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New FDA guidelines for anti-infective drugs 新的FDA抗感染药物指南
Antimicrobic Newsletter
Pub Date : 1990-01-01 DOI: 10.1016/0738-1751(90)90022-5
Thomas R. Beam Jr., David N. Gilbert, Calvin M. Kunin, D. Amsterdam

The 1977 Guidelines for the Evaluation of Anti-infective Drug Products are no longer useful. The IDSA has established a contract with the FDA to revise and update these documents. Thirteen sub-committees will address specific areas of infectious diseases. A general guideline will also be written that proposes modification of the drug evaluation process. The documents will be reviewed by specialist in infectious diseases and clinical microbiology working in practice, academic medicine, the pharmaceutical industry, and the FDA. A second series of draft documents will be prepared and reviewed again, with final approval provided by the FDA. Current plans call for presentation of these guidelines to FDA Advisory Committees in November 1990. Publication of most or all of these guidelines is the primary objective of the contract. If successful, the process may be used to develop guidelines for the evaluation of other classes of drugs, medical devices, and biologic products.

1977年《抗感染药品评价指南》已不再适用。IDSA已与FDA签订合同，修订和更新这些文件。13个小组委员会将处理传染病的具体领域。还将编写一份总指南，建议修改药物评价过程。这些文件将由传染病和临床微生物学专家、学术医学、制药行业和FDA审查。第二系列文件草案将被准备和再次审查，并由FDA提供最终批准。目前的计划要求在1990年11月向FDA咨询委员会提交这些指南。发布大部分或全部这些准则是本合同的主要目标。如果成功，该过程可用于制定其他类别药品、医疗器械和生物制品的评价指南。
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引用次数: 0
Editor's note 编者按
Antimicrobic Newsletter
Pub Date : 1990-01-01 DOI: 10.1016/0738-1751(90)90021-4
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引用次数: 0
The antimicrobic newsletter, volume 6, 1989 index 抗菌剂通讯，第6卷，1989年索引
Antimicrobic Newsletter
Pub Date : 1989-12-01 DOI: 10.1016/0738-1751(89)90008-7
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引用次数: 0
Fluoroquinolone-drug interactions: An overview 氟喹诺酮类药物相互作用综述
Antimicrobic Newsletter
Pub Date : 1989-12-01 DOI: 10.1016/0738-1751(89)90007-5
Randall A. Prince

It is apparent that the fluoroquinolones represent an important advancement in infectious disease therapy. However, like other anti-microbial compounds, they are not without side effects. An understanding and appreciation of fluoroquinolone-drug interactions is essential for their optimal clinical use. Many questions concerning the potential of the fluoroquinolones with regard to drug interactions still remain.

In addition, the majority of research on fluoroquinolone-drug interactions has been done in the research center environment using normal, healthy adult volunteers. The clinical significance of fluoroquinolone-drug interactions needs to be based upon observations in various patient populations, where feasible. Many of the aforementioned interactions could be influenced by race, dosage regimen design, smoking status of the patient, diet composition, and underlying organ function. Future research needs to assess the multiple factors of the clinical setting that might have an influence on patient outcome as a result of combining a fluoroquinolone with another interacting drug. Because norfloxacin and ciprofloxacin are commercially available in the United States, an active surveillance program in the community and institutional settings will help to identify and clarify many of the issues related to flouroquinolone-drug interactions.

很明显，氟喹诺酮类药物代表了传染病治疗的重要进展。然而，像其他抗微生物化合物一样，它们也不是没有副作用。了解和认识氟喹诺酮类药物的相互作用对其最佳临床应用至关重要。关于氟喹诺酮类药物在药物相互作用方面的潜力仍然存在许多问题。此外，大多数关于氟喹诺酮类药物相互作用的研究都是在研究中心的环境中进行的，使用的是正常、健康的成年志愿者。在可行的情况下，氟喹诺酮类药物相互作用的临床意义需要基于对不同患者群体的观察。上述许多相互作用可能受到种族、给药方案设计、患者吸烟状况、饮食组成和潜在器官功能的影响。未来的研究需要评估临床环境中的多种因素，这些因素可能会影响氟喹诺酮类药物与另一种相互作用药物联合使用对患者预后的影响。由于诺氟沙星和环丙沙星在美国是可以买到的，因此在社区和机构中开展积极的监测项目将有助于确定和澄清与氟喹诺酮类药物相互作用有关的许多问题。
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引用次数: 4
Editor's note 编者按
Antimicrobic Newsletter
Pub Date : 1989-12-01 DOI: 10.1016/0738-1751(89)90006-3
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引用次数: 0
Penetration of antibiotics into the CSF and the treatment of meningitis: Personal commentary and review of selected agents— part 2 抗生素进入脑脊液和脑膜炎的治疗:个人评论和所选药物的回顾-第2部分
Antimicrobic Newsletter
Pub Date : 1989-11-01 DOI: 10.1016/0738-1751(89)90045-2
Charles E. Cherubin
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引用次数: 0
Editor's note 编者按
Antimicrobic Newsletter
Pub Date : 1989-11-01 DOI: 10.1016/0738-1751(89)90044-0
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引用次数: 0
Report on the NCCLS subcommittee on antimicrobial susceptibility testing ncls抗微生物药敏试验小组委员会报告
Antimicrobic Newsletter
Pub Date : 1989-11-01 DOI: 10.1016/0738-1751(89)90046-4
J. Allan Waitz
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引用次数: 1
The comparative susceptibility of Campylobacter pylori at varying pH 不同pH下幽门弯曲杆菌的比较敏感性
Antimicrobic Newsletter
Pub Date : 1989-11-01 DOI: 10.1016/0738-1751(89)90047-6
Daniel Amsterdam
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引用次数: 0
Penetration of antibiotics into the CSF and the treatment of meningitis: Personal commentary and review of selected agents— part 1 抗生素进入脑脊液和脑膜炎的治疗:个人评论和所选药物的回顾-第1部分
Antimicrobic Newsletter
Pub Date : 1989-10-01 DOI: 10.1016/0738-1751(89)90021-X
C. Cherubin
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引用次数: 0
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