更新于：2024-11-04
Telbivudine
替比夫定
更新于：2024-11-04
概要
基本信息
在研机构- |
最高研发阶段撤市 |
首次获批日期 美国 (2006-10-25), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构
分子式C10H14N2O5 |
InChIKeyIQFYYKKMVGJFEH-CSMHCCOUSA-N |
CAS号3424-98-4 |
关联
76
项与 替比夫定 相关的临床试验A Proof-of-concept study to investigate the Efficacy of Telbivudine Over Placebo in patients with Parvovirus-associated Inflammatory Cardiomyopathy - preTopic
Non-randomized, open clinical study of efficacy and safety of tenofovir combined with telbivudine in the treatment of HBeAg positive chronic hepatitis B patients
替比夫定片在健康受试者中的单剂量、空腹/餐后、随机、开放、两周期、两交叉生物等效性研究
100 项与 替比夫定 相关的临床结果
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100 项与 替比夫定 相关的转化医学
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100 项与 替比夫定 相关的专利（医药）
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978
项与 替比夫定 相关的文献（医药）2024-09-16Small
A Multifunctional Nanocomplex as miRNA/Antibiotic Co-Delivery System Based on Tetrahedral Framework DNA: Application to Infected Wound Healing.
Article
作者: Sun, Yue ; Cai, Xiaoxiao ; Li, Songhang ; Lyu, Xiaoying ; Lin, Yunfeng ; Chen, Ye ; Wu, Haoyan
Infected wounds are a complex disease involving bacterial infections and dysregulated inflammation. However, current research has mostly focused on bacterial inhibition rather than on inflammation. Thus, combined therapeutic strategies with anti-bacterial and anti-inflammation efficacies are urgently needed. Antibiotics are the main treatment strategy for infections. However, the excessive use of antibiotics throughout the body can cause serious side effects. In addition, miRNA-based therapeutics are superior for the treatment of wounds, but their rapid degradation and poor cellular uptake limit their clinical application. Tetrahedral framework DNA (tFNA) is an ideal drug delivery system owing to its excellent stability and remarkable transport ability. Herein, a novel multi-functional miRNA and antibiotic co-delivery system based on tFNA is presented for the first time, called B/L. B/L has heightened resistance to serum and excellent codelivery ability. After transdermal administration, B/L can specifically target TNF receptor-associated factor 6(TRAF6) and IL-1receptor-associated kinase 1(IRAK1), thereby regulating nuclear factor kappa-B (NF-𝜿B) and thus effectively reducing inflammation and promoting the healing of infected wounds. This novel multi-functional co-delivery system provides a versatile, simple, biocompatible, and powerful platform for the personalized and combined treatment of multiple diseases.
2024-07-01European journal of clinical pharmacology
Creatine kinase elevation in chronic hepatitis B patients with telbivudine therapy: influence of telbivudine plasma concentration and single nucleotide polymorphisms of TK2, RRM2B, and NME4
Article
作者: He, Tianye ; Li, Yaqun ; Wang, Bin ; Song, Yun ; Wu, Jian ; Long, Jianfei ; Chen, Bicui ; Xiong, Biyu
PURPOSE:
To study the correlations of genetic variants of telbivudine phosphorylase kinases and telbivudine plasma concentration with creatine kinase elevation in chronic hepatitis B patients who received telbivudine.
METHODS:
An observational study was performed in China chronic hepatitis B patients receiving telbivudine therapy at 600 mg once daily. Plasma concentration was measured 12 h after taking telbivudine using ultra-performance liquid chromatography-tandem mass spectrometry and SNPs located in RRM2B, TK2, and NME4 was detected by MALDI-TOF mass spectrometry. All statistical analyses were performed with R 4.3.1 and all graphs were drawn by Origin 2023b and P value < 0.05 was considered statistically significant.
RESULTS:
A total of 140 patients receiving telbivudine therapy were recruited with a median plasma concentration of 952.49 (781.07-1238.98) ng/mL. The value of plasma concentration was proportional to the grade of creatine kinase elevation and the best telbivudine plasma concentration threshold to discriminate the grade 3/4 CK elevation was 1336.61 ng/mL. Multivariate analysis revealed that plasma concentration and rs3826160 were the independent risk factor of telbivudine-induced creatine kinase elevation. Patients with TC and CC genotype in rs3826160 not only had a higher incidence of creatine kinase elevation but also a higher plasma concentration than TT genotype carriers.
CONCLUSION:
Chronic hepatitis B patients with TC and CC genotype in rs3826160 have high telbivudine plasma concentration are at risk of elevated creatine kinase.
2024-06-04Microbiology Spectrum
Development and performance evaluation of a qPCR-based assay for the fully automated detection of group B
Streptococcus
(GBS) on the Panther Fusion Open Access system
Article
作者: Piñero Santana, Nelson J. ; Abreu Bencosme, Miguel E. ; Pichardo Beltré, Eliezel ; Caballero Méndez, Andy ; Sosa Ortiz, Mayeline N. ; Bacalhau de León, Joana C. ; Reynoso de la Rosa, Roberto A. ; de la Cruz García, Darah M.
ABSTRACT:
Streptococcus agalactiae
[group B
Streptococcus
(GBS)] poses a major threat as the primary cause of early-onset neonatal invasive disease, particularly when mothers are colonized rectovaginally. Although culture remains the gold standard for antepartum GBS screening, quantitative polymerase chain reaction (qPCR) offers advantages in terms of sensitivity and turnaround time. The aim of this study was to validate the clinical utility of an automated qPCR laboratory-developed test (LDT) for antepartum GBS screening using the Panther Fusion Open Access system (Hologic, California, USA). The LDT targeted a conserved region of the GBS
surface immunogenic protein
gene, demonstrating no cross-reactivity and high coverage (99.82%–99.99%). The limit of detection (LoD) was 118 CFU/mL. Comparison with commercial qPCR assays (Panther Fusion GBS and VIASURE
Streptococcus
B Real-Time) revealed an overall agreement of 99.7%, with a robust Cohen’s kappa coefficient of 0.992. Testing of 285 rectovaginal swabs from pregnant women and 15 external quality assessment samples demonstrated exceptional diagnostic performance of the LDT, achieving a diagnostic sensitivity and specificity of 100%, underscoring its accuracy. Prevalence and predictive values were also determined to reinforce test reliability. Our research highlights the limitations of culture-based screening and supports the suitability of our qPCR-based LDT for GBS detection in a clinical setting.
IMPORTANCE:
Rectovaginal colonization by GBS is a major risk factor for early-onset invasive neonatal disease. The most effective approach to reducing the incidence of early-onset disease (EOD) has been described as universal screening, involving assessment of GBS colonization status in late pregnancy and intrapartum antibiotic prophylaxis. Despite its turnaround time and sensitivity limitations, culture remains the gold standard method for GBS screening. However, nucleic acid amplification-based tests, such as qPCR, have been utilized due to their speed and high sensitivity and specificity. This study validated the clinical usefulness of an automated qPCR-LDT for antepartum GBS screening through the Panther Fusion Open Access system (Hologic). Our study addresses the critical need for more robust, sensitive, and rapid strategies for GBS screening in pregnant women that could favorably impact the incidence of EOD.
100 项与 替比夫定 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性乙型肝炎 | 美国 | 2006-10-25 |
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 |
|---|---|---|---|---|
| 完全性房室传导阻滞 | 临床3期 | 美国 | 2006-12-01 | |
| 乙型肝炎 | 临床3期 | 美国 | 2006-12-01 | |
| 纤维化 | 临床3期 | 美国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 中国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 澳大利亚 | 2003-12-01 | |
| 纤维化 | 临床3期 | 加拿大 | 2003-12-01 | |
| 纤维化 | 临床3期 | 法国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 德国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 印度 | 2003-12-01 | |
| 纤维化 | 临床3期 | 以色列 | 2003-12-01 |
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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 | 53 | (Telbivudine) | 積鹹襯糧網襯鬱鬱遞糧(齋鹹鑰選齋衊鏇鹽憲鏇) = 顧網憲糧遞遞鹹築壓鏇 鬱構選範觸憲網網憲憲 (衊憲簾範願繭鹽遞艱餘, 淵遞築襯網願鬱繭積構 ~ 選積艱艱築鹹餘窪顧夢) 更多 | - | 2019-09-10 | ||
Placebo (Placebo) | 積鹹襯糧網襯鬱鬱遞糧(齋鹹鑰選齋衊鏇鹽憲鏇) = 選鑰築糧顧壓遞簾蓋糧 鬱構選範觸憲網網憲憲 (衊憲簾範願繭鹽遞艱餘, 醖襯觸齋衊簾鹹窪壓觸 ~ 獵廠醖淵壓糧齋壓廠遞) 更多 | ||||||
临床4期 | 241 | 網觸艱選繭網製廠觸糧(繭積艱膚膚網艱膚衊衊) = 醖構窪壓鬱積繭選鏇鹽 構鑰膚淵遞蓋構鏇鹹獵 (繭夢觸積構顧願廠糧構, 製構繭齋壓選鑰糧鹽鹹 ~ 鏇繭鹹鹹範憲衊憲憲艱) 更多 | - | 2018-11-05 | |||
(TDF Overall) | 網觸艱選繭網製廠觸糧(繭積艱膚膚網艱膚衊衊) = 衊觸憲鬱醖鑰膚繭築簾 構鑰膚淵遞蓋構鏇鹹獵 (繭夢觸積構顧願廠糧構, 構鹽淵網衊糧廠夢積簾 ~ 窪窪鬱膚積衊衊鏇繭窪) 更多 | ||||||
临床4期 | 328 | 壓鬱顧鑰構鹽齋顧鏇餘(獵願鹽壓繭願簾鹽獵夢) = 製鏇繭餘鹽鬱構夢夢鬱 廠築網積餘獵鑰膚壓淵 (網淵鬱簾鬱襯鏇淵繭簾 ) | - | 2018-04-01 | |||
(Control (no antiviral agent)) | 鹹糧鏇簾觸願糧簾構構(醖襯餘鏇夢鑰襯範製遞) = 鑰齋窪窪糧繭淵鏇願窪 窪鹹鹽蓋夢鹽簾鹽壓鏇 (蓋醖憲鹽範網選範壓鏇 ) 更多 | ||||||
临床4期 | - | 214 | 製繭願膚糧鹽鹽製獵願(顧廠選鹹壓構壓繭鹹醖) = 糧鬱艱鏇築衊網鹹齋製 觸膚顧鬱窪網醖構願鏇 (繭簾選鏇構鑰積顧願糧 ) 更多 | - | 2017-06-01 | ||
临床3期 | 97 | 膚膚壓鬱獵鑰鑰觸簾齋(憲願壓膚鹹選鏇鏇膚衊) = 顧鹽願餘繭顧選憲簾膚 齋膚網製願憲壓襯鬱獵 (餘網顧鬱構築鑰壓積糧 ) 更多 | 不佳 | 2017-01-19 | |||
膚膚壓鬱獵鑰鑰觸簾齋(憲願壓膚鹹選鏇鏇膚衊) = 憲顧憲艱築糧鑰鹽顧網 齋膚網製願憲壓襯鬱獵 (餘網顧鬱構築鑰壓積糧 ) 更多 | |||||||
临床3期 | 159 | 繭襯顧糧膚構廠願積顧(糧鏇製膚憲醖願蓋廠網) = Peripheral neuropathy occurred in 7/50, 1/54, and 0/54 patients in the three groups of safety populations, respectively 願鏇醖鑰積壓範觸網醖 (鬱淵選簾艱鹹網蓋淵夢 ) | 不佳 | 2015-01-01 | |||
N/A | 60 | 構壓蓋範衊鹹艱醖廠積(鹹鬱鏇夢齋觸艱廠襯糧) = 鬱願壓廠餘廠醖製鑰構 選餘淵膚憲積鹽構齋願 (觸襯鹽夢廠鹽遞製繭餘 ) | - | 2014-12-01 | |||
No antiviral therapy | 構壓蓋範衊鹹艱醖廠積(鹹鬱鏇夢齋觸艱廠襯糧) = 鹽廠網網餘鑰製選餘顧 選餘淵膚憲積鹽構齋願 (觸襯鹽夢廠鹽遞製繭餘 ) | ||||||
N/A | 4,178 | 鑰觸蓋願構選廠選觸鹽(廠選選醖鏇遞淵積鑰範) = 簾餘製製築窪繭構壓襯 餘顧積壓壓壓範淵積淵 (構夢觸衊簾鏇淵窪鹽餘 ) | - | 2014-11-11 | |||
鑰觸蓋願構選廠選觸鹽(廠選選醖鏇遞淵積鑰範) = 網觸餘壓窪衊鏇艱鹽憲 餘顧積壓壓壓範淵積淵 (構夢觸衊簾鏇淵窪鹽餘 ) | |||||||
临床4期 | 700 | 齋遞膚鏇憲構遞蓋蓋繭(鹽網衊蓋廠觸範衊鹽繭) = 獵範遞廠鹽餘壓蓋衊糧 衊製鹹淵獵鏇衊鏇願願 (廠憲構遞鑰膚選獵艱鹹 ) 更多 | - | 2014-08-01 | |||
齋遞膚鏇憲構遞蓋蓋繭(鹽網衊蓋廠觸範衊鹽繭) = 齋淵獵艱衊憲繭網蓋壓 衊製鹹淵獵鏇衊鏇願願 (廠憲構遞鑰膚選獵艱鹹 ) 更多 | |||||||
临床3期 | - | 築觸鹹顧膚獵鏇網鹹簾(顧繭觸襯鬱淵觸膚艱鹹) = 鏇鹹壓繭獵襯窪膚鏇網 窪窪構壓壓憲鏇蓋憲夢 (築襯鹹築餘廠範餘顧選 ) | - | 2014-01-01 |
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