牛心包补片应用于后巩膜加固术的早期安全性与生物相容性

目的评估牛心包补片用于人眼后巩膜加固术的安全性和生物相容性。方法回顾性系列病例研究。分析2006年1月至2014年10月在上海和平眼科医院行后巩膜加固术的进展性轴性近视连续病例377例（670眼），其中应用牛心包生物补片组182例（330眼），年龄3~64岁，等效球镜度-6.00~-30.00 D，应用同种异体硬脑膜组195例（340眼），年龄3~61岁，等效球镜度-6.00~-33.00 D，随访时长为至少6个月。所有患者均行常规眼部检查，部分患者还行眼部高频B超检查。采用卡方检验对计数资料进行分析。结果牛心包补片组和硬脑膜组术后6个月最佳矫正视力提高的分别有105眼（31.8％）和119眼（35.0％），不变的有209眼（63.3％）和205眼（60.3％），下降的有16眼（4.8％）和16眼（4.7％），组间差异均无统计学意义（χ²=0.765，P>0.05）。术后第1天2组发生球结膜水肿的分别有225眼（68.2％） 和258眼（75.9％），组间差异有统计学意义（χ²=4.935，P<0.05）。2组病例在术后6个月内均未出现感染、视网膜脱离、眼内出血、斜视/斜视加重及复视等并发症。牛心包补片组有1例出现双眼排异反应，而硬脑膜组有1 例1眼出现排异反应，差异无统计学意义（发生率分别为0.61%和0.29%，P>0.05）。行眼部高频B超检查的硬脑膜组有术后至少6年患者10例19眼，均检测到加固条带，而且未见条带钙化；牛心包补片组有术后6~12个月患者15例28眼，均检测到加固条带，而且厚度正常，出现部分钙化的有3眼（P>0.05）。结论牛心包补片应用于人眼后巩膜加固术具有良好的安全性、生物相容性和耐降解性。

Early safety and biological compatibility of a bovine pericardium patch for posterior scleral reinforcement

Objective To investigate the early safety and biological compatibility of a bovine pericardium patch for posterior scleral reinforcement (PSR).Methods This was a retrospective case series study.Three hundred seventy-seven consecutive cases (670 eyes) of patients with progressive axial myopia who received PSRs at Shanghai Peace Eye Hospital from January 2006 to October 2014 were divided into two groups based on the type of reinforcement:a bovine pericardium patch was used in 330 eyes (182 cases) and dura mater was used in 340 eyes (195 cases).The follow-up time was more than 6 months.All patients underwent routine eye examinations and retro-ocular examination was performed on some patients using high frequency B-scan.Data were analyzed with chi-square tests.Results The constituent ratios of improvement,unchanged BCVA or a decline in BCVA 6 months postoperatively were 31.8％ and 35.0％,63.3％ and 60.3％,and 4.8％ and 4.7％,respectively,for both groups.There were no significant differences between the two groups (x2=0.765,P＞0.05).The incidence of chemosis was 68.2％ and 75.9％,respectively,for the two groups (x2=4.935,P＜0.05).There was no evidence of infection,retinal detachment,intraocular hemorrhage,strabismus or diplopia in any patients.Rejection was observed in both eyes of one patient in the bovine pericardium patch group,and one eye of one patient in the dura mater group(incidences were 0.61％ and 0.29％,respectively,in Fisher's exact test,P＞0.05).Local calcification was observed in three of 28 eyes in the test group,but not in 19 eyes of the control group (Fisher's exact test,P＞0.05).Conclusion Bovine pericardium patch is safe and biologically compatible for PSR.