Document Detail


Randomized trial of intravitreal clindamycin and dexamethasone versus pyrimethamine, sulfadiazine, and prednisolone in treatment of ocular toxoplasmosis.
MedLine Citation:
PMID:  20708269     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To compare the efficacy of intravitreal injection of clindamycin and dexamethasone with classic treatment for ocular toxoplasmosis.
DESIGN: Prospective, randomized single-masked clinical trial.
PARTICIPANTS: A total of 68 patients with active ocular toxoplasmosis were assigned randomly to 2 treatment groups: 34 in the intravitreal clindamycin plus dexamethasone (IVCD) group and 34 in the classic treatment (CT) group.
INTERVENTION: The IVCD group received 1 to 3 injection(s) of 1 mg intravitreal clindamycin and 400 μg dexamethasone, and the CT group received 6 weeks of treatment with pyrimethamine and sulfadiazine plus prednisolone. Antitoxoplasmosis antibodies (immunoglobulin [Ig] M and IgG) were measured using an enzyme-linked immunosorbent assay.
MAIN OUTCOME MEASURES: Changes in retinochoroidal lesion size, measured by a computer program written in the MATLAB environment, 6 weeks after initiation of treatment. Visual acuity (VA) changes, vitreous inflammatory response, adverse drug reactions, and rate of recurrence were secondary outcome measures.
RESULTS: The mean number of injections in the IVCD group was 1.6. The lesion size reduction was statistically significant after treatment in both IVCD and CT groups (P < 0.001 and P = 0.009, respectively). However, the difference in mean percentage of reduction at 6 weeks was not significant: 57.0 ± 27.8% in the IVCD group versus 58.4 ± 29.3% in the CT group (P = 0.569). In relation to the baseline, VA increased by 0.44 ± 0.24 and 0.29 ± 0.19 logarithm of the minimum angle of resolution units in the IVCD and CT groups, respectively (P < 0.001); however, the difference of VA improvement between the groups was not significant. The interaction effect of IgM and treatment group on lesion size reduction was significant (P = 0.002); this indicated that IgM-positive cases responded better to CT and IgM-negative cases responded better to IVCD treatment. Vitreous inflammation reduction was insignificant between the groups. Within 2 years, 4 eyes (2 in each group) had 1 episode of recurrence. Adverse drug reactions occurred in 2 patients in the CT group. No major injection-related complication was encountered in the IVCD group.
CONCLUSIONS: Intravitreal injection of clindamycin and dexamethasone may be an acceptable alternative to the classic treatment in ocular toxoplasmosis. It may offer the patient more convenience, a safer systemic side effect profile, greater availability, and fewer follow-up visits and hematologic evaluations.
Authors:
Masoud Soheilian; Alireza Ramezani; Ahmad Azimzadeh; Mohammad Mehdi Sadoughi; Mohammad H Dehghan; Reza Shahghadami; Mehdi Yaseri; Gholam A Peyman
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-08-12
Journal Detail:
Title:  Ophthalmology     Volume:  118     ISSN:  1549-4713     ISO Abbreviation:  Ophthalmology     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-01-04     Completed Date:  2011-01-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  134-41     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Ophthalmology and Ophthalmic Research Center, Labbafinejad Medical Center, Shahid Beheshti Medical University, Tehran, Iran. masoud_soheilian@yahoo.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Antibodies, Protozoan / blood
Antiprotozoal Agents / administration & dosage*
Clindamycin / administration & dosage
Dexamethasone / administration & dosage
Drug Therapy, Combination
Enzyme-Linked Immunosorbent Assay
Female
Glucocorticoids / administration & dosage*
Humans
Immunoglobulin M / blood
Intravitreal Injections
Male
Prednisolone / administration & dosage
Prospective Studies
Pyrimethamine / administration & dosage
Single-Blind Method
Sulfadiazine / administration & dosage
Toxoplasmosis, Ocular / drug therapy*,  immunology
Treatment Outcome
Visual Acuity / physiology
Young Adult
Chemical
Reg. No./Substance:
0/Antibodies, Protozoan; 0/Antiprotozoal Agents; 0/Glucocorticoids; 0/Immunoglobulin M; 18323-44-9/Clindamycin; 50-02-2/Dexamethasone; 50-24-8/Prednisolone; 58-14-0/Pyrimethamine; 68-35-9/Sulfadiazine

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