英文药名: Monovisc(Sodium Hyaluronate Injections)

中文药名: 透明质酸钠注射液

【中文品名】透明质酸
【药效类别】抗关节炎药，眼科用药
【通用药名】HYALURONIC ACID
【别　　名】HA, Healon, Hyalartil, ARTZ
【化学名称】 Hyaluronic acid
【CA登记号】[9004-61-9]
【分 子 式】CHNOPS·
【开发单位】LG Chemical, Kabi Pharmacia, 日本生物化学工业公司
【首次上市】1987年，日本
【用　　途】本品作为一种关节内注射药用于治疗骨关节炎；还用于白内障手术和矫形外科手术
药品简介

玻璃酸也称为透明质酸(hyaluronic acid) 是正常关节滑液重要成分之一。为了说明玻璃酸的功能, 先得从正常关节滑液的成分和功能说起。正常关节腔内含有少量关节滑液, 就象汽车轮轴的润滑油一样, 具有润滑,抗压的作用。同时还有营养支持保护关节软骨和滑膜细胞的功能。正常关节滑液包括蛋白质,玻璃酸,粘多糖,矿物质和水等。其中,玻璃酸为主要且最重要的成分之一(每毫升含2.5-3.5毫克) , 玻璃酸由正常滑膜细胞产生并分泌到关节腔内。每个玻璃酸分子平均为4-5百万道尔顿大小,在分子显微镜下就象长毛刷一样, 每个〝毛刷〞分枝上能攜帶很多水分子(大约500:1以上的水分子)。因此, 玻璃酸是润滑,抗压,支持保护关节软骨和滑膜细胞的主要成分之一.
医学研究发现: 在骨关节炎关节腔内, 由于滑膜细胞的老化, 或外伤变性, 滑膜细胞产生并分泌玻璃酸的能力显著下降。滑液中玻璃酸浓度、分子量的粘弹性均低于正常， 滑液中玻璃酸浓度每毫升少于2 毫克(含0.8-1.5毫克), 为正常的1/2到1/3;且分子量少于1百万道尔顿, 为正常的1/4到1/5，因此, 携带水分的能力显著降低(<200:1)。因而对滑膜细胞及软骨胶原纤维支架的支持和稳定作用减弱，润滑和抵抗机械力作用的生物学功能产生障碍，从而导致软骨细胞损伤。
因此,Balazs医生最早在1989 用从胚胎脐带基质提取的玻璃酸进行动物试验治疗关节炎,发现有显著疗效; 接着欧美进行大量研究发现: 玻璃酸关节内注射与其他治疗相比,能明显达到缓解疼痛，增加关节活动度的作用, 6个月为最显著。 除了提高滑液中玻璃酸钠含量，增强关节液的粘稠性和润滑功能，还可能改善滑液组织的炎症反应，促使关节内滑膜细胞生成高分子量的玻璃酸，为软骨的修复提供了高质量的原材料，有利于软骨的修复保护关节软骨，促进关节软骨的愈合与再生。为此,几年前FDA已批准玻璃酸关节内注射液用于治疗膝关节骨关节炎。现己可用于髋关节骨关节炎。 

3个注射过程为一个疗程, 每间隔一周由膝关节注射。
经过3个注射疗程，疼痛和僵硬可得到缓解,预期持续6-12个月。

Ostenil（透明质酸钠）也可以用由于膝关节滑膜炎, 其他外伤和退行性改变引起的疼痛和行动不便等症状。

Monovisc(Sodium hyaluronate Injection Kit)
Monovisc is a viscous substance derived from Hyaluronan that is naturally found in the body. It is a clear, highly purified, sterile solution that is injected directly in the knee to provide treatment for osteoarthritis.

Unlike other product for viscosupplementation, Monovisc is derived from non-animal, natural Hyaluronan and is designed for single injection only.

Monovisc is considered a young comer in the drug industry as its application for FDA approval is still pending before the federal government since 2008. It is manufactured by Anika Therapeutics, Inc., with headquarter in Bedford, Mass and referred to as  a leading industry that responsible in the creation of Orthovisc, a known OA treatment.

Monovisc is already approved for circulation in the European area and Turkey and is packed in disposable pre-filled glass and sterile syringe containing 4 ml (15 mg/ml) of Hyaluronate Acid.

Pharmacological Action

Osteoarthritis is a condition that affects the joints because of the abnormal functioning of the synovial fluid responsible in its lubrication. The possible cause of which is the poor viscosity and elasticity of the synovial fluid that decreases its normal functioning.

Synovial fluid is a very important substance in the cushioning and support of knee joints. Once the synovial fluid decreases, the cartilage protecting the 2 joint bones in the knee will be destroyed making the bones to rub each other thereby making movement painful.

Monovisc works by gaining back the natural function of this synovial fluid by restoring the body’s Hyaluronic acid.

Indication

Monovisc is indicated for the treatment of osteoarthritis in the knee and is used for viscosupplementation treatment. Viscosupplementation is prescribed only when the conservative treatment of osteoarthritis like non-pharmacological method (therapy) and pain management using analgesics proved to be ineffective.

Monovisc is only available upon prior Doctor’s prescription. Each nonpyrogenic solution contains the substance sodium hyaluronate mixed in phosphate-buffered saline.

Mode of Administration

Monovisc is administered through intra-articular injection, a procedure used in viscosupplementation. Intra-articular injection means direct injection into the knee and not in the vein or artery. It is desired that the procedure is to be performed only by a trained health care provider, preferably a rheumatologist or an orthopaedic surgeon.

Local anesthesia is used in preparing the patient’s knee for injection. After which, Monovisc substance will blend with the synovial fluid naturally found in the knee and henceforth establish a relief to pain caused by osteoarthritis.

Depending upon the efficacy of the medication on each patient, some finds immediate relief after the treatment. Efficacy of the treatment can sustain up to (6) six months after the first injection.

Contraindications and Cautions

Monovisc had been subjected to critical test and research in conformity to the product’s quality standard. It passes through stringent study and procedure to guarantee its efficacy and safety.

Like every medication, it is vital to exercise caution in its administration. Inform your doctor of your current state of health, whether you are pregnant or breast feeding a baby. Although there is no exact study with regards to this medication and pregnancy, it is vital to exercise caution by informing your Doctor.

Intra-articular injection of sodium hyalunorate has indicated swelling reactions to surrounding area or site of injection. Apply ice on the injected area immediately after the injection to reduce swelling and discomfort. To avoid infections, exercise aseptic procedure before and after the viscosupplementation procedure. Avoid strenuous leg activity for at least 48 hours after the injection.

Side Effects

Monovisc information does not outline specific side effects that are associated on the use of the medication. It is important to note that side effects occur and varies depending on different factors such as age, weight, gender, ethnicity and patient’s present state of health.

Serious side effect on the use of Monovisc is rare. There is however common side effects that are associated on the use of this medication such as: swelling and pain in the injected site. This occurrence are however considered natural occurrence of intra-articular procedure.

If any allergic reactions that will surface after the treatment like rash, itching, severe swelling in the face, tongue or throat, severe dizziness or breathing trouble, immediately report such condition to your health care provider for the institution of immediate medical intervention.  

Drug Interactions

For establishment of safety and precautionary procedure, it is important to inform your Doctor of any medications you are currently taking for him/her to assess any possible interactions with this drug. 

Possible interaction with ammonium substance (benzalkonium chloride) is observed on other products that contain sodium hyaluronate, the same formulation that is contained in Monovisc.

规格与剂型：15mg/ml 1支 x 4ml