Central Tuberculosis Division, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi, India. akumar@the union.org
Int J Tuberc Lung Dis. 2012 May;16(5):573-8. doi: 10.5588/ijtld.11.0482.
The Revised National Tuberculosis Control Programme (RNTCP) in India uses a fully intermittent thrice-weekly rifampicin-containing regimen for all tuberculosis (TB) patients, including those who are human immunodeficiency virus (HIV) infected, whereas the World Health Organization (WHO) recommends daily anti-tuberculosis treatment at least during the intensive phase. The WHO recommendation was based on the results of a meta-analysis demonstrating increased risk of recurrence and failure among HIV-infected TB patients receiving intermittent TB treatment compared to a daily regimen. Review of the primary evidence indicates limited, low-quality information on intermittency, mostly from observational studies in the pre-antiretroviral treatment (ART) era. Molecular epidemiology in India indicates that most of the recurrences and many of the failures result from exogenous re-infection, suggesting poor infection control and high transmission rather than poor regimen efficacy. Subsequently published studies have shown acceptable treatment outcomes among HIV-infected TB patients receiving intermittent anti-tuberculosis regimens with concomitant ART. Treatment outcomes among HIV-infected TB patients treated under programmatic conditions show low failure rates but high case fatality; death has been associated with lack of ART. The highest priority is therefore to reduce mortality by linking all HIV-infected TB patients to ART. While urgently seeking to reduce death rates among HIV-infected TB patients, given the poor evidence for change and operational advantages of an intermittent regimen, the RNTCP intends to collect the necessary evidence to inform national policy decisions through randomised clinical trials.
印度修订后的国家结核病控制规划 (RNTCP) 为所有结核病 (TB) 患者,包括人类免疫缺陷病毒 (HIV) 感染者,提供完全间歇性每周三次利福平含药方案,而世界卫生组织 (WHO) 建议至少在强化期内每日进行抗结核治疗。WHO 的建议是基于荟萃分析的结果,该分析表明与每日方案相比,接受间歇性 TB 治疗的 HIV 感染 TB 患者的复发和失败风险增加。对主要证据的审查表明,间歇性治疗的信息有限且质量低,主要来自抗逆转录病毒治疗 (ART) 前的观察性研究。印度的分子流行病学表明,大多数复发和许多失败是由于外源性再感染引起的,这表明感染控制不佳和高传播率,而不是方案疗效不佳。随后发表的研究表明,接受间歇性抗结核方案联合 ART 治疗的 HIV 感染 TB 患者的治疗结果可接受。在规划条件下治疗的 HIV 感染 TB 患者的治疗结果显示,失败率低但病死率高;死亡与缺乏 ART 有关。因此,当务之急是通过将所有 HIV 感染的结核病患者与 ART 联系起来,降低死亡率。在紧急寻求降低 HIV 感染的结核病患者死亡率的同时,鉴于改变的证据不足和间歇性方案的操作优势,RNTCP 打算通过随机临床试验收集必要的证据,为国家政策决策提供信息。