Dave Paresh, Vadera Bhavin, Kumar Ajay M V, Chinnakali Palanivel, Modi Bhavesh, Solanki Rajesh, Patel Pranav, Patel Prakash, Pujara Kirit, Nimavat Pankaj, Shah Amar, Bharaswadkar Sandeep, Rade Kiran, Parmar Malik, Nair Sreenivas Achuthan
State Tuberculosis Cell, Commissionerate of Health, Medical Services and Medical Education, Ministry of Health & Family Welfare, Gandhinagar, Gujarat, India.
World Health Organization (WHO) Country Office for India, New Delhi, India; State Tuberculosis Training and Demonstration Centre, Near Tuberculosis and Chest Department, Civil Hospital Campus, Asarwa, Ahmedabad, India.
PLoS One. 2015 Apr 13;10(4):e0121996. doi: 10.1371/journal.pone.0121996. eCollection 2015.
Revised National TB Control Programme (RNTCP) in India recommends that all previously-treated TB (PT) patients are offered drug susceptibility testing (DST) at diagnosis, using rapid diagnostics and screened out for rifampicin resistance before being treated with standardized, eight-month, retreatment regimen. This is intended to improve the early diagnosis of rifampicin resistance and its appropriate management and improve the treatment outcomes among the rest of the patients. In this state-wide study from Gujarat, India, we assess proportion of PT patients underwent rapid DST at diagnosis and the impact of this intervention on their treatment outcomes.
This is a retrospective cohort study involving review of electronic patient-records maintained routinely under RNTCP. All PT patients registered for treatment in Gujarat during January-June 2013 were included. Information on DST and treatment outcomes were extracted from 'presumptive DR-TB patient register' and TB treatment register respectively. We performed a multivariate analysis to assess if getting tested is independently associated with unfavourable outcomes (death, loss-to-follow-up, failure, transfer out).
Of 5,829 PT patients, 5306(91%) were tested for drug susceptibility with rapid diagnostics. Overall, 71% (4,113) TB patients were successfully treated - 72% among tested versus 60% among non-tested. Patients who did not get tested at diagnosis had a 34% higher risk of unsuccessful outcomes as compared to those who got tested (aRR - 1.34; 95% CI 1.20-1.50) after adjusting for age, sex, HIV status and type of TB. Unfavourable outcomes (particularly failure and switched to category IV) were higher among INH-resistant patients (39%) as compared to INH-sensitive (29%).
Offering DST at diagnosis improved the treatment outcomes among PT patients. However, even among tested, treatment outcomes remained suboptimal and were related to INH resistance and high loss-to-follow-up. These need to be addressed urgently for further progress.
印度修订后的国家结核病控制规划（RNTCP）建议，所有既往接受过治疗的结核病（PT）患者在诊断时均应使用快速诊断方法进行药敏试验（DST），并在接受标准化的8个月复治方案治疗前筛查利福平耐药情况。这旨在改善利福平耐药的早期诊断及其适当管理，并改善其余患者的治疗效果。在这项来自印度古吉拉特邦的全州范围研究中，我们评估了PT患者在诊断时接受快速DST的比例以及该干预措施对其治疗效果的影响。
这是一项回顾性队列研究，涉及对RNTCP常规维护的电子患者记录进行审查。纳入2013年1月至6月期间在古吉拉特邦登记接受治疗的所有PT患者。分别从“疑似耐多药结核病患者登记册”和结核病治疗登记册中提取药敏试验和治疗效果的信息。我们进行了多变量分析，以评估接受检测是否与不良结局（死亡、失访、治疗失败、转出）独立相关。
在5829例PT患者中，5306例（91%）接受了快速诊断方法的药敏试验。总体而言，71%（4113例）的结核病患者得到成功治疗，接受检测的患者中这一比例为72%，未接受检测的患者中为60%。在调整年龄、性别、艾滋病毒感染状况和结核病类型后，诊断时未接受检测的患者治疗失败的风险比接受检测的患者高34%（调整后风险比-1.34；95%置信区间1.20-1.50）。耐异烟肼患者的不良结局（尤其是治疗失败和转为IV类）发生率（39%）高于异烟肼敏感患者（29%）。
诊断时提供药敏试验改善了PT患者的治疗效果。然而，即使在接受检测的患者中，治疗效果仍不理想，且与异烟肼耐药和高失访率有关。为取得进一步进展，这些问题需要紧急解决。
