Topical Tacrolimus as Adjuvant Therapy to Corticosteroids in Acute Endothelial Graft Rejection After Penetrating Keratoplasty: A Randomized Controlled Trial
PURPOSE:To evaluate the efficacy of topical tacrolimus 0.05% as adjuvant therapy to corticosteroids in the treatment of acute endothelial rejection of a penetrating keratoplasty (PKP) graft. METHODS:Patients with the clinical diagnosis of acute endothelial rejection of a PKP graft were randomized in...
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| Veröffentlicht in: | Cornea 2018-03, Vol.37 (3), p.307-312 |
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| creator | Hashemian, Mohammad Nasser Latifi, Golshan Ghaffari, Reza Ghassemi, Hamed Ghanavati, Mehran Zarei Mohammadi, Seyed-Farzad Yasseri, Mehdi Fallah Tafti, Mohammad Reza Tafti, Zahra Fallah |
| description | PURPOSE:To evaluate the efficacy of topical tacrolimus 0.05% as adjuvant therapy to corticosteroids in the treatment of acute endothelial rejection of a penetrating keratoplasty (PKP) graft.
METHODS:Patients with the clinical diagnosis of acute endothelial rejection of a PKP graft were randomized into 2 groups—group 1receiving topical tacrolimus 0.05% as adjuvant therapy to corticosteroid treatment and group 2receiving only corticosteroid treatment. Main outcome measures were rejection reversal, time to rejection reversal, and recurrence of rejection.
RESULTS:Thirty-one eyes of 31 patients (17 and 14 eyes in group 1 and 2, respectively) were included in the study. The rejection episode completely resolved in 88.2% of patients in group 1 and 85.7% of patients in group 2 [hazard ratio = 0.60, 95% confidence interval (CI) = 0.28–1.29, P = 0.191]. After adjusting for preoperative factors using the inverse-probability weighting method, the time to resolution of rejection was significantly shorter in group 1 than group 2 (average treatment effect = 16, 95% CI, 3.7–28.7, P = 0.013). The recurrence rate of rejection was significantly higher in group 2 (39.7, 95% CI, 12.8–92.6 per 1000 months of follow-up) than in group 1 (3.6, 95% CI, 0.05–19.9 likewise); risk ratio11.1, 95% CI, 1.3–95.0, P = 0.028.
CONCLUSIONS:Topical tacrolimus 0.05% as an adjunct to steroids can hasten the resolution of endothelial rejection of a PKP graft and potentially decreases the recurrence of rejection. However, it may not improve rejection reversal success. |
| doi_str_mv | 10.1097/ICO.0000000000001408 |
| format | Article |
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METHODS:Patients with the clinical diagnosis of acute endothelial rejection of a PKP graft were randomized into 2 groups—group 1receiving topical tacrolimus 0.05% as adjuvant therapy to corticosteroid treatment and group 2receiving only corticosteroid treatment. Main outcome measures were rejection reversal, time to rejection reversal, and recurrence of rejection.
RESULTS:Thirty-one eyes of 31 patients (17 and 14 eyes in group 1 and 2, respectively) were included in the study. The rejection episode completely resolved in 88.2% of patients in group 1 and 85.7% of patients in group 2 [hazard ratio = 0.60, 95% confidence interval (CI) = 0.28–1.29, P = 0.191]. After adjusting for preoperative factors using the inverse-probability weighting method, the time to resolution of rejection was significantly shorter in group 1 than group 2 (average treatment effect = 16, 95% CI, 3.7–28.7, P = 0.013). The recurrence rate of rejection was significantly higher in group 2 (39.7, 95% CI, 12.8–92.6 per 1000 months of follow-up) than in group 1 (3.6, 95% CI, 0.05–19.9 likewise); risk ratio11.1, 95% CI, 1.3–95.0, P = 0.028.
CONCLUSIONS:Topical tacrolimus 0.05% as an adjunct to steroids can hasten the resolution of endothelial rejection of a PKP graft and potentially decreases the recurrence of rejection. However, it may not improve rejection reversal success.</description><identifier>ISSN: 0277-3740</identifier><identifier>EISSN: 1536-4798</identifier><identifier>DOI: 10.1097/ICO.0000000000001408</identifier><identifier>PMID: 29215395</identifier><language>eng</language><publisher>United States: Copyright Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Acute Disease ; Administration, Topical ; Adolescent ; Adrenal Cortex Hormones - therapeutic use ; Adult ; Aged ; Chemotherapy, Adjuvant ; Corneal Diseases - surgery ; Female ; Graft Rejection - drug therapy ; Humans ; Immunosuppressive Agents - administration & dosage ; Keratoplasty, Penetrating ; Male ; Middle Aged ; Ophthalmic Solutions - administration & dosage ; Prednisolone - therapeutic use ; Recurrence ; Tacrolimus - administration & dosage ; Young Adult</subject><ispartof>Cornea, 2018-03, Vol.37 (3), p.307-312</ispartof><rights>Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3568-a82783928d35b17a20bb403615f426a04c5a7857694ef66a75911badfc58e0183</citedby><cites>FETCH-LOGICAL-c3568-a82783928d35b17a20bb403615f426a04c5a7857694ef66a75911badfc58e0183</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27928,27929</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29215395$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hashemian, Mohammad Nasser</creatorcontrib><creatorcontrib>Latifi, Golshan</creatorcontrib><creatorcontrib>Ghaffari, Reza</creatorcontrib><creatorcontrib>Ghassemi, Hamed</creatorcontrib><creatorcontrib>Ghanavati, Mehran Zarei</creatorcontrib><creatorcontrib>Mohammadi, Seyed-Farzad</creatorcontrib><creatorcontrib>Yasseri, Mehdi</creatorcontrib><creatorcontrib>Fallah Tafti, Mohammad Reza</creatorcontrib><creatorcontrib>Tafti, Zahra Fallah</creatorcontrib><title>Topical Tacrolimus as Adjuvant Therapy to Corticosteroids in Acute Endothelial Graft Rejection After Penetrating Keratoplasty: A Randomized Controlled Trial</title><title>Cornea</title><addtitle>Cornea</addtitle><description>PURPOSE:To evaluate the efficacy of topical tacrolimus 0.05% as adjuvant therapy to corticosteroids in the treatment of acute endothelial rejection of a penetrating keratoplasty (PKP) graft.
METHODS:Patients with the clinical diagnosis of acute endothelial rejection of a PKP graft were randomized into 2 groups—group 1receiving topical tacrolimus 0.05% as adjuvant therapy to corticosteroid treatment and group 2receiving only corticosteroid treatment. Main outcome measures were rejection reversal, time to rejection reversal, and recurrence of rejection.
RESULTS:Thirty-one eyes of 31 patients (17 and 14 eyes in group 1 and 2, respectively) were included in the study. The rejection episode completely resolved in 88.2% of patients in group 1 and 85.7% of patients in group 2 [hazard ratio = 0.60, 95% confidence interval (CI) = 0.28–1.29, P = 0.191]. After adjusting for preoperative factors using the inverse-probability weighting method, the time to resolution of rejection was significantly shorter in group 1 than group 2 (average treatment effect = 16, 95% CI, 3.7–28.7, P = 0.013). The recurrence rate of rejection was significantly higher in group 2 (39.7, 95% CI, 12.8–92.6 per 1000 months of follow-up) than in group 1 (3.6, 95% CI, 0.05–19.9 likewise); risk ratio11.1, 95% CI, 1.3–95.0, P = 0.028.
CONCLUSIONS:Topical tacrolimus 0.05% as an adjunct to steroids can hasten the resolution of endothelial rejection of a PKP graft and potentially decreases the recurrence of rejection. However, it may not improve rejection reversal success.</description><subject>Acute Disease</subject><subject>Administration, Topical</subject><subject>Adolescent</subject><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Chemotherapy, Adjuvant</subject><subject>Corneal Diseases - surgery</subject><subject>Female</subject><subject>Graft Rejection - drug therapy</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Keratoplasty, Penetrating</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Ophthalmic Solutions - administration & dosage</subject><subject>Prednisolone - therapeutic use</subject><subject>Recurrence</subject><subject>Tacrolimus - administration & dosage</subject><subject>Young Adult</subject><issn>0277-3740</issn><issn>1536-4798</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUFv1DAQhS0Earel_wAhH7mk2EkcO9xWq9JWVGpVhXM0cSasFycOttNq-S38WFxtQYhD5-I5fO-N9R4h7zg756yWH683t-fsn-ElU6_IiouiykpZq9dkxXIps0KW7JichLBLkJRVfkSO8zpPXC1W5FfjZqPB0ga0d9aMS6AQ6LrfLQ8wRdps0cO8p9HRjfPRaBciemf6QM1E13qJSC-m3sUtWpNsLj0Mkd7jDnU0LhFDwukdThg9RDN9o1-SYXSzhRD3n-ia3kOSj-Yn9unCFNMnbFobn9zekjcD2IBnz-8p-fr5otlcZTe3l9eb9U2mC1GpDFQuVVHnqi9ExyXkrOtKVlRcDGVeASu1AKmErOoSh6oCKWrOO-gHLRQyropT8uHgO3v3Y8EQ29EEjdbChG4JLa9Thpzl4gktD2hKKwSPQzt7M4Lft5y1T720qZf2_16S7P3zhaUbsf8r-lNEAtQBeHQ2JRa-2-URfbtFsHH7svdvI9-bVw</recordid><startdate>201803</startdate><enddate>201803</enddate><creator>Hashemian, Mohammad Nasser</creator><creator>Latifi, Golshan</creator><creator>Ghaffari, Reza</creator><creator>Ghassemi, Hamed</creator><creator>Ghanavati, Mehran Zarei</creator><creator>Mohammadi, Seyed-Farzad</creator><creator>Yasseri, Mehdi</creator><creator>Fallah Tafti, Mohammad Reza</creator><creator>Tafti, Zahra Fallah</creator><general>Copyright Wolters Kluwer Health, Inc. All rights reserved</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201803</creationdate><title>Topical Tacrolimus as Adjuvant Therapy to Corticosteroids in Acute Endothelial Graft Rejection After Penetrating Keratoplasty: A Randomized Controlled Trial</title><author>Hashemian, Mohammad Nasser ; Latifi, Golshan ; Ghaffari, Reza ; Ghassemi, Hamed ; Ghanavati, Mehran Zarei ; Mohammadi, Seyed-Farzad ; Yasseri, Mehdi ; Fallah Tafti, Mohammad Reza ; Tafti, Zahra Fallah</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3568-a82783928d35b17a20bb403615f426a04c5a7857694ef66a75911badfc58e0183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Acute Disease</topic><topic>Administration, Topical</topic><topic>Adolescent</topic><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Chemotherapy, Adjuvant</topic><topic>Corneal Diseases - surgery</topic><topic>Female</topic><topic>Graft Rejection - drug therapy</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Keratoplasty, Penetrating</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Ophthalmic Solutions - administration & dosage</topic><topic>Prednisolone - therapeutic use</topic><topic>Recurrence</topic><topic>Tacrolimus - administration & dosage</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hashemian, Mohammad Nasser</creatorcontrib><creatorcontrib>Latifi, Golshan</creatorcontrib><creatorcontrib>Ghaffari, Reza</creatorcontrib><creatorcontrib>Ghassemi, Hamed</creatorcontrib><creatorcontrib>Ghanavati, Mehran Zarei</creatorcontrib><creatorcontrib>Mohammadi, Seyed-Farzad</creatorcontrib><creatorcontrib>Yasseri, Mehdi</creatorcontrib><creatorcontrib>Fallah Tafti, Mohammad Reza</creatorcontrib><creatorcontrib>Tafti, Zahra Fallah</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Cornea</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hashemian, Mohammad Nasser</au><au>Latifi, Golshan</au><au>Ghaffari, Reza</au><au>Ghassemi, Hamed</au><au>Ghanavati, Mehran Zarei</au><au>Mohammadi, Seyed-Farzad</au><au>Yasseri, Mehdi</au><au>Fallah Tafti, Mohammad Reza</au><au>Tafti, Zahra Fallah</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Topical Tacrolimus as Adjuvant Therapy to Corticosteroids in Acute Endothelial Graft Rejection After Penetrating Keratoplasty: A Randomized Controlled Trial</atitle><jtitle>Cornea</jtitle><addtitle>Cornea</addtitle><date>2018-03</date><risdate>2018</risdate><volume>37</volume><issue>3</issue><spage>307</spage><epage>312</epage><pages>307-312</pages><issn>0277-3740</issn><eissn>1536-4798</eissn><abstract>PURPOSE:To evaluate the efficacy of topical tacrolimus 0.05% as adjuvant therapy to corticosteroids in the treatment of acute endothelial rejection of a penetrating keratoplasty (PKP) graft.
METHODS:Patients with the clinical diagnosis of acute endothelial rejection of a PKP graft were randomized into 2 groups—group 1receiving topical tacrolimus 0.05% as adjuvant therapy to corticosteroid treatment and group 2receiving only corticosteroid treatment. Main outcome measures were rejection reversal, time to rejection reversal, and recurrence of rejection.
RESULTS:Thirty-one eyes of 31 patients (17 and 14 eyes in group 1 and 2, respectively) were included in the study. The rejection episode completely resolved in 88.2% of patients in group 1 and 85.7% of patients in group 2 [hazard ratio = 0.60, 95% confidence interval (CI) = 0.28–1.29, P = 0.191]. After adjusting for preoperative factors using the inverse-probability weighting method, the time to resolution of rejection was significantly shorter in group 1 than group 2 (average treatment effect = 16, 95% CI, 3.7–28.7, P = 0.013). The recurrence rate of rejection was significantly higher in group 2 (39.7, 95% CI, 12.8–92.6 per 1000 months of follow-up) than in group 1 (3.6, 95% CI, 0.05–19.9 likewise); risk ratio11.1, 95% CI, 1.3–95.0, P = 0.028.
CONCLUSIONS:Topical tacrolimus 0.05% as an adjunct to steroids can hasten the resolution of endothelial rejection of a PKP graft and potentially decreases the recurrence of rejection. However, it may not improve rejection reversal success.</abstract><cop>United States</cop><pub>Copyright Wolters Kluwer Health, Inc. All rights reserved</pub><pmid>29215395</pmid><doi>10.1097/ICO.0000000000001408</doi><tpages>6</tpages></addata></record> |
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| ispartof | Cornea, 2018-03, Vol.37 (3), p.307-312 |
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| subjects | Acute Disease Administration, Topical Adolescent Adrenal Cortex Hormones - therapeutic use Adult Aged Chemotherapy, Adjuvant Corneal Diseases - surgery Female Graft Rejection - drug therapy Humans Immunosuppressive Agents - administration & dosage Keratoplasty, Penetrating Male Middle Aged Ophthalmic Solutions - administration & dosage Prednisolone - therapeutic use Recurrence Tacrolimus - administration & dosage Young Adult |
| title | Topical Tacrolimus as Adjuvant Therapy to Corticosteroids in Acute Endothelial Graft Rejection After Penetrating Keratoplasty: A Randomized Controlled Trial |
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