PDF(Pubmed)
Abstract：
BACKGROUND: The prevalence of rejection is 10-30% in penetrating keratoplasty (PKP) case, and the rate is higher in cases of high-risk patients. Although using topical corticosteroids is a standard method for management the rejection of post-PKP patients, it may not be sufficiently potent in high-risk patients. Topical administration of tacrolimus (TAC) may be effective in suppression rejection after corneal transplantation. This study aimed to investigate the efficacy and safety of topical TAC in high-risk PKP patients in Japan.
METHODS: This study was a single centre, single-blinded, randomized controlled trial. Patients with a history of PKP, graft rejection, atopic dermatitis, or deep corneal neovascularisation who underwent PKP were enrolled. They were randomly assigned to receive 0.1% TAC ophthalmic suspension or artificial tear (AT) up to week 52 after surgery. All participants received 0.1% betamethasone up to week 13 after surgery then they received 0.1% fluorometholone up to week 52. The incidence of immunological rejection during the observation period was the main outcome measure in this study.
RESULTS: Thirty patients were enrolled in this study, and 12 eyes in the TAC group and 13 eyes in the AT group completed the study, respectively. Five out of 30 patients discontinued participation after providing informed consent. No serious adverse effects were developed in patients who received 0.1% TAC ophthalmic suspension. No rejection episodes occurred in the TAC group, while one eye in the AT group had rejection. Graft clarity, best spectacle-corrected visual acuity, intraocular pressure, and corneal endothelial cell density were not significantly different between the TAC and AT groups.
CONCLUSIONS: Our results demonstrated that good tolerability of 0.1% TAC ophthalmic suspension. However, we failed to demonstrate its efficacy in preventing immunological rejection in high-risk patients undergoing PKP.
BACKGROUND: This study was first registered in the University Hospital Medical Information Network (UMIN000029669, Date of registration: November 1, 2017). With the enforcement of the Clinical Trial Act in Japan, the study re-registered in the Japan Registry of Clinical Trials (jRCTs031180342, Date of registration: March 18, 2019).
METHODS: This study was a single centre, single-blinded, randomized controlled trial. Patients with a history of PKP, graft rejection, atopic dermatitis, or deep corneal neovascularisation who underwent PKP were enrolled. They were randomly assigned to receive 0.1% TAC ophthalmic suspension or artificial tear (AT) up to week 52 after surgery. All participants received 0.1% betamethasone up to week 13 after surgery then they received 0.1% fluorometholone up to week 52. The incidence of immunological rejection during the observation period was the main outcome measure in this study.
RESULTS: Thirty patients were enrolled in this study, and 12 eyes in the TAC group and 13 eyes in the AT group completed the study, respectively. Five out of 30 patients discontinued participation after providing informed consent. No serious adverse effects were developed in patients who received 0.1% TAC ophthalmic suspension. No rejection episodes occurred in the TAC group, while one eye in the AT group had rejection. Graft clarity, best spectacle-corrected visual acuity, intraocular pressure, and corneal endothelial cell density were not significantly different between the TAC and AT groups.
CONCLUSIONS: Our results demonstrated that good tolerability of 0.1% TAC ophthalmic suspension. However, we failed to demonstrate its efficacy in preventing immunological rejection in high-risk patients undergoing PKP.
BACKGROUND: This study was first registered in the University Hospital Medical Information Network (UMIN000029669, Date of registration: November 1, 2017). With the enforcement of the Clinical Trial Act in Japan, the study re-registered in the Japan Registry of Clinical Trials (jRCTs031180342, Date of registration: March 18, 2019).
摘要：
背景：在穿透性角膜移植术（PKP）病例中，排斥反应的发生率为10-30％，在高危患者中，这一比率更高。尽管使用局部皮质类固醇是治疗PKP后患者排斥反应的标准方法，它在高风险患者中可能不够有效。他克莫司（TAC）的局部给药可能有效抑制角膜移植后的排斥反应。本研究旨在探讨TAC在日本高危PKP患者中的疗效和安全性。
方法：这项研究是一个单一的中心，单盲,随机对照试验。有PKP病史的患者,移植排斥,特应性皮炎,纳入或接受PKP的深角膜新生血管形成.他们被随机分配接受0.1%TAC眼科混悬液或人工泪液(AT)直至手术后第52周。所有参与者在手术后第13周接受0.1％的倍他米松，然后在第52周接受0.1％的氟米龙。观察期间免疫排斥反应的发生率是本研究的主要结果指标。
结果：这项研究招募了30名患者，TAC组的12只眼和AT组的13只眼完成了研究，分别。在提供知情同意后，30名患者中有5名停止参与。在接受0.1%TAC眼用混悬液的患者中没有出现严重的不良反应。TAC组没有发生排斥反应,而AT组的一只眼睛有排斥反应。移植物清晰度,最佳眼镜矫正视力，眼内压,TAC组和AT组之间角膜内皮细胞密度差异无统计学意义。
结论:我们的结果表明0.1%TAC眼用混悬液具有良好的耐受性。然而,我们未能证明其在接受PKP的高危患者中预防免疫排斥反应的有效性.
背景：本研究首次在大学医院医疗信息网络（UMIN000029669，注册日期：2017年11月1日）注册。随着日本《临床试验法》的实施，该研究在日本临床试验注册中心重新注册(jRCTs031180342,注册日期:2019年3月18日).
方法：这项研究是一个单一的中心，单盲,随机对照试验。有PKP病史的患者,移植排斥,特应性皮炎,纳入或接受PKP的深角膜新生血管形成.他们被随机分配接受0.1%TAC眼科混悬液或人工泪液(AT)直至手术后第52周。所有参与者在手术后第13周接受0.1％的倍他米松，然后在第52周接受0.1％的氟米龙。观察期间免疫排斥反应的发生率是本研究的主要结果指标。
结果：这项研究招募了30名患者，TAC组的12只眼和AT组的13只眼完成了研究，分别。在提供知情同意后，30名患者中有5名停止参与。在接受0.1%TAC眼用混悬液的患者中没有出现严重的不良反应。TAC组没有发生排斥反应,而AT组的一只眼睛有排斥反应。移植物清晰度,最佳眼镜矫正视力，眼内压,TAC组和AT组之间角膜内皮细胞密度差异无统计学意义。
结论:我们的结果表明0.1%TAC眼用混悬液具有良好的耐受性。然而,我们未能证明其在接受PKP的高危患者中预防免疫排斥反应的有效性.
背景：本研究首次在大学医院医疗信息网络（UMIN000029669，注册日期：2017年11月1日）注册。随着日本《临床试验法》的实施，该研究在日本临床试验注册中心重新注册(jRCTs031180342,注册日期:2019年3月18日).
