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.

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

中文药名: 欣维可注射剂

品牌药生产厂家: Genzyme Corporation

Synvisc® (Hylan G-F 20) is an FDA-approved therapy that provides lubrication for your knee for those who suffer from osteoarthritis (OA) knee pain. It also acts as a "shock absorber" to cushion your knee joint. Synvisc® is a viscosupplement used to treat the pain of osteoarthritis of the knee. It lubricates and cushions your knee joint and relieves pain, which can allow you to move more freely for up to 6 months. Synvisc® supplements your knee fluid to relieve the pain and improve the knee joint’s natural shock absorbing abilities, allowing you to move more freely and get back to the activities you’ve been avoiding. Synvisc® is made from a natural substance similar to that found in normal, healthy joint fluid. Each package contains 3 disposable syringes.

Cautions
SYNVISC is generally well tolerated. However, it may not work for everyone. The side effects most commonly seen when SYNVISC is injected into the knee were pain, swelling and/or fluid buildup around the knee. Cases where the swelling is extensive or painful should be discussed with your doctor. Other side effects such as rash have been reported rarely. Before trying SYNVISC, tell your doctor if you are allergic to products from birds—such as feathers, eggs or poultry—or if your leg is swollen or infected. Talk to your doctor before resuming strenuous weight-bearing activities after treatment. SYNVISC has not been tested in children, pregnant women or women who are nursing. You should tell your doctor if you think you are pregnant or if you are nursing a child.

Ingredients
Hylan G-F 20

Product Information
SYNVISC is used to relieve knee pain due to OA. It is used for patients who do not get enough relief from simple painkillers, such as acetaminophen, or from xercise and physical therapy. It is a viscosupplement that lubricates and cushions your knee joint and relieves pain, which can allow you to move more freely for up to 6 months.
SYNVISC is a gel-like mixture that is made up of hylan A fluid, hylan B gel, and salt water. Hylan A and hylan B are made from a substance called hyaluronan (pronounced hye-a-loo-ROE-nan), also known as sodium hyaluronate that comes from chicken combs. This is a natural substance found in the body and is present in very high amounts in joints. The body’s own hyaluronan acts like a lubricant and a shock absorber in the joint and is needed for the joint to work properly. Osteoarthritis (pronounced os-TE-o- ar-THRI-tis) (OA) is a type of arthritis that involves the wearing down of cartilage (the protective covering on the ends of your bones). In OA, there may not be enough hyaluronan, and there may be a decrease in the quality of the hyaluronan in the joint. Synvisc comes in syringes containing 2 mL (half a teaspoon) of product. Synvisc is injected directly into your knee.

Cartilage wears away
Bone spurs may develop
Joint fluid breaks down
SYNVISC
How does SYNVISC® work?
In knees with osteoarthritis, the joint (synovial) fluid can break down and not provide the cushioning your knee requires. SYNVISC supplements your knee fluid to relieve the pain and improve the knee joint’s natural shock absorbing abilities, allowing you to move more freely and return to the activities you’ve been avoiding. SYNVISC is made from a natural substance similar to that found in normal, healthy joint fluid.

How is SYNVISC given?
SYNVISC is injected directly into the knee over the course of three doctor visits, one week apart. It’s a simple, in-office procedure that takes just a few minutes. After the injection, you can resume normal day-to-day activities but your doctor may recommend you avoid any strenuous exercise for about 24-48 hours.

What can I expect from SYNVISC treatment?
Generally, most people experience maximum pain relief 8-12 weeks after starting SYNVISC treatment. The full course of 3 injections is needed for maximum benefit.

What is Synvisc-One™?
Synvisc-One is a gel-like mixture that comes in a syringe containing 6 mL (1 ½ teaspoon) and is injected into your knee. It is made up of hylanAfluid, hylan B gel, and salt water. Hylan A and hylan B are made from a substance called hyaluronan (pronounced hy-al-u-ROE-nan), also known as sodium hyaluronate that comes from chicken combs. Hyaluronan is a natural substance found in the body and is present in very high amounts in joints. The body’s own hyaluronan acts like a lubricant and a shock absorber in the joint and is needed for the joint to work properly.

How is Synvisc-One different from SYNVISC®?
Synvisc-One is the same formulation as SYNVISC, but requires only one injection instead of three. It’s the only single-injection treatment that can provide up to six months of OA knee pain relief.

SYNVISC Safety
Since SYNVISC is injected directly into the knee, it has fewer serious side effects than pills, which are absorbed into the bloodstream. Side effects from SYNVISC are infrequent. In studies, about 7% of patients experienced pain, swelling and/or fluid buildup around the knee. Other side effects, such as rash, have been reported rarely.