肩関節周囲炎に対するヒアルロン酸ナトリウム（ＳＰＨ）の比較臨床試験

Abstract

Randomized comparative study was conducted with periarthritis scapulohumeralis to determine the efficacy, safety, and usefulness of SPH using 2.5ml of 1% SPH solution (S) or of 0.01% SPH solution (P) for intra-articular, intra-subacromial bursa or intrabiceps tendon sheath injection five times continuously in weekly intervals.1) Total number of patients examined was 152 (S: 76, P: 76). Among those patients, 139 (S: 67, P: 72) were adopted for the analysis of final global improvement and usefulness, and 150 (5: 74, P: 76) for analysis of general safety.2) With respect to final global improvement, the effective rate (more than “moderately improved”) of S group was 70.2% (47/67), and 36.1% (26/72) for P group.S group was significantly superior to P group.3) With respect to overall safety, incidence of side effects was 2.7% (2/74) for S group, 2.6% (2/76) for P group, and no significant difference was observed between S and P groups.4) With respect to usefulness, the rate of usefulness (more than “moderately useful”) of S group was 68.7% (46/67), and 38.9% (28/72) for P group.S group was significantly superior to P group.5) As for the change of global improvement and of patient's impression, S group was significantly superior to P group.As for improvement on symptoms, S group was significantly superior to P group in “rest pain, ” “pain under movement, ” “motion of washing face, ” “motion of arranging hair, ” “tying a string behind one's back, ” “put the hand on the opposite side of shoulder” and S group tended to be superior in “oppressive pain.” On the other hand, as for the range of motion, both S and P groups were equally improved, and no significant difference was observed between the two groups, but S group was superior in the rate of improvement. High effectiveness of SPH was proved in patients whose duration of symptoms is within one year and global severity is slight to moderate.With pespect to injection site, S group was superior to P group, both in subacromial bursa and biceps tendon sheath, and S group tended to be superior in glenohumeral joint.6) As an adverse side effect, slight to moderate local pain after injection of drugs was noted in 4 patients (S: 2, P: 2).No abnormality caused by the drugs was found in laboratory test values.In conclusion, SPH is considered to be useful in the treatment of periarthritis scapu-lohumeralis.