抄録
The clinical effect of afloqualone (HQ-495) was evaluated by a double blind trial in comparison with tolperisone HCI in 79 patients with low back pain and 68 patients with neck-arm-shoulder syndrome. Afloqualone was given in a daily dose of 60 mg to 77 patients and tolperisone HCl in a daily dose of 300 mg to 70 patients, both divided into 3 doses, for a period of 2 weeks. The following results were obtained.
1) Among the patients who participated in the clinical trial, 71 cases treated with afloqualone and 66 cases treated with tolperisone HCl were evaluable for group comparison.
2) There were noted no significant differences in the backgrouds of patients between the two patient groups.
3) The rate of global improvement both in subjective and objective symptoms was 76.1% with afloqualone and 68.2% with tolperisone HCl. The difference in the rate of global improvement between the two drugs was not statistically significant, but the former seemed to be superior to the latter. There was noted almost no difference in improvement between low back pain and neck-arm-shoulder syndrome.
4) Adverse side-effects such as gastrointestinal disturbances occurred in 11 cases (14.1%) treated with afloqualone and 13 cases (17.6%) treated with tolperisone HCl. Laboratory examinations revealed no abnormal findings indicative of clinical significance.
5) The rate of usefulness which was assessed both from global improvement and adverse side-effects was 66.2% with afloqualone and 62.9% with tolperisone HCl. There was no statistically significant difference between the two drugs.
The results obtained suggested that afloqualone is equal to or otherwise superior to tolperisone HCl in the treatment of low back pain and neck-arm-shoulder syndrome.
