Local delivery of tetracycline: from concept to clinical application.
Local delivery of tetracycline: from concept to clinical application.
复制标题
四环素的局部给药：从概念到临床应用。
DOI：
--
复制
发表时间：
1998
影响因子：
6.7
通讯作者：
M. Tonetti
中科院分区：
文献类型：
--
作者：
M. Tonetti
本文综述了近20年来支持控制释放装置治疗人类牙周炎的临床应用证据的发展。该器械是一种装载有25% w/w盐酸四环素的单片乙烯醋酸乙烯酯纤维（四环素纤维）。它以2 μ g/cm x h的稳态速率释放四环素，并在作用部位维持基本恒定的高效四环素浓度。一系列对照、随机、单盲、III期临床试验（共纳入463例患者）表明：（1）四环素纤维的疗效显著优于洁治和根面平整阳性对照;（2）四环素纤维与龈下机械清创术联合使用的疗效显著优于单纯清创术。来自这些研究的证据已经导致美国食品和药物管理局和欧盟监管机构批准了这种治疗方式。一项涉及欧洲和北美68名临床医生治疗的2711例受试者的临床使用研究表明，观察到的临床结局的程度具有临床相关性，并且很少观察到不良事件。各种临床研究旨在最佳纳入四环素纤维的治疗策略提供指导的情况下选择。应考虑治疗费用和不必要使用抗生素的问题。尽管如此，可以得出结论，四环素纤维与机械清创术的组合代表了一种记录在案的治疗替代方案，其应用可能为许多患者提供临床受益。
This manuscript reviews the development over the last 20 years of the evidence supporting the clinical application of a controlled delivery device for the treatment of human periodontitis. The device is a monolithic ethylene vinyl-acetate fibre loaded with 25% w/w tetracycline HCI (tetracycline fibre). It releases tetracycline at a steady state rate of 2 microg/cm x h and results in the maintenance of essentially constant, highly-effective concentrations of tetracycline at the site of action. A series of controlled, randomised, single-blind, phase-III clinical trials including a total of 463 patients has indicated that: (1) tetracycline fibres result in significantly better outcomes than the scaling and root planing positive control; (2) combination of tetracycline fibres with subgingival mechanical debridement results in significant improvement over debridement alone. Evidence from these studies has led to approval of this treatment modality by the US Food and Drug Administration and by the European Union Regulatory Bodies. A clinical usage study involving 2711 subjects treated by 68 clinicians in Europe and North America indicated that the magnitude of the observed clinical outcomes is clinically relevant and that adverse events were rarely observed. A variety of clinical investigations aimed at the optimal incorporation of tetracycline fibres in a treatment strategy provide guidance in case selection. Cost of therapy and concerns of unnecessary usage of antibiotics should be considered. It is nonetheless concluded that combination of tetracycline fibres with mechanical debridement represents a documented treatment alternative, the application of which may offer clinical benefits to many patients.
登录
查看更多内容
影响因子：
4.3
作者：
BAKER, PJ;EVANS, RT;GENCO, RJ
通讯作者：
GENCO, RJ
通过 DNA 探针和培养方法监测四环素纤维疗法。
影响因子：
3.5
作者：
Maiden,MF;Tanner,A;McArdle,S;Najpauer,K;Goodson,JM
通讯作者：
Goodson,JM
影响因子：
56.9
作者：
LANGER, R
通讯作者：
LANGER, R
影响因子：
4.3
作者：
ADRIAENS, PA;DEBOEVER, JA;LOESCHE, WJ
通讯作者：
LOESCHE, WJ
人类口腔厌氧菌对适合局部使用的抗生素的敏感性。
影响因子：
6.7
作者：
Baker,PJ;Evans,RT;Slots,J;Genco,RJ
通讯作者：
Genco,RJ