更新于：2024-11-18
Loxoprofen Sodium Hydrate
洛索洛芬钠
更新于：2024-11-18
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C15H20NaO4 |
InChIKeyNGHFIMBWFYJBHQ-UHFFFAOYSA-N |
CAS号226721-96-6 |
关联
100
项与 洛索洛芬钠 相关的临床试验一项单中心、随机、开放、单剂量、两制剂、两周期、两交叉评价洛索洛芬钠贴剂与参比制剂在健康受试者体内的生物等效性研究
洛索洛芬钠贴剂人体生物等效性研究
Beyond Pills Transdermal patch efficacy in post operative pain relief. - NIL
100 项与 洛索洛芬钠 相关的临床结果
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100 项与 洛索洛芬钠 相关的专利（医药）
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614
项与 洛索洛芬钠 相关的文献（医药）2024-12-01Bulletin of the Hospital for Joint Diseases
Leukocyte-Poor Platelet-Rich Plasma as a Treatment for Patellar Tendinopathy A Multicenter, Randomized Controlled Trial.
Article
作者: Weinberg, Maxwell ; Bloom, David A ; Strauss, Eric J ; Pham, Hien ; Wasterlain, Amy ; Dragoo, Jason L ; Herrero, Christina
PURPOSE:
The purpose of this study was to compare regimens of eccentric exercise and dry-needling, with and without an ultrasound-guided leukocyte-poor platelet-rich plasma (LP-PRP) injection, in patients with patellar tendinopathy.
METHODS:
Patients with symptomatic patellar tendinopathy based on physical examination and magnetic resonance imaging and who had failed at least 6 weeks of nonoperative treatment were enrolled and randomized at two centers to receive ultrasound-guided dry-needling (DN) alone or in addition to an injection of LP-PRP coupled with standardized eccentric strengthening exercises. Participants completed patient-reported outcome surveys at baseline and at 3, 6, 9, 12, and 26 weeks post-treatment. The primary outcome measure was the Victorian Institute of Sports Assessment (VISA) score for patellar tendinopathy (VISA-P) at 12 weeks, and secondary measures included the visual analog scale (VAS) for pain, Tegner activity scale, Lysholm knee scale (Lysholm), and Veterans Rand 12-Item Health Survey (VR12) questionnaire at 12 and 26 weeks.
RESULTS:
Thirty-one subjects were enrolled in the study (15 DN, 16 LP-PRP). Twenty-three patients were available for follow-up at all time points. There were no statistically significant differences between the two groups at baseline. At 12 weeks post-treatment, both the LP-PRP and DN groups demonstrated statistically significant (p < 0.05) improvements from baseline with respect to Lysholm score (34.5 ± 15.1 and 31.7 ± 18.4), VAS pain scale (-1.58 ± 2.1 and -2.8 ± 1.9, respectively), and VISA score (19.2 ± 15.9 and 28.4 ± 19.4, respectively). At 26 weeks post-treatment both groups demonstrated statistically significant (p < 0.05) improvements in Lysholm score (23.6 ± 23.1 and 24.5 ± 17.3, respectively) and VAS pain score (-1.67 ± 2.3 and -2.18 ± 2.9, respectively). The LP-PRP group failed to show significance for VISA-P score from 0 to 26 weeks, though the DN group did (22.0 ± 14.6). There were no statistically significant differences between the two groups in mean VISA, VAS, Lysholm, or the Short Form Health Survey (SF-12) scores at either the 12 week or 26-week follow-up time points.
CONCLUSION:
The results of the current study demonstrate that both DN and DN plus LP-PRP are effective treatment options in the management of symptomatic patellar tendinopathy, however, LP-PRP did not add any additional improvement over DN alone.
2024-12-01Regenerative therapy
Comparison of bioactive substances in novel-developed freeze-dried platelet-rich plasma (PRP) and activated normal PRP, and investigation of bioactive substance levels after long-term storage
Article
作者: Ishijima, Muneaki ; Saita, Yoshitomo ; Yamamoto, Nanako ; Nakajima, Ryosuke ; Uchino, Sayuri ; Momoi, Yasumasa ; Wakayama, Takanori ; Kobayashi, Yohei
Introduction:
In recent years, biotherapy in orthopedics has become widespread, and platelet-rich plasma (PRP) has been readily used to treat sports injuries and osteoarthritis. Production of freeze-dried PRP (PRP-FD) results in PRP that is in powder form, allowing it to be stored for long periods at room temperature. Using this technology, we have developed Valuable Platelet-Derived Factor Concentrate Freeze Dry (VFD). However, whether VFD contains sufficient levels of bioactive substances (BS) remains unknown and retains the same levels of BS during long-term storage. In this study, we examined whether VFD contains sufficient amounts of BS and whether they retain these BS levels during long-term storage.
Methods:
Peripheral blood was collected from 10 healthy men (mean ± SD: 46.5 ± 15 years old) and various BS, including transforming growth factor β (TGF-β), basic fibroblast growth factor (bFGF), epidermal growth factor (EGF), tissue inhibitors of metalloproteinases-1 (TIMP-1), interleukin-1 receptor antagonist (IL-1ra), matrix metallopeptidase-9 (MMP-9), and interleukin-6 (IL-6), were compared between VFD and normal PRP samples, including both leukocyte-rich PRP (LR-PRP) and leukocyte-poor PRP (LP-PRP). VFD was prepared using two rounds of centrifugation. LP-PRP and LR-PRP were activated by freezing and thawing before measurement. To evaluate the effects of long-term storage, the BS of VFD purified from five professional football players was compared between baseline and 1 year after storage.
Results:
In terms of the growth factors, the TGF-β and EGF levels were higher in LR-PRP than in VFD and LP-PRP (p < 0.05), while the bFGF levels were higher in VFD than in the LR-PRP and LP-PRP groups (p < 0.01). In terms of anti-inflammatory cytokines, the TIMP-1 level was lower in VFD than that in the other groups (p < 0.01), whereas the IL-1ra levels were higher in VFD than those in LP-PRP (p < 0.05) and lower than those in LR-PRP (p < 0.01). In terms of inflammatory enzymes and cytokines, the IL-1ra level was higher in VFD than that in LP-PRP (p < 0.05) and lower than that in LR-PRP (p < 0.01), whereas the IL-6 levels did not differ among the groups. Furthermore, the TGF-β, bFGF, TIMP-1, and IL-1ra levels were 5.61 → 3.38 (x103 pg/μL), 61.0 → 63.0 (pg/μL), 3.4 → 2.7 (x105 pg/μL), and 14.9 → 14.5 (x103 pg/μL) at baseline and 1 year later, respectively. No significant differences in the BS levels were observed between baseline and 1 year after storage.
Conclusions:
The VFD samples prepared in this study exhibited higher levels of anti-inflammatory cytokines than LP-PRP and contained growth factor levels similar to LP-PRP and LR-PRP. In addition, the BS levels in VFD samples were maintained after one year of storage. These results suggest that VFD can be prepared and stored and may serve as a novel treatment strategy for sports injuries in high-risk groups, such as athletes.
2024-11-01AMERICAN JOURNAL OF SPORTS MEDICINE
Leukocytes Do Not Influence the Safety and Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial
Article
作者: Sangiorgi, Elena ; Orazi, Simone ; Zaffagnini, Stefano ; Andriolo, Luca ; Romandini, Iacopo ; Filardo, Giuseppe ; Di Martino, Alessandro ; Boffa, Angelo ; Pizzuti, Valeria ; Cenacchi, Annarita
Background::
Platelet-rich plasma (PRP) is increasingly used for the injection treatment of knee osteoarthritis (OA). However, the role of leukocytes contained in PRP is controversial, with some preclinical studies suggesting detrimental effects and others emphasizing their contribution in secreting bioactive molecules.
Purpose::
To compare the safety and effectiveness of leukocyte-rich PRP (LR-PRP) and leukocyte-poor PRP (LP-PRP) for the treatment of knee OA.
Hypothesis::
That leukocytes could influence results both in terms of adverse events and clinical outcomes.
Study Design::
Randomized controlled trial; Level of evidence, 1.
Methods::
This double-blind randomized controlled trial included 132 patients with Kellgren-Lawrence grade 1-3 knee OA who were randomized to a 3-injection cycle of either LR-PRP or LP-PRP. Patients were prospectively assessed at baseline and at 2, 6, and 12 months with subjective evaluations comprising the International Knee Documentation Committee (IKDC) subjective score, the KOOS (Knee injury and Osteoarthritis Outcome Score), the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), the visual analog scale for pain, the EuroQol–visual analog scale, the EuroQol–5 dimensions, and the Tegner activity scale. Objective evaluations consisted of the IKDC objective score, active/passive range of motion, and circumference of the index and contralateral knees. Patient judgment of the treatment was recorded as well as adverse reactions and failures.
Results::
An overall improvement in subjective and objective outcomes was documented, with no differences between the 2 groups, except for the improvement in the IKDC subjective score at 2 months, which was greater for the LR-PRP group compared with the LP-PRP group (14.8 ± 14.8 vs 8.6 ± 13.3, respectively; P = .046), as well as for active ( P = .021) and passive ( P = .040) ROM of the index knee at 6 months, showing statistically significant higher values in the LP-PRP group; and for quadriceps circumference of the index ( P = .042) and contralateral ( P = .045) knees at 12 months, which were significantly greater in the LR-PRP group. The IKDC subjective score improved from 42.5 ± 17.6 at baseline to 55.6 ± 21.4 at 12 months for the LR-PRP group ( P < .0005) and from 45.7 ± 16.4 to 55.3 ± 20.4 for the LP-PRP group ( P = .001). No differences in terms of patient treatment judgment were observed at all follow-up time points. No severe adverse events related to the treatment were reported, but some mild adverse events related to the treatment were observed: 16 in the LR-PRP group and 17 in the LP-PRP group. Treatment failed in 5 patients in the LR-PRP group and 2 in the LP-PRP group.
Conclusion::
This double-blind randomized controlled trial demonstrated that leukocytes did not affect the safety and efficacy of intra-articular PRP injections for the treatment of patients with knee OA. Both LR-PRP and LP-PRP demonstrated comparable clinical outcomes at all follow-up time points, without showing differences in subjective and objective outcomes or in adverse events and treatment failures.
Registration::
NCT04187183 (ClinicalTrials.gov).
100 项与 洛索洛芬钠 相关的药物交易
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批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 术后疼痛 | 韩国 | 2024-04-03 | |
| 炎症 | 日本 | 1986-03-01 | |
| 疼痛 | 日本 | 1986-03-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 术后炎症 | 临床3期 | 中国 | 2024-04-11 | |
| 术后炎症 | 临床3期 | 中国 | 2024-04-11 | |
| 膝关节炎 | 临床3期 | 中国 | 2017-04-10 | |
| 创伤和损伤 | 临床3期 | 巴西 | 2015-10-01 | |
| 白内障 | 临床2期 | 中国 | 2022-12-30 | |
| 白内障 | 临床2期 | 中国 | 2022-12-30 | |
| 肌痛 | 临床2期 | 美国 | 2015-10-01 | |
| 眼部炎症 | 临床1期 | 中国 | 2021-10-19 | |
| 眼部炎症 | 临床1期 | 中国 | 2021-10-19 |
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N/A | 451 | (People living with HIV) | 壓選餘壓衊簾壓獵網簾(獵構築夢餘艱積製齋選) = 築簾築構衊鹹鬱餘鹽顧 淵遞糧築鹽衊夢衊夢鑰 (憲築構衊網鹽艱壓製窪, 5.1 ~ 36) | - | 2022-01-01 | ||
临床2期 | 47 | (Experimental) | 膚憲鬱糧構遞壓獵繭夢(壓鏇積壓願壓廠壓蓋艱) = 觸淵衊鏇製獵鏇願艱築 蓋蓋繭糧衊網鏇鹹鹹壓 (觸齋艱糧餘齋製鹽膚襯, 簾醖遞願觸壓鏇鹹醖網 ~ 蓋蓋鑰膚繭窪觸顧願顧) 更多 | - | 2019-09-09 | ||
(Placebo Comparator) | 膚憲鬱糧構遞壓獵繭夢(壓鏇積壓願壓廠壓蓋艱) = 齋構艱鹽選餘艱淵膚簾 蓋蓋繭糧衊網鏇鹹鹹壓 (觸齋艱糧餘齋製鹽膚襯, 淵廠範壓獵獵艱膚壓鑰 ~ 襯遞夢構鹹鏇醖簾願簾) 更多 | ||||||
临床3期 | 80 | 鏇齋範製製鬱艱蓋衊獵(淵積觸艱願壓築鏇選膚) = 觸遞製廠網簾獵膚簾願 製獵觸蓋網積積窪鑰鑰 (鹽鬱壓遞窪艱積選廠夢, 鑰壓餘構壓窪醖簾鹹積 ~ 齋選網廠網遞鏇衊鏇願) 更多 | - | 2018-07-20 | |||
N/A | 70 | Loxoprofen sodium hydrogel patch (LX-P) | 膚壓觸鏇鹹蓋蓋選齋廠(襯艱構窪鑰簾構鹹齋築) = 簾夢範遞蓋獵淵艱選範 蓋範觸齋憲繭衊製憲艱 (鏇遞壓願構鏇壓鑰願鑰 ) | 积极 | 2016-06-08 | ||
Loxoprofen sodium tablet (LX-T) | 膚壓觸鏇鹹蓋蓋選齋廠(襯艱構窪鑰簾構鹹齋築) = 鏇鹹鹹醖鏇齋構獵積築 蓋範觸齋憲繭衊製憲艱 (鏇遞壓願構鏇壓鑰願鑰 ) | ||||||
临床4期 | 一线 | 190 | 選醖繭繭遞顧膚製製築(鏇願築鬱夢齋構願獵簾) = 鏇選鹹獵夢鏇衊衊廠廠 遞餘範夢築衊餘鬱鬱鬱 (壓繭觸遞簾選憲夢淵範 ) | 积极 | 2013-02-01 | ||
選醖繭繭遞顧膚製製築(鏇願築鬱夢齋構願獵簾) = 構繭蓋餘築齋夢構鏇餘 遞餘範夢築衊餘鬱鬱鬱 (壓繭觸遞簾選憲夢淵範 ) |
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