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مقاله
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Abstract
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Title:
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Topical Tacrolimus as an Adjuvant Therapy in Acute Graft Rejection: A Randomized Clinical Pilot Study
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Author(s):
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Reza Ghaffari, MD Mohammad Nasser Hashemian, MD Hamed Ghasemi, MD Mehran Zarei Ghanavati, MD Golshan Latifi, MD
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Presentation Type:
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Oral
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Subject:
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Cornea and Anterior Segment
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Others:
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Presenting Author:
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Name:
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Golshan Latifi
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Affiliation :(optional)
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Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
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E mail:
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golshan24@yahoo.com
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Phone:
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22052316
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Mobile:
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09123265519
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Purpose:
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Immunological endothelial rejection is the main cause of graft failure. Corticosteroids are the mainstay of therapy, but potential side effects have encouraged the introduction of other drugs. Tacrolimus is an immunomodulator that inhibits the production of IL-2.This study was designed to evaluate the effect of adjuvant topical Tacrolimus 0.05% in management of acute graft rejection
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Methods:
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Design: Randomized prospective controlled pilot clinical trial.
Patients with the clinical diagnosis of acute endothelial rejection were included and randomized to “conventional treatment group” who were treated by a standardized steroid protocol and “Tacrolimus treatment group” who were treated by standardized steroid protocol plus topical Tacrolimus 0.05%.
Registration ID in IRCT: IRCT2014040617088N1
Main Outcome Measures: (1) resolution of rejection (resolved rejection vs. failed rejection) (2) time to resolution of rejection.
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Results:
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Thirty one eyes of 31 patients (23 male, 8 female)(mean age 41.77 ± 18.86) were included. Seventeen eyes (54.8%) were randomized to “Tacrolimus treatment group” and 14 eyes (45.2%) to “conventional treatment group”. Rejection episode was completely resolved in 88.2% of “Tacrolimus treatment group” and in 85.7% of “conventional treatment group”. (Hazard Ratio=0.60, CI=0.28-1.29, P=0.191) After adjusting for preoperative factors by Propensity Score method the Hazard ratio was still statistically insignificant. (HR=0.52, CI=0.12-2.26, P=0.38) Mean time to resolution of rejection was 14.3 ± 8 days (median(range): 11 (7 to 33)) in “Tacrolimus treatment group” and 31 ± 31.8 days (median(range): 19 (7 to 120)) in “conventional treatment group”. (Average treatment effect (ATE)=16.8 ,CI=-0.9-34.6, P=0.064).After adjusting for preoperative factors by Inverse-Probability Weighting (IPW) method the time to resolution of rejection was significantly longer in “conventional treatment group” than “Tacrolimus treatment group”. (ATE=16, CI=3.7-28.7, P=0.013)
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Conclusion:
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The use of Topical Tacrolimus 0.05% as an adjunct to topical steroids can fasten the resolution of graft rejection.
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Attachment:
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