薬理と治療

Abstract

Objective The objective of this study is to assess pain during the subcutaneous injection of tocilizumab(TCZ-SC)using physiological saline as the control in patients with rheumatoid arthritis. Method Either TCZ-SC(81 mg or 162 mg/2 weeks)or saline at corresponding volumes was injected at a 5-min interval to the right or left abdominal part of total 20 patients with rheumatoid arthritis. Immediately after each injection, the pain at the injection sites was assessed by order and using Wong-Baker Face Pain Rating Scale(FS)and visual analog scale(VAS). Results Twenty patients (8 in 81 mg dose group and 12 in 162 mg dose group)were included in this study. No difference was observed in pains at the injection sites of TCZ-SC and saline expressed by injection order, FS scores and VAS;thus in the analysis of injection order, patients who felt pain more in TCZ-SC were 50% in the 81 mg dose group and 58.3% in 162 mg dose group. In the analysis of variance of FS scores, the average values(95% CI) of the difference between TCZ-SC and saline were 0.00(-1.60 to 1.60)in the 81 mg dose group and 0.33(-0.49 to 1.16)in the 162 mg dose group. In the analysis of variance of VAS, the average values(95% CI)of the difference between TCZ-SC and saline were -12.4 mm (-40.5 to 15.8 mm)in the 81 mg dose group and 7.9 mm(-13.2 to 29.1 mm)in the 162 mg dose group. Conclusion Since there was not observed significant difference in pain at the injection sites between TCZ-SC groups and saline group, high adherence of injection can be expected for the present TCZ-SC.