Clinical evaluation of the effect of SI-6601A (Intra-articular injective preparation of Sodium Hyaluronate) on temporomandibular joint arthrosis:I: Early phase II clinical study

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概要

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• This clinical trial was performed preliminarily in order to investigate the drug's efficacy, safety and clinical usefulness in patients with temporomandibular joint arthrosis. The dose range for clinical use was examined.Patients were administered any one of doses of 0.50, 0.75, 1.00 and 1.25ml of SI-6601A (1% of sodium hyaluronate) by intra-articular injection five times continuously at weekly intervals.(1) Out of 110 patients enrolled, 4 patients were excluded and 8 patients dropped out of the study or discontinued the medication. The Final Global Improvement Rate (FGIR) and the Final Global Usefulness Rate (FGUR) were analyzed in 23 patients of the 0.50ml group, 22 patients of the 0.75ml group, 26 patients of the 1.00ml group and 27 patients of the 1.25ml group. The Overall Safety Rate (OSR) was studied in 106 patients.(2) 'Moderate' and 'Marked' improvement of the FGIR was seen in 44.9% of all patients. the 1.25ml group showed the highest rate (59.3%).(3) The incidence of adverse effects was 3.8% (4/106) in all patients. The complaints were earache, rash and increasing of GPT, but none of them was severe.(4) 'Useful' and 'Very useful' FGUR was seen in 43.9% of all patients. The 1.25ml group showed the highest rate (59.3%).(5) Impossible injections of the allocated dose were impossible for one patient of the 1.00ml group and for 3 patients of the 1.25ml group. Then 1.25ml of SI-6601A was estimated as the maximum volume against the superioarticular cavity of the TMJ.(6) In conclusion, SI-6601A with an injection volume ranging from 0.50ml to 1.25ml a time was shown to be useful in the treatment of TMJ arthrosis.

• 一般社団法人 日本顎関節学会の論文

一般社団法人 日本顎関節学会 | 論文

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