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一项评价羊膜移植在细菌性角膜炎愈合中有效性的随机临床试验。

A randomized clinical trial to evaluate the usefulness of amniotic membrane transplantation in bacterial keratitis healing.

机构信息

Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Ocul Surf. 2017 Apr;15(2):218-226. doi: 10.1016/j.jtos.2017.01.004. Epub 2017 Jan 25.

Abstract

PURPOSE

To determine whether early amniotic membrane transplantation improves the outcomes among patients with bacterial keratitis.

PATIENTS AND METHODS

In this prospective randomized clinical trial 49 eyes from 49 patients with bacterial keratitis received routine antibiotic therapy followed by double-layer amniotic membrane transplantation during 2-5 days after start up of the medications and the second group of 50 eyes from 50 patients only received routine antibacterial therapy. The main outcomes including visual acuity, corneal healing time, scar size, hypopyon size and duration as well as the depth of corneal opacity and neovascularization were followed for a six months period. In addition, Langerhans cells density and tectonic procedures were documented during the healing period.

RESULTS

Our results indicated statistically significant better best corrected visual acuity (p < 0.001), uncorrected visual acuity (p < 0.001), as well as contact lens corrected visual acuity (p < 0.001) at six months in the case group compared to control group. Corneal healing time, the depth of corneal opacity, hypopyon size and duration were not significantly different in the case group while the scar size (p < 0.001) was significantly smaller. Also significantly less corneal vascularization at six months (p < 0.001) and Langerhans cells density (p < 0.001) at one month were observed in the case group.

CONCLUSION

The early use of amniotic membrane transplantation in treatment of patients with bacterial keratitis was associated with better outcomes compared to antibiotic therapy alone. More comparative studies to investigate the probable side effects as well as the cost benefit of this method are needed.

摘要

目的

探讨早期羊膜移植对细菌性角膜炎患者结局的影响。

方法

前瞻性随机临床试验纳入 49 例(49 眼)细菌性角膜炎患者,随机分为两组,一组(25 例)在开始药物治疗后 2-5 天内接受双层羊膜移植联合常规抗生素治疗,另一组(24 例)仅接受常规抗菌治疗。主要观察指标包括视力、角膜愈合时间、瘢痕大小、前房积脓大小和持续时间、角膜混浊和新生血管的深度等,并随访 6 个月。此外,还记录了愈合期间的郎格汉斯细胞密度和组织工程程序。

结果

结果表明,治疗组在 6 个月时的最佳矫正视力(p < 0.001)、未矫正视力(p < 0.001)和接触镜矫正视力(p < 0.001)均明显优于对照组。然而,两组患者的角膜愈合时间、角膜混浊深度、前房积脓大小和持续时间无显著差异,而治疗组的瘢痕大小(p < 0.001)明显较小。治疗组在 6 个月时的角膜血管化程度(p < 0.001)和 1 个月时的郎格汉斯细胞密度(p < 0.001)明显较低。

结论

与单独使用抗生素治疗相比,细菌性角膜炎患者早期使用羊膜移植可获得更好的治疗效果。需要进一步开展更多的比较研究,以评估这种方法的可能副作用和成本效益。

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