Recombinant hyaluronidase.

Bascom Palmer Eye Institute, University of Miami, Miami, Florida, USA.
Clinical and Experimental Ophthalmology (Impact Factor: 1.95). 06/2013; DOI: 10.1111/ceo.12154
Source: PubMed

ABSTRACT We read with interest the article by Zamora-Alejo and colleagues (1) . We laud them for presenting a series of delayed onset hyaluronidase-related complications, and alerting your readership of this potential hazard. Although we concur with their inference of hyaluronidase-induced tissue toxicity, we cogitate that these were type B adverse drug reactions (idiosyncratic) (2) .

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    ABSTRACT: We have assessed the effect of two concentrations of hyaluronidase on the quality of peribulbar block, using a low volume, single injection technique. We studied 200 patients undergoing elective intraocular surgery, allocated randomly to one of three groups. Group 1 (n = 50) received peribulbar block with 5 ml of a 1:1 mixture of 0.5% plain bupivacaine and 2% plain lignocaine. Group 2 (n = 75) received this solution supplemented with hyaluronidase 50 iu ml-1. Group 3 (n = 75) received the same solution supplemented with hyaluronidase 300 iu ml-1. Lack of ocular motility was considered to be the only objective sign of successful block and movement of each rectus muscle was scored at 1-, 5- and 10-min intervals. If the block was successful at 5 min, the 10-min score was omitted. If the block was unsuccessful at 5 min, a second injection of 2% lignocaine 3 ml was given and additional assessments performed at 5-min intervals. At 1 min, ocular motility scores were significantly lower in group 3 compared with the control group (P < 0.05). The incidence of satisfactory block at 5 min was increased in both groups given hyaluronidase (group 2, P < 0.05; group 3, P < 0.001). There were no significant differences between groups 2 and 3 with respect to quality of block at 5 min. Hyaluronidase in both concentrations improved the quality of peribulbar block at 5 min, and when used in a concentration of 300 iu ml-1, also improved the speed of onset of block.
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    ABSTRACT: We define an adverse drug reaction as "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product." Such reactions are currently reported by use of WHO's Adverse Reaction Terminology, which will eventually become a subset of the International Classification of Diseases. Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). Timing, the pattern of illness, the results of investigations, and rechallenge can help attribute causality to a suspected adverse drug reaction. Management includes withdrawal of the drug if possible and specific treatment of its effects. Suspected adverse drug reactions should be reported. Surveillance methods can detect reactions and prove associations.
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    ABSTRACT: Background:  Periorbital inflammation following regional anaesthesia is commonly attributed to hyaluronidase allergy. This case series suggests an alternative explanation in some patients. Design:  Retrospective case series Participants:  Seven patients presenting with post-operative non-infectious periorbital inflammation following peribulbar or sub-tenons anaesthesia, presenting at four different institutions are described. Methods: Data on patient demographics, operative data, clinical presentation, treatment and allergy testing were collected among the four institutions. Main Outcome Measures:  Response to treatment and allergy testing were noted among the patients included in this study. Results:  Seven patients (5 female) underwent uneventful phacoemulsification under a peribulbar or subtenon's block all including hyaluronidase with concentrations ranging 50-250 IU/ml. The onset of inflammatory symptoms and signs varied from 12 hours to 3 days after the surgery. The most common form of presentation was lid swelling and chemosis. Patients were treated with oral corticosteroids, with good clinical response. Four patients underwent skin prick and intradermal testing to the local anaesthetic used, and to the suspect and a control hyaluronidase batch. The results were all negative excluding allergy as the aetiology of this toxic periorbital syndrome in at least these four patients. Conclusion:  Hyaluronidase toxicity, potentially related to concentration of hyaluronidase may be a cause of post-operative periorbital inflammation after cataract surgery, rather than hypersensitivity. © 2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.
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