Department of Ophthalmology, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.
Am J Transplant. 2015 Apr;15(4):1068-75. doi: 10.1111/ajt.13096. Epub 2015 Mar 11.
The fundamental problem of corneal transplantation is a severe shortage of donor tissues worldwide, resulting in approximately 1.5 million new cases of blindness annually. To explore an alternative to donor corneas, we conducted a clinical study in which implanted acellular porcine corneal stromas (APCSs) replaced the pathologic anterior corneas in 47 patients who had experienced fungal corneal infections. Subsequently, we demonstrated the safety and efficacy of APCSs in human keratoplasty for a minimum follow-up period of 6 months, during which time no recurrence of infection was observed. All corneal ulcers healed with the return of neovascularization. In addition, our results indicated that epithelialization occurred in all APCS grafts except four grafts; for these four, the grafts dissolved to varying degrees. Furthermore, most porcine grafts (n = 41) gradually became transparent without rejection, and an improvement of more than two lines in best corrected visual acuity (BCVA) was achieved in 34 eyes (∼72%). Finally, no patients showed any severe adverse reaction or any significant change in postoperative systemic safety indicators. Thus, we concluded that APCS grafts are safe and efficacious during lamellar keratoplasty in treating corneal fungal ulcers and potentially for other clinical diseases.
角膜移植的根本问题是全球供体组织严重短缺，导致每年约有 150 万新的失明病例。为了探索替代供体角膜的方法，我们进行了一项临床研究，将脱细胞猪角膜基质（APCS）植入 47 例真菌性角膜感染患者的病变前角膜中，以替代病变前角膜。随后，我们证明了 APCS 在人类角膜移植中的安全性和有效性，随访时间至少为 6 个月，在此期间未观察到感染复发。所有角膜溃疡均愈合，新生血管化恢复。此外，我们的研究结果表明，除了 4 个移植物外，所有 APCS 移植物均发生上皮化；对于这 4 个移植物，移植物溶解程度不同。此外，大多数猪移植物（n=41）逐渐变得透明，无排斥反应，34 只眼（约 72%）的最佳矫正视力（BCVA）提高了两行以上。最后，没有患者出现任何严重不良反应或术后全身安全性指标的任何显著变化。因此，我们得出结论，APCS 移植物在治疗真菌性角膜溃疡的板层角膜移植中是安全有效的，并且可能对其他临床疾病也有效。
