国产材料软壳技术在白内障超声乳化手术中的疗效评价

Evaluation on the clinical effects of the soft-shell technique with domestic materials during the cataract phacoemulsification

目的 评价国产材料软壳技术在白内障超声乳化手术中的疗效和安全性.方法 晶状体核分级≥Ⅲ级的白内障患者76例（82眼）.按照机械抽样法随机分为国产组[联合使用甲基纤维素和玻璃酸钠（透明质酸钠）]28眼、进口组（使用美国Alcon公司的DuoVisc产品）28眼和普通组（使用透明质酸钠）26眼,三组手术时前房使用不同材料注射.结果 国产组、进口组和普通组术后第1天裸眼视力分别为0.50±0.22、0.51±0.27、0.27±0.21,国产组与进口组比较差异无统计学意义（P＞0.05）,该两组与普通组比较差异均有统计学意义（P＜0.05）.三组术后第7天裸眼视力分别为0.61±0.17、0.63±0.18、0.58±0.18,三组间比较差异无统计学意义（P＞0.05）.术后第1天国产组、进口组和普通组的角膜水肿眼数分别为10、7、14眼.术后1个月角膜内皮细胞丢失率国产组、进口组和普通组分别为7.1%、7.0%、15.9%,国产组和进口组明显低于普通组,差异有统计学意义（P＜0.01）,国产组和进口组比较差异无统计学意义（P＞0.05）.结论 国产材料软壳技术能达到与进口材料同等的保护角膜内皮效果和安全性.

Objective To evaluate the efficacy of the soft-shell technique with domestic materials during the cataract phacoemulsification. Methods Eighty-two eyes of 76 patients with the mature cataract phacoemulsification were divided into 3 groups randomly, including 28 eyes using the soft-shell technique with sodium tvlose and sodium hyaluronate （the domestic group）,and 28 eyes using DuoVisc （Viscoat＋ProVisc） （the import group）, and 26 eyes using sodium hyaluronate （the common group）. Results The average naked vision was 0.50 ± 0.22,0.51 ± 0.27,0.27 ± 0.21 respectively on the first day after operation.There was no signiticant difference between the domestic group and the import group （P〉0.05 ）, while the first two groups and the common group had significant difference （P 〈 0.05）. The average naked vision was 0.61 ± 0.17,0.63 ± 0.18,0.58 ± 0.18 respectively 7 days after operation. There was no statistical difference among the three groups （P 〉 0.05 ）. The rate of corneal endothelial cells 1 month after operation was 7.1% in the domestic group,7.0% in the import group and 15.9% in the common group. It was clear that the rate in the domestic group and the import group was much lower than that in the common group. Meanwhile, the difference existed statistically between the two groups and the common group （P 〈 0.01 ）. However, the difference between the domestic group and the import group had no statistical significance. Conclusion The soft-shell technique with domestic materials is as safe and effective as that with the import materials in protecting the corneal endothelial cells during the cataract surgery in patients with the mature cataract.