Damien Foundation, Niamey, Niger; International Union Against Tuberculosis and Lung Disease, Paris, France.
Damien Foundation, Niamey, Niger.
Respir Med. 2020 Jan;161:105844. doi: 10.1016/j.rmed.2019.105844. Epub 2019 Nov 23.
In Niger, the Shorter Treatment Regimen (STR) has been implemented nationwide for rifampicin resistant tuberculosis (RR-TB), since 2008. No previous publication has shown the results from countrywide programmatic implementation using few exclusion criteria, nor exhaustively assessed the effect of initial resistance to companion drugs on outcomes.
The National Tuberculosis Programme and the Damien Foundation conducted a retrospective observational study to evaluate the management of RR-TB from 2008 to 2016. Baseline resistance to drugs was assessed phenotypically, complemented by screening the inhA, katG and pncA genes. Cured patients were followed-up for a period of one year after cure.
Among 1044 patients tested for rifampicin resistance, mainly previously treated patients, 332 were diagnosed with pulmonary RR/TB, 288 were enrolled on treatment and 255 started on STR. Six patients received a modified STR. Among 249 patients on standardised STR, 207 (83·1%) were cured relapse-free, eight (3·2%) had failure, 23 (9·2%) died, seven (2·8%) were lost to follow-up and four (1·6%) relapsed. The risk of unfavourable outcome was higher in patients with initial resistance to fluoroquinolones (aOR 20·4, 95%CI:5·6-74·6) and very severely underweight (aOR 3·9, 95%CI:1·5-10·1). Successful outcome was not affected by initial resistance to companion drugs. Serious ototoxicity was reported in eight patients (3·2%).
A comprehensive nationwide approach to multidrug-resistant tuberculosis management using the STR was feasible and successful. Outcomes were not affected by initial resistance to companion drugs. Our study confirms the effectiveness and safety of the STR.
Damien Foundation and Institute of Tropical Medicine-Antwerp.
自 2008 年以来，尼日尔在全国范围内实施了较短治疗方案（STR），用于治疗利福平耐药结核病（RR-TB）。以前没有任何出版物显示过在全国范围内实施该方案，且排除标准较少，也没有详尽评估初始对伴随药物的耐药性对结局的影响。
国家结核病规划和达米安基金会开展了一项回顾性观察性研究，以评估 2008 年至 2016 年 RR-TB 的管理情况。通过表型评估，结合对 inhA、katG 和 pncA 基因的筛查，评估药物的基线耐药性。治愈的患者在治愈后随访一年。
在 1044 名接受利福平耐药性检测的患者中，主要为既往治疗过的患者，332 例诊断为肺 RR/TB，288 例纳入治疗，255 例开始接受 STR。6 例患者接受了改良 STR。在 249 例接受标准化 STR 的患者中，207 例（83.1%）无复发治愈，8 例（3.2%）治疗失败，23 例（9.2%）死亡，7 例（2.8%）失访，4 例（1.6%）复发。初始对氟喹诺酮类药物耐药的患者（比值比 20.4，95%置信区间：5.6-74.6）和非常严重体重不足的患者（比值比 3.9，95%置信区间：1.5-10.1）不良结局的风险更高。初始对伴随药物的耐药性不影响治疗结局。8 例（3.2%）患者出现严重耳毒性。
采用 STR 对耐多药结核病进行全面的全国性管理是可行且成功的。治疗结局不受初始对伴随药物耐药性的影响。我们的研究证实了 STR 的有效性和安全性。
达米安基金会和安特卫普热带医学研究所。
