日前,美国FDA批准了Genzyme公司开发的海兰G-F 20(hylan G-F 20)凝胶剂Synvisc-One,用于单次关节内注射缓解已对保守的非药物疗法和单纯止痛药如对乙酰氨基酚(acetaminophen)等治疗没有适当响应的骨关节炎患者的膝疼痛。海兰G-F20是一种透明质酸钠多聚体,而Synvisc-One则为.

Synvisc-One获准治疗膝关节骨关节炎——单次注射即可缓解疼痛6个月

美国FDA批准了Synvisc-One(hylan G-F 20)的上市许可。Synvisc-One是用于缓解膝关节骨关节炎(OA)相关性疼痛的药物。

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。

“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。”

Synvisc-One为单次关节腔内注射给药。它是Genzyme公司Synvisc (hylan G-F 20)的替代治疗方案，后者是一种注射三次的黏弹性补充物，于1997年在美国获准上市，在全球范围内已有超过16年的应用历史。Synvisc-One含有Synvisc的同样有效成分，总治疗体积也与Synvisc相同，只是将6 ml的hylan G-F 20一次性注射给药。

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。在关节滑液中，透明质酸充当缓解疼痛和增强膝关节自然减震能力的角色。

Synvisc-One® (hylan G-F 20) and SYNVISC® (hylan G-F 20) are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

Important Safety Information
Before trying Synvisc-One or 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.  Synvisc-One and SYNVISC are only for injection into the knee, performed by a doctor or other qualified health care professional. Synvisc-One and SYNVISC have not been tested to show pain relief in joints other than the knee. Talk to your doctor before resuming strenuous weight-bearing activities after treatment.  Synvisc-One and SYNVISC have 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.  The side effects most commonly seen when Synvisc-One or SYNVISC is injected into the knee were pain, swelling and/or fluid buildup in or around the knee. Cases where the swelling is extensive or painful should be discussed with your doctor.  Allergic reactions such as rash and hives have been reported rarely.

In the treatment of osteoarthritis knee pain, SYNVISC is taking efficacy further. Because viscosupplements are injected directly into the knee, they have none of the GI or cardiovascular safety issues associated with oral medications.  And, SYNVISC is the only viscosupplement that can offer your patients:

Up to six months of knee pain relief with only three injections
Double the knee pain relief when added to standard treatment, such as diet, exercise, acetaminophen and NSAIDs.*1 Click the sections on the left to learn how SYNVISC provides a large analgesic treatment effect, as shown in clinical trials, and greater osteoarthritis knee pain relief than a non-cross-linked product.

* Precise placement of the injection into the joint space must be achieved in order to optimize efficacy and minimize adverse reactions. The knee joint should be aspirated before the SYNVISC injection.

Important Treatment Considerations
SYNVISC® (hylan G-F 20) and Synvisc-One® (hylan G-F 20) are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non pharmacologic therapy and simple analgesics, e.g., acetaminophen.

SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Use caution when injecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee to be treated.

Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment. Aspiration of any effusion prior to injection is highly recommended. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of SYNVISC and Synvisc-One have not been established in children or in pregnant or lactating women. It is unknown whether SYNVISC or Synvisc-One is excreted in human milk.

For SYNVISC

In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms have been extensive. Other side effects such as rash have been reported rarely.

For Synvisc-One

The most commonly reported related local adverse events were transient, mild-to-moderate arthralgia, arthritis, arthropathy, injection site pain and joint effusion. No serious adverse events have been reported in knees injected with Synvisc-One. Repeat treatment did not affect the safety profile. In the pivotal clinical trial, there was one related systemic event of syncope. The most common systemic side effects irrespective of relationship to Synvisc-One were headache, back pain, nasopharyngitis and influenza. Systemic adverse event profiles were similar between patients in the Synvisc-One and Saline Control groups.