Терапевтический архив (Sep 2003)
Long-term results of structum® administration (data from a multicenter trial)
Abstract
Aim. To evaluate duration of a clinical response to the drug structum in patients with osteoarthrosis (OA) of the knee and hip joints as well as structum effects on OA course and that of concomitant diseases. Material and methods. The duration of a clinical response to structum after the end of the treatment and its effect on OA and concominant diseases course were studied for 12 months in 9 centers participating in the study of the drug efficacy and tolerance in patients with gon- and coxarthrosis in an open multicenter randomized controlled 6-month trial. Out of 555 patients with OA of the knee and hip joints enrolled in the first study, the examination covered 373 patients: 159 patients of the test group treated for 6 months with structum and 214 controls. By basic clinical parameters the groups were similar. Clinical examination was made after structum treatment and 12 months later and included assessment of the number of exacerbations, hospitalizations, outpatient consultations, days of temporary disability for OA, pain in the joints while walking and at rest by the visual scale, Leken's functional index, x-ray pictures of the joints, administration of nonsteroidal anti-inflammatory drugs (NSAID), exacerbations of concomitant diseases (gastrointestinal diseases, arterial hypertension, ischemic heart disease). Results. An overall functional Leken's index in patients with gon- and coxarthrosis given structum 12 months after the treatment did not reach the initial values as well as pain and daily need in NSAID. Structum effect in patients with knee joint OA persisted for 4.6 months , in hip joint OA - 4.1 months; in patients with stage /-// the effect lasted longer than in stage III (5.2 and 4.6 months vs 4.17 and 3.24 months, respectively. Even short-term therapy with structum reduced the number of further exacerbations, hospitalizations and visits to their doctor. 12 months after structum therapy the effect persisted in 40% patients. Frequency of exacerbations of the concomitant diseases was less than in patients on continuous NSAID. Conclusion. Structum is a highly effective drug against OA as it acts long, reduces frequency of exacerbations, hospitalizations, visits to the doctor, duration of disability, NSAID requirement and improves the course of some concomitant diseases.
