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部份中文Gel-One处方资料（仅供参考）
中文名称：透明质酸钠凝胶
应用治疗：
眼科手术
眼科手术辅助用医疗器械，用于白内障摘除术和人工晶体手术等。
骨科手术
骨科手术，主要用于预防肌腱粘连，缝合术后于暴露肌腱吻合处、腱周、腱间均匀涂抹本品，也可于损伤修复部鞘内或局部注射，或二者并行，视情况而定。
关节腔内注射
常用于治疗骨关节炎及类风湿性关节炎等。
妇科手术
可涂布于子宫肌瘤剥除术、剖腹产术以及输卵管复通术后的吻合口表面；宫腔镜下的输卵管通液后以及宫腔粘连分解术后软组织粗糙面涂布；或于子宫内膜异位症和肿瘤造成的盆腔粘连松解术后使用。
各种腹腔镜手术
在直视条件下，通过导管将本品涂布于组织粗糙面。
美容手术
主要为注射除皱及注射塑形
其它手术
如甲状腺手术、泌尿外科、耳科手术后防止炎性粘连反应等。
注意事项
本品为无菌、无热原制品，应严格无菌操作，一次性使用。
必须在充分止血条件下使用，否则会降低防粘连效果。
仅适用于创面涂布，不得静脉注射。
本品不得稀释使用。
本品勿与含洁尔灭等阳离子化合物接触，以免产生浑浊。
包装破损，禁止使用。
禁忌及警告
对本品高度敏感和对鸟类蛋白高度敏感的患者严禁使用。
长时期使用该产品易产生增敏现象，一旦发生，立即停用，并咨询专业医师。
避免交叉感染，一支L.A.M IPS伤口愈合凝胶仅限一位患者使用。
避免本品与伤口和容器直接接触。
有效期过后请勿使用。
Biologics
Gel-One® Cross-linked Hyaluronate
Gel-One Hyaluronate is an injectable hyaluronate gel approved for the treatment of osteoarthritis (OA) of the knee that does not respond to other conservative treatments. It is the first low-volume viscosupplement available in a single-injection formula.
Unlike other viscosupplement treatments, highly purified Gel-One Hyaluronate requires only 3mL for safe, effective and complete treatment with no reports of pseudosepsis (severe acute inflammatory responses) in the pre-market clinical study.
In a major study of 379 randomized patients1 (248 receiving Gel-One Hyaluronate), the findings are clear:
Gel-One Hyaluronate demonstrated superior pain relief from baseline at 13 weeks when compared with a PBS control.
Patients receiving Gel-One Hyaluronate experienced, on average, a nearly 40% reduction in pain from baseline (28 mm reduction in WOMAC pain on a 100 mm VAS scale).
Zero incidents of pseudosepsis or any other severe adverse events were reported with Gel-One Hyaluronate treatment.
Side effects were as expected, and most commonly included joint swelling, joint effusion and joint pain.
1Of the 379 enrolled patients, 377 patients received either Gel-One Hyaluronate or PBS injection, and 375 patients were analyzed for the Intent to Treat (ITT) population. Patients reported pain with symptomatic OA of the knee defined by WOMAC VAS Pain subscore of ≥40 mm in the study knee and ≤20 mm in the contralateral knee. Patients meeting the following criteria were excluded at randomization: Kellgren-Lawrence Grade 4, severe inflammation or joint effusion in either knee. The ITT population included all treated patients who had any post-injection evaluations. Table 1 summarizes baseline and patient demographic characteristics for the ITT population.
Table 1: Patient Baseline Characteristics – ITT Population
|
Variable |
|
Gel-One (N=247) |
PBS (N=128) |
|
Age (years) |
Mean (SD) |
60.9 (10.2) |
60.3 (10.0) |
|
Gender (n) |
Male |
100 (40.5%) |
51 (39.8%) |
|
Female |
147 (59.5%) |
77 (60.2%) |
|
K-L Score – Study Knee (n) |
1 |
21 (8.5%) |
18 (14.1%) |
|
2 |
94 (38.1%) |
47 (36.7%) |
|
3 |
132 (53.4%) |
63 (49.2%) |
|
Study Knee |
|
|
|
|
WOMAC Pain Subscore (mm) |
Mean (SD) |
70.7 (14.4) |
68.0 (13.1) |
|
Total WOMAC Score (mm) |
Mean (SD) |
69.5 (16.0) |
67.8 (14.7) |
|
WOMAC Physical Function (mm) |
Mean (SD) |
68.9 (17.4) |
67.6 (15.8) |
|
WOMAC Stiffness (mm) |
Mean (SD) |
71.6 (17.5) |
69.3 (17.3) |
|
Contralateral Knee |
|
|
|
|
WOMAC Pain Subscore (mm) |
Mean (SD) |
7.3 (5.5) |
7.6 (5.6) |
Summary of Secondary Effectivenessa Endpoints at Week 13 – ITT Population
|
Effectiveness Measuresb |
Model-Estimated
Advantage
(Gel-One® - PBS) |
Two-sided Lower 95% Confidence Limit (mm) |
Two-sided
P-valuec |
|
Total WOMAC Score |
5.64 mm |
-0.20 |
0.0583 |
|
WOMAC Stiffness |
4.91 mm |
-1.31 |
0.1216 |
|
WOMAC Physical Function |
5.42 mm |
-0.47 |
0.0714 | a Based on the quadratic spline model at week 13.
b WOMAC Scale is 100mm.
c P-value was not adjusted for multiplicity of secondary endpoints.
There were no serious AEs or pseudoseptic reactions related to Gel-One Hyaluronate injection.
Conclusions
The study results demonstrated that a single injection of Gel-One Hyaluronate is safe and effective for treatment of pain in osteoarthritis of the knee in patients who have failed to respond to nonpharmacologic therapy, NSAIDs or simple analgesics.
Dosage
Gel-One Hyaluronate is packaged in a single-injection, 3mL syringe (1% solution [10 mg/mL], 30mg total hyaluronan). It is injected into the intra-articular space of the knee.
Storage
Store in the original package below 77°F (25°C). DO NOT FREEZE.
DO NOT USE after expiration date indicated on package.Gel-One Hyaluronate has a 12-month shelf life from date of manufacture.
STERILE CONTENTS intended for single use:
Use syringe immediately after blister package is opened.
Discard any unused Gel-One Hyaluronate.
DO NOT USE if the package has been opened or damaged, or if the syringe is cracked or broken.
Gel-One® is a registered trademark of Seikagaku Corporation.
Indication: Gel-One Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen.
Important Safety Information
Before using Gel-One Hyaluronate, tell your doctor if you are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry.Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. You should not receive a Gel-One Hyaluronate injection if you have a skin disease or infection around the area where the injection will be given.Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA.Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. You should tell your doctor if you think you are pregnant or if you are nursing a child. Talk to your doctor before resuming strenuous or pro-longed weight-bearing activities after treatment. The safety and effectiveness of repeat treatment cycles of Gel-One Hyaluronate have not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate are knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. Other conditions, including but not limited to skin redness and rash, knee stiffness, and bruising at the injection site, have also been reported rarely. If any of these symptoms or signs appears after you are given Gel-One Hyaluronate or if you have any other problems, you should call your doctor.
http://www.zimmer.com/en-US/hcp/common/product/gel-one.jspx?cate=biologics |
