Lathers Claire M
Center of Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855, USA.
J Clin Pharmacol. 2002 Jun;42(6):587-600. doi: 10.1177/00970002042006001.
Veterinary public health is a frontier in the fight against human disease, charged to control and eradicate zoonotic diseases that are naturally transmitted between vertebrate animals and man. Currently there is a need for clinical pharmacologists and all health care givers to limit the development of bacterial resistance in humans to contain the increased health care expenditures related to morbidity and mortality associated with the use of antimicrobials. The development of resistance predates the use of antibiotics and will always be a problem to the successful treatment of patients. Ongoing discussion debates the extent to which antibiotic use in animals contributes to the development of antibiotic resistance in humans. The veterinary use ofantibiotics as antimicrobial growth promoters is thought to influence the prevalence of resistance in animal bacteria and to be a risk factor for the emergence of antibiotic resistance in human pathogens. Transfer of antibiotic resistant bacteria from animals to humans may occur via contact, including occupational exposure and via the food chain. Resistance genes may transferfrom bacteria of animals to human pathogens in the intestinal flora of humans. Prevention of the development of resistance in humans necessitates good animal husbandry and hygienic measures to prevent cross contamination and a decrease in the use of antibiotics. Appropriate use of antibiotics for food animals will preserve the long-term efficacy of existing antibiotics, support animal health and welfare, and limit the risk of transfer of antibiotic resistance to humans. Investigators must also develop new antimicrobial agents. Poole (J Pharmacy Pharmacol 2001;53:283) recommends targeting the three predominate mechanisms of development of resistance by antimicrobials (i.e., antibiotic inactivation, target site modification, and altered uptake via restricted entry and/or enhanced efflux) to specifically complement the development of novel agents with novel bacterial targets. Bacterial resistance and its selection may be evaluated by comparing the relationship to antibiotic pharmacokinetic (PK) values obtained from serum concentrations and organism MICs (minimum inhibitory concentrations; concentration-dependent killing) to reveal culture and sensitivity tests in patients. Pharmacodynamic (PD) models may be developed to identify factors associated with the probability that bacterial resistance will develop. Thomas et al (Antimicrobial Agents Chemotherapy 1998;42:521) used this combined approach of PK/PD and MICs to examine data retrospectively. The role of clinical pharmacology is to work with PK/PD models such as these to determine the best use of antibiotics in humans to minimize the development of resistance. The role of any regulatory body responsible for the protection of the public health and food safety for consumers is to assess risk and to then communicate and manage the risk. Scientific uncertainty must be interpreted to propose sound policy options. The conversion of sound science into an appropriate regulatory policy to protect the public health is most important.
兽医公共卫生是抗击人类疾病的前沿领域,其职责是控制和根除在脊椎动物与人类之间自然传播的人畜共患病。目前,临床药理学家和所有医护人员都需要限制人类细菌耐药性的发展,以控制与使用抗菌药物相关的发病率和死亡率所导致的医疗保健费用增加。耐药性的发展早于抗生素的使用,并且始终是成功治疗患者的一个问题。正在进行的讨论辩论了动物使用抗生素在多大程度上导致了人类抗生素耐药性的发展。抗生素作为抗菌生长促进剂在兽医领域的使用被认为会影响动物细菌耐药性的流行,并且是人类病原体中出现抗生素耐药性的一个风险因素。抗生素耐药细菌从动物传播到人类可能通过接触发生,包括职业暴露以及通过食物链传播。耐药基因可能从动物细菌转移到人类肠道菌群中的人类病原体。预防人类耐药性的发展需要良好的畜牧管理和卫生措施以防止交叉污染,并减少抗生素的使用。对食用动物合理使用抗生素将保持现有抗生素的长期疗效,支持动物健康和福利,并限制抗生素耐药性转移到人类的风险。研究人员还必须开发新的抗菌药物。普尔(《药学与药理学杂志》2001年;53卷:283页)建议针对抗菌药物耐药性发展的三种主要机制(即抗生素失活、靶位修饰以及通过限制进入和/或增强外排改变摄取)来专门开发具有新型细菌靶点的新型药物。可以通过比较血清浓度和微生物最低抑菌浓度(MIC;浓度依赖性杀菌)获得的抗生素药代动力学(PK)值之间的关系来评估细菌耐药性及其选择,以揭示患者的培养和药敏试验结果。可以开发药效学(PD)模型来确定与细菌耐药性发展可能性相关的因素。托马斯等人(《抗菌药物化疗》1998年;42卷:521页)使用这种PK/PD和MIC的联合方法进行回顾性数据分析。临床药理学的作用是与诸如此类的PK/PD模型合作,以确定人类使用抗生素的最佳方式,从而最大限度地减少耐药性的发展。任何负责保护消费者公共卫生和食品安全的监管机构的作用是评估风险,然后沟通和管理风险。必须解读科学上存在的不确定性,以提出合理的政策选择。将可靠的科学转化为适当的监管政策以保护公众健康是最为重要的。