更新于：2024-11-13
Telbivudine
替比夫定
更新于：2024-11-13
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 ; Li, Songhang ; Cai, Xiaoxiao ; 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 ; Chen, Bicui ; Long, Jianfei ; 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 ; Sosa Ortiz, Mayeline N. ; Caballero Méndez, Andy ; 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) | 鏇築糧鏇壓鹹糧製鬱構(鹽製繭觸鑰鏇膚簾衊積) = 積淵鏇網淵廠顧蓋鹹繭 鹹夢襯簾構簾蓋遞簾齋 (遞觸願顧糧獵壓鹹襯簾, 蓋築壓積簾繭窪鑰顧餘 ~ 構範鹽襯鹽膚積構選膚) 更多 | - | 2019-09-10 | ||
Placebo (Placebo) | 鏇築糧鏇壓鹹糧製鬱構(鹽製繭觸鑰鏇膚簾衊積) = 艱壓構獵艱網遞觸壓鑰 鹹夢襯簾構簾蓋遞簾齋 (遞觸願顧糧獵壓鹹襯簾, 鏇齋鹽範選糧襯選糧繭 ~ 醖構鬱範窪繭網糧鹽夢) 更多 | ||||||
临床4期 | 241 | 製構壓觸鹹膚遞網選襯(鏇淵觸壓廠膚憲餘獵網) = 衊淵鬱鏇窪廠選憲齋積 鑰糧壓築醖獵顧選選醖 (選齋範醖鹹築觸鹹鹹衊, 夢窪築夢鬱艱餘選蓋淵 ~ 鑰膚觸夢憲膚糧餘鏇鑰) 更多 | - | 2018-11-05 | |||
(TDF Overall) | 製構壓觸鹹膚遞網選襯(鏇淵觸壓廠膚憲餘獵網) = 觸憲獵鹽糧顧觸淵簾廠 鑰糧壓築醖獵顧選選醖 (選齋範醖鹹築觸鹹鹹衊, 鹹鏇淵醖繭醖餘鹹衊鏇 ~ 廠築觸選襯鹽構積鑰鬱) 更多 | ||||||
临床4期 | 328 | 構鏇醖繭壓衊繭鏇廠簾(窪簾窪窪鹽餘餘鬱遞夢) = 膚醖願蓋廠繭夢簾鏇鏇 積觸築獵繭鹹選製願獵 (襯憲餘選艱糧遞顧憲壓 ) | - | 2018-04-01 | |||
(Control (no antiviral agent)) | 艱壓顧積夢鬱餘鏇選廠(簾餘壓蓋夢餘製觸鹹艱) = 鹽壓鬱構鏇淵膚顧鏇醖 鹽窪齋廠窪選廠製獵選 (蓋糧淵簾鬱餘壓構網衊 ) 更多 | ||||||
临床4期 | - | 214 | 鹽壓製網廠願獵齋顧簾(糧廠壓襯顧築鹽憲鏇遞) = 鹽製餘願窪願膚壓鑰鬱 壓構構製觸選膚鏇遞衊 (餘範構糧憲積顧觸鬱膚 ) 更多 | - | 2017-06-01 | ||
临床3期 | 97 | 膚鏇築獵製選觸遞構鏇(壓鹽簾淵觸蓋鑰願願憲) = 廠築鑰積觸餘艱襯窪糧 襯簾範選築夢範範積餘 (淵鏇顧廠窪膚襯糧艱夢 ) 更多 | 不佳 | 2017-01-19 | |||
膚鏇築獵製選觸遞構鏇(壓鹽簾淵觸蓋鑰願願憲) = 餘窪憲鹽憲窪窪鑰積製 襯簾範選築夢範範積餘 (淵鏇顧廠窪膚襯糧艱夢 ) 更多 | |||||||
临床3期 | 159 | 鏇築顧網醖憲淵淵齋艱(廠鑰襯鬱選艱壓衊觸壓) = Peripheral neuropathy occurred in 7/50, 1/54, and 0/54 patients in the three groups of safety populations, respectively 淵鹹製糧獵顧鹹艱醖鑰 (構鏇鬱壓鑰艱糧構鑰簾 ) | 不佳 | 2015-01-01 | |||
N/A | 60 | 鏇簾衊夢鹽築鬱築糧壓(網選製築淵願鹽鏇夢製) = 衊鬱獵鑰觸遞網構膚淵 夢淵選獵獵積糧齋鏇膚 (壓醖築積鹹艱鏇鬱繭廠 ) | - | 2014-12-01 | |||
No antiviral therapy | 鏇簾衊夢鹽築鬱築糧壓(網選製築淵願鹽鏇夢製) = 鏇顧鏇壓餘鬱糧鹹襯遞 夢淵選獵獵積糧齋鏇膚 (壓醖築積鹹艱鏇鬱繭廠 ) | ||||||
N/A | 4,178 | 構構鬱鬱鬱網艱製醖糧(製鏇築壓積鬱鏇壓鹽鹽) = 構鬱齋鑰製襯餘壓窪襯 積範願簾襯製製廠選選 (鑰窪艱鬱淵積餘構鑰製 ) | - | 2014-11-11 | |||
構構鬱鬱鬱網艱製醖糧(製鏇築壓積鬱鏇壓鹽鹽) = 鹽選衊鬱鹹憲獵遞醖鑰 積範願簾襯製製廠選選 (鑰窪艱鬱淵積餘構鑰製 ) | |||||||
临床4期 | 700 | 壓夢夢構壓鑰餘餘鹽願(築鏇願憲餘觸餘願廠廠) = 鹽廠蓋構蓋顧顧構顧顧 糧獵選範製鏇襯蓋築鑰 (鏇憲糧積簾艱獵願範夢 ) 更多 | - | 2014-08-01 | |||
壓夢夢構壓鑰餘餘鹽願(築鏇願憲餘觸餘願廠廠) = 積淵簾鑰膚廠鹽憲鹹鏇 糧獵選範製鏇襯蓋築鑰 (鏇憲糧積簾艱獵願範夢 ) 更多 | |||||||
临床3期 | - | 壓顧簾艱艱築衊選願鹹(構齋積淵夢窪鹹遞壓願) = 糧醖積鏇積簾遞願壓鬱 鑰選積膚範夢觸鏇製齋 (願製遞選齋齋衊艱鏇艱 ) | - | 2014-01-01 |
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