Fixed-dose combination drugs for tuberculosis - Application in standardised treatment regimens

Fixed-dose combination drugs for tuberculosis - Application in standardised treatment regimens
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DOI:
10.2165/00003495-200363060-00002
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发表时间:
2003-01-01
期刊:
影响因子:
11.5
通讯作者:
Fourie, B
Fourie, B
中科院分区:
医学1区
文献类型:
--
作者:
Blomberg, B;Fourie, B

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短期化疗对治疗结核病非常有效。然而,治疗的长度(大于或等于6个月)和复杂性(三种或四种不同的药物)使得坚持治疗变得困难。不稳定的治疗不仅不能治愈病人,而且还会产生慢性传染性病例,这些病例可能会分泌出耐药结核细菌。世卫组织建议的短程直接观察治疗(DOTS)战略为结核病控制中合理使用诊断、药物供应以及病例和规划管理服务提供了一个全面的组织和基础设施框架。世卫组织和其他组织建议使用固定剂量组合制剂,作为促进结核病最佳药物治疗的进一步措施。在结核病控制中使用fdc将简化医生的处方和患者的药物摄入,以及该规划的药物供应管理。通过防止单一疗法和促进摄入足够剂量的抗结核药物成分,预期fdc将有助于防止耐药性的出现。本文介绍了在结核病规划中使用fdc的国际建议。根本问题是获得高质量的药品供应。现有一个质量检测实验室网络,包括fdc的生物利用度检测,最近建立的全球结核病药物基金(GDF)向请求援助的国家提供高质量的结核病药物,包括4种fdc药物。本文讨论成功过渡到基于氟氯化碳的处理的要求。它强调需要适当修订方案文件(方案手册、培训单元、治疗准则和表格),培训各级工作人员,仔细计算药物需求,并制定计划,以用尽现有的松散片剂库存,并同时在方案的各级分阶段使用非处方药。对有不良反应的患者进行个体化治疗的松散药物应存放在区或中央卫生机构。
Short-course chemotherapy is highly efficacious in treating tuberculosis (TB). However, the length (greater than or equal to6 months) and complexity (three or four different drugs) of the treatment makes adherence difficult. Erratic treatment not only fails to cure patients but also creates chronically contagious cases, who may excrete drug-resistant TB bacteria. The Directly Observed Treatment Short-course (DOTS) strategy recommended by WHO-provides a comprehensive organisational and infrastructural framework for the rational use of diagnosis, drug supply, as well as case and programme management services, in TB control. WHO and other organisations recommend fixed-dose combination formulations (FDCs) as a further step to facilitate the optimal drug treatment of TB. Using FDCs in TB control will simplify the doctor's prescription and patient's drug intake, as well as the drug supply management of the programme. By preventing monotherapy and facilitating the ingestion of adequate doses of the constituent anti-TB drugs, FDCs are expected to help prevent the emergence of drug resistance.This article presents the international recommendations for the use of FDCs in TB programmes. The fundamental issue is to obtain drug supplies of good quality. A laboratory network for quality testing, including bioavailability testing of FDCs exists, and the recently established Global TB Drug Facility (GDF) supplies quality TB drugs, including 4-drug FDCs, to countries requesting assistance. This articles deals with the requirements for a successful transition to FDC-based treatment. It emphasises the need for appropriately revised programme documentation (programme manual, training modules, treatment guidelines and forms), training of staff at all levels, carefully calculated drug needs, and a plan for the exhaustion of existing stocks of loose tablets and the phasing-in of FDCs at all levels of the programme at the same time. Loose drugs for individualised treatment of patients with adverse effects should be kept at district or central health institutions.