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DOI 10.3390/toxins10110448

Медицинская библиотека · Toxins · 2018

AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study.

Eleopra Roberto, Rinaldo Sara, Lettieri Christian, Santamato Andrea, Bortolotti Paolo, Lentino Carmelo, Tamborino Carmine, Causero Araldo, Devigili Grazia

СтатьяМногоцентровое исследованиеРандомизированное исследованиеПеревод в очереди

Аннотация

Background

Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport®) (AboBoNT-A) injections versus placebo as a novel treatment option to improve hip range of motion, pain and quality of life.

Methods

This prospective randomized double-blind multicenter study (EudraCT # 2012-004890-25) recruited 46 outpatients with hip OA who were randomized 2:1 to the Treatment Group (TG; 31 subjects), or the Placebo Group (PG; 15 subjects). The TG received 400 U of AboBoNT-A injected into the adductor muscles, and the PG received placebo solution. The primary endpoints were the difference in Harris Hip Score (HHS) and Visual Analogic Scale for pain (VAS) at Week 4 between groups (TG vs. PG). Secondary endpoints were the change from baseline in HHS, VAS pain, Medical Research Council scale for muscle strength (MRC) and Short Form scale (SF-36) scores.

Results

In TG at Week 4, the HHS and VAS score were significantly improved compared to PG, and pairwise assessments showed significant improvements in HSS and VAS pain at each time point compared to baseline for TG. No significant changes were observed in MRC and SF-36 over time, though SF-36 showed a positive trend. There were no significant differences from baseline in the PG. No adverse events were detected in either treatment group.

Conclusions

AboBoNT-A injections in hip OA improve range of motion and pain without any significant side effects.

Для цитирования: Eleopra Roberto, Rinaldo Sara, Lettieri Christian, Santamato Andrea, Bortolotti Paolo, Lentino Carmelo, Tamborino Carmine, Causero Araldo, Devigili Grazia. AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study.. Toxins. 2018. DOI: 10.3390/toxins10110448.

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