Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix®) injections versus local anesthetic in osteoarthritis of the hip
Tóm tắt
Comparison of intra-articular bacterial-derived hyaluronic acid (Hyalubrix®) (HA) with local analgesia (mepivacaine) for osteoarthritis (OA) of the hip. A pilot prospective, double-blind, 6-month randomized trial of 42 patients with hip OA. HA or mepivacaine was administered twice (once a month) under ultrasound guidance. Efficacy measurements included the Lequesne's algofunctional index, a visual analog scale for pain, concomitant use of analgesia, patient and physician global measurement, and safety. Patients in the HA group exhibited a significantly reduced Lequesne's algofunctional index 3 and 6 months after treatment (P < 0.001) and significantly reduced visual analog scale pain scores 3 and 6 months after treatment (P < 0.05) compared with the local anesthetic group. All primary and secondary measures were significantly improved versus baseline, but other than the above were not different from each other at 3 or 6 months. Adverse effects were minimal. This comparative study suggests a beneficial effect and safety of intra-articular HA in the management of hip OA. ISRCTN39397064.
Tài liệu tham khảo
Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F: Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998, 41: 778-799. 10.1002/1529-0131(199805)41:5<778::AID-ART4>3.0.CO;2-V.
National Center for Health Statistics: Prevalence of osteoarthritis in adults by age, sex, race and geographic area: United States 1960-62. Vital and Health Statistics no. 15, series 11. 1966, Washington, DC: Government Printing Office
American College of Rheumatology Subcommittee on Osteoarthritis Guidelines: Recommendation for the medical management of osteoarthritis of hip and knee: 2000 update. Arthritis Rheum. 2000, 43: 1905-1915. 10.1002/1529-0131(200009)43:9<1905::AID-ANR1>3.0.CO;2-P.
Helin-Salmivaara A, Saarelainen S, Grönroos JM, Vesalainen R, Klaukka T, Huupponen R: Risk of upper gastrointestinal events with the use of various NSAIDs: a case-control study in a general population. Scand J Gastroenterol. 2007, 42: 923-932. 10.1080/00365520701192326.
Meagher EA: Cardiovascular and renovascular implications of COX-2 inhibition [review]. Curr Pharm Des. 2004, 10: 603-611. 10.2174/1381612043453153.
Joshi GP, Gertler R, Fricker R: Cardiovascular thromboembolic adverse effects associated with cyclooxygenase-2 selective inhibitors and nonselective antiinflammatory drugs [review]. Anesth Analg. 2007, 105: 1793-1804. 10.1213/01.ane.0000286229.05723.50. table of contents
Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P: OARSI recommendations for the management of hip and knee osteoarthritis. Part II: OARSI evidence-based, expert consensus guidelines [review]. Osteoarthritis Cartilage. 2008, 16: 137-162. 10.1016/j.joca.2007.12.013.
Bekerom van der M, Lamme B, Sermon A, Mulier M: What is the evidence for viscosupplementation in the treatment of patients with hip osteoarthritis? Systematic review of the literature. Arch Orthop Trauma Surg. 2008, 128: 815-823. 10.1007/s00402-007-0447-z.
Adams ME, Atkinson MH, Lussier AJ, Schulz JI, Siminovitch KA, Wade JP, Zummer M: The role of viscosupplementation with Hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing Hylan G-F 20 alone, Hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthritis Cartilage. 1995, 3: 213-226. 10.1016/S1063-4584(05)80013-5.
Altman RD, Moskowitz R: Intra-articular sodium hyaluronate (Hyalgan) in the treatment of patients with osteoarthritis of the knee: a randomised clinical trial. J Rheumatol. 1998, 25: 2203-2212.
Qvistgaard E, Kristoffersen H, Terslev L, Danneskiold-Samsoe B, Torppedersen S, Bliddal H: Guidance by ultrasound of intra-articular injections in the knee and hip joints. Osteoarthritis Cartilage. 2001, 9: 512-517. 10.1053/joca.2001.0433.
Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G: Intraarticular corticosteroid for treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006, CD005328-2
Aggarwal A, Sempowski IP: Hyaluronic acid injections for knee osteoarthritis. Systematic review of the literature. Can Fam Physician. 2004, 50: 249-256.
HYAP15 (Hyalubrix®) Clinical Investigator's Brochure; Fidia S.p.A, Padova, Italy. 2004
Zuniga JR, Ibanez C, Kozacko M: The analgesic efficacy and safety of intra-articular morphine and mepivicaine following temporomandibular joint arthroplasty. J Oral Maxillofac Surg. 2007, 65: 1477-1485. 10.1016/j.joms.2007.04.001.
Crawford RW, Gie GA, Ling RS, Murray DW: Diagnostic value of intra-articular anaesthetic in primary osteoarthritis of the hip. J Bone Joint Surg Br. 1998, 80: 279-281. 10.1302/0301-620X.80B2.8299.
Kleiner JB, Thorne RP, Curd JG: The value of bupivicaine hip injection in the differentiation of coxarthrosis from lower extremity neuropathy. J Rheumatol. 1991, 18: 422-427.
Migliore A, Martin LS, Alimonti A, Valente C, Tormenta S: Efficacy and safety of viscosupplementation by ultrasound-guided intra-articular injection in osteoarthritis of the hip. Osteoarthritis Cartilage. 2003, 11: 305-306. 10.1016/S1063-4584(03)00008-6.
Migliore A, Tormenta S, Martin Martin LS, Valente C, Massafra U, Latini A, Alimonti A: Safety profile of 185 ultrasound-guided intra-articular injections for treatment of rheumatic diseases of the hip. Reumatismo. 2004, 56: 104-109. [in Italian]
Pham T, Heijde van der D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M: OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004, 12: 389-399. 10.1016/j.joca.2004.02.001.
Conrozier T, Vignon E: Is there evidence to support the inclusion of viscosupplementation in the treatment paradigm for patients with hip osteoarthritis [review]. Clin Exp Rheumatol. 2005, 23: 711-716.
Fernández López JC, Ruano-Ravina A: Efficacy and safety of intraarticular hyaluronic acid in the treatment of hip osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2006, 14: 1306-1311. 10.1016/j.joca.2006.08.003.
Qvistgaard E, Christensen R, Torp-Pedersen S, Bliddal H: Intra-articular treatment of hip osteoarthritis: a randomized trial of hyaluronic acid, corticosteroid, and isotonic saline. Osteoarthritis Cartilage. 2006, 14: 163-170. 10.1016/j.joca.2005.09.007.
Tikiz C, Unlu Z, Sener A, Efe M: Comparison of the efficacy of lower and higher molecular weight viscosupplementation in the treatment of hip osteoarthritis. Clin Rheumatol. 2005, 24: 244-250. 10.1007/s10067-004-1013-5.
Conrozier T, Bertin P, Mathieu P, Charlot J, Bailleul F, Treves R, Vignon E, Chevalier X: Intra-articular injections of hylan G-F 20 in patients with symptomatic hip osteoarthritis: an open label, multicentre, pilot study. Clin Exp Rheumatol. 2003, 21: 605-610.
Karson AS, Bates DW: Screening for adverse events. J Eval Clin Pract. 1999, 5: 23-32. 10.1046/j.1365-2753.1999.00158.x.
Moreland LW: Intra-articular hyaluronan (hyaluronic acid) and hylans for the treatment of osteoarthritis: mechanisms of action [review]. Arthritis Res Ther. 2003, 5: 54-67. 10.1186/ar623.
Migliore A, Tormenta S, Massafra U, Martin Martin LS, Carloni E, Padalino C, Alimonti A, Granata M: 18 month observation study on efficacy of intraarticular hyaluronic acid (Hylan G-F 20) injections under ultrasound guidance in hip osteoarthritis. Reumatismo. 2006, 58: 39-49.
Migliore A, Tormenta S, Martin LSM, Valente C, Massafra U, Granata M, Alimonti A: Open pilot study of ultrasound-guided intra-articular injection of hylan G-F 20 (Synvisc) in the treatment of symptomatic hip osteoarthritis. Clin Rheumatol. 2005, 24: 285-289. 10.1007/s10067-004-1009-1.
Brocq O, Tran G, Breuil V, Grisot C, Flory P, Euller-Ziegler L: Hip osteoarthritis: short-term efficacy and safety of viscosupplementation by Hylan G-F 20. An open-label study in 22 patients. Joint Bone Spine. 2002, 69: 388-391. 10.1016/S1297-319X(02)00416-5.
Caglar-Yagci H, Unsal S, Yagci I, Dulgeroglu D, Ozel S: Safety and efficacy of ultrasound-guided intra-articular hylan G-F 20 injection in osteoarthritis of the hip: a pilot study. Rheumatol Int. 2005, 25: 341-344. 10.1007/s00296-004-0441-5.
Vad VB, Sakalkale D, Sculco TP, Wickiewicz TL: Role of hylan G-F 20 in treatment of osteoarthritis of the hip joint. Arch Phys Med Rehabil. 2003, 84: 1224-1226. 10.1016/S0003-9993(03)00140-0.
Pourbagher MA, Ozalay M, Pourbagher A: Accuracy and outcome of sonographically guided intra-articular sodium hyaluronate injection in patients with osteoarthritis of the hip. J Ultrasound Med. 2005, 24: 1391-1395.