组患者的logMAR视力从治疗前的-0.9345±0.0194提高至-0.8050±0.0221,平均提高了0.1295±0.0203;两组患者治疗前后,logMAR视力差异无统计学意义(Z=0.56,P=0.57).Bevacizumab治疗组患者的黄斑中心凹厚度从治疗前的(325.4±52.3)μm降至(269.1±21.3)μm,平均降低了(56.3±18.5)μm;Ranibizumab治疗组患者的黄斑中心凹厚度从治疗前的(342.0±45.1)μm 降至(277.2±35.5)μm,平均降低了(67.8±23.2)μm,两组患者治疗前后,降低黄斑中心凹厚度的差异无统计学意义(Z=1.13,P=0.26).Bevacizumab治疗组患者注射部位炎症发生率为4.1%(34/823只眼),Ranibizumab治疗组患者注射部位炎症发生率为3.8%(30/797只眼),两组患者注射部位炎症发生率差异无统计学意义(Z=0.74,P=0.46).Bevacizumab治疗组患者结膜下出血发生率为3.3%(27/823只眼),Ranibizumab治疗组患者结膜下出血发生率为3.4%(27/797只眼),两组患者结膜下出血发生率差异无统计学意义(Z=0.98,P=0.33).Bevacizumab治疗组总体的并发症和不良反应发生率为10.2%(84/823只眼),Ranibizumab治疗组总体的并发症和不良反应发生率为9.5%(76/797只眼),两组间并发症和不良反应的发生率差异也无统计学意义(χ~2=0.21,P=0.65).结论 Meta分析结果表明Bevacizumab与Ranizumab治疗新生血管性眼病具有相似的疗效和安全性,但尚需高质量的前瞻性研究结果进一步证实.
    목적 평개Bevacizumab여Ranibizumab파리체강내주사치료신생혈관성안병적유효성급안전성.방법 회췌분석.채용Cochrane계통평개방법,검색Medline(1966지2009년)、Embase(1966지2009년)、Cochrane도서관(2009년)급중국생물의학문헌수거고CBM(1979지2009년)유관Bevacizumab여Ranibizumab치료신생혈관성안병적림상연구문헌자료,안조납입화배제표준한정연구대상,통과Jadad평분량표진행문헌질량평고후,사용Cochrane협작망제공적RevMan 4.2통계연건진행수거분석.Bevacizumab여Ranibizumab치료신생혈관성안병적료효화안전성비교채용합병효응검험,결과이Z치표시.결과 공납입Bevacizumab여Ranibizumab치료신생혈관성안병적림상대조연구7항(1620지안).각항연구중적료효존재이질성,채용수궤효응모형,장납입적연구결과진행Meta분석.결과 현시,Bevacizumab치료조환자적logMAR시력종치료전적일0.9031±0.0323제고지-0.7635±0.0214,평균제고료0.1396±0.0225;Ranibizumab치료조환자적logMAR시력종치료전적-0.9345±0.0194제고지-0.8050±0.0221,평균제고료0.1295±0.0203;량조환자치료전후,logMAR시력차이무통계학의의(Z=0.56,P=0.57).Bevacizumab치료조환자적황반중심요후도종치료전적(325.4±52.3)μm강지(269.1±21.3)μm,평균강저료(56.3±18.5)μm;Ranibizumab치료조환자적황반중심요후도종치료전적(342.0±45.1)μm 강지(277.2±35.5)μm,평균강저료(67.8±23.2)μm,량조환자치료전후,강저황반중심요후도적차이무통계학의의(Z=1.13,P=0.26).Bevacizumab치료조환자주사부위염증발생솔위4.1%(34/823지안),Ranibizumab치료조환자주사부위염증발생솔위3.8%(30/797지안),량조환자주사부위염증발생솔차이무통계학의의(Z=0.74,P=0.46).Bevacizumab치료조환자결막하출혈발생솔위3.3%(27/823지안),Ranibizumab치료조환자결막하출혈발생솔위3.4%(27/797지안),량조환자결막하출혈발생솔차이무통계학의의(Z=0.98,P=0.33).Bevacizumab치료조총체적병발증화불량반응발생솔위10.2%(84/823지안),Ranibizumab치료조총체적병발증화불량반응발생솔위9.5%(76/797지안),량조간병발증화불량반응적발생솔차이야무통계학의의(χ~2=0.21,P=0.65).결론 Meta분석결과표명Bevacizumab여Ranizumab치료신생혈관성안병구유상사적료효화안전성,단상수고질량적전첨성연구결과진일보증실.
    Objective To evaluate the efficacy and safety in treatment of ocular neovascularization by Bevacizumab versus Ranibizumab.Methods It was a systematic review and meta-analysis.According to evaluation guidelines of Cochrane collaboration,clinical controlled trials(CCTs)comparing Bevacizumab and Ranibizumab in treatment of ocular neovascularization were searched using Medline,EMbase,the Cochrane Library and CBM.Methodology qualities of literatures were performed by experienced researchers according to the Jadad Score.RevMan 4.2 offered by Cochrane was used to do the meta-analysis.The differences of efficacy and safety in treatment of ocular neovascularization by Bevacizumab versus Ranibizumab were analyzed through statistical test for incorporative effect(the test results were shown by Z value).Results Only 7 literatures came into meta-analysis(1620 eyes).The result of analysis showed that Bevacizumab could improve the BCVA and cut down the CFT in treatment of ocular neovascularization,and that Bevacizumab did not display any statistically difference in improving best-corrected visual acuity(converted to logMAR,Bevacizumab group,from -0.9031±0.0323 to -0.7635±0.0214,improving by 0.1396±0.0225:anibizumab group,from -0.9345±0.0194 to -0.8050±0.0221,improving by 0.1295±0.0203,Z=0.56,P=0.57),and cutting down the central foveal thickness [Bevacizumab group,from (325.4±52.3)μm to (269.1±21.3)μm,cutting down by(56.3±18.5)μm;Ranibizumab group,from (342.0±45.1)μm to(277.2±35.5)μm,cutting down by(67.8±23.2)μm,Z=1.13,P=0.26] and safety [inflammation at injection site,Bevacizumab group,4.1%(34/823 eyes);Ranibizumab group,3.8%(30/797 eyes),Z=0.74,P=0.46;subconjunctival hemorrhage,Bevacizumab group,3.3%(27/823 eyes);Ranibizumab group,3.4%(27/797 eyes),Z=0.98,P=0.33;total complications,Bevacizumab group,10.2%(84/823 eyes);Ranibizumab group,9.5%(76/797 eyes),χ~2=0.21,P=0.65] compared with Ranibizumab.Conclusions Meta-analysis shows that Bevacizumab has equal efficacy and safety to Ranibizumab in treatment of ocular neovascularization. However,a high quality perspective study is still required for further analysis.
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