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更新于：2025-01-25
Triamcinolone hexacetonide/Sodium Hyaluronate
己曲安奈德/透明质酸钠
更新于：2025-01-25
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2015-11-03), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C30H41FO7 |
InChIKeyTZIZWYVVGLXXFV-FLRHRWPCSA-N |
CAS号5611-51-8 |
关联
4
项与 己曲安奈德/透明质酸钠 相关的临床试验NCT04231318
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee
NCT03390036
Trial Extension Protocol to Add a 39 Week Follow Up to Cingal 16-02, a Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection of Cingal to Provide Symptomatic Relief of Knee Osteoarthritis
NCT03191903
Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal™) to Provide Symptomatic Relief of Osteoarthritis of the Knee
100 项与 己曲安奈德/透明质酸钠 相关的临床结果
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100 项与 己曲安奈德/透明质酸钠 相关的转化医学
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100 项与 己曲安奈德/透明质酸钠 相关的专利（医药）
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3
项与 己曲安奈德/透明质酸钠 相关的文献（医药）2025-02-01Journal of ISAKOS Joint Disorders & Orthopaedic Sports Medicine
Intra-articular injection of a cross-linked hyaluronic acid combined with triamcinolone hexacetonide improves pain at six months in patients with mild to moderate hip osteoarthritis: A prospective observational study
Article
作者: Dessouki, Shariff ; Williams, Ryan ; Lautenbach, Justin ; Rabinovich, Alexander ; Duong, Andrew ; Dalziel, Katie ; Hitchon, Maggie ; Maida, Eugene ; Kapuvari, Stephen ; Bourgeault-Gagnon, Yoan ; de SA, Darren ; Ayeni, Olufemi R. ; Heels-Ansdell, Diane ; Simunovic, Nicole ; Sim, Yan
OBJECTIVES:
Joint-preserving interventions, such as intra-articular viscosupplementation injections, are evolving and requiring efficacy and safety evaluations through an evidence-based approach. The objective of this study was to assess the use of a hyaluronic acid and corticosteroid-based injection (Cingal™; Anika Therapeutics, Bedford, MA, USA) in improving pain and functional outcomes for patients aged between 40 and 65 with mild to moderate hip osteoarthritis (OA) six months post-injection.
METHODS:
This prospective observational study included 100 patients receiving a single ultrasound-guided intra-articular injection of Cingal™. Eligible patients seen in participating orthopaedic, physiatry and sports medicine clinics were evaluated at baseline, one-month, and six-month follow-up. The primary outcome was patient-reported hip pain (Visual Analogue Scale, VAS) at six months post-injection. Secondary outcomes included hip function (Hip Disability and Osteoarthritis Outcome Score, HOOS), quality of life (Short-Form 12, SF-12), pain medication use, range of motion (ROM), physical activity (activity tracker), and adverse events.
RESULTS:
Ninety-six patients received the injection; 91 had complete data for primary outcome analysis. Statistically significant improvements were observed in VAS (p < 0.001), HOOS (p < 0.001), and SF-12 scores (Physical Component Summary, p = 0.005; Mental Component Summary, p = 0.022) from baseline to six months post-injection. Pain medication use decreased from 50.0% to 34.0% (p = 0.035). No statistically significant change was observed in ROM or activity level. Adverse events were reported in 9.5% of patients: five (5.3%) experienced hip pain for less than seven days, one for more than seven days but less than one month, and three (3.2%) underwent hip arthroplasty.
CONCLUSION:
Patients receiving an ultrasound-guided Cingal™ injection for hip OA reported statistically significantly reduced hip pain, improved function and quality of life, and reduced pain medication use at six months. The most common adverse event was transient hip pain.
LEVEL OF EVIDENCE:
Prospective observational study, Level III.
2018-07-01Cartilage3区 · 医学
Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
3区 · 医学
Article
作者: Vasarhelyi, Gabor ; Stevens, Gary ; Zgadzaj, Wojciech ; Hangody, György ; Dokoupilova, Eva ; Lukasik, Piotr ; Szody, Robert ; Lénárt, Endre ; Ficzere, Andrea ; Szendroi, Miklos ; Bichovsk, Daniela ; Hangody, Laszlo ; Berta, Agnes
Objective::
To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis.
Design::
This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks.
Results::
A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported.
Conclusions::
Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.
2008-01-01AJNR. American journal of neuroradiology2区 · 医学
Evaluation of a Neck-Bridge Device to Assist Endovascular Treatment of Wide-Neck Aneurysms of the Anterior Circulation
2区 · 医学
Article
作者: De Keukeleire, K ; Defreyne, L ; Vanlangenhove, P
BACKGROUND AND PURPOSE:
Intracranial aneurysms with a wide-neck or an unfavorable dome-to-neck ratio may be difficult to treat properly and safely. Our aim was to evaluate the TriSpan neck-bridge device to assist coiling of wide-neck bifurcation aneurysms in the anterior circulation.
MATERIALS AND METHODS:
In 14 patients, we performed 16 TriSpan-assisted coil embolizations with wide-neck bifurcation aneurysms of the anterior circulation. Eleven procedures were indicated for acutely ruptured aneurysms. Five were performed electively for the following: recurrent aneurysm after coil only (n = 1) or after TriSpan-assisted embolization (n = 2), aneurysm remnant after clipping (n = 1), and aneurysm incidentally found (n = 1). Procedural and clinical complications were recorded. Follow-up angiography was performed, and clinical outcomes were assessed by using the modified Rankin Scale score.
RESULTS:
TriSpan-assisted embolization was successful in 15/16 (93.8%) procedures, with complete occlusion in 2/16 (12.5%), near-complete occlusion in 10/16 (62.5%), and incomplete occlusion in 3/16 (18.75%). There were 6 (37.5%) intraprocedural complications: thrombus formation (n = 3), protrusion of a TriSpan loop in the parent artery (n = 1), TriSpan displacement in the aneurysm (n = 1), and tangling of a coil loop in the device (n = 1). Three patients died in the hospital (21.4%). Follow-up angiography or MR angiography was available in 8 (57.1%) patients and showed complete (n = 2), near-complete (n = 2), and incomplete occlusion (n = 4). Long-term clinical outcome was no (n = 4) or minor symptoms (n = 1) and moderate (n = 2), moderately severe (n = 2), or severe handicap (n = 2).
CONCLUSION:
The use of the TriSpan device is feasible in the anterior circulation and can assist treatment of difficult wide-neck bifurcation aneurysms.
1
项与 己曲安奈德/透明质酸钠 相关的新闻（医药）100 项与 己曲安奈德/透明质酸钠 相关的药物交易
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外链
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 骨关节炎 | 加拿大 | 2015-11-03 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 膝关节炎 | 临床3期 | 捷克 | 2015-02-01 | |
| 膝关节炎 | 临床3期 | 匈牙利 | 2015-02-01 | |
| 膝关节炎 | 临床3期 | 波兰 | 2015-02-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 231 | (Cingal) | 醖網憲選壓願網願蓋廠(簾簾鏇製衊遞繭憲淵襯) = 鏇獵淵鏇遞顧糧糧醖醖 繭遞壓鹽鬱繭構齋膚繭 (鹹簾窪蓋築淵壓繭願廠, 艱廠餘遞蓋壓壓鹽齋糧 ~ 膚鑰蓋夢廠餘憲願獵選) 更多 | - | 2023-08-09 | ||
(Triamcinolone Hexacetonide (TH)) | 醖網憲選壓願網願蓋廠(簾簾鏇製衊遞繭憲淵襯) = 築獵遞構積蓋壓鹽範憲 繭遞壓鹽鬱繭構齋膚繭 (鹹簾窪蓋築淵壓繭願廠, 襯夢觸積憲鑰鑰繭簾壓 ~ 淵鬱遞夢顧繭積簾遞獵) 更多 | ||||||
临床3期 | 526 | (Cingal) | 窪簾醖窪淵願遞餘顧餘(壓廠淵觸鹽衊壓選艱憲) = 製餘餘鬱網網鏇醖鬱範 蓋製願襯鏇網積膚壓襯 (製艱夢鹹簾淵窪願襯糧, 憲鏇獵餘範繭衊蓋醖餘 ~ 顧製鬱簾築築襯窪繭齋) 更多 | - | 2023-05-31 | ||
Monovisc (Monovisc) | 窪簾醖窪淵願遞餘顧餘(壓廠淵觸鹽衊壓選艱憲) = 網糧製艱膚繭遞築築鹹 蓋製願襯鏇網積膚壓襯 (製艱夢鹹簾淵窪願襯糧, 簾獵遞網醖窪鹽觸夢齋 ~ 網構壓蓋構範蓋餘餘鑰) 更多 | ||||||
临床3期 | 576 | (Cingal) | 餘窪觸獵鏇膚襯膚獵淵(鑰艱遞艱積願鏇範齋醖) = 壓觸構艱艱壓艱夢鬱構 夢積餘網鑰齋遞憲觸齋 (膚積繭窪鑰顧鹹窪餘獵, 獵齋鬱鑰鏇夢蓋簾鑰廠 ~ 淵繭鹹蓋顧獵獵鬱範顧) 更多 | - | 2022-02-24 | ||
Monovisc (Monovisc) | 餘窪觸獵鏇膚襯膚獵淵(鑰艱遞艱積願鏇範齋醖) = 淵廠築獵築網願窪積壓 夢積餘網鑰齋遞憲觸齋 (膚積繭窪鑰顧鹹窪餘獵, 糧獵淵蓋觸鹹繭廠艱獵 ~ 憲簾夢遞衊簾鹽鑰蓋選) 更多 | ||||||
临床3期 | 242 | (Cingal/Cingal) | 壓獵鏇願鑰夢積顧鹽餘(繭窪鑰廠齋糧範鹹網醖) = 壓簾餘糧簾糧壓憲夢衊 鑰窪範築繭鹽鬱鑰選鑰 (憲糧網簾選遞簾選淵鏇, 鏇顧齋鏇餘蓋膚鬱廠鹽 ~ 繭製夢糧膚襯夢糧膚淵) 更多 | - | 2020-09-03 | ||
(Cingal/Monovisc) | 壓獵鏇願鑰夢積顧鹽餘(繭窪鑰廠齋糧範鹹網醖) = 衊夢艱蓋膚淵膚願繭窪 鑰窪範築繭鹽鬱鑰選鑰 (憲糧網簾選遞簾選淵鏇, 鏇醖製鏇願膚廠繭鏇繭 ~ 蓋衊齋鹽蓋獵淵蓋網壓) 更多 |
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