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翼状胬肉术中使用丝裂霉素对降低其复发的随机对照研究         
翼状胬肉术中使用丝裂霉素对降低其复发的随机对照研究
作者:程瑜 钟一… 文章来源:上海交通大学医学院附属瑞金医院眼科 200025 点击数:1455 更新时间:2006/5/28 17:09:41
摘要 目的 观察同一浓度的丝裂霉素棉片留置不同时间对翼状胬肉复发的影响。方法 采用前瞻性双盲随机对照研究,将240例病人随机分成两组,盲法为盲病人、随访人员。随机采用随机数字表法并做调整使两组病例数相等,用密封不透光信封按顺序编号将随机号隐藏。对照组采0.02%MMC术中放置3分钟,即在翼状胬肉去除后,球结膜缝合前。试验组采用0.02%MMC术中放置5分钟。随访1年,观察它们的复发率及并发症,并对其复发风险进行分析。结果 1. 二组的复发率分别为16.95%和15.83%,两组复发率比较的卡方检验,P值=0.816>0.05,两组总体复发率差别无统计学意义。2. 翼状胬肉术后复发率与年龄有关, 以5岁为一年龄段,其相应的RR值=0.819,说明年龄每增大5岁,其复发的危险性降低19.1%。结论 1.术中应用丝裂霉素可降低翼状胬肉的复发率,0.02%丝裂霉素棉片术中留置3分钟与5分钟,术后复发率,经统计学检验差异无显著性。故术中仅用3分钟棉片留置即可降低翼状胬肉的复发率。2.从 Kaplan-Meier曲线可以看出翼状胬肉术后复发率与年龄有关, 年龄每增大5岁,其复发的危险性降低19.1%。3.用0.02%丝裂霉素术中留置5分钟联合翼状胬肉切除治疗翼状胬肉,随访1年,需要治疗89例病人可以防止1例复发。 关键词: 随机对照研究 双盲 丝裂霉素 翼状胬肉 手术治疗 [Abstract] Objective To study the effect of mitomycin Cof the same concentration on the recurrence of pterygium with different time. Methods In our prospective study, 240 patients were divided into experimental group and control group randomized and double-blind method was carried out at the same time. During the operation, 0.02% mitomycin C(MMC) was detained for 5 minutes in experimental group or 3 minutes in control group. The follow-up period was 1 year and recurrence and complications were studied. Results The recurrence of pterygium in control group or experimental group was 16.95% or 15.83% respectively(p=0.816>0.05). There was no significant difference between the two groups. It was found that the recurrence of pterygium was related to the age and the related risk(RR) was 0.819. If the age increased 5 years, the risk of recurrence decreased 19.1%. Conclusion Application of MMC during the operation cloud decrease the recurrence of pterygium. Because the recurrence of pterygium was not related to the different time of application of 0.02% MMC, 3 minutes detainment was enough during operation. The recurrence of pterygium was related to the age, and if the age increased 5 years, the risk of recurrence decreased 19.1%. [Key words] randomized controlled study; double-blind; mitomycin C; pterygium; operation
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