Document Detail


Effect of polymerized-type I collagen in knee osteoarthritis. II. In vivo study.
MedLine Citation:
PMID:  19397687     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Polymerized-Type I Collagen (Polymerized-Collagen) is an anti-inflammatory and a tissue regenerator biodrug. The aim of the study was to evaluate the efficacy and safety of intra-articular injections of Polymerized-Collagen in patients with knee osteoarthritis (OA). METHODS AND DESIGN: Patients (n=53) were treated with 12 intra-articular injections of 2 mL of Polymerized-Collagen (n=27) or 2 mL of placebo (n=26) during 6 months. Follow up period was 6 months. The primary endpoints included Western Ontario and McMaster University Osteoarthritis Index, Lequesne index, and pain intensity on a visual analogue scale (VAS). Secondary outcomes were patient global score, investigator global score and drug evaluation. Clinical improvement was determined if the decrease in pain exceeds 20 mm on a VAS and patients achieved at least 20% of improvement from baseline. Urinary levels of C-terminal crosslinking telopeptide of collagen type II (CTXII) and serum high-sensitivity C-reactive protein (hsCRP) were determined by enzyme immunoassays. Statistical analysis was performed by intention to treat. RESULTS: Polymerized-Collagen was safe and well tolerated. Patients had a statistically significant improvement (P<0.05) from baseline vs. Polymerized-Collagen and vs. placebo at 6 months in: Lequesne Index (13.1+/-0.5 vs. 7.1+/-0.7 vs. 9.6+/-0.8; P=0.027), WOMAC (9.0+/-0.5 vs. 4.0+/-0.6 vs. 5.80+/-0.8; P=0.032), patient VAS (60.0+/-2.6 vs. 20.6+/-2.4 vs. 36.1+/-4.5; P=0.003), physician VAS (49.8+/-1.9 vs. 16.8+/-2.9 vs. 29.8+/-2.9; P=0.002), patient global score (1.08+/-0.1 vs. 2.7+/-0.1 vs. 1.9+/-0.2; P=0.028) and analgesic usage (30.1+/-9.4 vs. 11.0+/-3.4 vs. 17.9+/-4.9; P=0.001). This improvement was persistent during the follow up. A threefold increase in CTXII was determined in placebo group. No differences were found on hs CRP and incidence of adverse events between groups. CONCLUSION: Polymerized-Collagen is safe and effective in the treatment of knee OA.
Authors:
J Furuzawa-Carballeda; O A Mu?oz-Chabl?; S I Mac?as-Hern?ndez; A Agualimpia-Janning
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-04-23
Journal Detail:
Title:  European journal of clinical investigation     Volume:  39     ISSN:  1365-2362     ISO Abbreviation:  Eur. J. Clin. Invest.     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2009-06-23     Completed Date:  2010-02-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0245331     Medline TA:  Eur J Clin Invest     Country:  England    
Other Details:
Languages:  eng     Pagination:  598-606     Citation Subset:  IM    
Affiliation:
Department of Immunology and Rheumatology, Instituto Nacional de Ciencias M?dicas y Nutrici?n Salvador Zubir?n, Mexico City, Mexico. jfuruzawa@gmail.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Collagen Type I / administration & dosage*
Epidemiologic Methods
Female
Humans
Injections, Intra-Articular / methods
Male
Osteoarthritis, Knee / drug therapy*
Pain Measurement
Treatment Outcome
Chemical
Reg. No./Substance:
0/Collagen Type I

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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