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目的介绍美国食品药品管理局(FDA)新版《全身用抗菌药品和抗菌敏感性试验装置说明书的敏感试验资料指导原则》的要点,希望对我国抗菌药品说明书中该部分内容的撰写、使用和监管有所启迪。方法抗菌药品生产企业可参考该《指导原则》,及时更新药品说明书中的抗菌药敏感性资料内容,将抗菌药敏感性试验结果及时准确的告诉医生,以选择合适的抗菌药治疗感染性疾病,减少耐药性的发生。结果该《指导原则》能有效地指导生产抗菌药品的企业撰写及更新抗菌药敏感试验资料。结论抗菌药物敏感性试验结果是抗菌药品说明书中的重要内容,为指导医生患者合理用药,减少抗菌药耐药性的蔓延,该项内容应引起相关药品生产企业、医生及药品监管部门的高度关注。
Objective To introduce the essentials of the Guidelines for the Sensitive Test Data of the Newly Used Antibacterial Drugs and Antibacterial Sensitivity Test Apparatus of the U.S. Food and Drug Administration (FDA), and to write, use and supervise the content of the antimicrobial drug in our country Inspired. Methods Antibacterial drug manufacturers may refer to the “Guiding Principles” to promptly update the content of antimicrobial susceptibility data in the drug specification, timely and accurately tell the doctor about the antimicrobial susceptibility test results to select appropriate antimicrobial agents for the treatment of infectious diseases, Reduce the occurrence of drug resistance. Results The Guiding Principles effectively guide companies producing antimicrobials to write and update antimicrobial susceptibility testing data. Conclusion The result of antibacterial drug sensitivity test is an important part of the manual of antibacterial drugs. To guide rational use of drugs in patients and reduce the spread of antibacterial drug resistance, this content should be of great concern to the relevant pharmaceutical manufacturers, doctors and drug regulators .