Blomberg B, Spinaci S, Fourie B, Laing R
Centre for International Health, University of Bergen, Bergen, Norway.
Bull World Health Organ. 2001;79(1):61-8. Epub 2003 Nov 5.
There is considerable exigency to take all necessary steps to cure tuberculosis cases and prevent further emergence of drug-resistant tuberculosis. The most important of these steps is to ensure that the treatment, particularly of sputum smear-positive cases, is adequate and that patients adhere to their treatment by supervised, direct observation of drug-taking according to the standardized regimens. Use of fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO and the International Union Against Tuberculosis and Lung Disease (IUATLD) as an additional step to ensuring proper treatment. FDCs simplify the prescription of drugs and the management of drug supply, and may also limit the risk of drug-resistant tuberculosis arising as a result of inappropriate drug selection and monotherapy. Only FDCs of proven quality and proven rifampicin bioavailability should be purchased and used. In most situations, blood levels of the drugs are inadequate because of poor drug quality rather than poor absorption. This is true irrespective of the human immunodeficiency virus (HIV) infection status of the tuberculosis patients (other than those with overt acquired immunodeficiency syndrome, with CD4 counts < 200 cells/mm3). Currently, WHO, IUATLD and their partners are developing strategies for ensuring that only quality FDCs are used in tuberculosis programmes. A simplified and effective protocol for assessment of rifampicin bioavailability has been developed, and laboratories are being recruited to form a supranational network for quality assurance of FDCs. Standardization of FDC drug formulations has been proposed, which limits rifampicin-containing preparations to nine (including a four-drug FDC and three paediatric FDCs).
采取一切必要措施治愈结核病病例并防止耐药结核病的进一步出现已刻不容缓。这些措施中最重要的是确保治疗，尤其是痰涂片阳性病例的治疗足够充分，并通过按照标准化治疗方案对服药进行监督、直接观察，确保患者坚持治疗。世界卫生组织（WHO）和国际防痨和肺部疾病联盟（IUATLD）现建议使用抗结核固定剂量复合制剂（FDC）作为确保适当治疗的额外措施。FDC简化了药物处方和药品供应管理，还可能降低因药物选择不当和单一疗法导致耐药结核病产生的风险。应只购买和使用经证实质量可靠且利福平生物利用度达标的FDC。在大多数情况下，药物血药浓度不足是由于药品质量差而非吸收不良所致。无论结核病患者的人类免疫缺陷病毒（HIV）感染状况如何（除了那些明显患有获得性免疫缺陷综合征、CD4细胞计数<200个细胞/mm³的患者），情况都是如此。目前，WHO、IUATLD及其合作伙伴正在制定战略，以确保结核病防治项目中只使用质量合格的FDC。已制定了一项简化且有效的利福平生物利用度评估方案，并正在招募实验室，以组建一个FDC质量保证跨国网络。已提议对FDC药物制剂进行标准化，将含利福平的制剂限制为9种（包括一种四联FDC和三种儿童FDC）。
