羊膜在小梁切除术中抗瘢痕作用的随机对照研究

Randomized-controlled trial of anti-scarring effectiveness on filtrating surgery combined with amnioticmembrane

背景小梁切除术后滤过泡的瘢痕化是手术失败的主要原因，术中丝裂霉素c（MMC）的应用可抑制胶原纤维的增生，改善滤过泡的功能，但术后并发症较多，影响手术效果。羊膜在抗青光眼滤过手术中的作用已有较多研究，与MMCl临床效果的比较研究却较少。目的评价羊膜在小梁切除术中应用后的临床效果。方法本研究为I}缶床随机对照试验。经北京大学第三医院临床试验伦理委员会批准，患者及家属均于术前签署知情同意书。共纳入2009年10月至2011年10月在北京大学第三医院眼科行小梁切除术的原发性青光眼患者47例52眼，按照单盲和随机对照的原则，采用随机数字表法将患者分为羊膜组26眼及MMC组26眼，前者行小梁切除术联合结膜及巩膜瓣下羊膜植入术，后者在小梁切除术中于结膜及巩膜瓣下给予质量分数0．02％MMC作用3min。患者随访期为3个月，分别于术后1周、2周、1个月、3个月时测量2个组术眼的眼压和前房深度，检查滤过泡形态的功能，评估并发症的发生率，并对术眼的前房深度、滤过泡情况进行分级。术后疗效的判断指标主要是眼压的变化。结果2个组患者的术前人口基线特征均衡（均P〉0．05）。MMC组和羊膜组分别有17眼和22眼完成最终3个月的随访。羊膜组术后3个月眼压为（16．60±5．04）mmHg（1mmHg=0．133kPa），与术前（23．52_＋6．52）mmHg相比明显降低；MMC组术后3个月眼压值为（17．04-＋3．69）mmHg，比术前（24．09-＋12．79）mmHg明显下降（均P〈0．05）。术后3个月MMC组及羊膜组眼压下降值各为6．94mmHg及6．98mmHg。术后1周、2周、1个月和3个月羊膜组与MMC组比较眼压值的差异均无统计学意义（t=0．972，P：0．336；t=-0．512，P=0．611；t=-0．372，P=0．712；t=0．427，P=0．672）。两组问术后3个月滤过泡高度为1～3级的眼数、滤过泡血管化为l～3级的眼数、各范围分级眼数的差异均无统计学意义（∥=0．99l，P：0．320；∥=0．474，P=0．491；X。=2．008，P=0．156）。羊膜组总成功率为90．49％，MMC组总成功率为100％，差异有统计学意义（X。=26．180，P=0．000）。术后1周、2周及1个月MMC组不同级别的滤过泡渗漏发生率与羊膜组比较差异均无统计学意义（∥=3．556，P=0．059；∥=1．129，P=0．800；y。=0．434，P=0．510），术后3个月两组滤光泡渗漏情况相同。结论小梁手术中联合羊膜植入术后的短期疗效与小梁手术中联合MMC的降眼压效果和滤过泡形态学表现接近，但羊膜植入术浅前房和滤过泡渗漏发生率不高于MMC组。

Background The scar formation of filtering bleb is a cause of filtering operation failure. The topical application of nfitomyein C （MMC） can inhibit the growth of eollagenous fiber and improve function of bleb. However,some adverse effects of MMC are being closely concerned. Many studies have conformed the efficacy of amniotic membrane in filtering operation, but the comparison study between MMC and amniotic membrane is still lack. Objective Purpose of this study was to evaluate the anti-scarring effectiveness of amniotic membrane after its use in the filtrating surgery. Methods A randomized, controlled trial was designed. This study was approved by Ethic Committee of Peking University Third Hospital Eye Center. Written informed consent was obtained from each patient initial of this study. Fifty-two eyes of 47 patients with primary glaucoma were included in Peking University Third Hospital Eye Center from October 2009 to October 2011. The eyes were divided into two groups according to single blindness design and randomized digital table. Trabeculectomy combined with amniotic implantation was performed in the patients of the amniotic group,and trabeculectomy combined with 0.02% MMC in the patients of the MMC group. The patients were followed-up for 3 months. Intraocular pressure （IOP）, the anterior chamber depth, filtering bleb shape,incidence of complication and operative efficacy were measured and evaluated. Results Nosignificant difference was found in the demography between two groups （P〉0.05）. Seventeen patients in the MMC group and twenty-two patients in the amniotic group finished the trial. The IOP in the amniotic membrane group was （16.60＋5.04） mmHg on the third month afler operation and that before operation was （23.52＋-6.52）mmHg. In the MMC group,the IOP was（24.09_＋ 12.79 ）mmHg on the third months after operation, and that before operation was （17.04＋3.69） mmHg. Significant difference was found in the IOP between preoperation and postoperation in both groups（P〈0.05）, lOP differential value on the third month was 6.98 mmHg in the amniotic membrane group and 6.94 mmHg in the MMC group. No significant differences were seen in the IOP between the amniotic membrane group and the MMC group in 1 week,2 weeks, l month and 3 mouths（t=0.972,P=O. 336;t=-O. 512,P=0.611; t = -0. 372, P = 0.712 ; t = 0. 427, P = 0. 672 ）. There were no significant differences in the number of eyes in the height grade,vascularization and perimeter classification of the filtering blebs 1 week,2 weeks and 1 month after surgery between these two groups （X2 = 0. 991, P = 0. 320 ; X2 = 0. 474, P = 0. 491 ; Xz = 2. 008, P = 0. 156 ）. The total effective rate of surgery was 90.49% in the amniotic membrane group and 100% in MMC group,with a significant difference between them（x2 = 26. 180,P= 0. 000）. There were not significantly different in the incidences of bleb leakage in 1 week,2 weeks and 1 month after operation between the MMC group and the amniotic group （X2 = 3. 556, P = 0. 059 ; X2 = 1. 129,P=0. 800; X2 =0. 434, P = 0. 510 ）. Conclusions Combination of trabeculectomy with amniotic implantation has a similar lowing-IOP effect to trabeculectomy combined with MMC. The incidence of bleb leakage in the trabeculectomy combined with amniotic implantation dose not increase when compare with trabeculectomy combined MMC.