Safety outcomes and long-term effectiveness of ex vivo autologous cultured limbal epithelial transplantation for limbal stem cell deficiency
Safety outcomes and long-term effectiveness of ex vivo autologous cultured limbal epithelial transplantation for limbal stem cell deficiency
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DOI：
10.1136/bjophthalmol-2015-308272
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发表时间：
2017-05-01
影响因子：
4.1
通讯作者：
Ponzin, Diego
中科院分区：
文献类型：
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作者：
Fasolo, Adriano;Pedrotti, Emilio;Ponzin, Diego
目的评价离体自体培养角膜缘干细胞移植（CLET）的安全性和有效性。方法我们回顾了接受 65 个 CLET 治疗的 59 名连续患者的临床记录。手术后一年将疗效分为成功、部分成功或失败。考虑到 CLET 后第一年记录的副作用和并发症以及一年后报告的副作用和并发症，包括与后续治疗相关的事件，进行了安全性分析。结果 CLET 后平均随访时间为 6.0 +/- 4.1 年。 69% 的 CLET 在手术后 1 年内出现一种或多种不良事件 (AE) 或药物不良反应 (ADR)，其中炎症是最常见的 (42%)，其次是角膜上皮缺陷/脱皮 (31%) 和纤维蛋白下的血液凝固 (24%)。术后一年，59 例初次 CLET 手术中，41% 成功，39% 部分成功，20% 失败。原发性 CLET 不成功记录的最常见不良反应是溃疡性角膜炎、熔化/穿孔和上皮缺陷/去上皮化。 6 例 CLET 失败需要进行重建穿透性角膜移植术 (PK)。在具有良好结果的 CLET 中，13 只眼睛接受了矫正 PK（平均 4.8 +/- 3.4 年），此后 7 只眼睛保持了角膜上皮的完整性，5 只眼睛显示角膜表面衰竭，1 只眼睛出现复发性上皮缺陷。据报道，在矫正或重建 PK 后，分别有 71% 和 58% 的患者出现角膜移植排斥反应。 7 例具有良好结果的原发性 CLET 此后恶化，总体 3 年长期有效性为 68%。 结论 这项研究解决了与角膜缘干细胞缺陷患者自体 CLET 后眼表稳态紊乱相关的可能风险的重要问题，尽管大多数患者经历了良好的长期获益。
Purpose To evaluate the safety and effectiveness of ex vivo autologous cultured limbal stem cell transplantation (CLET).Methods We reviewed the clinical records of 59 consecutive patients treated with 65 CLETs. Efficacy was graded 1 year after surgery as successful, partially successful or failed. A safety analysis was performed considering side effects and complications that were recorded during the first year after CLET and those reported later than 1 year, including the events related to subsequent treatments.Results The mean post-CLET follow-up was 6.0 +/- 4.1 years. 69% of CLETs had either one or more adverse events (AEs), or adverse drug reactions (ADRs), within 1 year of surgery, with inflammation being the most common (42%), followed by corneal epithelium defects/disepithelialisation (31%), and blood coagula under the fibrin (24%). One year after surgery, 41% of the 59 primary CLET procedures were successful, 39% partially successful and 20% failed. The most common ADRs recorded for the primary unsuccessful CLETs were ulcerative keratitis, melting/perforation, and epithelial defects/disepithelialisation. Six failed CLETs required reconstructive penetrating keratoplasty (PK). Among CLETs with a favourable outcome, 13 underwent corrective PK (mean 4.8 +/- 3.4 years), and thereafter seven eyes maintained integrity of the corneal epithelium, five showed corneal surface failure, and one had recurrent epithelial defects. Corneal graft rejection episodes were reported in 71% and 58% of patients following corrective or reconstructive PK, respectively. Seven primary CLETs with a favourable outcome worsened thereafter, and the overall 3-year long-term effectiveness was 68%.Conclusions This study addresses important issues regarding possible risks associated with disarray of the ocular surface homeostasis following autologous CLET in patients with limbal stem cell deficiency, despite the fact that the majority of patients experienced a favourable long-term benefit.