Guglielmetti L, Hewison C, Avaliani Z, Hughes J, Kiria N, Lomtadze N, Ndjeka N, Setkina S, Shabangu A, Sikhondze W, Skrahina A, Veziris N, Furin J
Sanatorium, Centre Hospitalier de Bligny, Briis-sous-Forges, France; Médecins Sans Frontières, Paris, France; Sorbonne Université, Université Pierre et Marie Curie 06, Unité 1135, Team E13 (Bactériologie), CR7 Institut National de la Santé et de la Recherche Médicale, Centre d'Immunologie et des Maladies Infectieuses, Paris, France.
Médecins Sans Frontières, Paris, France.
Int J Tuberc Lung Dis. 2017 Feb 1;21(2):167-174. doi: 10.5588/ijtld.16.0493.
For the first time in almost 50 years, there are new drugs available for the treatment of tuberculosis (TB), including bedaquiline (BDQ) and delamanid (DLM). The rate of introduction, however, has not kept pace with patient needs. It is estimated that as many as 23% of multidrug-resistant TB (MDR-TB) patients have an indication for receiving BDQ. As this is the first time the MDR-TB community is introducing new medications, it is important to understand how implementation can be developed in a variety of settings.
A qualitative assessment of country TB programs in which more than 5% of MDR-TB patients were started on BDQ under program conditions.
National TB programs in Belarus, France, Georgia, South Africa, and Swaziland all started sizeable cohorts of patients on BDQ in 2015. Common factors observed in these programs included experience with compassionate use/expanded access, support from implementing partners, and adequate national or donor-supported budgets. Barriers to introduction included restriction of BDQ to the in-patient setting, lack of access to companion drugs, and the development of systems for pharmacovigilance.
The five countries in this paper are examples of the introduction of new therapeutic options for the treatment of TB.
近50年来首次有新药可用于治疗结核病（TB），包括贝达喹啉（BDQ）和地拉曼啶（DLM）。然而，新药引入的速度未能跟上患者需求。据估计，多达23%的耐多药结核病（MDR-TB）患者有使用BDQ的指征。由于这是耐多药结核病群体首次引入新药物，了解如何在各种环境中开展实施工作很重要。
对国家结核病规划进行定性评估，这些规划中有超过5%的耐多药结核病患者在规划条件下开始使用BDQ。
白俄罗斯、法国、格鲁吉亚、南非和斯威士兰的国家结核病规划在2015年都让相当数量的患者开始使用BDQ。在这些规划中观察到的共同因素包括同情用药/扩大使用的经验、实施伙伴的支持以及充足的国家或捐助方支持的预算。引入的障碍包括将BDQ限制在住院环境使用、无法获得辅助药物以及药物警戒系统的建立。
本文中的五个国家是引入结核病新治疗选择的范例。
