Clinical evaluation of the effect of SI-6601A (Intra-articular injective preparation of Sodium Hyaluronate) on temporomandibular joint arthrosis:II: Late phase II clinical study
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A multicenter randomized comparative study was conducted on 155 patients with temporomandibular joint arthrosis (TMJ) to find the optimal dose regimen for SI-6601A (intra-articular injective preparation of sodium hyaluronate).Patients were administered any one of doses of 0.25ml (SL group), 0.75ml (SM group), and 1.25ml (SH group) of SI-6601A (1% of sodium hyaluronate) by intra-articular injection five times continuously at weekly intervals.(1) Out of 155 patients enrolled, 11 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 45 patients of the SL group, 45 patients of the SM group and 46 patients of the SH group. The Overall Safety Rate (OSR) was studied in 48 patients in each group.(2) There was no significant difference among the 3 groups in the patients' demography at the time of the first drug administration.(3) 'Moderate' and 'Marked' improvement of FGIR was seen in 40.0% for the SL group, 40.0% for the SM group and 54.3% for the SH group. The SH group had the highest rate.(4) The incidence of adverse effects was 3.5% (5/144) in all patients. The complaints were nausea and headache, but none of them was severe.(5) The clinical usefulness score was 'Useful' and 'Very useful' in 37.8% of the SL group, in 40.0% of the SM group and in 56.5% of the SH group. The SH group had the highest rate.(6) Injections of the allocated dose were impossible for 2 patients of the SM group and in 2 patients of the SH group. Then 1.25ml of SI-6601A was estimated as the maximum volume against the superior articular cavity of the TMJ.(7) In conclusion, SI-6601A was shown to be useful in the treatment of TMJ arthrosis, and an optimal dose of 1.25ml injection volume a time was suggested.
- 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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