Clinical evaluation of NK-433 (centrally acting muscle relaxant, lanperisone hydrochloride) on temporomandibular joint arthrosis:II: Phase III Clinical Study
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Randomized comparative study by double blind experiment was conducted in 241 patients with temporomandibular joint arthrosis to determine the efficacy, safety and usefulness of NK-433 using 150mg of lanperisone hydrochloride (NK group) or of 7.5mg of lanperisone hydrochloride (CT group) for 2 weeks in twice a day continuously.(1) Total number of patients enrolled was 241 (121 in NK group, 120 in CT group). Among those patients, 217 (108 in NK group, 109 in CT group) were adopted for the analysis of final global improvement, overall safety and usefulness.(2) With respect to final global improvement, the effective rate (more than "moderately improved") of NK group was 56.5% (61/108), and 39.4% (43/109) for CT group. NK group was significantly superior to CT group.(3) With respect to overall safety, the safety rate (more than "probably safe") of NK group was 92.6%, and 92.7% for CT group. No significant difference was observed between the two groups.(4) With respect to usefulness, the rate of usefulness ("more than moderately useful") was 55.6% (60/108) for NK group, and 38.5% (42/109) for CT group. NK group was significantly superior to CT group.(5) As for "female", "20's", "initial", "without other disease", "masticatory muscle disorders" and "duration shorter than 1 year" in the characteristics of the patients for the changes of the global improvement, NK group was significantly superior to CT group.(6) After 2 weeks, NK group was significantly superior to CT group.In conclusion, NK-433 (150mg in twice a day for 2 weeks) is considered to be useful in the treatment of temporomandibular joint 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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