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一线抗结核药物短缺对结核病控制的影响 - 美国,2012-2013 年。

Impact of a shortage of first-line antituberculosis medication on tuberculosis control - United States, 2012-2013.

出版信息

MMWR Morb Mortal Wkly Rep. 2013 May 24;62(20):398-400.

Abstract

Tuberculosis (TB) disease is treated in most cases with a regimen of several drugs taken for 6-9 months. Currently, 10 drugs are approved by the Food and Drug Administration (FDA) for treatment of TB. Of these, the four drugs that form the core for first-line treatment regimens are isoniazid (INH), rifampin, ethambutol, and pyrazinamide. In November 2012, the United States began to experience a severe interruption in the supply of INH. To assess the extent of the problem and its impact on TB control programs, a nationwide survey of programs was conducted in January 2013 by the National Tuberculosis Controllers Association (NTCA). The results indicated that the INH shortage was interfering with patient care and could contribute to TB transmission in the United States. This report summarizes the findings of that survey, which showed that 79% of the responding health departments reported difficulties with procuring INH within the last month, with 15% reporting that they no longer had INH and 41% reporting that they would no longer have a supply within 1 month of the survey. Because of local interruptions in INH supply, responding TB programs were changing INH suppliers (69%), prioritizing patients for treatment of latent TB infection (LTBI) (72%), delaying LTBI treatment (68%), and changing to alternative LTBI treatment regimens (88%). Potential solutions for alleviating the INH shortage and averting future shortages include maintaining a national supply of first-line drugs, sharing INH among jurisdictions, working with the World Health Organization's Global Drug Facility to obtain INH from foreign manufacturers, and strengthening reporting of shortages and impending shortages by drug suppliers to FDA.

摘要

结核病(TB)疾病在大多数情况下采用几种药物联合治疗方案,治疗期为 6-9 个月。目前,美国食品药品监督管理局(FDA)批准了 10 种药物用于治疗结核病。其中,异烟肼(INH)、利福平、乙胺丁醇和吡嗪酰胺这四种药物是一线治疗方案的核心药物。2012 年 11 月,美国开始经历严重的异烟肼供应中断。为了评估问题的严重程度及其对结核病控制项目的影响,国家结核病控制协会(NTCA)于 2013 年 1 月对项目进行了全国范围的调查。结果表明,异烟肼短缺正在干扰患者的治疗,可能导致美国结核病的传播。本报告总结了该调查的结果,结果显示,79%的参与卫生部门报告称,在过去一个月内,采购异烟肼存在困难,15%的部门报告称,他们已经没有异烟肼了,41%的部门报告称,在调查后的 1 个月内,他们将没有异烟肼供应。由于当地异烟肼供应中断,参与的结核病项目正在改变异烟肼供应商(69%)、优先考虑治疗潜伏性结核感染(LTBI)的患者(72%)、延迟 LTBI 治疗(68%)以及改变替代 LTBI 治疗方案(88%)。缓解异烟肼短缺和避免未来短缺的潜在解决方案包括维持国家一线药物供应、在司法管辖区之间共享异烟肼、与世界卫生组织全球药品供应机制合作从外国制造商处获得异烟肼,以及加强药品供应商向 FDA 报告短缺和即将短缺的情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a994/4604936/c3fc85ca0d8c/398-400f1.jpg

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