英文药名: Synvisc(Hylan G-F 20 Injection Kit)

中文药名: 欣维可注射剂

生产品牌药厂家: Genzyme Corporation

药品介绍

欣维可（Synvisc）海兰G-F20（hylanG-F20）是一种含海兰（hylan）的无菌非热源性弹粘液体，而海兰（hylan）则是玻璃酸钠（即玻璃酸钠盐）的衍生物，由重复的N-乙酰葡萄胺和葡萄醛酸钠的双糖单元组成。欣维可（Synvisc）的缓冲生理氯化钠溶液（pH值为7.2±0.3）中含有海兰A（hylanA）与海兰B（hylabB）(每毫升8.0毫克±2.0毫克)。

规格
欣维可（Synvisc）是装在玻璃注射器内供应的，针筒容积为2.25毫升，所装的欣维可（Synvisc）为2毫升。注射器内的液剂为无菌、非热源性物质，请务必在2℃至30℃之间的室温中储藏，但切勿冷冻。

*特点
欣维可（Synvisc）的生物特性与玻璃酸钠相似，而玻璃酸钠是滑液中决定其弹粘性的成人发。但欣维可（Synvisc）的机械（弹粘）特性比滑液及浓度相当的玻璃酸钠溶液优越。海兰（hylan）在体内能以玻璃酸钠同样的途径降解。

适应症
▲欣维可（Synvisc）是滑液的临时代用与补充品
▲欣维可（Synvisc）可治疗各种程度关节病的患者
▲欣维可（Synvisc）对经常需要活动的病变关节尢为有效
▲欣维可（Synvisc）在治疗膝关节炎所引起的疼痛时仅用于关节部位
欣维可（Synvisc） 通过补充弹粘性来达到疗效的，这种疗法能恢复患关节炎的关节组织的生一昨流变状态。采用欣维可（Synvisc）来进行弹粘性补充治疗能减轻疼痛和减少不知，并允许关节有较大的活动余地。体外进行的研究试验表明，欣维可（Synvisc）能保护软骨细胞，不使它们受到物理性和化学性的伤害。

禁忌症
腿部静脉和淋巴回流障碍的患者；膝关节感染或炎症的患者。

警告
严禁用于血管内注射。

注意事项
1.在关节注射时会偶见短暂的疼痛和肿胀；
2.如有大量关节渗出液时不得使用欣维可（Synvisc）；
3.妊娠妇女或18岁以下未成年者尚未试用过欣维可（Synvisc）；

剂量与使用
1.注射欣维可（Synvisc）前，如有关节渗出液，必须先行去除滑液和渗出液再行注射；
2.如发现包装开启或破损，切勿使用；
3.务必在室温下使用；
4.使用务必遵守无菌操作程序，去除针帽时尢需小心；
5.使用适当规格的针头（如7至12号或18至22号）；
6.切勿将欣维可（Synvisc）重新消毒；
7.仅限于节关腔内注射；
8.每个注射器内的液剂仅供一次注射使用。

剂量与疗程
欣维可（Synvisc）的推荐疗程是在膝关节部位注射三次，每次间隔一周。为了达到最大的疗效，必须要完成三次注射，治疗收效的病人有有效期通常为十二至二十六周，但有些患者会长些，也有些患者会短些，欣维可（Synvisc）治疗仅对受注射的膝关节有效，但它不会产生全身性影响，如有需要，可以重复欣维可（Synvisc）注射疗程，但每个疗程产至少相隔四周。

*每毫升含量
每毫升含有：海兰8.0毫克，氯化钠8.5毫克，磷酸氢二钠0.16毫克，磷酸二氢钠不合物0.04毫克，以及灭菌注射用水适量（符合美国药典标准）。

有效期
2℃-30℃下保存，有效期为二年。请参阅注射器上的失效日期。

*海兰G-F20(商品名:欣维可)是通过高分子交链技术,合成的高分子医用透明质酸,用于关节腔注射,以补充关节液的黏弹性.美国辛辛那提州威灵敦骨科和运动医疗中心Edward Miller教授在1999年全美骨科年会上报道了一组病例,通过临床观察,骨性关节炎患者在运用欣维可后,有72.6%的病人推迟了接受了全膝关节置换的时间.
关节腔内注射外源性医用透明质酸,通过补充关节液的黏弹性,从而恢复关节的内环境,吸收外力对关节的冲击和震荡,营养关节软骨,润滑关节面.

在Edward Miller教授的报道中,大多数膝骨性关节炎患者在疾病进入晚期,将不可避免地接受全膝关节置换,以改善关节的活动度和降低疼痛. 65岁以上的老年人骨性关节炎的患病率超过50%.全美有大约1千六百万的骨性关节炎的患者,而这其中有1千三百多万为膝关节炎. 1995年全美国有225,000例全膝关节置换术. Edward Miller教授观察了108例患者,其中男性52例,女性56例,平均年龄62岁,所有病人对NSAIDS药物和关节腔注射激素疗效不佳.这些病人每周接受膝关节腔注射欣维可一次,连续三周,有97例随访时间超过18个月.所有病人没有观察到严重的不良反应.有8例出现注射后关节肿胀,疼痛,经过患肢制动,局部冰孵,抬高患肢等处理,上述不良反应缓解.

透明质酸（Synvisc）和富含血小板血浆（PRP）注射剂

富含血小板血浆（PRP）

血小板是血液中的小细胞，富含生长因子。这些生长因子与各种组织的愈合有关，包括骨骼、肌腱、软骨和皮肤。PRP的潜在应用包括肌肉、肌腱和韧带损伤（包括网球肘和足底筋膜炎/足跟痛和肌肉撕裂等情况）以及骨性关节炎。我们还将注射剂用作软骨和半月板修复手术的术后补充。

在诊所抽取少量的自身血液，放入特殊的离心机。该仪器可以在数分钟内快速浓缩血小板数量。随后，这种富含血小板的血浆将被用于多项用途的使用。我们中心使用Arthrex ACP系统。

透明质酸

透明质酸是膝盖中正常骨液的成分。这种液体具有润滑作用，确保顺畅无痛的运动功能。发生骨关节炎时，透明质酸含量减少，给予注射剂的目的是补充或代替这种润滑剂。此外，透明质酸具有良好的消炎作用，有助于缓解疼痛和肿胀。患者可在本中心接受注射。我们采用经FDA认证的单次注射，称为Synvisc One， 这将缓解多达6个月的疼痛。必要时可以重复注射。

给患者注射Synvisc-one 的图片

Description: Synvisc Injections (Hylan GF 20) is a sterile, pyrogen-free, viscoelastic fluid containing Gilan. Gilan is a derivative of hyaluronan (sodium salt of hyaluronic acid) and consists of repeating disaccharide units N-atsetilglikozamina glyukuronata and sodium. The molecular weight of Hylan A nearly 6 million Hylan B is a hydrated gel. Synvisc Injections contains Hylan A and B Gillan (8.0 mg ± 2,0 mg / 1 mL), diluted in physiological solution of sodium chloride (pH 7,2 ± 0,3).
Feature: Synvisc is a biological analogue of hyaluronan. Hyaluronan – a component of synovial fluid, contributing to its viscoelastic properties. Mechanical (viscoelastic) properties of Synvisc, however, higher than those of synovial fluid and hyaluronan solutions at comparable concentrations. Synvisc Injections has elasticity (the coefficient of G ¢) 111 ± 13 Pascal (Pa) and viscosity (the coefficient of G ¢ ¢) 25 ± 2 Pa, measured at a frequency of 2.5 Hz. Elasticity and viscosity of synovial fluid of persons aged 18-27 years, measured by the same method and at the same frequency are, respectively: G ¢ = 117 ± 13 Pa and G ¢ ¢ = 45 ± 8 Pa. Hylan GF 20 excreted the same ways that Hylan, and its decay products are not toxic.
Indications: Synvisc is intended to temporarily replace or supplement the synovial fluid. Synvisc is indicated in patients suffering from osteoarthritis at any stage of the flow. Synvisc is most effective in the treatment of patients with active lifestyle and regularly load on the affected joint. Synvis Injections c is intended only for intra-articular injection for the treatment of pain caused by osteoarthritis of the knee.
Therapeutic effect: Synvisc Injections associated with \ “the completion of the viscosity, \”, whereby the improved rheological and physiological status of tissues of the affected joint. Completion of the viscosity when administered Synvisc reduces pain and discomfort with subsequent improvement of the function of the affected joint. In vitro studies have shown that Synvisc protects articular cartilage from mechanical and chemical damage. Contra Introduction Synvisc is contraindicated in the presence of venous or lymphatic stasis on the side of the affected joint. Should not be administered Synvisc Injections into infected or severely inflamed joints, as well as the presence of signs of skin infection in the immediate vicinity of the injection site.

Warning: Not for intravascular injection. Synvisc Injections should not be given extra-articular, including, in the synovial tissue or joint capsule. In this case, there may be local adverse reactions.
Caution: Do not enter Synvisc in the presence of significant intra-articular effusion. As well as after any other invasive procedures on the joints, after injection of Synvisc recommend the patient to adhere to gentle treatment and avoid unnecessary burdens on the joint for several days. Synvisc Injections are not used for the treatment of pregnant women and children under 18 years old. Synvisc contains small amounts of chicken protein, and therefore the treatment of patients with hypersensitivity appropriate caution.

Side Effects: After injection of Synvisc can take place a short-term pain, swelling at the injection site and / or the emergence of intra-articular exudation. In some cases, exudation may be significant and cause more prolonged pain. In these cases it is necessary to produce a puncture of the joint and removing fluid from it followed by microscopy to exclude infection and microcrystalline arthropathy (gout). Usually, such reactions are completely disappear within a few days and do not affect the effectiveness of treatment. In clinical trials the drug was not been a single case of infection after injection Synvisc Injections, and for clinical use reported only a few such cases.

Application: Before injection, intra-articular Synvisc remove exudate, if any. Do not use Synvisc if the package opened or damaged. Introduction Synvisc carried out at room temperature. Introduction Synvisc is aseptic procedure, so exercise proper caution when removing the protective cap from the syringe. Use the appropriate needle size (18 to 22). To prevent leakage of the drug during administration hold the cannula tip in close contact with the syringe. Do not expose the Synvisc re-sterilization. Enter Synvisc Injections strictly in joint space. The contents of the syringe is intended for single use.

Dosage: The recommended course of treatment with Synvisc includes three injections into the cavity of the knee joint with an interval of 1 week. For maximum effect, must complete all three shots. The maximum recommended dose – six injections over six months with an interval between the courses of at least 4 weeks. The duration of effect in patients responding to treatment, usually at least twenty-six weeks, but often these terms are more persistent. Treatment Synvisc Injections only affects the affected joint, which introduces the drug, systemic effect Synvisc did not cause.

Shelf life: Store at 2 ° C to 30 ° C. Do not freeze.

Synvisc-One—单次注射即可缓解膝关节骨关节炎疼痛6个月
Genzyme Biosurgery公司研发生产Synvisc-One(hylan G-F 20)用于缓解膝关节骨关节炎(OA)相关性疼痛。Synvisc-One是目前美国批准治疗膝关节骨关节炎相关性疼痛的唯一一种单次注射的黏弹性填充物。该药的问世有望使更多患者从黏弹性物填充疗法中获益，同时还可降低多次注射的总费用。Synvisc-One于2009年2月26日获得美国FDA的批准。
“只需一次注射，骨关节炎患者就可以获得长达6个月的临床效果显著的疼痛缓解，而且对于某些患者来说，这种疼痛缓解可以延缓其进行全膝关节置换术，”北美关节镜学会主席、明尼苏达大学医学院临床教授Jack M. Bert博士说，“这种单次注射方案将使医师和患者双方都获得便利。”
黏弹性补充疗法是一种将透明质酸或其衍生物如hylan G-F 20注入膝关节以替代滑液的治疗方法。骨关节炎患者的滑液通常变得稀薄，透明质酸浓度下降。通过向患者病变骨关节注射透明质酸，从而替代OA患者已退化的骨滑液，达到缓解疼痛和增强膝关节对自然震动的吸收能力。
Synvisc-One通过一次性关节内注射给药，它是在Genzyme同类产品Synvisc的基础上发展而来。Synvisc需要注射3次，1997年就在美国获准上市销售，16年来应用范围已遍及全世界。
Synvisc-One也已经在欧盟、一些亚洲和拉美国家获得批准。自从该药获准销售以来，已有将近10000名患者在用该药治疗。