抄録
The efficacy, safety and utility of afloqualone on spastic paralysis were evalu-ated in comparison with tolperisone hydrochloride by a multi-center double-blind study in which 29 institutions participated throughout the country.
Afloqualone was given in a dose of 20 mg three times a day and tolperisone in a dose of 100 mg three times a day. A total number of 187 patients with cerebral and spinal spastic paralysis were treated with either drug for 4 weeks. Of them, 80 cases treated with afloqualone and 83 cases with tolperisone were evaluable for group comparison, totalling 163 cases, and 24 caseswere excluded from evaluation.
The drug efficacy was assessed both from neurological signs (neurological tests) and improvement in subjective symptoms before the start of and after 4 weeks of treatment. Overall safety rating (OSR) was judged on the basis of side effects and values of laboratory tests. Global utility rating (GUR) was evaluated by weighing both FGIR (final global improvement rating) and OSR. The results obtained were as follows:
1. There were no significant differences in background factors of patients.
2. Afloqualone was significantly superior to tolperisone HCl in terms of GUR and global improvement rating of subjective symptoms ata significant level of 5% as well as in FGIR and global improvement rating of neurological signs at a signi-ficant level of 10%.
3. By individual symptoms, improvements of “knee jerk reflex (2W) ”, “Achilles tendon reflex (2W & 4W) ”, “pathological reflex of lower extremities (4W) ”, and “gait (4W) ” were significantly better in afloqualone group than in tolperisone group at a significant level of 5%, and afloqualone was also significantly super-ior to tolperisone HCl at a significant level of 10% in improving “knee jerk reflex (4W) ”, “clonus in sitting position (2W) ” and “stiffness at exercise”.
4. Statistical analysis on stratified items of GUR showed significant differences in favour of afloqualone in the items of “cerebral” ofdiagnosis, “yes” of complications, “incomplete” of the degree of paralysis, “no” of previous drug therapy, “no” of past operation, “yes” of concomitant drugs, “no” of concomitant physical therapy, “more than 3 years” in the duration of illness, and “slight” in the degree of spastisity on passive movement. Multiple regression analysis revealed that the responsible factor for significant differences was only the test drugs of afloqualone and tolperisone HCl.
5. Side effects occurred in 18 cases of afloqualone group (23%) and in 22 cases of tolperisone group (27%). No serious adverse reaction was noted in both groups, but 5 cases of tolperisone group had to be discontinued treatment because of side effects. Laboratory tests disclosed no abnormal findings in either group.
The results obtained showed that afloqualone was a useful drug for the treatment of cerebral and spinal spastic paralysis.
