翼状胬肉切除联合自体球结膜移植术中使用纤维蛋白胶和缝线有效性的随机对照试验的Meta分析

Meta analysis of RCT for effectiveness and safety of fibrin glue versus suture in pterygium excision with conjunctival autograft

背景目前国外已将医用纤维蛋白胶用于翼状胬肉切除联合自体球结膜移植术植片的固定，其临床效果和安全性评价的临床随机对照试验（RCT）和回顾性研究已有报道，但单个研究的样本量较少。目的采用荟萃分析的方法对翼状胬肉切除联合自体球结膜移植术中使用纤维蛋白胶和缝线的有效性和安全性进行评价，为临床提供高等级的研究证据。方法按照拟定的检索策略，计算机检索MEDLINE（2000年1月至2010年10月）、Embase（2000年1月至2010年10月）、Cochrane协作网“CENTRAL”数据库（2010年4期）、中国生物医学文献数据库（2000年1月至2010年10月）、中国期刊全文数据库（2000年1月至2010年10月），并采用手工检索等方法收集会议文献及检索检出文献的参考文献，最大限度地收集与翼状胬肉切除联合自体球结膜移植术中使用纤维蛋白胶和缝线相关的临床RCT文献，采用Jadad量表评分对纳入的文献进行质量评价，采用RevMan5．0软件进行异质性检验和合并效应量的统计学分析，用Meta分析对纤维蛋白胶和缝线用于翼状胬肉切除联合自体球结膜移植术植片固定的有效性进行评价，其评价指标为手术时间、复发率、术后并发症。结果按照纳入标准和排除标准共纳入与翼状胬肉切除联合自体球结膜移植术中使用纤维蛋白胶和缝线相关的RCT文献6篇，发表于2004--2010年，研究文献来自中国、新西兰、瑞典、以色列、土耳其、马来西亚等国家，发表文种均为英文。纳入文献的Jadad评分为4～5分，总样本量377例401眼。Meta分析结果表明，与缝线固定法相比，纤维蛋白胶用于翼状胬肉切除联合自体球结膜移植术植片的固定可缩短手术时间[MD=14．23，95％CI（-16．18～-12．29），P=0．00]并降低复发率[RR=0．49，95％CI（0．26～0．95），P=0．03]。在植片裂开或丢失率方面，两种固定方法的差异无统计学意义[RR=3．41，95％CI（0．85～13．68），P=0．08]。结论在翼状胬肉切除联合自体球结膜移植术中，使用纤维蛋白胶黏合植片代替缝线缝合植片疗效好，操作简单。由于本系统评价纳入研究病例数较少，上述结论有待更多设计严谨的大样本RCT加以验证。

Background Fibrin glue has been utilized to adhere the graft during the pterygium excision with conjunetival autografts. Several relevant clinical randomized controlled trial（RCT） and retrospective studies have been published abroad, but the samples for its effectiveness and safety issue of fibrin glue and suture are still underinvestigation. Objective Current study was to quantiftcationally assess the efficacy and safety of fibrin glue versus sutures in the application of pterygium excision with conjunctival autografts. Methods Based on established search strategy, a computerized literature search was conducted to identify all citations concerning the RCT for effectiveness and safety evaluation of fibrin glue and suture for the graft fixation during the pterygium excision with eonjunctival autografts from MEDLINE （from 2000 to October, 2010）, Elbase （from 2000 to October, 2010）, Cochrane Central Register of Controlled Trials （ Issue 4,2010） , CBMdise （ 2000 to October 2010 ） , CNKI （ 2000 to October 2010）, and the relevant conference proceedings and references searched by hand was performed as supplement. The included literature was scored with Jadad table. The Cochrane Collaboration＇ s RevMan 5.0 software was used for the test of heterogeneity or test for overall effect. The effective indexes, such as operative duration, recurrence rate and complication,were evaluated by Meta analysis. Results Six RCTs involving 401 eyes of 377 participants were identified. These literatures were published with English in 2004-2010 from China, New Zealand, Sweden,Israel,Turkey and Malasia and the Jadad scores were 4-5. The quantitatively analysis revealed that fibrin glue appeared to short the operative time compared with suturing method （ MD = 14.23 ; 95% CI： - 16.18 - 12.29 ; P = 0.00） and drop the rate of recurrence （ RR = 0.49,95% CI： 0.26 - 0.95 ; P = 0.03 ）. No significant differences were found in the rate of postoperative graft dehiscence or absence （RR=3. 41,95% CI=0. 85-13.68;P=0.08）. Conclusions Fibrin glue shows the good effectiveness and easy application during the pterygium excision with conjunetival autografts . Long-term follow-up of multi-central RCTs with a larger number of eases are still needed to support this conclusion.