Sodium hyaluronate

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Sodium hyaluronate
Systematic (IUPAC) name
Hyaluronan Sodium
Clinical data
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Sodium hyaluronate is the sodium salt of hyaluronan. The name hyaluronic acid is derived from the Greek word ύαλος (hyalos) meaning vitreous, and uronic acid as it was first isolated from the vitreous humour in the eye and possesses a high uronic acid content. The term hyaluronate also refers to the conjugate base of hyaluronic acid. Because the molecule typically exists in vivo in its polyanionic form, it is most commonly referred to as hyaluronan. It is a visco-elastic polymer normally found in the aqueous and vitreous humour. Sodium hyaluronate is a viscous solution consisting of a high molecular weight (500,000-730,000 daltons) fraction of purified natural sodium hyaluronate in buffered physiological sodium chloride. Hyaluronic acid is a natural complex sugar of the glycosaminoglycan family and is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine. Sodium hyaluronate occurs naturally on the corneal endothelium, bound to specific receptors for which it has a high affinity.

Contents

[edit] Chemistry

Properties of hyaluronan were first determined in the 1930s in the laboratory of Karl Meyer.[1]. Chemically, sodium hyaluronate referred to as Sodium (2S,3S,4R,5R,6R)-3- [(2S,3R,4R,5S,6R)-3-acetamido-4-[(2R,3R,4S,5S,6S)-6-carboxy-3,4,5-trihydroxyoxan-2-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-4,5-dihydroxyoxane-2-carboxylic acid. It is produced by biological culture of genetic transformed bacteria.[2][unreliable source?]

[edit] Medical use in Orthopaedic Surgery

Lubricating the Joints
Sodium Hyaluronate Injections in the Knee
Sodium Hyaluronate Injections in Hallux Rigidus

Sodium hyaluronate is used in Orthopaedics Surgery, as a viscosupplement, administered through a series of injections into the knee joint, increasing the viscosity of the synovial fluid, which helps lubricate, cushion and reduce pain in the joint.[3]. It is generally used as a last resort before surgery[4] and provides symptomatic relief, by recovering the viscoelasticity of the articular fluid, and by stimulating new production from synovial fluid.[3] Use of sodium hyaluronate may reduce the need for joint replacement.[5] Injections appear to increase in effectiveness over the course of four weeks, reaching a peak at eight weeks and retaining some effectiveness at six months, with greater benefit for osteoarthritis than oral analgesics.[6] It may also be effective when used with other joints.[7] Today it is established the use of Sodium hyaluronate in these human joints: [8]

  • Large Joints: Hip, Knee, Ankle, Shoulder (Frozen Shoulder, Osteoarthritis, Impigment Syndrome), Elbow, Wrist
  • Small Joints: Thumb osteoarthritis, PIP Joints in Fingers, MP Joints in Fingers, MP Joint in Hallux Rigidus, Temporomandibular OA
  • Tendons: Use of Sodium hyaluronate in Tendons was first performed by Harry Gouvas between 2002-2004. It is established today the use in De Quervain Tenonditis, Tibialis Posterior Tenonditis, Metatarsalgia Tenonditis in Foot, Heel Fat Pad relief[9]

[edit] Medical Use in Plastic Surgery

Sodium hyaluronate may also be used in plastic surgery to reduce wrinkles on the face or as a filler in other parts of the body.[10]

[edit] Medical Use in Ophthalmology

Sodium hyaluronate may be used in ophthalmology to assist in the extraction of cataracts, the implantation of intraocular lenses, corneal transplants, glaucoma filtration, retinal attachment and in the treatment of dry eyes.[11]

[edit] Medical Use in Urology

Urology: Sodium hyaluronate is also used to coat the bladder lining in treating interstitial cystitis.

[edit] Rules in Use of Sodium Hyaluronate, in Orthopaedics

Basic principles for using Sodium hyaluronate injections in human joints were determined by Harry Gouvas in year 1998 [12], [13]. Subsequently also made in 2003 by Jubb RW and collaborators [14]. The company Fidia Italia issued an illustrated guide, until 01.01.2011, entitled «Hyalart ®: Handbook endarthrikis injection therapy. The Technique. " [15]. In the past there was a significant gap in the instructions and incorrect instructions. For example, the maker of the Fidia HYALART ® has offered and granted in 1998 for free needles 21G-30mm casting, which proved painful, traumatic and sometimes causing synovitis or some slight bleeding particularly in patients receiving Sintrom ®, Iscover ®, and Aspirin- Salospir ®. Harry Gouvas introduced the widespread use of needles 23G-30mm not have these disadvantages and suitable for all joints and all indications. The basic principles of use of Sodium hyaluronate injections in Orthopedics by Harry Gouvas are as follows [16], [17]:

  • (1) X-rays: A joint that will be punctured should be checked before radiologically. Rare hand, the physician may become surprised by unusual findings such as tumors, cartilaginous free bodies, foreign bodies, etc. [18], [19].
  • (2) Precautions: Injections of joints in patients suffering from diabetes mellitus, in patients receiving anticoagulant therapy, or under anticoagulant treatment in cardiac valvular disease, psoriatic arthritis, with microcrystalline arthritis (chondrasbestosis, Chondrocalcinosis) must be done carefully and with special rules. Location inflamed skin should be avoided. [20], [21].
  • (3) Hygrarthrosis or Haemarthrosis: Hinge the joint has a lot of synovial fluid (yellow color liquid, or other) must first be punctured and then injected Sodium hyaluronate preferably with Cortisone. If it is a traumatic haemarthrosis is recent (active), blood must be removed and should not be Sodium hyaluronate injections, but postponed for one month later. The synovial fluid or blood of haemarthrosis must be collected in sterile plastic cup, must be titrated and recorded. If there is suspicion of septic arthritis or tuberculous arthritis (hazy gray), or rheumatoid arthritis (opaque color with fibrin clots) should be sent to the laboratory.[22], [23].
  • (4) Antiseptics: The injection site is well shaved and cleaned thoroughly with an antiseptic. We recommend a colorless antiseptic Octenisept ® (Octenidine hydrochloride + Phenoxyethanol). The antiseptic Povidone (Betadine ®), Cetrimide (Cetavlon ®), and Chlorexidine (Hibitane ®) is good to avoid, both because the skin colorisation and because it is highly toxic. [24], [25].
  • (5) Plain Drape: A sterile plain drape, of three layers like Secu-Drape ® 75X90 cm is useful for the isolation of the region and the deposition of materials infusions. [26], [27].
  • (6) Gloves: The classical view is that "the doctor should wear sterile gloves latex". In Harry Gouvas series of 22,363 patients, although was in use "flat latex gloves non-sterile single use" did not indicate any infection (septic arthritis) in 15 years of use. So simple gloves lastex, are acceptable and even the cost difference. [28], [29].
  • (7) Local anesthesia: Injections of Sodium hyaluronate are made always under local anesthesia, usually with a solution of Lidocaine (Xylocaine ® Astra) 2% - Vials 50ml. Local anesthesia of the skin usually is not used, except rare cases of patients in over-sensitivity, where one hour before applying the cream Lidocaine + Prilocaine (Emla ® Astra). Cooling Spray anesthesia such as Ethyl Chloride strictly prohibited indoors because of the danger of explosion in the hall, etc., they are intended only for outdoors. The amount of Lidocaine injected into each joint varies. In the knee, eg a quantity sufficient is 2ml, while smaller joints is 1 ml. The attention of Orthopaedic that a minor but dangerous minority of people are allergic to Lidocaine (Xylocaine ®) or the excipients of the clinic and must be available (even with available purchase invoice) emergency medications treat this allergy. These are injected epinephrine - adrenaline eg Adrenaline ® Amp, or Adrenaline Anapen ® Amp + antihistamine Dimetindene (Amp Fenistil ®) + Cortisone injected rapid-acting Solu-Cortef ® or Solu-Medrol ® 250mg or 500mg. In cases of generalized allergy granted and three, there should also be available to address laryngospasm airway. [30], [31].
  • (8) Syringes and Needles: It is obvious that syringes for local anesthesia should be sterilized single use, volume is usually 2,5 ml. The Sodium hyaluronate trade form, usually has his own syringe available pre-filled. Not so, however, in Italy, where the drug Hyalart ® comes as Hyalgan ® packaged 5 vials, which require separate syringes. The appropriate needle for the knee, the shoulder, ankle and elbow is the 23G-30mm. Rarely, obese people need longer needle eg 21G-60mm. In the small joints of the hand and foot, can use the same needle 23G-30mm or smaller 26G-10mm. Used needles should be disposed of in special yellow sharps container (Contaminated Sharps Container). [32], [33].
  • (9) Bleeding: Always, we ask the patient if he takes anticoagulants or antithrombotic drugs such as Acenocoumarol (Sintrom ®), Aspirin ®, Salospir ®, Clopidogrel (Iscover ®, Plavix ®, etc.), and if so, take particular care to avoid bleeding. The use of fine needle eliminated this risk completely.
  • (10) Technique: The entrance of the needle hurts the top of the skin and the skin so it has the original amount of Xylocaine ® infused there. We expect 1-2 seconds and continue carefully with needle entry and simultaneous injection of anesthetic. So even if the needle "dropped" onto the synovium pushes him and does not perforates. If the membrane is punctured by the perceived difficulty of importing liquid and the absence of the characteristic sound vacuum, and by the existence of resistance and needed turnaround. We recommend that upon entry of the needle in the knee joint infused a small amount of air to be suppressed by the membrane and to create space through any existing adhesions. The safe introduction of this quantity of air in 5ml-10ml, after the procedure causes a stirring of Hyaluronic walking with a beeping sound that patients find it "funny". This sound lasts a few hours to 2 days. The sound was popularized and puns on "Greasing" or the "famous Olive oil of Kalamata" contribute to the therapeutic procedure in compliance to treatment (compliance). Obviously 5 or fewer injections in joints made by the same needle with "screwing" of an ampoule after the other. The small joints like some special techniques described in the special chapter. For example, the thumb and big toe need traction with "Chinese Finger baboo» to open the joint. [34], [35].
  • (11) Dosage: The dosage of Sodium hyaluronate is dependent on the size of the joint. The usual dose for the knee is 5 Amps of 2ml, shoulder 3 Amps 2ml, the ankle 2-3 Amps 2ml, and the small joints of the fingers and tendon 0,5-2 ml. The grant is a lump (once per day, OPD use) and repetition may be applied in 6-12 months on average. Last company Fidia published work for every semester and every four months. Originally eprotathi officially granted the knee with an injection every week, a total of 5 injections. Disadvantages of Injections of Sodium hyaluronate once weekly are as follows: This method is obsolete because there is no longer a risk of allergic proteins bird (modern hyaluronate produced by genetic technology) + multiple needle entries, in each week is dangerous for synovitis of injury or infection + repeating every week is not acceptable to the patient due to discomfort + results in a lump sum allocation is better than the weekly administration + medical insurance costs five times more. For all these a lot of literature is available. [36] and [37], [38].
  • (12) End of procedure: After the intervention of the needle is withdrawn abruptly and does not hurt. Hansaplast a local following flame is applied for 24 hours and immediate ambulation of the patient is started. The terms "the joint that underwent treatment with Hyaluronic put at rest for 24 hours at least"we do not agree. Always advise the patient to walk or do exercises joint from the first day. It also warned that the improvement will be slow, and for any pain the first time and provide them with prescription painkillers and anti-inflammatory, for a short period and defines the next session injection at 6 -12 months. [39], [40].

[edit] Contraindications

Sodium hyaluronate is contraindicated for people who are sensitive to hyaluronate preparations, or when there are infections or skin disease at the injection site.

[edit] Adverse effects

[edit] Mechanism of action

Sodium hyaluronate functions as a tissue lubricant and is thought to play an important role in modulating the interactions between adjacent tissues. Sodium hyaluronate is a polysaccharide which is distributed widely in the extracellular matrix of connective tissue in man. It forms a viscoelastic solution in water which makes it suitable for aqueous and vitreous humor in ophthalmic surgery. Mechanical protection for tissues (iris, retina) and cell layers (corneal, endothelium, and epithelium) are provided by the high viscosity of the solution. Elasticity of the solution assists in absorbing mechanical stress and providing a protective buffer for tissues. This viscoelasticity enables maintenance of a deep chamber during surgical manipulation since the solution does not flow out of the open anterior chamber. In facilitating wound healing, it is thought that it acts as a protective transport vehicle, taking peptide growth factors and other structural proteins to a site of action. It is then enzymatically degraded and active proteins are released to promote tissue repair.[41] Sodium hyaluronate is being used intra-articularly to treat osteoarthritis.

[edit] Physical and chemical properties

Sodium hyaluronate is an ophthalmic agent with viscoelastic properties that is used in joints to supplement synovial fluid.

[edit] Pharmacokinetics

Sodium hyaluronate is absorbed and diffuses slowly out of the injection site. It is eliminated via the canal of Schlemm.

[edit] History

Sodium hyaluronate (Hyaluronan) was produced for the first time in Italy by Fidia in 1963, and started to be in use to treat osteoarthritis of the knee in year 1997 with the product Hyalart/Fidia Italy, in intra-articular injections.[3]. In year 2008 the international patent of Hyalart Hyalgan), finished and many Generics of Sodium hyaluronate were available in the market, like Yardel, Gonilert, Viscure, Arthryal, Euflexxa, Go-On, "Synvisc", "Monovisc", etc


[edit] Trade - Brand names of Sodium hyaluronate

Sodium Hyaluronate

Brand names of Sodium hyaluronate in Market include (alphabetically):

  • AMO Vitrax (ocular)
  • AMVISIC Plus (ocular)
  • CYSTISTAR, Healon (ocular)
  • HYLO-COMOD (Eye Drop)
  • EUFLEXXA, Bio Technology General (Israel)-Meditrina SA (Rx articular), Molecular weight: 2,400,000-3,600,000 Daltons
  • GONILERT/Verisfield (UK) (Rx/articular). Molecular weight:1,800,000-2,000,000 Daltons
  • HYALGAN (USA)(Medcical Device/Rx articular)
  • HYALART-Fidia (Italy)(Rx/articular), Molecular weight: 1,800,000-2,000,000 Daltons
  • MONOVISC-Anika (USA)(MedicalDevice/articular)
  • RECOSYN-Merckle Recordati (Germany) Recosyn info leaflet
  • VISCURE-Cube (UK)(Rx/articular), Molecular weight:1,800,000-2,000,000 Daltons
  • YARDEL-Libytec (Impfstoffwerk Dessau-Tornau/Germany,(Rx/articular), Molecular weight:1,800,000-2,000,000 Daltons

[edit] References

  1. ^ Meyer K, Hobby GL, Chaffee E, Dawson MH (January 1940). "THE HYDROLYSIS OF HYALURONIC ACID BY BACTERIAL ENZYMES". J Exp Med 71 (2): 137–46. doi:10.1084/jem.71.2.137. PMC 2135078. PMID 19870951. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2135078. 
  2. ^ Yardel/Libitec brochure 2011, page 4
  3. ^ a b c d Puhl, W.; Scharf, P. (1997). "Intra-articular hyaluronan treatment for osteoarthritis". Annals of the rheumatic diseases 56 (7): 441. doi:10.1136/ard.56.7.441. PMC 1752402. PMID 9486013. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1752402.  edit
  4. ^ Karlsson, J.; Sjögren, L. S.; Lohmander, L. S. (2002). "Comparison of two hyaluronan drugs and placebo in patients with knee osteoarthritis. A controlled, randomized, double-blind, parallel-design multicentre study". Rheumatology (Oxford, England) 41 (11): 1240–1248. PMID 12421996.  edit
  5. ^ Kotz, R.; Kolarz, G. (1999). "Intra-articular hyaluronic acid: Duration of effect and results of repeated treatment cycles". American journal of orthopedics (Belle Mead, N.J.) 28 (11 Suppl): 5–7. PMID 10587245.  edit
  6. ^ Bannuru, R. R.; Natov, N. S.; Dasi, U. R.; Schmid, C. H.; McAlindon, T. E. (2011). "Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis – meta-analysis". Osteoarthritis and Cartilage 19 (6): 611–619. doi:10.1016/j.joca.2010.09.014. PMID 21443958.  edit
  7. ^ Salk, R. S.; Chang, T. J.; d'Costa, W. F.; Soomekh, D. J.; Grogan, K. A. (2006). "Sodium Hyaluronate in the Treatment of Osteoarthritis of the Ankle: A Controlled, Randomized, Double-Blind Pilot Study". The Journal of Bone and Joint Surgery 88 (2): 295–302. doi:10.2106/JBJS.E.00193. PMID 16452740.  edit
  8. ^ Harry Gouvas:"Treatment of Osteoarthritis with Sodium Hyaluronate", Monography, Athens 2012, ISBN 978-960-87328-5-8
  9. ^ Harry Gouvas:"Treatment of Osteoarthritis with Sodium Hyaluronate", Monography, Athens 2012, ISBN 978-960-87328-5-8
  10. ^ Beasley, K.; Weiss, M.; Weiss, R. (2009). "Hyaluronic Acid Fillers: A Comprehensive Review". Facial Plastic Surgery 25 (2): 086–094. doi:10.1055/s-0029-1220647. PMID 19415575.  edit
  11. ^ Shimmura, S.; Ono, M.; Shinozaki, K.; Toda, I.; Takamura, E.; Mashima, Y.; Tsubota, K. (1995). "Sodium hyaluronate eyedrops in the treatment of dry eyes". The British journal of ophthalmology 79 (11): 1007–1011. PMC 505317. PMID 8534643. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=505317.  edit
  12. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  13. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  14. ^ Jubb RW et al: "Use of Sodium Hyaluronate in clinical practice", International Journal of Clinical Practice, July August 2003, Vol 57 No 6, 467
  15. ^ Fidia Italy: «Hyalart ®: Handbook endarthrikis injection therapy. Technique ", edition 2001
  16. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  17. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  18. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  19. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012,ISBN 978-960-87328-5-8
  20. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  21. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  22. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  23. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  24. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  25. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  26. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  27. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  28. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  29. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  30. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  31. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  32. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  33. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  34. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  35. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  36. ^ Harry Gouvas: "Use of Sodium Hyaluronate in Orthopaedics", Greek Wikipedia
  37. ^ Kostakos Athanasios: "New treatments for osteoarthritis": Modern hyaluronate formulations may be used for lump strength, newspaper" Eleftherotypia " Athens, October 2010
  38. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  39. ^ Harry Gouvas: Use of Sodium Hyaluronate in Orthopaedics, Greek Wikipedia
  40. ^ Harry Gouvas: “Use of Sodium hyaluronate in Osteoarthritis”, Monography, Athens 2012, ISBN 978-960-87328-5-8
  41. ^ Boucher, W. S.; Letourneau, R.; Huang, M.; Kempuraj, D.; Green, M.; Sant, G. R.; Theoharides, T. C. (2002). "Intravesical sodium hyaluronate inhibits the rat urinary mast cell mediator increase triggered by acute immobilization stress". The Journal of urology 167 (1): 380–384. doi:10.1016/S0022-5347(05)65472-9. PMID 11743360.  edit
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