CAJ | 학술논문

背景临床上贝伐单抗(bevacizumab)和曲安奈德(TA)已广泛用于糖尿病性黄斑水肿(DME)的治疗,但由于二者单独治疗都存在一些弊端,因此一些学者尝试二者联合治疗,但其疗效存在争议. 目的系统评价玻璃体腔内注射bevacizumab联合TA与单独注射bevacizumab治疗DME短期疗效的差异. 方法用循证医学方法检索美国国立医学图书馆、荷兰医学文摘、循证医学数据库、中国期刊全文数据库中有关bevacizumab联合TA与单独注射bevacizumab治疗DME短期疗效的随机对照临床试验(RCTs)文献进行二次分析,遵循Cochrane Handbook 5.0质量评价原则评价纳入研究的质量.分析的疗效结局指标包括中央黄斑厚度(CMT)及最佳矫正视力(BCVA)变化,安全性评价指标为局部和全身不良事件.连续变量的计量资料采用加权均数差(WMD)作为合并效应量,计数资料采用相对危险度(RR)为疗效分析统计量,采用Cochrane协作网的Revman5.0软件对效应合并量进行统计学处理.结果共纳入9篇RCTs文献,共665眼.Meta分析结果显示,治疗后12周、18周时bevacizumab联合TA组CMT改善程度优于单独注射bevacizumab组,差异均有统计学意义(WMD=-44.69,95％ CI:25.27～64.11,P＜0.000 001;WMD=-66.86,95％ CI:40.67 ～ 93.05,P＜0.000 001),而在治疗后6周及6个月时两组间差异无统计学意义(WMD=-15.40,95％ CI:-4.04 ～ 34.85,P=0.12; WMD=-2.57,95％ CI:-19.62 ～ 24.75,P=0.82).治疗后6周时bevacizumab联合TA组BCVA(LogMAR值)的改善值优于单独注射bevacizumab组,差异有统计学意义(WMD =-0.04,95％ CI:-0.08～-0.00,P=0.05),而在治疗后12周、18周及6个月时两组间差异均无统计学意义(WMD=-0.04,95％ CI:-0.12 ～0.05,P=0.36;WMD =-0.04,95％ CI:-0.11～0.03,P=0.28;WMD=0.03,95％ CI:-0.05～0.12,P=0.45).两种治疗方式间术后一过性前房反应的发生率差异无统计学意义(RR=0.89,95％ CI:0.49～ 1.60,P=0.70),bevacizumab联合TA组继发性高眼压的发生率为(30/327),单独注射bevacizumab组治疗眼未发生继发性高眼压.结论 Bevacizumab联合TA玻璃体腔内注射治疗DME在减轻黄斑水肿方面疗效明显优于单独注射bevacizumah组,但两种方法在改善BCVA方面效果无明显差异.Bevacizumab联合TA玻璃体腔内注射后发生继发性高眼压的风险高于单独注射bevacizumab应用组,但用降眼压药物后眼压能够控制. 揹景臨床上貝伐單抗(bevacizumab)和麯安奈德(TA)已廣汎用于糖尿病性黃斑水腫(DME)的治療,但由于二者單獨治療都存在一些弊耑,因此一些學者嘗試二者聯閤治療,但其療效存在爭議. 目的繫統評價玻璃體腔內註射bevacizumab聯閤TA與單獨註射bevacizumab治療DME短期療效的差異. 方法用循證醫學方法檢索美國國立醫學圖書館、荷蘭醫學文摘、循證醫學數據庫、中國期刊全文數據庫中有關bevacizumab聯閤TA與單獨註射bevacizumab治療DME短期療效的隨機對照臨床試驗(RCTs)文獻進行二次分析,遵循Cochrane Handbook 5.0質量評價原則評價納入研究的質量.分析的療效結跼指標包括中央黃斑厚度(CMT)及最佳矯正視力(BCVA)變化,安全性評價指標為跼部和全身不良事件.連續變量的計量資料採用加權均數差(WMD)作為閤併效應量,計數資料採用相對危險度(RR)為療效分析統計量,採用Cochrane協作網的Revman5.0軟件對效應閤併量進行統計學處理.結果共納入9篇RCTs文獻,共665眼.Meta分析結果顯示,治療後12週、18週時bevacizumab聯閤TA組CMT改善程度優于單獨註射bevacizumab組,差異均有統計學意義(WMD=-44.69,95％ CI:25.27～64.11,P＜0.000 001;WMD=-66.86,95％ CI:40.67 ～ 93.05,P＜0.000 001),而在治療後6週及6箇月時兩組間差異無統計學意義(WMD=-15.40,95％ CI:-4.04 ～ 34.85,P=0.12; WMD=-2.57,95％ CI:-19.62 ～ 24.75,P=0.82).治療後6週時bevacizumab聯閤TA組BCVA(LogMAR值)的改善值優于單獨註射bevacizumab組,差異有統計學意義(WMD =-0.04,95％ CI:-0.08～-0.00,P=0.05),而在治療後12週、18週及6箇月時兩組間差異均無統計學意義(WMD=-0.04,95％ CI:-0.12 ～0.05,P=0.36;WMD =-0.04,95％ CI:-0.11～0.03,P=0.28;WMD=0.03,95％ CI:-0.05～0.12,P=0.45).兩種治療方式間術後一過性前房反應的髮生率差異無統計學意義(RR=0.89,95％ CI:0.49～ 1.60,P=0.70),bevacizumab聯閤TA組繼髮性高眼壓的髮生率為(30/327),單獨註射bevacizumab組治療眼未髮生繼髮性高眼壓.結論 Bevacizumab聯閤TA玻璃體腔內註射治療DME在減輕黃斑水腫方麵療效明顯優于單獨註射bevacizumah組,但兩種方法在改善BCVA方麵效果無明顯差異.Bevacizumab聯閤TA玻璃體腔內註射後髮生繼髮性高眼壓的風險高于單獨註射bevacizumab應用組,但用降眼壓藥物後眼壓能夠控製.
배경 림상상패벌단항(bevacizumab)화곡안내덕(TA)이엄범용우당뇨병성황반수종(DME)적치료,단유우이자단독치료도존재일사폐단,인차일사학자상시이자연합치료,단기료효존재쟁의. 목적 계통평개파리체강내주사bevacizumab연합TA여단독주사bevacizumab치료DME단기료효적차이. 방법 용순증의학방법검색미국국립의학도서관、하란의학문적、순증의학수거고、중국기간전문수거고중유관bevacizumab연합TA여단독주사bevacizumab치료DME단기료효적수궤대조림상시험(RCTs)문헌진행이차분석,준순Cochrane Handbook 5.0질량평개원칙평개납입연구적질량.분석적료효결국지표포괄중앙황반후도(CMT)급최가교정시력(BCVA)변화,안전성평개지표위국부화전신불량사건.련속변량적계량자료채용가권균수차(WMD)작위합병효응량,계수자료채용상대위험도(RR)위료효분석통계량,채용Cochrane협작망적Revman5.0연건대효응합병량진행통계학처리.결과 공납입9편RCTs문헌,공665안.Meta분석결과현시,치료후12주、18주시bevacizumab연합TA조CMT개선정도우우단독주사bevacizumab조,차이균유통계학의의(WMD=-44.69,95％ CI:25.27～64.11,P＜0.000 001;WMD=-66.86,95％ CI:40.67 ～ 93.05,P＜0.000 001),이재치료후6주급6개월시량조간차이무통계학의의(WMD=-15.40,95％ CI:-4.04 ～ 34.85,P=0.12; WMD=-2.57,95％ CI:-19.62 ～ 24.75,P=0.82).치료후6주시bevacizumab연합TA조BCVA(LogMAR치)적개선치우우단독주사bevacizumab조,차이유통계학의의(WMD =-0.04,95％ CI:-0.08～-0.00,P=0.05),이재치료후12주、18주급6개월시량조간차이균무통계학의의(WMD=-0.04,95％ CI:-0.12 ～0.05,P=0.36;WMD =-0.04,95％ CI:-0.11～0.03,P=0.28;WMD=0.03,95％ CI:-0.05～0.12,P=0.45).량충치료방식간술후일과성전방반응적발생솔차이무통계학의의(RR=0.89,95％ CI:0.49～ 1.60,P=0.70),bevacizumab연합TA조계발성고안압적발생솔위(30/327),단독주사bevacizumab조치료안미발생계발성고안압.결론 Bevacizumab연합TA파리체강내주사치료DME재감경황반수종방면료효명현우우단독주사bevacizumah조,단량충방법재개선BCVA방면효과무명현차이.Bevacizumab연합TA파리체강내주사후발생계발성고안압적풍험고우단독주사bevacizumab응용조,단용강안압약물후안압능구공제.
Background Bevacizumab and triamcinolone acetonide (TA) has been widely used in the treatment of diabetic macular edema (DME) clinically,but the effectiveness of both treatment has disadvantage.Therefore,some researchers try to combine bevacizumab with TA for the management of DME,but its efficacy is controversial.Objective This study was to evaluate the efficacy and safety of intraovitreal injection of bevacizumab combined with TA versus bevacizumab for DME.Methods The randomized controlled trials (RCTs) of bevacizumab combined with TA versus bevacizumab via intraovitreal injection for DME were searched from Pubmed,EMbase,Cochrane Library,CNKI.The methodological quality of the literature was evaluated according to evidencebased medicine (EBM),and the quality of the RCTs was appraised based on the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.The outcome indicators including the change values of central macular thickness (CMT) and best-corrected visual acuity (BCVA) as well as the safety indicators including topical and system adverse response of RCTs were analyzed with Cochrane Collaboration' s software RevMan 5.0.Results Nine RCTs were included with 665 eyes.The decrease value of CMT was more remarkable in the bevacizumab combined with TA group than that of the only bevacizumab group 12 weeks and 18 weeks after intravitreal injection (WMD =-44.69,95％ CI:25.27-64.11,P ＜ 0.000 001 ; WMD =-66.86,95％ CI:40.67-93.05,P ＜ 0.000 001).However,no significant differences were found in the change value of CMT in 6 weeks and 6 months after injection between the two groups (WMD =-15.40,95％ CI:-4.04-34.85,P =0.12 ; WMD =-2.57,95％ CI:-19.62-24.75,P =0.82).The improvement value of BCVA (LogMAR) in the bevacizumab combined with TA group was superior to that of the only bevacizumab group 6 weeks after injection (WMD =-0.04,95 ％ CI:-0.08--0.00,P =0.05),but there were no significant differences between the two groups at 12weeks,18 weeks and 6 months after treatment (WMD =-0.04,95％ CI:-0.12-0.05,P=0.36;WMD =-0.04,95％ CI:-0.11-0.03,P=0.28; WMD =0.03,95％ CI:-0.05-0.12,P=0.45).The incidence rate of transient anterior response after injection was not significantly different between the two groups (RR =0.89,95％ CI:0.49-1.60,P =0.70).Secondary ocular hypertension after injection occurred in 30 eyes in the bevacizumab combined with TA group,but no hypertension was seen in the only bevacizumab group.Conclusions Compared with only bevacizumab,intravitreal injection of bevacizumab combined with TA has a better efficacy in improving CMT but no obvious dominant in increasing BCVA for early DME.Intravitreal injection of bevacizumab combined with TA seemingly has a higher risk of inducing controllable ocular hypertension than administration of only bevacizumab.